research papers on ethics committee

Relevance and Challenges of Ethics Committees

Open Access
First Online: 12 May 2023

Cite this chapter

You have full access to this open access chapter

Kristi Lõuk 10

Part of the book series: Lecture Notes in Computer Science ((LNCS,volume 13875))

3440 Accesses

2 Citations

6 Altmetric

This article explores the role of ethics committees in ensuring ethical research and innovation, which is essential for maintaining trust in science and innovation. The paper argues that the ethics infrastructure must function at the levels of research and innovation institutions, as well as regional and national levels, and should follow agreed-upon rules and requirements. The changing role of ethics committees is discussed, emphasizing their involvement in investigating potential research misconduct and coordinating the activities of all ethics committees within an institution. The article concludes that for a research and innovation institution, it is of crucial importance to consider the entire ethics infrastructure, including the functions of different ethics committees and ways of implementation through transparency, involvement, policies, procedures, and communication to safeguard that both researchers and the public have trust in ethics infrastructure and ethics committees.

You have full access to this open access chapter, Download chapter PDF

Research Ethics Codes and Guidelines

Ethics and Integrity in Research: Disciplines and Professions

ethics committees
research ethics
research integrity
responsible research and innovation
trust in science

1 Introduction

Science is a social arrangement in which different stakeholders (e.g. research-performing organizations, research funding organizations, publishers, and ethics committees) should fulfill their distinctive roles.

Since science is a collective enterprise, it is necessary to build mutual trust. Trust should be built between researchers and innovators, and with society. Researchers and innovators must be able to trust the results of previously conducted research. Society must be able to trust researchers and innovators by giving them the means to carry out research and contribute to it, e.g. participating as research subjects or participating in co-creation. Researchers and innovators can be trusted if they are trustworthy, meaning that they behave honestly, are objective, respect the autonomy and privacy of research subjects, treat animals and the environment with care, and are responsible. To ensure trust in science, it is necessary not only that researchers and innovators fulfill their responsibilities, but also that they have the willingness to do so. Researchers and innovators and research and innovation organizations (both research performing and funding organizations) bear the responsibility for fostering trust in science and ethical research.

Research and innovation organizations should create and sustain environments that encourage ethical research and innovation through education and clear policies e.g. the Singapore Statement [ 1 ]. In The Bonn PRINTEGER Statement [ 2 ] the role of the leaders of institutions is specified and institutional responsibilities are described, e.g. increasing transparency in misconduct cases, having effective and safe whistle-blowing channels, establishing a research integrity committee, and appointing an ombudsperson. Moreover, in its report the European Science Foundation has stressed the need to set structures at the national level as well. They have outlined that successful approaches to promoting good research practices include establishing an adequate institutional framework, which includes research ethics committees and research integrity offices, both at the institutional and national levels [ 3 ]. Additionally, it should be pointed out that the governance system of ethical research and innovation should fit each country, taking into account its size, research infrastructure, and available resources [ 3 ]. Furthermore, if unintended consequences emerge, the system should be revised or policies should be changed accordingly [ 4 ]. Also, it should be analyzed whether the members of the research and innovation institutions are motivated to act according to operating principles.

According to Sarah R. Davies, issues related to research integrity can also be regarded more broadly, as a form of soft governance implemented through codes, norms and ELSI (ethical, legal, and social implications) activities [ 5 ]. Therefore, ethics committees should be seen and should function as a part of the governance system of ethical research and innovation. Such a system includes stakeholders (e.g. researchers, administration, case investigators), and procedures and requires an ethics-promoting climate [ 6 ]; it also consists of oversight, instruction, and policies [ 7 ].

One example of an ethical system of governance for research and innovation in organizations has been developed within the Horizon 2020 project ETHNA. Having a clear implementation and governance system that fits the research-performing or funding organizations including responsible research and innovation (RRI) office(r), ethics codes, policies, and tools shows commitment to ethical research and to carrying out research and innovation activities in a responsible way.

2 Ethical Research: From Fragments to the Whole Research Process

It is expected that research and innovation are done ethically and with high quality. Ethical norms should be followed through all stages of research, from planning and applying for research grants to the publication of research results.

While research ethics has been focusing on the protection of research subjects, research integrity has emerged as a response to misconduct cases, mainly about fabrication, falsification, and plagiarism (FFP). Research misconduct is understood more broadly than FFP, especially in Europe. For example, Foeger and Zimmermann state that “[research misconduct] also covers, for example, destruction of primary data, unjustified authorship, and the sabotage of research activities or dishonest attempts to lower the scientific reputation of another researcher” [ 8 ]. A more specific list of possible acts of misconduct is presented by Faintuch and Faintuch [ 9 ] comprising the following issues: lack of protection of data, violation of confidentiality, clandestine data access; animal abuse; inadequate human consent regarding aims and benefits, risks and harms, coercion or exploitation of subjects; ghost authorship Footnote 1 , questionable personal credits, failure of registration and ethical approval, breach of good (clinical) practices, lack of transparency regarding the relationship with funders, undisclosed commercial or personal interests, noncompliance with publisher ethics, nonprofessional language, salami slicing Footnote 2 , lack of sharing data with co-investigators, study participants, other authorized parties, harassment, bullying, disrespectful behaviour, dishonest mentoring of students, fellows, junior staff, misuse of research funds, false or exaggerated academic titles, qualifications, professional experience, retaliation against whistle-blowers, deceit, scamps, pseudoscience, malicious misconduct allegations. Often, these practices emerge due to the reward criteria in research that value quantity over quality. This issue needs to be dealt with at the level of science as a system. The aforementioned list includes not only acts from the realm of research integrity but also covers the domain of research ethics. It has increasingly been argued (e.g. Ron Iphofen [ 13 ]) that the two of them be viewed together, as both are required for ethical research and innovation. Another definition of research ethics and research integrity is provided by Ana Marušić in this book in her chapter “Evidence-based Research Integrity.” Braun, Ravn, and Frankus [ 14 ] showed that while research ethics committees do their task before researchers begin the actual research, research integrity offices handle possible misconduct cases after the research has been done and a concrete action or behavior has taken place. Whereas the first of them focuses on planning and design, and the other on conduct and implementation, both are needed to safeguard ethical research. At the practical level, the platform “The Embassy of Good Science” is the outcome of the European Commission’s initiated and funded research projects EnTIRE and VIRT2UE within the H2020 program, focusing both on issues of research integrity and research ethics.

3 What Do We Mean When We Talk About Ethics Committees?

When encountering the term ‘ethics committee’, one must pay attention to its meaning, as any committee or commission that deals with ethical issues can be called an ethics committee. Thus, there are committees that deal with ethical issues in different contexts, with different tasks, and at different levels.

Historically, research ethics committees have the longest tradition in ethical research. Their main task has been to ensure the rights and well-being of human research subjects and/or animals participating in research. As such, they constitute an additional safeguard mechanism, both for subjects and researchers. Based on the written documents submitted to the committee, the task of such committees is to weigh the risks and benefits of the study. Only studies with a proportional relationship between scientific validity, social value, fair participant protection, favorable risk-benefit ratio, independent review, informed consent, respect for participants, and collaborative partnership [ 15 ] should be conducted. The role of ethics committees originated in medical research. For example, in the Helsinki Declaration of the World Medical Association [ 16 ], it has been a requirement since 1975 to obtain the ethics committee’s approval before starting a study. Later, this requirement of prior approval was extended from biomedicine to other fields of research. Social scientists have seen this development as problematic, as the requirement coming from biomedicine may not be suitable for social sciences and humanities [ 17 , 18 ]. The need to obtain the approval of the ethics committee before starting the research may derive from national legislation, but it may also be required, for example, by research funding agencies or journals where the results of the research are to be published.

At the practical level, the Council of Europe’s Steering Committee on Bioethics has worked out a “Guide for Research Ethics Committee Members” [ 19 ]. The guide addresses issues related to the appointment of research ethics committee members, emphasizing that the process should be transparent and fair. The requirements for the composition of the committees can be determined either at the level of national law or through guidance documents (e.g. the ETHNA framework) giving recommendations on the number of members of the committee, their qualifications, involvement of lay persons (those whose expertise is not in a specific type of research and who are there to represent the perspective of participants). Having clear policies and making them known is very important for addressing possible conflicts of interest.

However, several critical notes have been addressed to ethics committees. It has been claimed that the requirement of an ethics review is often only formal [ 20 ]. From the initial idea to help researchers to balance risks and harms and consider possible benefits of the research and innovation project or proposal [ 20 ], the process has boiled down to checking relevant boxes from the checklist or ethics issues table. As such, the “tick the right box” approach does not serve the original purpose of analysing the ethical aspects of one’s research and innovation project.

Based on the situation in the United States, it has been claimed that institutional review boards are understaffed, overburdened; that they do not devote enough time, lack sufficient experience, and do not have institutional support [ 21 , 22 ]. Additionally, there have been discussions on how to define and measure the quality of an institutional review board [ 23 , 24 ]; how to deal with inconsistencies in research ethics committee review [ 25 ]; how to address the disciplinary distinctions in the ethics review process, [ 26 ] and the reasons why retrospective review should be added to a prospective one [ 27 ].

Although this is quite a tough slate of criticism to be dealt with, these issues can be addressed at the institutional or national level by providing resources, education, and training opportunities. The ETHNA project has given its input by creating a set of guidance tools and a toolbox to help institutions [ 28 ]. Additionally, the recommendation has been made that institutional review boards be accredited [ 29 ]. Increasing institutional support can mean various things, from hiring more support staff for the ethics committee to providing more training opportunities for members of the institutional review board [ 21 ], or requiring ethics committee members to obtain obligatory ethics training.

At the same time, ethics committees can not only review research but also deal with the investigation of possible cases of misconduct. In addition to the ‘ethics committee’, the body may also bear the name of the ‘ethics commission’, ‘integrity committee’, ‘research integrity board’, or ‘misconduct commission’, etc. Also, investigations are mentioned in the Bonn PRINTEGER Statement [ 2 ], where it is stated that the integrity committee can function either at the institutional or national level. However, the document does not specify whether appeals can be carried out at the national or institutional levels. Whereas the PRINTEGER Statement focuses on the level of research-performing organisations, the ENRIO handbook “Recommendations for the Investigations of Research Misconduct” [ 30 ] provides guidance both at the local and national level, e.g. regarding which decisions should be handled at what level and discusses the advantages of local or national bodies. The mutual learning exercise (MLE) in the research integrity final report gives a recommendation “to create a national research integrity body that could help coordinate, monitor, educate, communicate and promote research integrity in a country” [ 3 ]. In addition to establishing a national body, having national-level research integrity officers is important [ 3 ]. With regard to oversight, the MLE report suggests having an appeal system for research integrity investigations. This would be especially important in countries where there are no research ethics and integrity bodies at a national level [ 3 ].

Since the field of responsible research and innovation covers more than research integrity, the ethics infrastructure at all levels should be adapted accordingly. This should go hand in hand with processes determining that necessary regulations and guidance documents on all types of ethics committees are in place. Firstly, the lack of regulations on ethics committees might be a cause for various misconduct cases. Secondly, the ethics infrastructure should cover all aspects of ethics committees, from ethics review to integrity investigations. Thirdly, both should be in place, a regulatory framework as well as good practice guidance documents. We now turn to ethics (governance) bodies at the institutional level of a research and innovation institution.

4 What Should the Ethics Committee(s) Do?

One of the biggest challenges for a research and innovation institution is to work out an ethical governance system that suits the institution and serves it well. For ethics committees within the ETHNA System [ 28 ] the following activities are recommended for consideration.

First, the question should be considered what is the purpose of the ethics committee on research and innovation and how does the committee relate to the RRI Office(r) whose task it is to disseminate the concepts of the ETHNA system, establish performance indicators and monitor the progress of the system in the organization? Different options are available, as the committee can function as a governance committee by keeping an eye on the practical implementation of responsible research and innovation, but it can also create the space for discussions over procedures, commitments, and values.

Second, the question arises of the scope of the ethics committee. Who are the internal and external stakeholders to be involved in deliberations on ethical governance? Does the committee cover one or all of the key aspects of responsible research and innovation: research integrity, gender perspective, open access, and public engagement, or only one of them?

Third, the main principles of action of the ethics committee should be agreed upon. Having such principles, making them known, and acting on them are of crucial importance for building and maintaining trust, both within the institution and with external stakeholders. Within the ETHNA system, the focus is on the following principles: confidentiality, impartiality, fairness, anonymity, the accuracy of information, and fair, respectful, and mediated agreements [ 28 ]. One question that arises is whether it is possible to act based on the principle of anonymity when personal contact and additional queries for information might be needed for mediating and agreement.

Fourth, choosing a suitable model of the ethics committee for the research performing or research funding organization is crucial. In a way, this is the cornerstone aspect of the whole system. The ethics committee, its size, needs and resources should fit the institution and should help implementing the ethical governance of RRI in the organization. Does the institution need a standing or an ad hoc committee? Both have their advantages and disadvantages. Having a permanent committee enables continuous operation, so for large research and innovation institutions this would be recommended. However, if the number of situations to be dealt with is low and resources are limited, it would be advisable to have an ad hoc committee instead.

Fifth, what are the functions of the ethics committee members, and what kind of profiles are needed? The way members of ethics committees are selected or nominated and the period of appointment should be known within the institution and by external stakeholders. Other aspects to consider are: how does renewal take place? For how many terms can a person be a member of the ethics committee? How does replacement or dismissal take place? What are the tasks of the secretary? Is the secretary a member of the committee or a member of the committee’s support staff? What IT solutions are there or needed to support the work of the committee?

The solution provided by the ETHNA System is to nominate a committee for 4 years, but there are also other possible solutions, e.g. for a period of three years or five years. The next step is to map what profiles of people are needed in the ethics committee. What are the research and innovation and teaching activities the institution is carrying out? For example, doing research with human subjects, animal research, or research on biobanks or genetically modified organisms requires special expertise and potentially also a separate committee for reviewing these research projects. As such, it can be that in an institution there are separate ethics review boards for health research and biobank research, social sciences and humanities, animal research, and genetically modified organisms. One joint characteristic is that all of these committees should have a representative from the Ethics Committee of the institution and an ethics expert, and a law expert. Depending on how you are building up or changing the system, it can also be that the ethics and/or governance committee consists of representatives of the other ethics committees of the institution (mostly chairpersons). For example, the University of Liverpool in the United Kingdom has a research integrity and governance committee [ 31 ] that among other tasks has to oversee the work of other committees.

The sixth activity should be about describing the objectives assigned to the ethics committee. Those can include raising awareness, providing advice, helping with conflict resolution, and updating good practice guidelines, among others.

Seventh, what are the principles of the action of the ethics committee? This means that the frequency and interval between committee meetings should be thought through. For standing committees, it can be once a month, and for ad hoc committees whenever necessary. Compared to review and investigation committees, governance committees with the task of oversight and monitoring, and updating policies, should meet a couple of times a year. The schedule should be agreed upon and the information should be made publicly available (on the website of the institution or the webpage of the committee). How is the quorum for decisions decided? In most cases, this means that half of the members should be present. At the practical level, there can be differences, depending on whether or not the secretary is a member of the committee. Do external experts participate in decision-making? Is voting allowed or should deliberations take place until a consensus is reached? How often will the committee issue various reports? How will the body in the institution approve the establishment of the ethics committee on research and innovation?

Eighth, what are the monitoring indicators for the ethics committee? There should be progress indicators and performance indicators and these should be included and made known in the action plan of the ETHNA system.

5 Implementation of the Ethics Infrastructure

For a research and innovation institution, it is important to take into account whether the creation of committees and ethics infrastructure starts from scratch or if the already existing elements are changed and/or developed. If the existing system is changed and developed further, it is necessary to consider, negotiate and communicate tasks and responsibilities. How do ethics committees relate to ombudspersons and/or good science counselors? Would something be taken away from one committee and given to another? Will any new additional committees be created? Will some of the committees have their duties stripped? It is also necessary to consider how all parties affected by these changes are interconnected and how to involve them in the process, providing them with information about possible changes and asking for feedback.

Implementation of the ethics infrastructure also depends on the size of the research and innovation organization or research funding institution as well as on the size and institutional structures of the country where the institution operates. One way to create or change the system is to think about all the different stages of research and innovation and what is needed there. For example, a committee or committees are needed to review the research proposals in the planning stage, then to handle possible misconduct cases. Alternatively, there may also be a need for a committee governing the whole system and providing counseling at all stages of research and innovation. Additionally, does the governance committee also act as an appeal committee, or are there other committees at the regional and/or national level to manage the appeals?

It also needs to be considered whether it is necessary to do everything by yourself in your institution or whether there is a possibility to cooperate, especially in a small country and in a small research and innovation institution. Additionally, there might be regulatory aspects to be taken into account, such as the ones specifying that some types of research and innovation activities should be reviewed by a specific body not at the same institution, and should rather be done by a regional or national committee(for example this might be the case for clinical trials in some countries). For a small institution in a small country, it can very well be that all the tasks related to governance, review, and investigations take place in one single ethics committee.

To sum up, it is of crucial importance to think through the following questions. Why does the research and innovation institution need an ethics committee? What should the committee do? Do you change the current system or start anew? How do you involve all stakeholders in the process? Do you have the necessary resources (people, infrastructure, etc.) to implement the ethics infrastructure?

When creating a system of ethical governance, it is especially important to avoid making all researchers and innovators feel like their primary task is to constantly prove that all is done by regulations and guidelines of good practice.

Rather than only expecting compliance with codes and regulations, policies should be supportive and aim toward good outcomes. For example, Zwart and Meulen [ 32 ] are of the opinion that only using bottom-up processes can foster ethics and integrity in research, and that integrity work must take place in everyday research settings. This should be done by research institutions by facilitating open dialogue and fostering a culture of deliberation, e.g. by creating a safe space for discussing issues from everyday practice. Nevertheless, Zwart and Meulen are of the opinion that the focus should be at the institutional level, not on the level of an individual researcher; not on exposure and punishment, but rather on having a supportive ecosystem. Therefore, a supportive culture is needed, and creating it is the responsibility of the leaders. Furthermore, there should be a variety of training available, for various stakeholders. In this process, not only ethics committees for review and investigation of possible misconduct are needed, but in addition, there should also be persons in the research and innovation institution to whom people can turn to get advice (before handing in an application to get research ethics approval or an application that a misconduct investigation should be started). This can be a good science counselor, ombudsperson, ethics officer, research integrity office or officer. Such persons should also act as mediators giving advice, as well as listening to feedback and the reactions of the users of the ethics infrastructure to further enhance the system.

To implement ethical infrastructure and to help leaders of institutions, another project funded by the European Commission, SOPs4RI, has also worked out templates and guidelines for writing research integrity promotion plans, both for research-performing organizations and research funding organizations [ 33 , 34 , 35 ]. The name “promotion plan” might be misleading, since the actual focus is broader, covering preparation (diagnosis, assessing readiness, finding the right people, creating the plan), execution, and monitoring. This is similar to the ETNHA action plan as the plan has to be concrete and contain concrete actions, listing specific responsibilities and deadlines.

At the practical level, it should be thought through how the dissemination of the role and functions of the ethics committees in a research and innovation institution should take place. Furthermore, will there be educational activities provided about the ethical infrastructure in general for members of different ethics committees (new and current) and for researchers and innovators? Whose task will it be to provide them? The plan should have a concrete bearer of responsibility, be it the ethics officer, the research integrity officer, the ethics committee chair, or someone else.

If the earlier questions remain unspecific, let us consider two concrete examples. First, since the framework program Horizon Europe, the European Commission changed the table on ethical issues by adding the category artificial intelligence [ 36 ]. Who in the research and innovation institution should be aware of this requirement and who has to organize educational activities and the communication plan for those to whom it is relevant? Furthermore, does this require that the duties of the ethics review committee members have to be updated and the members educated, so researchers and innovators can submit research protocols encompassing AI to the ethics review committee of the research and innovation institution? Does the institution need to update its policies? For more specific debate about issues related to AI, see the chapter “Ethics and Development of Advanced Technology Systems in Public Administration” by António da Costa Alexandre and Luís Moniz Pereira in this book.

The other case is about chatbot ChatGPT, the AI tool that can create sentences and, in some cases, has been listed as an author of a research paper [ 37 ]. Who has to provide information about the possible threats of this development? Should the guidelines and policies about investigating possible misconduct be changed? What can the governance committee do regarding this challenge? Do the institution and ethics committee members have the knowledge to assess whether a text (e.g. research project submitted for ethics review) has been written by a researcher or a chatbot? Would it be possible to provide training about this matter for members of the institution (including members of the ethics committee)?

In these cases, it is not possible to provide a solution that would be suitable to all research and innovation institutions, but each institution should have a bearer of responsibility that fits its ethics infrastructure. Additionally, for successful implementation, a transition period is recommended to carry out communication activities and to enable the institution members to take part in the educational activities.

To sum up and return to the action and implementation plans, a question that needs further elaboration -- and not just being marked in proposed plans -- is whether the writers of the plan are in a position to write down the specific bearers of responsibility for each task and area or whether the bearers of responsibilities have to be specified by leaders of the institution at a later point. Additionally, it should be realized that there might be some issues that can only be dealt with to some extent at the institutional level as they may also require being addressed at the national level (e. g. national policy). Limitation of consideration to only one level may hinder the impact of creating and maintaining a culture of ethics and integrity.

6 Conclusion

Ethics infrastructure and governance are needed to safeguard trust in science. Ethics committees have an important role in the ethics infrastructure ensuring ethical research and innovation. The infrastructure must function at the institutional level and there should be cooperation with the national level. The tasks of the ethics committee(s) within the research and innovation institution can vary, from issuing approvals to investigating (possible) misconduct to governance of the system. An example of an ethical system of governance for research and innovation in organizations developed was introduced based on the results of the H2020 ETNHA project, with a special focus on activities related to ethics committees. Additionally, for successful implementation of the system of ethical governance in a research and innovation institution, an action plan should be followed. Through involvement, and communication of policies and procedures, the plan should safeguard that both researchers and the public have trust in ethics infrastructure and ethics committees.

Ghost authorship means that someone who has contributed substantially to the manuscript is not named as an author or given acknowledgment. It is problematic as it compromises academic integrity and may mask conflicts of interest [ 10 ]. Ghost authorship has also been addressed concerning ethics committees. David Shaw has claimed that when ethics committees improve the quality of a research proposal by suggesting major revisions, they should be acknowledged for their contribution. Ethics committees are ghost authors if they are not credited as authors or their contribution is not mentioned in the acknowledgment section [ 11 ].

The term, ‘salami slicing’ (also salami publication or salami publishing) refers to activities where the smallest publishable unit of data is included in the publication [ 12 ].

Singapore Statement (2010). https://wcrif.org/guidance/singapore-statement

Forsberg, E.-M., et al.: Working with research integrity—guidance for research performing organisations: the Bonn PRINTEGER statement. Sci. Eng. Ethics 24 (4), 1023–1034 (2018). https://doi.org/10.1007/s11948-018-0034-4

Article Google Scholar

Drenth, P., et. al.: Fostering research integrity in Europe: a report by the ESF Member Organization Forum on Research Integrity (2010). https://www.esf.org/fileadmin/user_upload/esf/ResearchIntegrity_Report2011.pdf

Hermeren, G., et al.: Mutual Learning Exercise (MLE) on Research Integrity. Processes and Structures (2019). https://ec.europa.eu/research-and-innovation/sites/default/files/rio/report/MLE%2520RI_Final%2520Report_0.pdf

Davies, S.R.: An ethics of the system: talking to scientists about research integrity. Sci. Eng. Ethics 25 (4), 1235–1253 (2018). https://doi.org/10.1007/s11948-018-0064-y

Six, F., Lawton, A.: Towards a theory of integrity systems: a configurational approach. Int. Rev. Adm. Sci. 79 , 639–658 (2013). https://doi.org/10.1177/0020852313501124

Anderson, M.S.: Global research integrity about the United States: research integrity infrastructure. Account. Res. 21 , 1–8 (2014). https://doi.org/10.1080/08989621.2013.822262

Foeger, N., Zimmerman, S.: Research integrity: perspectives from Austria and Canada. In: Bretag, T. (ed.) Handbook of Academic Integrity, pp. 809–821. Springer, Singapore (2016). https://doi.org/10.1007/978-981-287-098-8_41

Chapter Google Scholar

Faintuch, J., Faintuch, S.: Past and current status of scientific, academic, and research fraud. In Faintuch, J., Faintuch, S. (eds.) Integrity of Scientific Research, pp. 3–8, Springer, Cham (2022). https://doi.org/10.1007/978-3-030-99680-2_1

Ngai, S., et al.: Haunted manuscripts: ghost authorship in the medical literature. Account. Res. 12 , 103–114 (2005). https://doi.org/10.1080/08989620590957175

Shaw, D.M.: The ethics committee as ghost author. J. Med. Ethics 37 , 706 (2011). https://doi.org/10.1136/medethics-2011-100120

Ding, D., et al.: Duplicate and salami publication: a prevalence study of journal policies. Int. J. Epidemiol. 49 , 281–288 (2020). https://doi.org/10.1093/ije/dyz187

Iphofen, R.: Regulating research. In: Iphofen, R. (ed.) Handbook of Research Ethics and Scientific Integrity, pp. 17–32. Springer, Cham (2020). https://doi.org/10.1007/978-3-030-16759-2_52

Braun, R., Ravn, T., Frankus, E.: What constitutes expertise in research ethics and integrity? Res. Ethics 16 , 1–16 (2020). https://doi.org/10.1177/1747016119898402

Emanuel, E., Wendler, D., Grady, C.: An ethical framework for biomedical research. In: Emanuel, E.J., et al. (eds.) The Oxford Textbook of Clinical Research Ethics, pp. 123–135. Oxford University Press, Oxford (2008)

Google Scholar

WMA (World Medical Association): Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (1964/2013). https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

Schrag, Z.M.: Ethical imperialism. Institutional Review Boards and the Social Sciences, 1965–2009. Johns Hopkins University Press, Baltimore (2010)

Israel, M.: Research Ethics and Integrity for Social Scientists, 2nd edn. SAGE, London (2015)

Council of Europe: Guide for Research Ethics Committee Members (2012). https://www.coe.int/t/dg3/healthbioethic/activities/02_biomedical_research_en/Guide/Guide_EN.pdf

Iphofen, R.: Ethical Decision-Making in Social Research. A Practical Guide. Palgrave Macmillan, London (2011)

Resnik, D.B.: The Ethics of Research with Human Subjects. Protecting People, Advancing Science, Promoting Trust. Springer, Cham (2018). https://doi.org/10.1007/978-3-319-68756-8

Department of Health and Human Services: Institutional Review Boards. A Time for Reform (1998). https://oig.hhs.gov/oei/reports/oei-01-97-00193.pdf

Lynch, H.F., et al.: “We measure what we can measure”: struggles in defining end evaluating institutional review board quality. Soc. Sci. Med. 292 , 114614 (2022). https://doi.org/10.1016/j.socscimed.2021.114614

Scherzinger, G., Bobbert, M.: Evaluation of research ethics committees: criteria for the ethical quality of the review process. Account. Res. 24 , 152–176 (2017). https://doi.org/10.1080/08989621.2016.1273778

Trace, S., Kolstoe, S.E.: Measuring inconsistency in research ethics committee review. BMC Med. Ethics 18 , 65 (2017). https://doi.org/10.1186/s12910-017-0224-7

Carniel, J., et al.: The ethics review and the humanities and social sciences: disciplinary distinctions in ethics review processes. Res. Ethics. (2022). https://doi.org/10.1177/17470161221147202

Dawson, A., et al.: Why research ethics should add retrospective review. BMC Med. Ethics 20 , 68 (2019). https://doi.org/10.1186/s12910-019-0399-1

Gonzales-Esteban, E., et al.: D.4.2. Final Concept of the ETHNA System (2022). https://ethnasystem.eu/wp-content/uploads/2022/02/D4.2_ETHNA_final-concept.pdf

National Bioethics Advisory Commission: Ethical and Policy Issues in Research Involving Human Participants: Recommendations of the National Bioethics Advisoty Commission. IRB: Ethics; Hum. Res. 23 , 14–16 (2001). https://doi.org/10.2307/3564051

ENRIO handbook: Recommendations for the Investigation of Research Misconduct (2019). http://www.enrio.eu/wp-content/uploads/2019/03/INV-Handbook_ENRIO_web_final.pdf

University of Liverpool: Research Integrity and Governance Committee (2023). https://www.liverpool.ac.uk/governance/university-committees/research-integrity-and-governance-committee/

Zwart, H., ter Meulen, R.: Addressing research integrity challenges: from penalising individual perpetrators to fostering research ecosystem quality care. Life Sci. Soc. Policy 15 (1), 1–5 (2019). https://doi.org/10.1186/s40504-019-0093-6

Horbach, S.P.J.M, Sorensen, M.P.: How to create and implement a Research Integrity Implementation Plan (RIPP). A guideline (ver. 2.0) (2022). https://sops4ri.eu/wp-content/uploads/Implementation-Guideline_FINAL.pdf

SOPs4RI: Guideline for Promoting Research Integrity in Research Funding Organisations (2022). https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/guideline-for-promoting-research-integrity-in-research-performing-organisations_horizon_en.pdf

SOPs4RI: Template for writing a research integrity promotion plan for research performing organisations (2022). https://sops4ri.eu/wp-content/uploads/Template-Research-Integrity-Promotion-Plan-RPOs_FINAL.pdf

EU Grants: How to complete your ethics self-assessment (2021). https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/common/guidance/how-to-complete-your-ethics-self-assessment_en.pdf

Stokel-Walker, C.: ChatGPT listed as author on research papers: many scientists disapprove. Nature 613 , 620–621 (2023). https://doi.org/10.1038/d41586-023-00107-z

Download references

Acknowledgments

I would like to thank the reviewers of this chapter for their helpful suggestions and Tiina Kirss for her help with English expression.

Author information

Authors and affiliations.

University of Tartu, Ülikooli 18, 50090, Tartu, Estonia

Kristi Lõuk

You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Kristi Lõuk .

Editor information

Editors and affiliations.

Universitat Jaume I, Castelló, Spain

Elsa González-Esteban

Ramón A. Feenstra

NOVA School of Science and Technology, UNINOVA - CTS and LASI NOVA University of Lisbon, Monte da Caparica, Portugal

Luis M. Camarinha-Matos

Rights and permissions

Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/ ), which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license and indicate if changes were made.

The images or other third party material in this chapter are included in the chapter's Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the chapter's Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder.

Reprints and permissions

Copyright information

About this chapter

Lõuk, K. (2023). Relevance and Challenges of Ethics Committees. In: González-Esteban, E., Feenstra, R.A., Camarinha-Matos, L.M. (eds) Ethics and Responsible Research and Innovation in Practice. Lecture Notes in Computer Science, vol 13875. Springer, Cham. https://doi.org/10.1007/978-3-031-33177-0_8

Download citation

DOI : https://doi.org/10.1007/978-3-031-33177-0_8

Published : 12 May 2023

Publisher Name : Springer, Cham

Print ISBN : 978-3-031-33176-3

Online ISBN : 978-3-031-33177-0

eBook Packages : Computer Science Computer Science (R0)

Share this chapter

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

Publish with us

Policies and ethics

Find a journal
Track your research

An official website of the United States government

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Publications
Account settings
My Bibliography
Collections
Citation manager

Save citation to file

Email citation, add to collections.

Create a new collection
Add to an existing collection

Add to My Bibliography

Your saved search, create a file for external citation management software, your rss feed.

Search in PubMed
Search in NLM Catalog
Add to Search

Ethics Committees: Structure, Roles, and Issues

Affiliations.

1 Department of Clinical Immunology and Rheumatology, King George's Medical University, Lucknow, India. [email protected].
2 Department of Clinical Rheumatology and Immunology, University Hospital in Krakow, Krakow, Poland.
3 National Institute of Geriatrics, Rheumatology and Rehabilitation, Warsaw, Poland.
4 Department of Internal Medicine N2, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine.
5 Departments of Rheumatology and Research and Development, Dudley Group NHS Foundation Trust (Teaching Trust of the University of Birmingham, UK), Russells Hall Hospital, Dudley, UK.
6 Department of Biology and Biochemistry, South Kazakhstan Medical Academy, Shymkent, Kazakhstan.
PMID: 37365729
PMCID: PMC10293659
DOI: 10.3346/jkms.2023.38.e198

An Ethics Committee (EC) is an independent body composed of members with expertise in both scientific and nonscientific arenas which functions to ensure the protection of human rights and the well-being of research subjects based on six basic principles of autonomy, justice, beneficence, nonmaleficence, confidentiality, and honesty. MEDLINE, Scopus, and Directory of Open Access Journals were searched for studies relevant to this topic. This review is focused on the types of research articles that need EC approval, the submission process, and exemptions. It further highlights the constitution of ECs, their duties, the review process, and the assessment of the risk-benefit of the proposed research including privacy issues. It's pertinent for academicians and researchers to abide by the rules and regulations put forth by ECs for upholding of human rights and protecting research subjects primarily, as well as avoiding other issues like retraction of publications. Despite various issues of cost, backlogs, lack of expertise, lesser representation of laypersons, need for multiple approvals for multisite projects, conflicts of interest, and monitoring of ongoing research for the continued safety of participants, the ECs form the central force in regulating research and participant safety. Data safety and monitoring boards complement the ECs for carrying out continuous monitoring for better protection of research subjects. The establishment of ECs has ensured safe study designs, the safety of human subjects along with the protection of researchers from before the initiation until the completion of a study.

Keywords: Beneficence; Confidentiality; Ethics Committees, Research; Human Rights; Privacy; Research Subjects.

PubMed Disclaimer

Conflict of interest statement

The authors have no potential conflicts of interest to disclose.

Fig. 1. Timelines of events that led…

Fig. 1. Timelines of events that led to the establishment of Ethics Committees.

Fig. 2. Recommended composition of the Ethics…

Fig. 2. Recommended composition of the Ethics Committee.

Fig. 3. The factors assessed in the…

Fig. 3. The factors assessed in the process of review of a study by an…

Publication types

Search in MeSH

LinkOut - more resources

Full text sources.

Europe PubMed Central
Korean Academy of Medical Sciences
PubMed Central

Citation Manager

NCBI Literature Resources

MeSH PMC Bookshelf Disclaimer

The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Unauthorized use of these marks is strictly prohibited.

Log in using your username and password

Search More Search for this keyword Advanced search
Latest content
Current issue
Write for Us
BMJ Journals

http://orcid.org/0000-0002-1112-4389 Ben Parkinson 1 ,
http://orcid.org/0000-0003-4308-4219 David Barrett 2
1 Nursing , Glasgow Caledonian University , Glasgow , UK
2 Department of Health Sciences , University of York , York , UK
Correspondence to Dr Ben Parkinson, Nursing, Glasgow Caledonian University, Glasgow G4 0BA, UK; ben.parkinson{at}gcu.ac.uk

https://doi.org/10.1136/ebnurs-2022-103643

Statistics from Altmetric.com

Request permissions.

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Nursing Research

Nursing research often involves collection of data from human participants. Participants involved with research may be vulnerable, acutely unwell or even lack capacity to make decisions. Protecting the safety and well-being of all participants is a requirement and nurse researchers need to ensure the ethical principles of autonomy, non-maleficence, beneficence and justice are maintained throughout the research process. 1

To protect participants, research studies are subject to approval by research ethics committees (RECs)—sometimes called research ethics boards or institutional review boards. 1 Securing REC approval can be a complex process, requiring nurse researchers to demonstrate that the proposed study meets the necessary ethical and research governance requirements for research involving human participants. This paper will provide an overview of the role of RECs and offer guidance to nurse researchers applying for REC approval.

Research ethics committees

RECs came to prominence in the second half of the 20th century. The internationally recognised Declaration of Helsinki— first adopted in 1964, but amended several times since then—states all researchers need to secure REC approval before commencing research involving human participants, in order to safeguard the health and well-being of those involved. 2 RECs can be part of national research authorities (such as the National Office for Research Ethics Committees in Ireland), and/or sit within organisations such as hospitals and universities. Their role is to provide independent scrutiny of research and to determine whether proposed studies can be given ethical approval.

REC approval is a formal process that nurse researchers complete before commencing research involving human participants. An initial step is to establish whether the study needs REC approval. Usually, research involving human participants requires REC approval, but deciding whether a study is research can be difficult. The lines between research, audit and evaluation are blurred, so it is useful to think carefully about whether the study meets the criteria for research ( table 1 ). 3 Some tools exist to help make this decision, including the ‘Do I need REC review’ tool provided in by the Health Research Authority in the UK ( http://www.hra-decisiontools.org.uk/ethics/ ).

View inline

Evaluation, audit, research

What do RECs consider when scrutinising research protocols?

RECs consider a wide range of issues related to research ethics and integrity. REC applications can be lengthy documents including a detailed protocol, participant information sheets, consent documents and data collection tools. There may be different criteria or templates used across different RECs and variation does exist in the process and outcomes of REC review. 4 Despite this variation though, there is some agreement about what is important and the areas that need addressed in their REC applications. 5

Scientific value: does the study ask important questions; is the proposed methodology appropriate; will the research produce useful findings?

Resources: are there adequate resources available for the research; is the research team sufficiently competent and experienced to complete the research?

Risk assessment: does the risk assessment show a favourable risk-benefit ratio for people involved in the study and wider community?

Independent review: has an independent review of the research happened? What patient and public involvement has occurred?

Recruitment: will recruitment be fair, free from coercion, and are the risks and benefits of the research shared equally within society?

Consent: will participants provide informed voluntary consent, and will participants be able to withdraw their consent and remove themselves from the research should they wish to do so?

Privacy: does the study protect participants’ privacy and personal data?

Protection: does the research have adequate safety and welfare measures to ensure participants’ well-being?

Supporting documents: are research documents accessible enough for the intended audience, and do they provide enough information about the research, so participants can make an informed decision about participating?

What happens after the REC review?

Once the review process is complete, the REC will decide on the most appropriate outcome for the research. Though some different terminology may be used in different countries, REC decisions usually fall into one of the following: approved, approved with conditions, or revise and resubmit ( table 2 ). 6

REC decisions

What can help get an REC application approved?

Securing REC approval can be a lengthy and stressful process. Approval times vary between RECs, but some RECs can take several months to provide a decision on an application. 7 It is important that nurse researchers factor in the time taken to secure REC approval when planning research projects; even the most experienced researchers often need to revise their REC applications before being approved, and the process can take longer than expected. 6 This could have implications for funding or—in the case of student projects—for meeting academic deadlines. Taking simple steps before submitting the REC application can help minimise the chances of having to resubmit the REC application and can help expedite the research process.

Steps to take when applying for REC approval

Find out about the application process for the REC you will be using (eg, submission process, documents required, timelines involved). Some RECs use online submission systems, so it may be necessary to create an account and/or learn how to navigate the system.

All nurse researchers need to allow enough time for the REC review process and should assume they will need to revise the REC application because even experienced nurse researchers may have to revise their REC applications.

Involve stakeholders when designing the study and preparing an application for REC approval.

Consider the ethical principles of autonomy (respect of persons), non-maleficence, beneficence and justice when designing the research. 1

Complete a risk assessment and evaluate whether the potential benefits outweigh the possible risks associated with the research.

Write the research protocol using the structure recommended by the REC or an established framework such as the ‘Ethics Tool Kit’. 8

Ensure the participant-facing documents (such as information sheets) are comprehensive and that the language is accessible for the intended audience.

Get peer feedback on the application from an experienced researcher who is not involved in the study.

Use version control to manage the different versions of key documents.

Check all documents before submission to avoid unnecessary delays in the review process.

RECs are crucial in protecting the health, safety and well-being of research participants. In order to receive approval from these committees, nurse researchers need to ensure that their proposals are clear, comprehensive, informed by stakeholder input and focused on the well-being of those who will take part in their study.

World Medical Association
Twycross A ,
Brandenburg C ,
Thorning S ,
Ruthenberg C
Glasziou P ,
Chalmers I , et al
Wacholtz MC ,
Barnes M , et al

Twitter @ParkinsonBen1, @barrett1972

Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

Competing interests None declared.

Provenance and peer review Commissioned; internally peer reviewed.

Read the full text or download the PDF:

DOI: 10.3346/jkms.2023.38.e198
Corpus ID: 258995532

Ethics Committees: Structure, Roles, and Issues

P. Mehta , O. Zimba , +2 authors Marlen Yessirkepov
Published in Journal of Korean medical… 30 May 2023
Law, Medicine

Figures and Tables from this paper

8 Citations

Research integrity: where we are and where we are heading, ethics and scientific publication in ukraine: the current state, government initiatives for research ethics during covid-19 pandemic in korea, leveraging artificial intelligence to detect ethical concerns in medical research: a case study, case-based review standards (cabaret): considerations for authors, reviewers, and editors, features of the course of severe and critical covid-19 in pregnant women: a prospective cross-sectional study, a simple guide to randomized controlled trials., mesenchymal stem cell therapy for azoospermia: navigating differentiation challenges and charting future frontiers in male fertility treatment, 96 references, ethics approval: responsibilities of journal editors, authors and research ethics committees, differences between research ethics committees, how do we know that research ethics committees are really working the neglected role of outcomes assessment in research ethics review, working with the institutional review board., institutional review board approval as an educational tool, profile and role of the members of ethics committees in hospitals and research organisations in pune, india., education of ethics committee members: experiences from croatia, current status of the institutional review boards in korea: constitution, operation, and policy for protection of human research participants., oversight of human participants research: identifying problems to evaluate reform proposals, burdens on research imposed by institutional review boards: the state of the evidence and its implications for regulatory reform., related papers.

Showing 1 through 3 of 0 Related Papers

Open access
Published: 28 March 2008

How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review

Carl H Coleman 1 &
Marie-Charlotte Bouësseau 2

BMC Medical Ethics volume 9 , Article number: 6 ( 2008 ) Cite this article

22k Accesses

78 Citations

1 Altmetric

Metrics details

Countries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants.

Research ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices.

The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals.

Outcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of studies? Second, does the process affect prospective participants' decisions about whether to participate in research? Third, does it change participants' subjective experiences in studies or their attitudes about research? Fourth, does it reduce the riskiness of research? Fifth, does it result in more research responsive to the local community's self-identified needs? Sixth, is research ethics committees' guidance to researchers actually being followed?

Peer Review reports

Many countries are investing significant resources in creating or strengthening "research ethics committees" (RECs) to review proposed research involving human participants, either within research institutions, as part of governmental agencies, or in the private sector. Implicit in these efforts is the assumption that REC review will result in research that better complies with applicable ethical principles. Yet, surprisingly little attention has been devoted to testing the empirical validity of this assumption. As a result, it is possible that countries are wasting scarce financial and human resources on processes that do not result in any real protections for research participants or their communities. In addition, without a system for evaluating RECs' actual impact, opportunities for remedying correctable problems with RECs are likely to be missed.

The importance of evaluating the effectiveness of RECs should be obvious. Yet, despite the emphasis on quality assessment in other areas of health care, "there has been near silence on the possibility of applying quality assessment techniques to ethics practices [ 1 ]." While the need for quality assessment in research ethics is beginning to receive greater attention [ 2 ], the focus has largely been on evaluating the quality of the deliberations that take place in RECs' meetings, as opposed to the impact of those deliberations on the research process itself.

Existing mechanisms for evaluating RECs are primarily limited to governmental or private auditing and accreditation programs. While both auditing and accreditation can make important contributions to the quality of research review systems, they are incapable of answering many critical questions about RECs' impact on research practices. Moreover, comprehensive auditing and accreditation programs require an investment of human and financial resources that is unfeasible for many low- and middle-income countries. In this article, we look beyond auditing and accreditation to consider other mechanisms for assessing and improving the quality of RECs' work.

While the focus of this article is RECs in low- and middle-income countries, the issues it addresses are relevant everywhere. In the United States, for example, an increasing chorus of critics has charged that the process of research ethics review imposes substantial costs for the research enterprise that exceed any benefits to research participants [ 3 , 4 ]. Determining whether the costs of ethics review are in fact justified requires a better understanding of the impact of ethics review on how research is actually performed.

The Increasing Role of REC Review

REC review is a cornerstone of international guidelines on research with human participants. For example, the Council for International Organizations of Medical Sciences (CIOMS) states that "all proposals to conduct research involving human subjects must be submitted for review and approval to one or more independent ethical and scientific review committees [ 5 ]." Similar obligations appear in guidelines issued by the International Conference on Harmonization (ICH) [ 6 ], the Council of Europe [ 7 ], and UNESCO [ 8 ]. These guidelines require RECs to ensure that the risks of proposed studies are reasonable in relation to the anticipated benefits, that the investigators have adequate plans for obtaining participants' informed consent, and that other ethical issues, such as confidentiality and equitable participant selection, have been adequately addressed.

However, these international guidelines are not legally binding in countries that have not chosen to adopt them. Thus, whether REC review is required for any particular study depends on the requirements of national laws and policies. In the United States and many other wealthy countries, review by an REC is mandatory for most research involving human participants [ 9 ]. By contrast, in many low-income countries, there are no laws requiring REC oversight, or laws that exist are incomplete or under-enforced [ 10 , 11 ]. When research is conducted in collaboration with foreign research sponsors, some type of ethics review may be required by the laws of the sponsor's country, but such laws do not always require review by local RECs. For example, while the United States Food and Drug Administration (FDA) has extensive regulations governing REC review for clinical trials conducted pursuant to an Investigational New Drug Application (IND), those regulations do not apply to foreign trials not conducted pursuant to an IND. Instead, the FDA will accept data from non-IND foreign trials as long as the trial "conforms to the ethical principles contained in the Declaration of Helsinki [ 12 ]," which contains only very general provisions on ethical review.

In recent years, however, many low and middle-income countries have begun to pay greater attention to developing or strengthening RECs. For example, at the 2004 Ministerial Summit on Health Research in Mexico City, health officials from 58 countries called for national governments to adopt regulations providing for the "ethical oversight" of research [ 13 ]. In many African countries, governments have enacted, or are in the process of enacting, legislation requiring REC review of research involving human participants [ 14 , 15 ]. Even without a governmental mandate, many research institutions in resource-poor countries have created RECs on their own initiative, sometimes in collaboration with other countries [ 11 ] or with non-governmental organizations [ 16 ].

One reason for this increasing interest in RECs is that research sponsors are conducting more of their studies in low and middle-income countries, both because it is less expensive [ 17 ] and because it has become increasingly difficult to find a sufficient number of qualified participants in the sponsors' home countries [ 18 ]. In addition, a few highly-publicized controversies have led to greater attention to the potential for exploitation in the context of international collaborative research. For example, a lawsuit currently pending against the foreign sponsors of a Nigerian study of an anti-meningitis drug alleges that children in the control group were not given adequate medications, that parents were not told that effective treatment for meningitis was readily available outside of the study, and that documents claiming that the study had been approved by a Nigerian ethics review process were forged [ 19 ]. Publicity about cases like this has given sponsors a greater incentive to support the development of local RECs.

Challenges for REC Review

For a country that lacks any research oversight system, creating a review process – any review process – is likely to have a positive impact. For example, requiring researchers to submit their protocols to RECs creates an incentive for researchers to actually have written protocols. Requiring them to document the informed consent process reduces the likelihood that individuals will be enrolled in studies without even being asked for consent. In other words, simply requiring prior approval to do research should help weed out the truly egregious cases of researcher misconduct.

Designing a system to evaluate the ethical acceptability of studies that pass this minimal screening function raises more challenging conceptual and practical difficulties. On the most basic level, the very concept of "ethics review" is inherently ambiguous, particularly in the critical area of risk-benefit assessment. Identifying the risks and potential benefits of research, and determining whether the balance between them is "reasonable," depend not only on scientific arguments but also on value judgments that usually have no clearly right or wrong resolution. In the absence of objective standards, RECs must rely on individuals' discretionary judgments, an approach that risks overemphasizing the personal values and biases of the individuals who happen to be serving on the committee [ 20 ]. In addition, the discretionary nature of risk-benefit assessment increases the potential for inconsistent decision-making, not only between different RECs but also within a single REC as it confronts similar issues from meeting to meeting. Of course, in a pluralistic society, absolute uniformity in ethical decision-making is neither realistic nor desirable. However, widespread inconsistency, particularly within a single REC, creates the impression that ethical standards are being applied in an arbitrary manner.

Some RECs deal with the amorphous nature of risk-benefit assessment by spending most of their time on detail-oriented questions that appear more susceptible to objective resolution, such as parsing the wording of informed consent forms [ 21 ]. Unfortunately, while rewriting consent forms is undoubtedly important in some situations, when it becomes the primary focus of ethics review larger ethical questions can easily become lost. Indeed, some critics charge that an obsessive focus on rewriting consent forms can actually undermine the protection of research participants, as it may simply result in longer and more confusing forms that participants will be less likely to understand [ 22 ].

On a more practical level, the effectiveness of REC review is often hampered by insufficient financial and human resources [ 15 ]. These limitations make it difficult to create committees with sufficient expertise and diversity, to provide funding for staff support, and to provide training for committee members. Ensuring the independence of RECs can also be a significant challenge. For example, in institutional-based RECs, committee members may be asked to vote on proposals submitted by colleagues who are personal friends, or by senior members of their department who control decisions about promotion and tenure.

The problem of independence is particularly acute for RECs in low and middle-income countries. Because such countries may depend on the financial or other benefits associated with foreign-sponsored research, RECs may be under explicit or implicit pressure not to reject research protocols or to insist on changes that might lead sponsors to take their studies elsewhere [ 23 ]. Adding to these problems is the fact that, in many resource-poor countries, RECs must carry out their work in the absence of a well-developed regulatory structure or a culture of compliance with administrative and procedural requirements.

Existing Oversight Mechanisms for RECs

In many countries, REC oversight is the responsibility of national governmental agencies. In the United States, for example, the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) are responsible for overseeing most RECs in the country (where they are known as institutional review boards, or IRBs). These agencies conduct site visits of selected programs, either without cause or in response to a specific problem, and they also have less formal procedures for responding to individual complaints. OHRP's site visits include a review of 20–35 randomly-selected protocols and meeting minutes dating back one to four years [ 24 ].

Some countries require RECs to go through a formal process of governmental accreditation. For example, in New Zealand, the Health Research Council accredits research ethics committees. If a study proceeds without the approval of an accredited ethics committee, participants who suffer injuries may not be eligible for compensation from the country's no-fault compensation system [ 25 ]. Approval by an accredited committee is also necessary for researchers to obtain access to data held by the New Zealand Health Information Service database [ 26 ]. Accreditation usually involves a combination of self-assessment and external reviews, focusing on issues like committee membership, operating procedures, and the documentation of meetings [ 27 ].

There are also voluntary accreditation programs for RECs. The largest of these is run by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) [ 28 ]. Obtaining AAHRPP accreditation is an intensive process that usually takes 12–18 months, including both document reviews and a 2–4 day site visit during which dozens of persons involved in all aspects of the research program are individually interviewed. In order to be accredited, programs must demonstrate not only that they are in compliance with all applicable regulatory requirements, but also that they have developed guidelines for addressing certain issues not expressly covered by the regulations (e.g., standards governing the participation of decisionally incapacitated persons in research). While most of the programs that have received AAHRPP accreditation are located in the United States, AAHRPP has also accredited programs in Canada, Singapore, and South Korea.

In addition to AAHRPP, the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), a network of local and regional ethics organizations working with several United Nations organizations, has established a voluntary "recognition" program for RECs. The program offers recognition to RECs that demonstrate that they "(1) have a structure and composition appropriate to the amount and nature of research being conducted; (2) have appropriate management and operational procedures; (3) review protocols in a timely fashion according to established procedure; (4) adequately and effectively communicate decisions to investigators; and (5) have appropriate practices regarding documentation and archiving [ 29 ]." The SIDCER program includes educational components designed to support RECs' progress toward recognition. Committees from China, Philippines, South Korea, Thailand and Taiwan have already been recognized through this process.

Finally, some mechanisms also exist for evaluating the qualifications of individual REC members. For example, a non-profit organization in the United States called Public Responsibility in Medicine and Research (PRIMR) offers a certification program for IRB members and staff, which "evaluates and validates individuals' knowledge of ethical principles, historical events, regulatory requirements, and operational and functional issues relating to IRBs and other human subjects protection programs [ 30 ]." Persons who pass the certification test are authorized to include the acronym CIP ("certified IRB professional") in their professional titles.

All of these mechanisms can make important contributions to the quality of the ethics review process. Auditing and accreditation programs encourage RECs to develop standardized policies and procedures, which helps promote the consistent application of ethical principles. They also provide a means for checking whether RECs are actually adhering to the policies and procedures they claim to be following. Private accreditation programs have the added advantage of encouraging RECs to develop policies and procedures for issues that are insufficiently addressed at the regulatory level. Certification programs for REC members can complement the accreditation process by promoting a common base of knowledge about applicable ethical and regulatory principles. Moreover, both accreditation and certification are likely to enhance the status of RECs within their own institutions, which may make it easier for RECs to gain necessary institutional resources.

However, these mechanisms also have inherent limitations. Most significantly, they focus primarily on questions about RECs' structure and process, such as how committees are constituted, whether their standard operating procedures are complete, and whether the process of protocol review is adequately documented [ 31 ]. One danger with this focus is that it may exacerbate RECs' tendency to emphasize form over substance. A recent study of OHRP enforcement activities highlights this problem; it found that "the agency continues to nitpick consent forms, depends upon (and demands) extensive documentation of compliance activities, and finds the remedy for most problems to be 'more' – review of studies, internal monitoring procedures, education, forms." The result of this focus, the authors conclude, is "a culture of red tape rather than a culture of ethics [ 24 ]."

A larger concern with an exclusive focus on structure and process is that it is incapable of answering the bottom-line question: whether REC review actually protects the rights and interests of research participants and their communities. For example, the fact that an REC has documented that it has considered a protocol's risks and potential benefits does not mean that it has done a good job identifying or weighing these factors. Nor does it show that studies that are approved by the committee have more favorable risk-benefit profiles than those that are turned down. Similarly, the fact that an REC has concluded that a consent form contains all relevant information does not mean that prospective participants who read the form will actually understand or absorb the information, or that it will have any appreciable impact on their decision-making process. In short, all that auditing and accreditation programs tell us is whether RECs are carrying out the specific tasks that have been assigned to them. While this is certainly an important question, even an affirmative answer does not prove that an REC system "works."

Integrating Quality Assurance Principles into REC Assessment

Principles developed through decades of experience with quality assurance and improvement in other areas of health care can guide the development of effective oversight programs for RECs. The most basic of these principles is that, before the quality of any program or service can be evaluated, the relevant elements of quality must be identified with precision. Quality is a multifaceted concept, including factors like the technical competence with which an activity is performed, the impact of the activity on morbidity and mortality, and the activity's cost effectiveness. Choosing which of these goals to emphasize "requires a commitment to finding out what patients and the community need, want, and expect from the health service [ 32 ]."

Thus, the first step in developing a comprehensive quality assurance program for RECs should be to identify what prospective research participants and their communities hope to get out of the ethics review process. For example, is the concern that people are being misled into enrolling in studies in which they would have refused to participate had they known what they were getting into? If so, it would be useful to know whether REC review has an impact on the number of people who go through the informed consent process and then decide not to participate. Alternatively, the goal might be to increase the extent to which participants feel respected in the research process, regardless of whether they end up making different decisions about participating [ 33 ]. In that case, we should try to find out whether REC review actually affects participants' subjective experiences in studies or their attitudes about research. Both of these questions, of course, depend on first determining whether prospective participants understand the information that has been presented to them in the consent process. While some research related to this question has already been conducted [ 34 ], assessing participants' understanding has not yet been systematically integrated into the process of REC oversight.

Similar questions can be raised about the process of risk-benefit assessment. For example, is REC review considered important because of a concern that research is generally "too risky"? If so, we should look at whether adopting an REC process actually affects the riskiness of research – perhaps by investigating whether REC review has an impact on the incidence of adverse events. Or is the concern that, without RECs, research might not address the health needs of the local community? In that case, we might want to see whether studies approved by an REC are in fact consistent with the local community's needs.

These broad outcome-oriented questions will not always be easy to answer. Outcomes assessment is one of the trickiest areas of quality assurance; numerous confounding variables can undermine the validity of simple before-and-after comparisons. For example, in many health care programs, outcome measurements such as mortality rates can be useful indicators of the quality of services, but they may also reflect "differences in the resources available, the risk factors of the patient group, data accuracy, and chance alone [ 35 ]." Likewise, an increase in adverse events following the creation of an REC does not necessarily mean that the REC is a failure; it may instead reflect a shift towards studies related to more serious conditions, where the greater potential benefits justify a higher degree of risk. Developing methodologically sound measures of assessing REC outcomes is an area ripe for further research.

Another important dimension of quality assurance that existing oversight efforts do not incorporate is the basic question of whether RECs' guidance to researchers is actually being followed. For example, do researchers really utilize the informed consent processes described in their protocols, or do they simply hand prospective participants a consent form and ask them to sign it? RECs could adopt a variety of relatively simple methods to generate information relevant to this question, such as soliciting feedback from prospective participants through questionnaires or suggestion boxes. Or, borrowing a practice used in other health care settings, they could use actors to play the role of prospective research participants, in order to evaluate how people are treated when they go through the informed consent process [ 32 ]. While these measures would require some additional resources, they are far less expensive than many other methods of quality assurance – for example, going through an 18-month process of obtaining accreditation.

Finally, and most importantly, a "monitoring system is not an end in itself [ 36 ];" the information generated through an assessment process must be used to stimulate improvements in practice. Doing this requires a commitment to a process of continuous quality improvement, in which information from the assessment process is disseminated to key decision-makers and incorporated into practice. Thus, an REC might ask researchers involved in approved studies to report back about the most common questions asked by prospective participants during the informed consent process, and then use this information to change the way they evaluate informed consent forms in the future. Global or regional meetings of RECs, as well as online discussion forums, can provide valuable opportunities for sharing information and identifying and promoting best practices. In addition to disseminating information among REC members, it is important to share findings about REC practices with external audiences like administrative authorities and community leaders.

Low and middle-incomes countries are increasingly demonstrating their capacity to put into practice concrete mechanisms for enforcing ethical requirements. International cooperation has been a key factor in this progress. However, it is not clear whether these systems have led to substantial improvements in the way that research is actually conducted. It is time to look beyond the basic question of whether RECs are complying with existing standards to the larger question of whether compliance with these standards is having the desired results.

Wolf SM: Quality assessment of ethics in health care: the accountability revolution. American Journal of Law & Medicine. 1994, 20: 105-128. at 110.

Google Scholar

Taylor HA: Moving beyond compliance: measuring ethical quality to enhance the oversight of human subjects research. IRB: Ethics & Human Research. 2007, 29 (5): 9-14.

Hyman DA: Institutional review boards: is this the least worst we can do?. Northwestern University Law Review. 2007, 101: 749-773.

Mueller JH: Ignorance is neither bliss nor ethical. Northwestern University Law Review. 2007, 101: 809-836.

Council for International Organizations of Medical Sciences: International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva. 2002

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: Guideline for Good Clinical Practice. 1996, [ http://www.ich.org/LOB/media/MEDIA482.pdf ]

Council of Europe: Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Biomedical Research. 2005, [ http://conventions.coe.int/treaty/en/treaties/html/195.htm ]

UNESCO: Universal Declaration on Bioethics and Human Rights, art. 19. 2005, [ http://portal.unesco.org/en/ev.php-URL_ID=31058&URL_DO=DO_TOPIC&URL_SECTION=201.html ]

Coleman CH, Menikoff JA, Goldner JA, Dubler NN: The Ethics and Regulation of Research with Human Subjects. 2005, Newark, NJ: Lexis

Hyder AA: Ethical review of health research: a perspective from developing country researchers. Journal of Medical Ethics. 2004, 30: 68-72. 10.1136/jme.2002.001933.

Article Google Scholar

Caniza MA: Establishment of ethical oversight of human research in El Salvador: lessons learned. The Lancet. 2006, 7: 1027-1033. 10.1016/S1470-2045(06)70977-9.

21 C.F.R. § 312.120. 2008

Ministerial Summit on Health Research: The Mexico Statement on Health Research. 2004, [ http://www.who.int/rpc/summit/agenda/en/mexico_statement_on_health_research.pdf ]

Networking for Ethics on Biomedical Research in Africa: NEBRA Final Report. 2006, [ http://www.trree.org/site/en_nebra.phtml ]

Kass NE, Adnan AH, Ademola A, Appiah-Poku J, Barsdorf N, Elsayed DE, Mokhachane M, Mupenda B, Ndebele P, Ndossi G, Sikateyo G, Tangwa G, Tindana P: The structure and function of research ethics committees in Africa: a case study. PLoS Medicine. 2007, 4 (1): e3-10.1371/journal.pmed.0040003.

African Malaria Trust Network. [ http://www.amanet-trust.org/ext/news/HREGrant.htm ]

Macklin R: Double Standards in Medical Research in Developing Countries. 2004, Cambridge University Press

Book Google Scholar

Research Notes – Clinical Trials: Efforts To Increase Participation Examined. American Health Line. June 22, 2006

Nwabueze RN: Ethical review of research involving human subjects in Nigeria: legal and policy issues. Indiana International and Comparative Law Review. 2003, 14: 87-116.

Coleman CH: Rationalizing risk assessment in human subject research. Arizona Law Review. 2004, 46: 1-51.

Beh HG: The role of institutional review boards in protecting human subjects: are we really ready to fix a broken system?. Law & Psychology Review. 2002, 26: 1-46.

Burris S, Moss K: U.S. health researchers review their ethics review boards: a qualitative study. Journal of Empirical Research on Human Research Ethics. 2006, 1 (2): 39-58. 10.1525/jer.2006.1.2.39.

Coleman CH, Bouësseau MC: Strengthening local review of research in Africa: is the IRB model relevant?. Bioethics Forum. 2006, [ http://www.bioethicsforum.org/ethics-review-of-medical-research-in-Africa.asp ]

Burris S, Welsh J: Regulatory paradox in the protection of human research subjects: a review of OHRP enforcement letters. Northwestern University Law Review. 2007, 101: 643-685.

New Zealand Injury Prevention, Rehabilitation, and Compensation Act, § 32(6). [ http://interim.legislation.govt.nz/libraries/contents/om_isapi.dll?clientID=858250283&infobase=pal_statutes.nfo&jump=a2001-049%2fs.32&softpage=DOC#JUMPDEST_a2001-049/s.32 ]

Health Research Council of New Zealand: Accredited Ethics Committees. 2005, [ http://www.hrc.govt.nz/root/Ethics/Ethics%20Overview/Accredited_Ethics_Committees.html ]

See, for example, National Patient Safety Agency (United Kingdom): Quality Assurance – Accreditation. [ http://www.nres.npsa.nhs.uk/recs/quality/accreditation.htm ]

Association for the Accreditation of Human Research Protection Programs, Inc. [ http://www.aahrpp.org/www.aspx ]

UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR): SIDCER Recognition Programme. 2005, [ http://www.sidcer.org/new_web/main/SIDCER_RecPro.doc ]

Public Responsibility in Medicine and Research: Certification. 2007, [ http://www.primr.org/certification/certification.html ]

Emanuel EJ, Wood A, Fleischman A, Bowen A, Getz KA, Grady C, Levine C, Hammerschmidt DE, Faden R, Eckenwiler L, Muse CT, Sugarman J: Oversight of human participants research: identifying problems to evaluate reform proposals. Annals of Internal Medicine. 2004, 141: 282-291.

Quality Assurance Project: Quality assurance of health care in developing countries. at14., [ http://www.qaproject.org/pubs/PDFs/DEVCONT.pdf ]

Saver RS: Medical research and intangible harm. University of Cincinnati Law Review. 2006, 74: 941-1012.

Flory J, Emanuel E: Interventions to improve research participants' understanding in informed consent for research: a systematic review. JAMA. 2004, 292: 1593-1601. 10.1001/jama.292.13.1593.

Brown RW: Why is quality assurance so difficult? A review of issues in quality assurance over the last decade. Internal Medicine Journal. 2002, 32: 331-337. 10.1046/j.1445-5994.2002.00240.x. at 332.

Quality Assurance Project: Monitoring the quality of primary care. at 3., [ http://www.qaproject.org/pubs/PDFs/hmngrfinal.pdf ]

Pre-publication history

The pre-publication history for this paper can be accessed here: http://www.biomedcentral.com/1472-6939/9/6/prepub

Download references

Acknowledgements

Dr. Bouësseau is a staff member of the World Health Organization. The authors alone are responsible for the views expressed in this publication and they do not necessarily represent the decisions, policy or views of the World Health Organization.

Author information

Authors and affiliations.

Seton Hall Law School, Newark, New Jersey, USA

Carl H Coleman

Department of Ethics, Equity, Trade & Human Rights, World Health Organization, Geneva, Switzerland

Marie-Charlotte Bouësseau

You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Carl H Coleman .

Additional information

Competing interests.

The author(s) declare that they have no competing interests.

Authors' contributions

CHC and MCB jointly developed the ideas presented in this article. CHC wrote the first draft, and both authors jointly revised the draft. Both authors read and approved the final manuscript.

Rights and permissions

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0 ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Reprints and permissions

About this article

Cite this article.

Coleman, C.H., Bouësseau, MC. How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review. BMC Med Ethics 9 , 6 (2008). https://doi.org/10.1186/1472-6939-9-6

Download citation

Received : 21 October 2007

Accepted : 28 March 2008

Published : 28 March 2008

DOI : https://doi.org/10.1186/1472-6939-9-6

Share this article

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

Research Participant
Prospective Participant
Accreditation Program
Ethic Review Process
Research Ethic Committee Review

BMC Medical Ethics

ISSN: 1472-6939

General enquiries: [email protected]

Loading metrics

Open Access

Policy Forum

Policy Forum articles provide a platform for health policy makers from around the world to discuss the challenges and opportunities in improving health care to their constituencies.

See all article types »

The Structure and Function of Research Ethics Committees in Africa: A Case Study

* To whom correspondence should be addressed. E-mail: [email protected]

Adnan Ali Hyder,
Ademola Ajuwon,
John Appiah-Poku,
Nicola Barsdorf,
Dya Eldin Elsayed,
Mantoa Mokhachane,
Bavon Mupenda,
Paul Ndebele,
Godwin Ndossi,
Bornwell Sikateyo,
Godfrey Tangwa,
Paulina Tindana
Nancy E Kass,
Adnan Ali Hyder,
Ademola Ajuwon,
John Appiah-Poku,
Nicola Barsdorf,
Dya Eldin Elsayed,
Mantoa Mokhachane,
Bavon Mupenda,
Paul Ndebele,

Published: January 23, 2007

https://doi.org/10.1371/journal.pmed.0040003
Reader Comments

Citation: Kass NE, Hyder AA, Ajuwon A, Appiah-Poku J, Barsdorf N, Elsayed DE, et al. (2007) The Structure and Function of Research Ethics Committees in Africa: A Case Study. PLoS Med 4(1): e3. https://doi.org/10.1371/journal.pmed.0040003

Copyright: © 2007 Kass et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Funding: This project was funded, in part, by a grant from the Fogarty International Center, National Institutes of Health R25 TW01604.

Competing interests: The authors have declared that no competing interests exist.

Abbreviations: FWA, Federal Wide Assurance; IRB, institutional review board; JHU, Johns Hopkins University; REC, research ethics committee; WHO, World Health Organization

According to international guidelines [ 1 , 2 ] and several nations' laws [ 3–5 ], research with humans requires independent ethics committee review. In the United States, committees are called institutional review boards (IRBs) [ 6 ]; elsewhere they generally are called research ethics committees (RECs). Committees are designed to: provide third party review, thereby minimizing conflicts of interest; protect the welfare of research participants through attention to risks, benefits, and informed consent; and avoid exploitation of vulnerable individuals and populations.

Most literature examining RECs comes from wealthier countries. One US study found “serious concerns” with the quality of 14% of IRB reviews [ 7 ]. Another found that IRBs focused predominantly on consent documentation, spending less time examining voluntariness, selection of participants, and risk [ 8 ]. Many US [ 9–15 ] and international [ 16–18 ] studies have found that different research ethics committees reach different conclusions when reviewing the same study.

Several scholars and advisory bodies have made recommendations to address challenges facing US IRBs [ 19–22 ]. However, there has been little research examining procedures, strengths, and challenges of RECs in developing countries. Two case reports describe disagreements between host and sponsoring country RECs [ 23 , 24 ], and an international survey reports differences in sponsoring and host country reviews [ 25 ]. Three articles describe RECs within one country (Turkey [ 26 ], Granada [ 27 ], and Sudan [ 28 ]), and five within a larger region.

Rivera described 20 RECs in Latin America, finding that only 45% had standard operating procedures and that members had limited training [ 29 ]. Coker examined RECs in Central and Eastern Europe [ 30 ]. Ten countries had national committees, most committees included non-medical members, and three provided training. The World Health Organization's (WHO) Southeast Asian Regional Office, finding that only some of the 16 respondents had national RECs, called for capacity development in the area of research ethics [ 31 ].

Most literature examining research ethics committees comes from wealthier countries.

The WHO African Regional Office found that 36% of member countries had no REC. In the countries that did have RECs, most RECs met monthly, five met quarterly, and one never met [ 32 ]. Finally, Milford examined African RECs' resource needs in the context of HIV vaccine trial preparedness, finding that 97% believed African RECs had inadequate training in ethics and HIV vaccine trials and 80% believed African RECs had inadequate training in health research ethics.

Additional information on how African RECs function, including their staffing, operating procedures, strengths, and challenges would be useful for African and international researchers working within Africa, and for growing efforts to enhance ethics capacity on this vast continent. We therefore used a case study approach to shed light on the structure and functioning of RECs in Africa.

The Johns Hopkins Bloomberg School of Public Health received a training grant from the Fogarty International Center in 2000 to train three African professionals in bioethics each year [ 33 ]. Several of these professionals explicitly seek to increase the scholarly and administrative capacity of their African RECs. In 2004, program faculty and trainees created a structured questionnaire to document the history, composition, functioning, financing, strengths, and challenges of RECs with which the trainees were affiliated. Questionnaires were completed by e-mail. Follow up e-mails clarified responses. Data were entered into Microsoft Excel and tabulated. Trainees and faculty met for two days in 2005 to refine concepts and work on the manuscript.

Results of Our Case Study

Eleven of the 12 trainees who attended the program in 2001–2004 collaborated. Nine had personal experience on one or more African REC. Another trainee secured information from her institution's REC; one contributed no data. One trainee worked with two committees in his country; another worked with two committees from two countries. Twice, two trainees from the same country were affiliated with different RECs. Thus, twelve RECs were included in this case study from nine African countries: Democratic Republic of the Congo, Ghana (2), Kenya, Nigeria, South Africa (2), Sudan (2), Tanzania, Zambia, and Zimbabwe.

History of research ethics committees.

The oldest committee was from South Africa, established in 1967. The REC of the Medical Research Council of Zimbabwe was formed in 1974 but had intermittent functioning until 1992, when it became more formally established. Two RECs began in the 1980s; eight were started within the last five years, including two (Kenya and Democratic Republic of the Congo) created by the trainee the year before data collection.

Six of the 12 RECs had Federal Wide Assurances (FWAs) from the US government, an indication that the institution had received US research funds or collaborated with US institutions [ 34 ]. Two RECs were established as a requirement of international collaboration. The remaining RECs were established because of a recognized need for independent ethics review. Trainees' efforts were responsible for existing or pending FWAs of three African institutions.

Composition.

RECs ranged from nine to 31 members. One included only physicians and scientists, while most had clinicians, social scientists, economists, nutritionists, pharmacists, statisticians, pastors, and lawyers. Ten had lay or non-scientist members; two did not (see Table 1 ). One required that a third of the members should be lay persons, including a traditional chief and representatives from local organizations. Another asked the local community to nominate a community member. None required gender balance, but all consciously included both men and women.

PPT PowerPoint slide
PNG larger image
TIFF original image

Composition of RECs in Case Study

https://doi.org/10.1371/journal.pmed.0040003.t001

REC meetings.

One REC recently stopped meeting in person; reviews were conducted by the chair or individual members. All other committees met in person: two met irregularly, based on need; another met twice per year or as needed; one met every two months; and seven met monthly.

All committees (except the one that did not meet) had requirements for quorum (half, or half plus one). One required two-thirds attendance. Meeting quorum, in general, was not difficult. One trainee said members were committed to duties; two said meetings were scheduled in advance or on weekends. Two said quorum was a problem. One described significant member turnover; another said busy members had problems with punctuality and attendance.

Training of REC members.

Two committees had members with no training. Six RECs had received training only since the Johns Hopkins University (JHU)–Fogarty trainee returned and provided it. Four RECs had individual members who attended external workshops; one committee conducted Good Clinical Practice courses semi-annually.

Conflicts of interest.

All RECs required that members be excused if their protocol was under review. Other potential conflicts were raised, however, which may be harder to manage. Two discussed conflicts posed when a departmental colleague had a protocol under review. One said such reviews were sent to another department, even to a department with less expertise, to avoid conflicts. Another described unease voicing objections when fellow members' protocols were reviewed, fearing being labeled unfriendly. Another believed community members were loathe to reject protocols because studies bring employment. Another said protocols bring income to the institution and sometimes questions were not raised so projects could clear quickly.

Procedural and administrative issues.

Most RECs had basic administrative capabilities, although the REC that no longer met in person lacked any administrative infrastructure. Two RECs lacked standard operating procedures. Nine had such procedures in place, five of which had been written by the trainee upon returning to Africa. All eleven RECs that met kept minutes.

All RECs had a mechanism for reviewing research project amendments to approved studies, although most did not require a review for study changes or amendments. In four RECs, the JHU–Fogarty trainee created the amendment mechanism. Of the 12 RECs, two routinely conducted annual reviews (both instituted this practice after the trainee returned to Africa); two conducted annual reviews when required by an external funder or driven by the principal investigator; and eight did not conduct annual reviews.

All trainees said REC funding was a challenge. Three had no operating funds whatsoever. For the other nine, funding came solely or in combination from government (2), foreign agencies (1), and/or fees for reviews (6). Fees for review varied greatly. One REC used a “sliding scale,” charging US$5 for proposals submitted by students, US$10 for studies submitted by post-graduate trainees, and US$20 for all other research proposals. Another did not charge for institutional applications, but required US$365 for external applications and US$585 for industry studies. Some used a “fixed fee” structure, such as US$100 for all applications or 1% of the study's budget, once funded. All RECs benefited from “in-kind” donations of institutional resources, such as space, photocopying, mail distribution, and services of staff with other responsibilities.

Eight RECs did not pay members (though some reimbursed travel); four paid a “sitting allowance.” Five RECs had paid staff; seven did not. RECs that paid staff all had budgetary allotments or charged fees.

REC review.

The number of protocols reviewed per year varied tremendously. Three RECs reviewed eight to 12 protocols per year, three reviewed 30–50, five reviewed 100–250, and one reviewed 600 per year. Two RECs with small portfolios only reviewed internally funded protocols. Most reviewed a mixture of internal and external projects.

Seven RECs required all protocols to be reviewed, although two started this policy only after the JHU–Fogarty trainee returned to the institution. The five other RECs only reviewed research when required by the funder. Review time generally corresponded to the frequency with which the REC met. Most completed reviews in one to two months, ranging from two weeks to more than three months. Four RECs looked equally at science, ethics, and budget, while another four reviewed science and ethics, but not budget. Two spent little time on ethics, while another focused almost exclusively on ethics as another committee reviewed the science.

Trainees mentioned several strengths of their RECs. First, the creation of so many new committees is a strength in itself. Also, many committees have at least a few members who received some training in ethics, through the REC, the JHU–Fogarty trainee, or external workshops. Several trainees mentioned that their REC has a reputation with sponsors for integrity and/or that the REC provides useful feedback to researchers.

Challenges.

Inadequate training and funding consistently were mentioned as the biggest challenges. These scholars acknowledged significant time and effort for member training. Reviewers were often poorly equipped to review according to ethics criteria, which led to a disproportionate focus on the science. Trainees mentioned inadequate training of staff and administrators in REC procedures; one trainee raised the issue that RECs have weak monitoring systems due to funding constraints.

Budget constraints were mentioned by nearly everyone. Running an REC is expensive, and one trainee suggested that for this reason poor countries will simply avoid the creation of a REC unless required. Another said that governments must be made aware of the importance of research ethics to convince them to fund RECs. Several mentioned that REC members had multiple responsibilities and thus, they would be more committed if they could be paid, especially since serving on the REC might actually deny them income they would otherwise have received for that time. One REC had no stationery, space, computers, or communication facilities. In another, a foreign investigator donated $200 for stationery supplies when the REC started, but there were no other funds for staff or infrastructure. An REC started by the JHU–Fogarty trainee used the trainee's personal laptop for its official business. Trainees also used their reentry grants provided by the JHU program to help enhance REC infrastructure.

Another challenge was the tendency of a few RECs to “rubber stamp” approvals in order to secure international funding. Related to this challenge, a couple of trainees raised a concern about REC independence. One said outsiders, researchers, and politicians could interfere in the REC process, and another said the “culture of corruption” is prevalent in some parts of Africa, which could affect the integrity of the committee. In some regions, investigators could engage in “IRB shopping,” whereby they could submit their protocol to a new REC if it was rejected by a first. A few trainees were concerned about possible abuse of the expedited review option in their RECs, as expedited reviews do not incur the delay and expense of convening a full committee meeting. Two specifically mentioned a lack of national guidelines and local operating procedures as a challenge to good work. Another voiced a concern that institutions would often select “top management” individuals to be members who might not have appropriate skills or time.

Suggestions.

Given the challenges raised, it was not surprising to hear trainees suggest the need for more training, funding, independence, and political commitment to improve REC functioning. In addition, innovative suggestions also emerged: training workshops on how to interpret ethics principles in light of local norms; public outreach programs about research; creation of networks of African RECs to share materials, resources, and capacity building; creation of mechanisms to facilitate communication between host and sponsor country RECs; joint meetings between REC members and investigators to brainstorm solutions to shared challenges; human rights advocacy to help enhance participants' and researchers' awareness about rights in research; and more empirical research on ethics and African research.

This case study reports on the experience of ten African professionals with 12 African RECs. These 12 RECs represent a range of experiences, from a committee formed 30 years ago to two recent ones. All, to greater or lesser extents, are functional, although one never meets as a committee. All cite the need for additional training, more attention to ethics issues, and more funding for staffing, transportation, and supplies.

Many challenges described here are not unique to African RECs. Wealthier countries, too, have heard criticism about inadequate funding, staffing, and training of committees [ 35–40 ]. Poor countries, however, inevitably feel these needs more acutely. Further, additional challenges may arise from resources being limited. We heard of institutions or community members exerting pressure to approve research that would bring jobs, infrastructure development, money, and intellectual cache to the local setting. Kilama suggested that poverty itself is a threat to independence, since poverty can blind researchers, participants, and RECs alike to any problems in studies that bring jobs, medicines, or prestige to a community [ 41 ]. Challenges to people's integrity may be more typical where individuals can expedite or bypass usual procedures through informal transfer of funds, as occurs in some countries.

External mandates often were the impetus for a committee forming and, in some cases, contributed start-up resources. While some committees still only review externally sponsored projects, others used external requirements as a catalyst to create a conscientious committee, committed to ethics review, training, and integrity. Absent the external mandate, changes may have happened more slowly.

Encouraging lessons.

Positive lessons can be drawn from this case study. First, research ethics review is increasingly routine in Africa. More African institutions require and are equipped to provide review, all but one of the committees in this case study meet in person, and membership is relatively diverse. There are growing opportunities in Africa for training in Good Clinical Practice and research methodology. Increasingly, African investigators submit to international journals that require REC review as a condition of publication; African journals now, also, generally require REC review of published studies [ 42 , 43 ], and a special meeting of the Forum for African Medical Editors in 2005 developed further guidelines for journal submission and review, including guidelines related to ethics [ 42 ]. Nonetheless, several of these committees are new, and some were created by the trainee. In the future, other researchers may start an African collaboration, find no RECs exist locally, and will need to facilitate creation of one. More guidance exists to assist in this task, but it can appear somewhat daunting [ 44 ].

Second, these experiences suggest committees become more stable, equipped, and trained over time. Thus, some challenges described may reflect how new most African RECs are. Committees with the longest history are the most established with regard to procedures, funding, and staffing. One trainee described his REC focusing almost entirely on science when first created, with community members deferring to scientific ones. Over time, members gained training and experience, and reviews began to include more ethics.

Third, this case study suggests individuals can make a difference. RECs included here were not random: a professional associated with them had just completed intensive training in research ethics. Nonetheless, with limited funds and variable institutional support, a small number of individuals created two RECs, others created and implemented standard operating procedures, review forms, and regular review where none existed, and most now provide training for members, researchers, and/or the public.

Further progress likely will involve a confluence of funders' requirements for review, institutional commitments, and individual contributions. Indeed, successful change requires systemic commitment. One individual cannot effect long-term change without institutional support, which is more likely with national requirements for review [ 45 ]. National policies are more likely to be developed when international funders, aid agencies, and journals establish that RECs are required and review must be the norm. National and institutional commitment must be set as policy and implemented through influx of resources for RECs.

To make committees' work meaningful, however, there must be a commitment, as many have suggested, to training and better resources. We join others calling for a shared library of resources, model standard operating procedures [ 46 ], model consent forms, and copies of training presentations; fortunately, such resources increasingly are available through the Internet. African professionals must find means to access continuing ethics education [ 41 , 47 ]. Challenging ethics dilemmas will always arise in research; those tasked with resolving them will need ongoing support and training to navigate reasonable solutions.

Limitations of our case study.

This case study has several limitations. The data are self-reported, through the lens of individuals who received intensive training in research ethics. Thus, their views may reflect more sophisticated understanding of how RECs should function than other REC members might provide. Further, the capacity of RECs, as reported, was often recently enhanced due to the efforts of the JHU–Fogarty trainee. Most new African RECs presumably are not started with these resources and intellectual capacity development, so the speed with which new RECs develop procedures and skills for ethics review may happen more slowly.

This report describes 12 RECs in Africa. It does not claim to be representative of African RECs as a whole. Further, this case study examined REC functioning but does not attempt to draw a conclusion about how ethical research is in Africa. Even the most conscientious REC review does not guarantee a well-executed study. Without study monitoring, it is impossible to know the relationship between REC quality and the quality of approved research [ 48 , 49 ].

This case study examines the history, operations, strengths, and challenges of 12 African RECs. We hope this will help researchers working in Africa better understand the landscape of ethics review and help funders target resources for capacity development in a continent where health research is so critical to development, and local responsibility for research functions is critical for research.

Supporting Information

Alternative language abstract s1. french translation of the abstract by bm.

https://doi.org/10.1371/journal.pmed.0040003.sd001

(31 KB DOC).

Acknowledgments

We are grateful for the research assistance of Rachel Harrison.

1. World Medical Association (2000) Declaration of Helsinki: Ethical principles for medical research involving human subjects. Edinburgh: World Medical Association.
2. Council for International Organizations of Medical Sciences (1991) International guidelines for ethical review of epidemiological studies. Geneva: Council for International Organizations of Medical Sciences.
3. Indian Council of Medical Research (2000) Ethical guidelines on biomedical research involving human subjects. New Delhi: Indian Council of Medical Research.
4. Thailand Ministry of Public Health Ethics Committee (1995) Rule of the medical council on the observance of medical ethics. Thailand: Ministry of Public Health.
5. National Consensus Conference on Bioethics and Health Research in Uganda (1997) Guidelines for the conduct of health research involving human subjects in Uganda.
View Article
Google Scholar
7. (1996) Final report of advisory committee on human radiation experiments. New York: Oxford University Press.
20. US Department of Health and Human Resources/Office of the Inspector General (1998) Institutional review boards: A system in jeopardy. Overview and recommendations.
21. National Bioethics Advisory Commission (2001) Ethical and policy issues in research involving human participants. Available: http://www.georgetown.edu/research/nrcbl/nbac/human/oversumm.html . Accessed 19 December 2006.
22. Institute of Medicine (2002) Responsible research: A systems approach to protecting research participants. Washington (D. C.): National Academy Press.
31. WHO South East Asian Regional Office (2002) Ethics in health research. New Delhi: World Health Organization.
32. Kirigia JM, Wambebe C, Baba-Mousa A (2005) Status of national research bioethics committees in the WHO African region. BMC Medical Ethics 6.
33. Fogarty International Center (2005) International Bioethics Education and Career Development Award. Available: http://www.fic.nih.gov/programs/training_grants/bioethics/index.htm . Accessed 19 December 2006.
34. US Department of Health and Human Resources (2006) Office for Human Research Protections. Available: http://www.hhs.gov/ohrp . Accessed 19 December 2006.
35. Bell H, Whiton J, Connelly S (1998) Evaluation of NIH implementation of Section 491 of the Public Health Service Act. Mandating Program of Protection for Research Subjects.
37. US Department of Health and Human Resources/Office of the Inspector General (1998) Institutional review boards: A time for reform.
38. US Department of Health and Human Resources/Office of the Inspector General (2000) Protecting human research subjects: Status of recommendations.
39. Bliwise R (1999) Managing a medical makeover. Duke Magazine 85.
41. Kilama WL (2003) Equipping Africa's researchers for global collaboration. Science and Development Network.
42. Forum for African Medical Editors (2004) FAME editorial guidelines. Available: http://www.who.int/tdr/networking/fame/fame_guidelines.htm . Accessed 19 December 2006.
43. Central African Journal of Medicine (2006) Author guidelines. Available: http://www.ajol.info/submissions.php?jid=52 . Accessed 19 December 2006.
44. World Health Organization (2000) Operational Guidelines for ethical committees that review biomedical research. Geneva: World Health Organization.

Have a language expert improve your writing

Run a free plagiarism check in 10 minutes, generate accurate citations for free.

Knowledge Base

Methodology

Ethical Considerations in Research | Types & Examples

Ethical Considerations in Research | Types & Examples

Published on October 18, 2021 by Pritha Bhandari . Revised on May 9, 2024.

Ethical considerations in research are a set of principles that guide your research designs and practices. Scientists and researchers must always adhere to a certain code of conduct when collecting data from people.

The goals of human research often include understanding real-life phenomena, studying effective treatments, investigating behaviors, and improving lives in other ways. What you decide to research and how you conduct that research involve key ethical considerations.

These considerations work to

protect the rights of research participants
enhance research validity
maintain scientific or academic integrity

Why do research ethics matter, getting ethical approval for your study, types of ethical issues, voluntary participation, informed consent, confidentiality, potential for harm, results communication, examples of ethical failures, other interesting articles, frequently asked questions about research ethics.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe for research subjects.

You’ll balance pursuing important research objectives with using ethical research methods and procedures. It’s always necessary to prevent permanent or excessive harm to participants, whether inadvertent or not.

Defying research ethics will also lower the credibility of your research because it’s hard for others to trust your data if your methods are morally questionable.

Even if a research idea is valuable to society, it doesn’t justify violating the human rights or dignity of your study participants.

Here's why students love Scribbr's proofreading services

Discover proofreading & editing

Before you start any study involving data collection with people, you’ll submit your research proposal to an institutional review board (IRB) .

An IRB is a committee that checks whether your research aims and research design are ethically acceptable and follow your institution’s code of conduct. They check that your research materials and procedures are up to code.

If successful, you’ll receive IRB approval, and you can begin collecting data according to the approved procedures. If you want to make any changes to your procedures or materials, you’ll need to submit a modification application to the IRB for approval.

If unsuccessful, you may be asked to re-submit with modifications or your research proposal may receive a rejection. To get IRB approval, it’s important to explicitly note how you’ll tackle each of the ethical issues that may arise in your study.

There are several ethical issues you should always pay attention to in your research design, and these issues can overlap with each other.

You’ll usually outline ways you’ll deal with each issue in your research proposal if you plan to collect data from participants.


Voluntary participation	Your participants are free to opt in or out of the study at any point in time.
Informed consent	Participants know the purpose, benefits, risks, and funding behind the study before they agree or decline to join.
Anonymity	You don’t know the identities of the participants. Personally identifiable data is not collected.
Confidentiality	You know who the participants are but you keep that information hidden from everyone else. You anonymize personally identifiable data so that it can’t be linked to other data by anyone else.
Potential for harm	Physical, social, psychological and all other types of harm are kept to an absolute minimum.
Results communication	You ensure your work is free of or research misconduct, and you accurately represent your results.

Voluntary participation means that all research subjects are free to choose to participate without any pressure or coercion.

All participants are able to withdraw from, or leave, the study at any point without feeling an obligation to continue. Your participants don’t need to provide a reason for leaving the study.

It’s important to make it clear to participants that there are no negative consequences or repercussions to their refusal to participate. After all, they’re taking the time to help you in the research process , so you should respect their decisions without trying to change their minds.

Voluntary participation is an ethical principle protected by international law and many scientific codes of conduct.

Take special care to ensure there’s no pressure on participants when you’re working with vulnerable groups of people who may find it hard to stop the study even when they want to.

Prevent plagiarism. Run a free check.

Informed consent refers to a situation in which all potential participants receive and understand all the information they need to decide whether they want to participate. This includes information about the study’s benefits, risks, funding, and institutional approval.

You make sure to provide all potential participants with all the relevant information about

what the study is about
the risks and benefits of taking part
how long the study will take
your supervisor’s contact information and the institution’s approval number

Usually, you’ll provide participants with a text for them to read and ask them if they have any questions. If they agree to participate, they can sign or initial the consent form. Note that this may not be sufficient for informed consent when you work with particularly vulnerable groups of people.

If you’re collecting data from people with low literacy, make sure to verbally explain the consent form to them before they agree to participate.

For participants with very limited English proficiency, you should always translate the study materials or work with an interpreter so they have all the information in their first language.

In research with children, you’ll often need informed permission for their participation from their parents or guardians. Although children cannot give informed consent, it’s best to also ask for their assent (agreement) to participate, depending on their age and maturity level.

Anonymity means that you don’t know who the participants are and you can’t link any individual participant to their data.

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, and videos.

In many cases, it may be impossible to truly anonymize data collection . For example, data collected in person or by phone cannot be considered fully anonymous because some personal identifiers (demographic information or phone numbers) are impossible to hide.

You’ll also need to collect some identifying information if you give your participants the option to withdraw their data at a later stage.

Data pseudonymization is an alternative method where you replace identifying information about participants with pseudonymous, or fake, identifiers. The data can still be linked to participants but it’s harder to do so because you separate personal information from the study data.

Confidentiality means that you know who the participants are, but you remove all identifying information from your report.

All participants have a right to privacy, so you should protect their personal data for as long as you store or use it. Even when you can’t collect data anonymously, you should secure confidentiality whenever you can.

Some research designs aren’t conducive to confidentiality, but it’s important to make all attempts and inform participants of the risks involved.

As a researcher, you have to consider all possible sources of harm to participants. Harm can come in many different forms.

Psychological harm: Sensitive questions or tasks may trigger negative emotions such as shame or anxiety.
Social harm: Participation can involve social risks, public embarrassment, or stigma.
Physical harm: Pain or injury can result from the study procedures.
Legal harm: Reporting sensitive data could lead to legal risks or a breach of privacy.

It’s best to consider every possible source of harm in your study as well as concrete ways to mitigate them. Involve your supervisor to discuss steps for harm reduction.

Make sure to disclose all possible risks of harm to participants before the study to get informed consent. If there is a risk of harm, prepare to provide participants with resources or counseling or medical services if needed.

Some of these questions may bring up negative emotions, so you inform participants about the sensitive nature of the survey and assure them that their responses will be confidential.

The way you communicate your research results can sometimes involve ethical issues. Good science communication is honest, reliable, and credible. It’s best to make your results as transparent as possible.

Take steps to actively avoid plagiarism and research misconduct wherever possible.

Plagiarism means submitting others’ works as your own. Although it can be unintentional, copying someone else’s work without proper credit amounts to stealing. It’s an ethical problem in research communication because you may benefit by harming other researchers.

Self-plagiarism is when you republish or re-submit parts of your own papers or reports without properly citing your original work.

This is problematic because you may benefit from presenting your ideas as new and original even though they’ve already been published elsewhere in the past. You may also be infringing on your previous publisher’s copyright, violating an ethical code, or wasting time and resources by doing so.

In extreme cases of self-plagiarism, entire datasets or papers are sometimes duplicated. These are major ethical violations because they can skew research findings if taken as original data.

You notice that two published studies have similar characteristics even though they are from different years. Their sample sizes, locations, treatments, and results are highly similar, and the studies share one author in common.

Research misconduct

Research misconduct means making up or falsifying data, manipulating data analyses, or misrepresenting results in research reports. It’s a form of academic fraud.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement about data analyses.

Research misconduct is a serious ethical issue because it can undermine academic integrity and institutional credibility. It leads to a waste of funding and resources that could have been used for alternative research.

Later investigations revealed that they fabricated and manipulated their data to show a nonexistent link between vaccines and autism. Wakefield also neglected to disclose important conflicts of interest, and his medical license was taken away.

This fraudulent work sparked vaccine hesitancy among parents and caregivers. The rate of MMR vaccinations in children fell sharply, and measles outbreaks became more common due to a lack of herd immunity.

Research scandals with ethical failures are littered throughout history, but some took place not that long ago.

Some scientists in positions of power have historically mistreated or even abused research participants to investigate research problems at any cost. These participants were prisoners, under their care, or otherwise trusted them to treat them with dignity.

To demonstrate the importance of research ethics, we’ll briefly review two research studies that violated human rights in modern history.

These experiments were inhumane and resulted in trauma, permanent disabilities, or death in many cases.

After some Nazi doctors were put on trial for their crimes, the Nuremberg Code of research ethics for human experimentation was developed in 1947 to establish a new standard for human experimentation in medical research.

In reality, the actual goal was to study the effects of the disease when left untreated, and the researchers never informed participants about their diagnoses or the research aims.

Although participants experienced severe health problems, including blindness and other complications, the researchers only pretended to provide medical care.

When treatment became possible in 1943, 11 years after the study began, none of the participants were offered it, despite their health conditions and high risk of death.

Ethical failures like these resulted in severe harm to participants, wasted resources, and lower trust in science and scientists. This is why all research institutions have strict ethical guidelines for performing research.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

Normal distribution
Measures of central tendency
Chi square tests
Confidence interval
Quartiles & Quantiles
Cluster sampling
Stratified sampling
Thematic analysis
Cohort study
Peer review
Ethnography

Research bias

Implicit bias
Cognitive bias
Conformity bias
Hawthorne effect
Availability heuristic
Attrition bias
Social desirability bias

Ethical considerations in research are a set of principles that guide your research designs and practices. These principles include voluntary participation, informed consent, anonymity, confidentiality, potential for harm, and results communication.

Scientists and researchers must always adhere to a certain code of conduct when collecting data from others .

These considerations protect the rights of research participants, enhance research validity , and maintain scientific integrity.

Anonymity means you don’t know who the participants are, while confidentiality means you know who they are but remove identifying information from your research report. Both are important ethical considerations .

You can keep data confidential by using aggregate information in your research report, so that you only refer to groups of participants rather than individuals.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement but a serious ethical failure.

Cite this Scribbr article

If you want to cite this source, you can copy and paste the citation or click the “Cite this Scribbr article” button to automatically add the citation to our free Citation Generator.

Bhandari, P. (2024, May 09). Ethical Considerations in Research | Types & Examples. Scribbr. Retrieved August 19, 2024, from https://www.scribbr.com/methodology/research-ethics/

Is this article helpful?

Pritha Bhandari

Other students also liked, data collection | definition, methods & examples, what is self-plagiarism | definition & how to avoid it, how to avoid plagiarism | tips on citing sources, get unlimited documents corrected.

✔ Free APA citation check included ✔ Unlimited document corrections ✔ Specialized in correcting academic texts

Main Navigation

Contact NeurIPS
Code of Ethics
Code of Conduct
Create Profile
Journal To Conference Track
Diversity & Inclusion
Proceedings
Future Meetings
Exhibitor Information
Privacy Policy

NeurIPS 2024, the Thirty-eighth Annual Conference on Neural Information Processing Systems, will be held at the Vancouver Convention Center

Monday Dec 9 through Sunday Dec 15. Monday is an industry expo.

Registration

Pricing » Registration 2024 Registration Cancellation Policy »

Conference Hotels NeurIPS has contracted Hotel guest rooms for the Conference at group pricing, requiring reservations only through this page. Please do not make room reservations through any other channel, as it only impedes us from putting on the best Conference for you. We thank you for your assistance in helping us protect the NeurIPS conference.

Announcements

See the Visa Information page for changes to the visa process for 2024.
The call for High School Projects has been released
The Call For Papers has been released
The accepted competitions have been released.

Latest NeurIPS Blog Entries [ All Entries ]

Aug 02, 2024
Jun 19, 2024
Jun 04, 2024
May 17, 2024
May 07, 2024
Apr 17, 2024
Apr 15, 2024
Mar 03, 2024
Dec 11, 2023
Dec 10, 2023

Important Dates

	Mar 15 '24 11:46 AM PDT *
	Apr 05 '24 (Anywhere on Earth)
	Apr 21 '24 (Anywhere on Earth)
Main Conference Paper Submission Deadline	May 22 '24 01:00 PM PDT *
	May 22 '24 01:00 PM PDT *
	Jun 14 '24 (Anywhere on Earth)
	Sep 05 '24 (Anywhere on Earth)
Main Conference Author Notification	Sep 25 '24 06:00 PM PDT *
Datasets and Benchmarks - Author Notification	Sep 26 '24 (Anywhere on Earth)
Workshop Accept/Reject Notification Date	Oct 09 '24 (Anywhere on Earth)
	Oct 23 '24 (Anywhere on Earth)
	Oct 30 '24 (Anywhere on Earth)
	Nov 15 '24 11:00 PM PST *
	Timezone:

If you have questions about supporting the conference, please contact us .

View NeurIPS 2024 exhibitors » Become an 2024 Exhibitor Exhibitor Info »

Organizing Committee

General chair, program chair, workshop chair, workshop chair assistant, tutorial chair, competition chair, data and benchmark chair, diversity, inclusion and accessibility chair, affinity chair, ethics review chair, communication chair, social chair, journal chair, creative ai chair, workflow manager, logistics and it, mission statement.

The Neural Information Processing Systems Foundation is a non-profit corporation whose purpose is to foster the exchange of research advances in Artificial Intelligence and Machine Learning, principally by hosting an annual interdisciplinary academic conference with the highest ethical standards for a diverse and inclusive community.

About the Conference

The conference was founded in 1987 and is now a multi-track interdisciplinary annual meeting that includes invited talks, demonstrations, symposia, and oral and poster presentations of refereed papers. Along with the conference is a professional exposition focusing on machine learning in practice, a series of tutorials, and topical workshops that provide a less formal setting for the exchange of ideas.

More about the Neural Information Processing Systems foundation »

NeurIPS uses cookies to remember that you are logged in. By using our websites, you agree to the placement of cookies.

An official website of the United States government

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Publications
Account settings

Preview improvements coming to the PMC website in October 2024. Learn More or Try it out now .

Advanced Search
Journal List
Springer Nature - PMC COVID-19 Collection

Ethical Issues in Research: Perceptions of Researchers, Research Ethics Board Members and Research Ethics Experts

Marie-josée drolet.

1 Department of Occupational Therapy (OT), Université du Québec à Trois-Rivières (UQTR), Trois-Rivières (Québec), Canada

Eugénie Rose-Derouin

2 Bachelor OT program, Université du Québec à Trois-Rivières (UQTR), Trois-Rivières (Québec), Canada

Julie-Claude Leblanc

Mélanie ruest, bryn williams-jones.

3 Department of Social and Preventive Medicine, School of Public Health, Université de Montréal, Montréal (Québec), Canada

In the context of academic research, a diversity of ethical issues, conditioned by the different roles of members within these institutions, arise. Previous studies on this topic addressed mainly the perceptions of researchers. However, to our knowledge, no studies have explored the transversal ethical issues from a wider spectrum, including other members of academic institutions as the research ethics board (REB) members, and the research ethics experts. The present study used a descriptive phenomenological approach to document the ethical issues experienced by a heterogeneous group of Canadian researchers, REB members, and research ethics experts. Data collection involved socio-demographic questionnaires and individual semi-structured interviews. Following the triangulation of different perspectives (researchers, REB members and ethics experts), emerging ethical issues were synthesized in ten units of meaning: (1) research integrity, (2) conflicts of interest, (3) respect for research participants, (4) lack of supervision and power imbalances, (5) individualism and performance, (6) inadequate ethical guidance, (7) social injustices, (8) distributive injustices, (9) epistemic injustices, and (10) ethical distress. This study highlighted several problematic elements that can support the identification of future solutions to resolve transversal ethical issues in research that affect the heterogeneous members of the academic community.

Introduction

Research includes a set of activities in which researchers use various structured methods to contribute to the development of knowledge, whether this knowledge is theoretical, fundamental, or applied (Drolet & Ruest, accepted ). University research is carried out in a highly competitive environment that is characterized by ever-increasing demands (i.e., on time, productivity), insufficient access to research funds, and within a market economy that values productivity and speed often to the detriment of quality or rigour – this research context creates a perfect recipe for breaches in research ethics, like research misbehaviour or misconduct (i.e., conduct that is ethically questionable or unacceptable because it contravenes the accepted norms of responsible conduct of research or compromises the respect of core ethical values that are widely held by the research community) (Drolet & Girard, 2020 ; Sieber, 2004 ). Problematic ethics and integrity issues – e.g., conflicts of interest, falsification of data, non-respect of participants’ rights, and plagiarism, to name but a few – have the potential to both undermine the credibility of research and lead to negative consequences for many stakeholders, including researchers, research assistants and personnel, research participants, academic institutions, and society as a whole (Drolet & Girard, 2020 ). It is thus evident that the academic community should be able to identify these different ethical issues in order to evaluate the nature of the risks that they pose (and for whom), and then work towards their prevention or management (i.e., education, enhanced policies and procedures, risk mitigation strategies).

In this article, we define an “ethical issue” as any situation that may compromise, in whole or in part, the respect of at least one moral value (Swisher et al., 2005 ) that is considered socially legitimate and should thus be respected. In general, ethical issues occur at three key moments or stages of the research process: (1) research design (i.e., conception, project planning), (2) research conduct (i.e., data collection, data analysis) and (3) knowledge translation or communication (e.g., publications of results, conferences, press releases) (Drolet & Ruest, accepted ). According to Sieber ( 2004 ), ethical issues in research can be classified into five categories, related to: (a) communication with participants and the community, (b) acquisition and use of research data, (c) external influence on research, (d) risks and benefits of the research, and (e) selection and use of research theories and methods. Many of these issues are related to breaches of research ethics norms, misbehaviour or research misconduct. Bruhn et al., ( 2002 ) developed a typology of misbehaviour and misconduct in academia that can be used to judge the seriousness of different cases. This typology takes into consideration two axes of reflection: (a) the origin of the situation (i.e., is it the researcher’s own fault or due to the organizational context?), and (b) the scope and severity (i.e., is this the first instance or a recurrent behaviour? What is the nature of the situation? What are the consequences, for whom, for how many people, and for which organizations?).

A previous detailed review of the international literature on ethical issues in research revealed several interesting findings (Beauchemin et al., 2021 ). Indeed, the current literature is dominated by descriptive ethics, i.e., the sharing by researchers from various disciplines of the ethical issues they have personally experienced. While such anecdotal documentation is relevant, it is insufficient because it does not provide a global view of the situation. Among the reviewed literature, empirical studies were in the minority (Table 1 ) – only about one fifth of the sample (n = 19) presented empirical research findings on ethical issues in research. The first of these studies was conducted almost 50 years ago (Hunt et al., 1984 ), with the remainder conducted in the 1990s. Eight studies were conducted in the United States (n = 8), five in Canada (n = 5), three in England (n = 3), two in Sweden (n = 2) and one in Ghana (n = 1).

Summary of Empirical Studies on Ethical Issues in Research by the year of publication

References	Country	Types of research participants	Study design
Hunt et al., ( )	USA	marketing researchers	mixed-methods
Pope & Vetter ( )	USA	members of the American psychological association	quantitative
Swazey et al., ( )	USA	doctoral candidates and faculty members	quantitative
Balk ( )	USA	study participants	mixed-methods
Sigmon ( )	USA	psychopathology researchers	quantitative
Fraser ( )	UK	education researchers	qualitative
Lynöe et al., ( )	Sweden	research ethics board members, researchers, healthcare politicians and district nurses	quantitative
Bouffard ( )	Canada	researchers, health professionals and patients	qualitative
Davison ( )	UK	social work researchers	qualitative
Miyazaki & Taylor ( )	USA	non-traditional undergraduate students	quantitative
Mondain & Bologo ( )	Ghana	researcher participants and other stakeholders	qualitative
Wiegand & Funk ( )	Canada	nurses	quantitative
McGinn ( )	USA	nanotechnology researchers	quantitative
Colnerud ( )	Sweden	researchers	qualitative
Lierville et al., ( )	Canada	Managers, Researchers, Unit Leaders and Practitioners	Qualitative
Giorgini et al., ( )	USA	researchers	mixed-methods
Birchley et al., ( )	UK	smart-home researchers	qualitative
Jarvis ( )	Canada	research participants (women and their family members), health care providers and key stakeholders	qualitative
Drolet & Girard ( )	Canada	occupational therapist researchers	qualitative

Further, the majority of studies in our sample (n = 12) collected the perceptions of a homogeneous group of participants, usually researchers (n = 14) and sometimes health professionals (n = 6). A minority of studies (n = 7) triangulated the perceptions of diverse research stakeholders (i.e., researchers and research participants, or students). To our knowledge, only one study has examined perceptions of ethical issues in research by research ethics board members (REB; Institutional Review Boards [IRB] in the USA), and none to date have documented the perceptions of research ethics experts. Finally, nine studies (n = 9) adopted a qualitative design, seven studies (n = 7) a quantitative design, and three (n = 3) a mixed-methods design.

More studies using empirical research methods are needed to better identify broader trends, to enrich discussions on the values that should govern responsible conduct of research in the academic community, and to evaluate the means by which these values can be supported in practice (Bahn, 2012 ; Beauchemin et al., 2021 ; Bruhn et al., 2002 ; Henderson et al., 2013 ; Resnik & Elliot, 2016; Sieber 2004 ). To this end, we conducted an empirical qualitative study to document the perceptions and experiences of a heterogeneous group of Canadian researchers, REB members, and research ethics experts, to answer the following broad question: What are the ethical issues in research?

Research Methods

Research design.

A qualitative research approach involving individual semi-structured interviews was used to systematically document ethical issues (De Poy & Gitlin, 2010 ; Hammell et al., 2000 ). Specifically, a descriptive phenomenological approach inspired by the philosophy of Husserl was used (Husserl, 1970 , 1999 ), as it is recommended for documenting the perceptions of ethical issues raised by various practices (Hunt & Carnavale, 2011 ).

Ethical considerations

The principal investigator obtained ethics approval for this project from the Research Ethics Board of the Université du Québec à Trois-Rivières (UQTR). All members of the research team signed a confidentiality agreement, and research participants signed the consent form after reading an information letter explaining the nature of the research project.

Sampling and recruitment

As indicated above, three types of participants were sought: (1) researchers from different academic disciplines conducting research (i.e., theoretical, fundamental or empirical) in Canadian universities; (2) REB members working in Canadian organizations responsible for the ethical review, oversight or regulation of research; and (3) research ethics experts, i.e., academics or ethicists who teach research ethics, conduct research in research ethics, or are scholars who have acquired a specialization in research ethics. To be included in the study, participants had to work in Canada, speak and understand English or French, and be willing to participate in the study. Following Thomas and Polio’s (2002) recommendation to recruit between six and twelve participants (for a homogeneous sample) to ensure data saturation, for our heterogeneous sample, we aimed to recruit approximately twelve participants in order to obtain data saturation. Having used this method several times in related projects in professional ethics, data saturation is usually achieved with 10 to 15 participants (Drolet & Goulet, 2018 ; Drolet & Girard, 2020 ; Drolet et al., 2020 ). From experience, larger samples only serve to increase the degree of data saturation, especially in heterogeneous samples (Drolet et al., 2017 , 2019 ; Drolet & Maclure, 2016 ).

Purposive sampling facilitated the identification of participants relevant to documenting the phenomenon in question (Fortin, 2010 ). To ensure a rich and most complete representation of perceptions, we sought participants with varied and complementary characteristics with regards to the social roles they occupy in research practice (Drolet & Girard, 2020 ). A triangulation of sources was used for the recruitment (Bogdan & Biklen, 2006 ). The websites of Canadian universities and Canadian health institution REBs, as well as those of major Canadian granting agencies (i.e., the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council of Canada, Fonds de recherche du Quebec), were searched to identify individuals who might be interested in participating in the study. Further, people known by the research team for their knowledge and sensitivity to ethical issues in research were asked to participate. Research participants were also asked to suggest other individuals who met the study criteria.

Data Collection

Two tools were used for data collecton: (a) a socio-demographic questionnaire, and (b) a semi-structured individual interview guide. English and French versions of these two documents were used and made available, depending on participant preferences. In addition, although the interview guide contained the same questions, they were adapted to participants’ specific roles (i.e., researcher, REB member, research ethics expert). When contacted by email by the research assistant, participants were asked to confirm under which role they wished to participate (because some participants might have multiple, overlapping responsibilities) and they were sent the appropriate interview guide.

The interview guides each had two parts: an introduction and a section on ethical issues. The introduction consisted of general questions to put the participant at ease (i.e., “Tell me what a typical day at work is like for you”). The section on ethical issues was designed to capture the participant’s perceptions through questions such as: “Tell me three stories you have experienced at work that involve an ethical issue?” and “Do you feel that your organization is doing enough to address, manage, and resolve ethical issues in your work?”. Although some interviews were conducted in person, the majority were conducted by videoconference to promote accessibility and because of the COVID-19 pandemic. Interviews were digitally recorded so that the verbatim could be transcribed in full, and varied between 40 and 120 min in duration, with an average of 90 min. Research assistants conducted the interviews and transcribed the verbatim.

Data Analysis

The socio-demographic questionnaires were subjected to simple descriptive statistical analyses (i.e., means and totals), and the semi-structured interviews were subjected to qualitative analysis. The steps proposed by Giorgi ( 1997 ) for a Husserlian phenomenological reduction of the data were used. After collecting, recording, and transcribing the interviews, all verbatim were analyzed by at least two analysts: a research assistant (2nd author of this article) and the principal investigator (1st author) or a postdoctoral fellow (3rd author). The repeated reading of the verbatim allowed the first analyst to write a synopsis, i.e., an initial extraction of units of meaning. The second analyst then read the synopses, which were commented and improved if necessary. Agreement between analysts allowed the final drafting of the interview synopses, which were then analyzed by three analysts to generate and organize the units of meaning that emerged from the qualitative data.

Participants

Sixteen individuals (n = 16) participated in the study, of whom nine (9) identified as female and seven (7) as male (Table 2 ). Participants ranged in age from 22 to 72 years, with a mean age of 47.5 years. Participants had between one (1) and 26 years of experience in the research setting, with an average of 14.3 years of experience. Participants held a variety of roles, including: REB members (n = 11), researchers (n = 10), research ethics experts (n = 4), and research assistant (n = 1). As mentioned previously, seven (7) participants held more than one role, i.e., REB member, research ethics expert, and researcher. The majority (87.5%) of participants were working in Quebec, with the remaining working in other Canadian provinces. Although all participants considered themselves to be francophone, one quarter (n = 4) identified themselves as belonging to a cultural minority group.

Description of Participants

Participant number	Gender	Age	Year(s) of experience	Participant’s role(s)
P1	F	20–25	1–5	REB member, and research assistant
P2	F	45–50	10–15	REB member
P3	F	35–40	20–25	Researcher
P4	H	55–60	20–25	REB member, research ethics expert, and researcher
P5	H	70–75	20–25	REB member and researcher
P6	H	45–50	5–10	REB member
P7	H	40–45	5–10	REB member, research ethics expert, and researcher
P8	H	45–50	15–20	REB member, research ethics expert, and researcher
P9	F	35–40	5–10	REB member
P10	F	65–70	25–30	Researcher and research ethics expert
P11	F	60–65	20–25	REB member
P12	F	45 − 40	20–25	Researcher
P13	F	40–45	5–10	REB member
P14	H	30–35	1–15	Researcher
P15	F	40–45	5–10	REB member and researcher
P16	H	50–55	20–25	Researcher

With respect to their academic background, most participants (n = 9) had a PhD, three (3) had a post-doctorate, two (2) had a master’s degree, and two (2) had a bachelor’s degree. Participants came from a variety of disciplines: nine (9) had a specialty in the humanities or social sciences, four (4) in the health sciences and three (3) in the natural sciences. In terms of their knowledge of ethics, five (5) participants reported having taken one university course entirely dedicated to ethics, four (4) reported having taken several university courses entirely dedicated to ethics, three (3) had a university degree dedicated to ethics, while two (2) only had a few hours or days of training in ethics and two (2) reported having no knowledge of ethics.

Ethical issues

As Fig. 1 illustrates, ten units of meaning emerge from the data analysis, namely: (1) research integrity, (2) conflicts of interest, (3) respect for research participants, (4) lack of supervision and power imbalances, (5) individualism and performance, (6) inadequate ethical guidance, (7) social injustices, (8) distributive injustices, (9) epistemic injustices, and (10) ethical distress. To illustrate the results, excerpts from verbatim interviews are presented in the following sub-sections. Most of the excerpts have been translated into English as the majority of interviews were conducted with French-speaking participants.

An external file that holds a picture, illustration, etc.
Object name is 10805_2022_9455_Fig1_HTML.jpg

Ethical issues in research according to the participants

Research Integrity

The research environment is highly competitive and performance-based. Several participants, in particular researchers and research ethics experts, felt that this environment can lead both researchers and research teams to engage in unethical behaviour that reflects a lack of research integrity. For example, as some participants indicated, competition for grants and scientific publications is sometimes so intense that researchers falsify research results or plagiarize from colleagues to achieve their goals.

Some people will lie or exaggerate their research findings in order to get funding. Then, you see it afterwards, you realize: “ah well, it didn’t work, but they exaggerated what they found and what they did” (participant 14). Another problem in research is the identification of authors when there is a publication. Very often, there are authors who don’t even know what the publication is about and that their name is on it. (…) The time that it surprised me the most was just a few months ago when I saw someone I knew who applied for a teaching position. He got it I was super happy for him. Then I looked at his publications and … there was one that caught my attention much more than the others, because I was in it and I didn’t know what that publication was. I was the second author of a publication that I had never read (participant 14). I saw a colleague who had plagiarized another colleague. [When the colleague] found out about it, he complained. So, plagiarism is a serious [ethical breach]. I would also say that there is a certain amount of competition in the university faculties, especially for grants (…). There are people who want to win at all costs or get as much as possible. They are not necessarily going to consider their colleagues. They don’t have much of a collegial spirit (participant 10).

These examples of research misbehaviour or misconduct are sometimes due to or associated with situations of conflicts of interest, which may be poorly managed by certain researchers or research teams, as noted by many participants.

Conflict of interest

The actors and institutions involved in research have diverse interests, like all humans and institutions. As noted in Chap. 7 of the Canadian Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2, 2018),

“researchers and research students hold trust relationships, either directly or indirectly, with participants, research sponsors, institutions, their professional bodies and society. These trust relationships can be put at risk by conflicts of interest that may compromise independence, objectivity or ethical duties of loyalty. Although the potential for such conflicts has always existed, pressures on researchers (i.e., to delay or withhold dissemination of research outcomes or to use inappropriate recruitment strategies) heighten concerns that conflicts of interest may affect ethical behaviour” (p. 92).

The sources of these conflicts are varied and can include interpersonal conflicts, financial partnerships, third-party pressures, academic or economic interests, a researcher holding multiple roles within an institution, or any other incentive that may compromise a researcher’s independence, integrity, and neutrality (TCPS2, 2018). While it is not possible to eliminate all conflicts of interest, it is important to manage them properly and to avoid temptations to behave unethically.

Ethical temptations correspond to situations in which people are tempted to prioritize their own interests to the detriment of the ethical goods that should, in their own context, govern their actions (Swisher et al., 2005 ). In the case of researchers, this refers to situations that undermine independence, integrity, neutrality, or even the set of principles that govern research ethics (TCPS2, 2018) or the responsible conduct of research. According to study participants, these types of ethical issues frequently occur in research. Many participants, especially researchers and REB members, reported that conflicts of interest can arise when members of an organization make decisions to obtain large financial rewards or to increase their academic profile, often at the expense of the interests of members of their research team, research participants, or even the populations affected by their research.

A company that puts money into making its drug work wants its drug to work. So, homeopathy is a good example, because there are not really any consequences of homeopathy, there are not very many side effects, because there are no effects at all. So, it’s not dangerous, but it’s not a good treatment either. But some people will want to make it work. And that’s a big issue when you’re sitting at a table and there are eight researchers, and there are two or three who are like that, and then there are four others who are neutral, and I say to myself, this is not science. I think that this is a very big ethical issue (participant 14). There are also times in some research where there will be more links with pharmaceutical companies. Obviously, there are then large amounts of money that will be very interesting for the health-care institutions because they still receive money for clinical trials. They’re still getting some compensation because its time consuming for the people involved and all that. The pharmaceutical companies have money, so they will compensate, and that is sometimes interesting for the institutions, and since we are a bit caught up in this, in the sense that we have no choice but to accept it. (…) It may not be the best research in the world, there may be a lot of side effects due to the drugs, but it’s good to accept it, we’re going to be part of the clinical trial (participant 3). It is integrity, what we believe should be done or said. Often by the pressure of the environment, integrity is in tension with the pressures of the environment, so it takes resistance, it takes courage in research. (…) There were all the debates there about the problems of research that was funded and then the companies kept control over what was written. That was really troubling for a lot of researchers (participant 5).

Further, these situations sometimes have negative consequences for research participants as reported by some participants.

Respect for research participants

Many research projects, whether they are psychosocial or biomedical in nature, involve human participants. Relationships between the members of research teams and their research participants raise ethical issues that can be complex. Research projects must always be designed to respect the rights and interests of research participants, and not just those of researchers. However, participants in our study – i.e., REB members, researchers, and research ethics experts – noted that some research teams seem to put their own interests ahead of those of research participants. They also emphasized the importance of ensuring the respect, well-being, and safety of research participants. The ethical issues related to this unit of meaning are: respect for free, informed and ongoing consent of research participants; respect for and the well-being of participants; data protection and confidentiality; over-solicitation of participants; ownership of the data collected on participants; the sometimes high cost of scientific innovations and their accessibility; balance between the social benefits of research and the risks to participants (particularly in terms of safety); balance between collective well-being (development of knowledge) and the individual rights of participants; exploitation of participants; paternalism when working with populations in vulnerable situations; and the social acceptability of certain types of research. The following excerpts present some of these issues.

Where it disturbs me ethically is in the medical field – because it’s more in the medical field that we’re going to see this – when consent forms are presented to patients to solicit them as participants, and then [these forms] have an average of 40 pages. That annoys me. When they say that it has to be easy to understand and all that, adapted to the language, and then the hyper-technical language plus there are 40 pages to read, I don’t understand how you’re going to get informed consent after reading 40 pages. (…) For me, it doesn’t work. I read them to evaluate them and I have a certain level of education and experience in ethics, and there are times when I don’t understand anything (participant 2). There is a lot of pressure from researchers who want to recruit research participants (…). The idea that when you enter a health care institution, you become a potential research participant, when you say “yes to a research, you check yes to all research”, then everyone can ask you. I think that researchers really have this fantasy of saying to themselves: “as soon as people walk through the door of our institution, they become potential participants with whom we can communicate and get them involved in all projects”. There’s a kind of idea that, yes, it can be done, but it has to be somewhat supervised to avoid over-solicitation (…). Researchers are very interested in facilitating recruitment and making it more fluid, but perhaps to the detriment of confidentiality, privacy, and respect; sometimes that’s what it is, to think about what type of data you’re going to have in your bank of potential participants? Is it just name and phone number or are you getting into more sensitive information? (participant 9).

In addition, one participant reported that their university does not provide the resources required to respect the confidentiality of research participants.

The issue is as follows: researchers, of course, commit to protecting data with passwords and all that, but we realize that in practice, it is more difficult. It is not always as protected as one might think, because professor-researchers will run out of space. Will the universities make rooms available to researchers, places where they can store these things, especially when they have paper documentation, and is there indeed a guarantee of confidentiality? Some researchers have told me: “Listen; there are even filing cabinets in the corridors”. So, that certainly poses a concrete challenge. How do we go about challenging the administrative authorities? Tell them it’s all very well to have an ethics committee, but you have to help us, you also have to make sure that the necessary infrastructures are in place so that what we are proposing is really put into practice (participant 4).

If the relationships with research participants are likely to raise ethical issues, so too are the relationships with students, notably research assistants. On this topic, several participants discussed the lack of supervision or recognition offered to research assistants by researchers as well as the power imbalances between members of the research team.

Lack of Supervision and Power Imbalances

Many research teams are composed not only of researchers, but also of students who work as research assistants. The relationship between research assistants and other members of research teams can sometimes be problematic and raise ethical issues, particularly because of the inevitable power asymmetries. In the context of this study, several participants – including a research assistant, REB members, and researchers – discussed the lack of supervision or recognition of the work carried out by students, psychological pressure, and the more or less well-founded promises that are sometimes made to students. Participants also mentioned the exploitation of students by certain research teams, which manifest when students are inadequately paid, i.e., not reflective of the number of hours actually worked, not a fair wage, or even a wage at all.

[As a research assistant], it was more of a feeling of distress that I felt then because I didn’t know what to do. (…) I was supposed to get coaching or be supported, but I didn’t get anything in the end. It was like, “fix it by yourself”. (…) All research assistants were supposed to be supervised, but in practice they were not (participant 1). Very often, we have a master’s or doctoral student that we put on a subject and we consider that the project will be well done, while the student is learning. So, it happens that the student will do a lot of work and then we realize that the work is poorly done, and it is not necessarily the student’s fault. He wasn’t necessarily well supervised. There are directors who have 25 students, and they just don’t supervise them (participant 14). I think it’s really the power relationship. I thought to myself, how I saw my doctorate, the beginning of my research career, I really wanted to be in that laboratory, but they are the ones who are going to accept me or not, so what do I do to be accepted? I finally accept their conditions [which was to work for free]. If these are the conditions that are required to enter this lab, I want to go there. So, what do I do, well I accepted. It doesn’t make sense, but I tell myself that I’m still privileged, because I don’t have so many financial worries, one more reason to work for free, even though it doesn’t make sense (participant 1). In research, we have research assistants. (…). The fact of using people… so that’s it, you have to take into account where they are, respect them, but at the same time they have to show that they are there for the research. In English, we say “carry” or take care of people. With research assistants, this is often a problem that I have observed: for grant machines, the person is the last to be found there. Researchers, who will take, use student data, without giving them the recognition for it (participant 5). The problem at our university is that they reserve funding for Canadian students. The doctoral clientele in my field is mostly foreign students. So, our students are poorly funded. I saw one student end up in the shelter, in a situation of poverty. It ended very badly for him because he lacked financial resources. Once you get into that dynamic, it’s very hard to get out. I was made aware of it because the director at the time had taken him under her wing and wanted to try to find a way to get him out of it. So, most of my students didn’t get funded (participant 16). There I wrote “manipulation”, but it’s kind of all promises all the time. I, for example, was promised a lot of advancement, like when I got into the lab as a graduate student, it was said that I had an interest in [this particular area of research]. I think there are a lot of graduate students who must have gone through that, but it is like, “Well, your CV has to be really good, if you want to do a lot of things and big things. If you do this, if you do this research contract, the next year you could be the coordinator of this part of the lab and supervise this person, get more contracts, be paid more. Let’s say: you’ll be invited to go to this conference, this big event”. They were always dangling something, but you have to do that first to get there. But now, when you’ve done that, you have to do this business. It’s like a bit of manipulation, I think. That was very hard to know who is telling the truth and who is not (participant 1).

These ethical issues have significant negative consequences for students. Indeed, they sometimes find themselves at the mercy of researchers, for whom they work, struggling to be recognized and included as authors of an article, for example, or to receive the salary that they are due. For their part, researchers also sometimes find themselves trapped in research structures that can negatively affect their well-being. As many participants reported, researchers work in organizations that set very high productivity standards and in highly competitive contexts, all within a general culture characterized by individualism.

Individualism and performance

Participants, especially researchers, discussed the culture of individualism and performance that characterizes the academic environment. In glorifying excellence, some universities value performance and productivity, often at the expense of psychological well-being and work-life balance (i.e., work overload and burnout). Participants noted that there are ethical silences in their organizations on this issue, and that the culture of individualism and performance is not challenged for fear of retribution or simply to survive, i.e., to perform as expected. Participants felt that this culture can have a significant negative impact on the quality of the research conducted, as research teams try to maximize the quantity of their work (instead of quality) in a highly competitive context, which is then exacerbated by a lack of resources and support, and where everything must be done too quickly.

The work-life balance with the professional ethics related to work in a context where you have too much and you have to do a lot, it is difficult to balance all that and there is a lot of pressure to perform. If you don’t produce enough, that’s it; after that, you can’t get any more funds, so that puts pressure on you to do more and more and more (participant 3). There is a culture, I don’t know where it comes from, and that is extremely bureaucratic. If you dare to raise something, you’re going to have many, many problems. They’re going to make you understand it. So, I don’t talk. It is better: your life will be easier. I think there are times when you have to talk (…) because there are going to be irreparable consequences. (…) I’m not talking about a climate of terror, because that’s exaggerated, it’s not true, people are not afraid. But people close their office door and say nothing because it’s going to make their work impossible and they’re not going to lose their job, they’re not going to lose money, but researchers need time to be focused, so they close their office door and say nothing (participant 16).

Researchers must produce more and more, and they feel little support in terms of how to do such production, ethically, and how much exactly they are expected to produce. As this participant reports, the expectation is an unspoken rule: more is always better.

It’s sometimes the lack of a clear line on what the expectations are as a researcher, like, “ah, we don’t have any specific expectations, but produce, produce, produce, produce.” So, in that context, it’s hard to be able to put the line precisely: “have I done enough for my work?” (participant 3).

Inadequate ethical Guidance

While the productivity expectation is not clear, some participants – including researchers, research ethics experts, and REB members – also felt that the ethical expectations of some REBs were unclear. The issue of the inadequate ethical guidance of research includes the administrative mechanisms to ensure that research projects respect the principles of research ethics. According to those participants, the forms required for both researchers and REB members are increasingly long and numerous, and one participant noted that the standards to be met are sometimes outdated and disconnected from the reality of the field. Multicentre ethics review (by several REBs) was also critiqued by a participant as an inefficient method that encumbers the processes for reviewing research projects. Bureaucratization imposes an ever-increasing number of forms and ethics guidelines that actually hinder researchers’ ethical reflection on the issues at stake, leading the ethics review process to be perceived as purely bureaucratic in nature.

The ethical dimension and the ethical review of projects have become increasingly bureaucratized. (…) When I first started working (…) it was less bureaucratic, less strict then. I would say [there are now] tons of forms to fill out. Of course, we can’t do without it, it’s one of the ways of marking out ethics and ensuring that there are ethical considerations in research, but I wonder if it hasn’t become too bureaucratized, so that it’s become a kind of technical reflex to fill out these forms, and I don’t know if people really do ethical reflection as such anymore (participant 10). The fundamental structural issue, I would say, is the mismatch between the normative requirements and the real risks posed by the research, i.e., we have many, many requirements to meet; we have very long forms to fill out but the research projects we evaluate often pose few risks (participant 8). People [in vulnerable situations] were previously unable to participate because of overly strict research ethics rules that were to protect them, but in the end [these rules] did not protect them. There was a perverse effect, because in the end there was very little research done with these people and that’s why we have very few results, very little evidence [to support practices with these populations] so it didn’t improve the quality of services. (…) We all understand that we have to be careful with that, but when the research is not too risky, we say to ourselves that it would be good because for once a researcher who is interested in that population, because it is not a very popular population, it would be interesting to have results, but often we are blocked by the norms, and then we can’t accept [the project] (participant 2).

Moreover, as one participant noted, accessing ethics training can be a challenge.

There is no course on research ethics. […] Then, I find that it’s boring because you go through university and you come to do your research and you know how to do quantitative and qualitative research, but all the research ethics, where do you get this? I don’t really know (participant 13).

Yet, such training could provide relevant tools to resolve, to some extent, the ethical issues that commonly arise in research. That said, and as noted by many participants, many ethical issues in research are related to social injustices over which research actors have little influence.

Social Injustices

For many participants, notably researchers, the issues that concern social injustices are those related to power asymmetries, stigma, or issues of equity, diversity, and inclusion, i.e., social injustices related to people’s identities (Blais & Drolet, 2022 ). Participants reported experiencing or witnessing discrimination from peers, administration, or lab managers. Such oppression is sometimes cross-sectional and related to a person’s age, cultural background, gender or social status.

I have my African colleague who was quite successful when he arrived but had a backlash from colleagues in the department. I think it’s unconscious, nobody is overtly racist. But I have a young person right now who is the same, who has the same success, who got exactly the same early career award and I don’t see the same backlash. He’s just as happy with what he’s doing. It’s normal, they’re young and they have a lot of success starting out. So, I think there is discrimination. Is it because he is African? Is it because he is black? I think it’s on a subconscious level (participant 16).

Social injustices were experienced or reported by many participants, and included issues related to difficulties in obtaining grants or disseminating research results in one’s native language (i.e., even when there is official bilingualism) or being considered credible and fundable in research when one researcher is a woman.

If you do international research, there are things you can’t talk about (…). It is really a barrier to research to not be able to (…) address this question [i.e. the question of inequalities between men and women]. Women’s inequality is going to be addressed [but not within the country where the research takes place as if this inequality exists elsewhere but not here]. There are a lot of women working on inequality issues, doing work and it’s funny because I was talking to a young woman who works at Cairo University and she said to me: “Listen, I saw what you had written, you’re right. I’m willing to work on this but guarantee me a position at your university with a ticket to go”. So yes, there are still many barriers [for women in research] (participant 16).

Because of the varied contextual characteristics that intervene in their occurrence, these social injustices are also related to distributive injustices, as discussed by many participants.

Distributive Injustices

Although there are several views of distributive justice, a classical definition such as that of Aristotle ( 2012 ), describes distributive justice as consisting in distributing honours, wealth, and other social resources or benefits among the members of a community in proportion to their alleged merit. Justice, then, is about determining an equitable distribution of common goods. Contemporary theories of distributive justice are numerous and varied. Indeed, many authors (e.g., Fraser 2011 ; Mills, 2017 ; Sen, 2011 ; Young, 2011 ) have, since Rawls ( 1971 ), proposed different visions of how social burdens and benefits should be shared within a community to ensure equal respect, fairness, and distribution. In our study, what emerges from participants’ narratives is a definite concern for this type of justice. Women researchers, francophone researchers, early career researchers or researchers belonging to racialized groups all discussed inequities in the distribution of research grants and awards, and the extra work they need to do to somehow prove their worth. These inequities are related to how granting agencies determine which projects will be funded.

These situations make me work 2–3 times harder to prove myself and to show people in power that I have a place as a woman in research (participant 12). Number one: it’s conservative thinking. The older ones control what comes in. So, the younger people have to adapt or they don’t get funded (participant 14).

Whether it is discrimination against stigmatized or marginalized populations or interest in certain hot topics, granting agencies judge research projects according to criteria that are sometimes questionable, according to those participants. Faced with difficulties in obtaining funding for their projects, several strategies – some of which are unethical – are used by researchers in order to cope with these situations.

Sometimes there are subjects that everyone goes to, such as nanotechnology (…), artificial intelligence or (…) the therapeutic use of cannabis, which are very fashionable, and this is sometimes to the detriment of other research that is just as relevant, but which is (…), less sexy, less in the spirit of the time. (…) Sometimes this can lead to inequities in the funding of certain research sectors (participant 9). When we use our funds, we get them given to us, we pretty much say what we think we’re going to do with them, but things change… So, when these things change, sometimes it’s an ethical decision, but by force of circumstances I’m obliged to change the project a little bit (…). Is it ethical to make these changes or should I just let the money go because I couldn’t use it the way I said I would? (participant 3).

Moreover, these distributional injustices are not only linked to social injustices, but also epistemic injustices. Indeed, the way in which research honours and grants are distributed within the academic community depends on the epistemic authority of the researchers, which seems to vary notably according to their language of use, their age or their gender, but also to the research design used (inductive versus deductive), their decision to use (or not use) animals in research, or to conduct activist research.

Epistemic injustices

The philosopher Fricker ( 2007 ) conceptualized the notions of epistemic justice and injustice. Epistemic injustice refers to a form of social inequality that manifests itself in the access, recognition, and production of knowledge as well as the various forms of ignorance that arise (Godrie & Dos Santos, 2017 ). Addressing epistemic injustice necessitates acknowledging the iniquitous wrongs suffered by certain groups of socially stigmatized individuals who have been excluded from knowledge, thus limiting their abilities to interpret, understand, or be heard and account for their experiences. In this study, epistemic injustices were experienced or reported by some participants, notably those related to difficulties in obtaining grants or disseminating research results in one’s native language (i.e., even when there is official bilingualism) or being considered credible and fundable in research when a researcher is a woman or an early career researcher.

I have never sent a grant application to the federal government in English. I have always done it in French, even though I know that when you receive the review, you can see that reviewers didn’t understand anything because they are English-speaking. I didn’t want to get in the boat. It’s not my job to translate, because let’s be honest, I’m not as good in English as I am in French. So, I do them in my first language, which is the language I’m most used to. Then, technically at the administrative level, they are supposed to be able to do it, but they are not good in French. (…) Then, it’s a very big Canadian ethical issue, because basically there are technically two official languages, but Canada is not a bilingual country, it’s a country with two languages, either one or the other. (…) So I was not funded (participant 14).

Researchers who use inductive (or qualitative) methods observed that their projects are sometimes less well reviewed or understood, while research that adopts a hypothetical-deductive (or quantitative) or mixed methods design is better perceived, considered more credible and therefore more easily funded. Of course, regardless of whether a research project adopts an inductive, deductive or mixed-methods scientific design, or whether it deals with qualitative or quantitative data, it must respect a set of scientific criteria. A research project should achieve its objectives by using proven methods that, in the case of inductive research, are credible, reliable, and transferable or, in the case of deductive research, generalizable, objective, representative, and valid (Drolet & Ruest, accepted ). Participants discussing these issues noted that researchers who adopt a qualitative design or those who question the relevance of animal experimentation or are not militant have sometimes been unfairly devalued in their epistemic authority.

There is a mini war between quantitative versus qualitative methods, which I think is silly because science is a method. If you apply the method well, it doesn’t matter what the field is, it’s done well and it’s perfect ” (participant 14). There is also the issue of the place of animals in our lives, because for me, ethics is human ethics, but also animal ethics. Then, there is a great evolution in society on the role of the animal… with the new law that came out in Quebec on the fact that animals are sensitive beings. Then, with the rise of the vegan movement, [we must ask ourselves]: “Do animals still have a place in research?” That’s a big question and it also means that there are practices that need to evolve, but sometimes there’s a disconnection between what’s expected by research ethics boards versus what’s expected in the field (participant 15). In research today, we have more and more research that is militant from an ideological point of view. And so, we have researchers, because they defend values that seem important to them, we’ll talk for example about the fight for equality and social justice. They have pressure to defend a form of moral truth and have the impression that everyone thinks like them or should do so, because they are defending a moral truth. This is something that we see more and more, namely the lack of distance between ideology and science (participant 8).

The combination or intersectionality of these inequities, which seems to be characterized by a lack of ethical support and guidance, is experienced in the highly competitive and individualistic context of research; it provides therefore the perfect recipe for researchers to experience ethical distress.

Ethical distress

The concept of “ethical distress” refers to situations in which people know what they should do to act ethically, but encounter barriers, generally of an organizational or systemic nature, limiting their power to act according to their moral or ethical values (Drolet & Ruest, 2021 ; Jameton, 1984 ; Swisher et al., 2005 ). People then run the risk of finding themselves in a situation where they do not act as their ethical conscience dictates, which in the long term has the potential for exhaustion and distress. The examples reported by participants in this study point to the fact that researchers in particular may be experiencing significant ethical distress. This distress takes place in a context of extreme competition, constant injunctions to perform, and where administrative demands are increasingly numerous and complex to complete, while paradoxically, they lack the time to accomplish all their tasks and responsibilities. Added to these demands are a lack of resources (human, ethical, and financial), a lack of support and recognition, and interpersonal conflicts.

We are in an environment, an elite one, you are part of it, you know what it is: “publish or perish” is the motto. Grants, there is a high level of performance required, to do a lot, to publish, to supervise students, to supervise them well, so yes, it is clear that we are in an environment that is conducive to distress. (…). Overwork, definitely, can lead to distress and eventually to exhaustion. When you know that you should take the time to read the projects before sharing them, but you don’t have the time to do that because you have eight that came in the same day, and then you have others waiting… Then someone rings a bell and says: “ah but there, the protocol is a bit incomplete”. Oh yes, look at that, you’re right. You make up for it, but at the same time it’s a bit because we’re in a hurry, we don’t necessarily have the resources or are able to take the time to do things well from the start, we have to make up for it later. So yes, it can cause distress (participant 9). My organization wanted me to apply in English, and I said no, and everyone in the administration wanted me to apply in English, and I always said no. Some people said: “Listen, I give you the choice”, then some people said: “Listen, I agree with you, but if you’re not [submitting] in English, you won’t be funded”. Then the fact that I am young too, because very often they will look at the CV, they will not look at the project: “ah, his CV is not impressive, we will not finance him”. This is complete nonsense. The person is capable of doing the project, the project is fabulous: we fund the project. So, that happened, organizational barriers: that happened a lot. I was not eligible for Quebec research funds (…). I had big organizational barriers unfortunately (participant 14). At the time of my promotion, some colleagues were not happy with the type of research I was conducting. I learned – you learn this over time when you become friends with people after you enter the university – that someone was against me. He had another candidate in mind, and he was angry about the selection. I was under pressure for the first three years until my contract was renewed. I almost quit at one point, but another colleague told me, “No, stay, nothing will happen”. Nothing happened, but these issues kept me awake at night (participant 16).

This difficult context for many researchers affects not only the conduct of their own research, but also their participation in research. We faced this problem in our study, despite the use of multiple recruitment methods, including more than 200 emails – of which 191 were individual solicitations – sent to potential participants by the two research assistants. REB members and organizations overseeing or supporting research (n = 17) were also approached to see if some of their employees would consider participating. While it was relatively easy to recruit REB members and research ethics experts, our team received a high number of non-responses to emails (n = 175) and some refusals (n = 5), especially by researchers. The reasons given by those who replied were threefold: (a) fear of being easily identified should they take part in the research, (b) being overloaded and lacking time, and (c) the intrusive aspect of certain questions (i.e., “Have you experienced a burnout episode? If so, have you been followed up medically or psychologically?”). In light of these difficulties and concerns, some questions in the socio-demographic questionnaire were removed or modified. Talking about burnout in research remains a taboo for many researchers, which paradoxically can only contribute to the unresolved problem of unhealthy research environments.

Returning to the research question and objective

The question that prompted this research was: What are the ethical issues in research? The purpose of the study was to describe these issues from the perspective of researchers (from different disciplines), research ethics board (REB) members, and research ethics experts. The previous section provided a detailed portrait of the ethical issues experienced by different research stakeholders: these issues are numerous, diverse and were recounted by a range of stakeholders.

The results of the study are generally consistent with the literature. For example, as in our study, the literature discusses the lack of research integrity on the part of some researchers (Al-Hidabi et al., 2018 ; Swazey et al., 1993 ), the numerous conflicts of interest experienced in research (Williams-Jones et al., 2013 ), the issues of recruiting and obtaining the free and informed consent of research participants (Provencher et al., 2014 ; Keogh & Daly, 2009 ), the sometimes difficult relations between researchers and REBs (Drolet & Girard, 2020 ), the epistemological issues experienced in research (Drolet & Ruest, accepted; Sieber 2004 ), as well as the harmful academic context in which researchers evolve, insofar as this is linked to a culture of performance, an overload of work in a context of accountability (Berg & Seeber, 2016 ; FQPPU; 2019 ) that is conducive to ethical distress and even burnout.

If the results of the study are generally in line with those of previous publications on the subject, our findings also bring new elements to the discussion while complementing those already documented. In particular, our results highlight the role of systemic injustices – be they social, distributive or epistemic – within the environments in which research is carried out, at least in Canada. To summarize, the results of our study point to the fact that the relationships between researchers and research participants are likely still to raise worrying ethical issues, despite widely accepted research ethics norms and institutionalized review processes. Further, the context in which research is carried out is not only conducive to breaches of ethical norms and instances of misbehaviour or misconduct, but also likely to be significantly detrimental to the health and well-being of researchers, as well as research assistants. Another element that our research also highlighted is the instrumentalization and even exploitation of students and research assistants, which is another important and worrying social injustice given the inevitable power imbalances between students and researchers.

Moreover, in a context in which ethical issues are often discussed from a micro perspective, our study helps shed light on both the micro- and macro-level ethical dimensions of research (Bronfenbrenner, 1979 ; Glaser 1994 ). However, given that ethical issues in research are not only diverse, but also and above all complex, a broader perspective that encompasses the interplay between the micro and macro dimensions can enable a better understanding of these issues and thereby support the identification of the multiple factors that may be at their origin. Triangulating the perspectives of researchers with those of REB members and research ethics experts enabled us to bring these elements to light, and thus to step back from and critique the way that research is currently conducted. To this end, attention to socio-political elements such as the performance culture in academia or how research funds are distributed, and according to what explicit and implicit criteria, can contribute to identifying the sources of the ethical issues described above.

Contemporary culture characterized by the social acceleration

The German sociologist and philosopher Rosa (2010) argues that late modernity – that is, the period between the 1980s and today – is characterized by a phenomenon of social acceleration that causes various forms of alienation in our relationship to time, space, actions, things, others and ourselves. Rosa distinguishes three types of acceleration: technical acceleration , the acceleration of social changes and the acceleration of the rhythm of life . According to Rosa, social acceleration is the main problem of late modernity, in that the invisible social norm of doing more and faster to supposedly save time operates unchallenged at all levels of individual and collective life, as well as organizational and social life. Although we all, researchers and non-researchers alike, perceive this unspoken pressure to be ever more productive, the process of social acceleration as a new invisible social norm is our blind spot, a kind of tyrant over which we have little control. This conceptualization of the contemporary culture can help us to understand the context in which research is conducted (like other professional practices). To this end, Berg & Seeber ( 2016 ) invite faculty researchers to slow down in order to better reflect and, in the process, take care of their health and their relationships with their colleagues and students. Many women professors encourage their fellow researchers, especially young women researchers, to learn to “say No” in order to protect their mental and physical health and to remain in their academic careers (Allaire & Descheneux, 2022 ). These authors also remind us of the relevance of Kahneman’s ( 2012 ) work which demonstrates that it takes time to think analytically, thoroughly, and logically. Conversely, thinking quickly exposes humans to cognitive and implicit biases that then lead to errors in thinking (e.g., in the analysis of one’s own research data or in the evaluation of grant applications or student curriculum vitae). The phenomenon of social acceleration, which pushes the researcher to think faster and faster, is likely to lead to unethical bad science that can potentially harm humankind. In sum, Rosa’s invitation to contemporary critical theorists to seriously consider the problem of social acceleration is particularly insightful to better understand the ethical issues of research. It provides a lens through which to view the toxic context in which research is conducted today, and one that was shared by the participants in our study.

Clark & Sousa ( 2022 ) note, it is important that other criteria than the volume of researchers’ contributions be valued in research, notably quality. Ultimately, it is the value of the knowledge produced and its influence on the concrete lives of humans and other living beings that matters, not the quantity of publications. An interesting articulation of this view in research governance is seen in a change in practice by Australia’s national health research funder: they now restrict researchers to listing on their curriculum vitae only the top ten publications from the past ten years (rather than all of their publications), in order to evaluate the quality of contributions rather than their quantity. To create environments conducive to the development of quality research, it is important to challenge the phenomenon of social acceleration, which insidiously imposes a quantitative normativity that is both alienating and detrimental to the quality and ethical conduct of research. Based on our experience, we observe that the social norm of acceleration actively disfavours the conduct of empirical research on ethics in research. The fact is that researchers are so busy that it is almost impossible for them to find time to participate in such studies. Further, operating in highly competitive environments, while trying to respect the values and ethical principles of research, creates ethical paradoxes for members of the research community. According to Malherbe ( 1999 ), an ethical paradox is a situation where an individual is confronted by contradictory injunctions (i.e., do more, faster, and better). And eventually, ethical paradoxes lead individuals to situations of distress and burnout, or even to ethical failures (i.e., misbehaviour or misconduct) in the face of the impossibility of responding to contradictory injunctions.

Strengths and Limitations of the study

The triangulation of perceptions and experiences of different actors involved in research is a strength of our study. While there are many studies on the experiences of researchers, rarely are members of REBs and experts in research ethics given the space to discuss their views of what are ethical issues. Giving each of these stakeholders a voice and comparing their different points of view helped shed a different and complementary light on the ethical issues that occur in research. That said, it would have been helpful to also give more space to issues experienced by students or research assistants, as the relationships between researchers and research assistants are at times very worrying, as noted by a participant, and much work still needs to be done to eliminate the exploitative situations that seem to prevail in certain research settings. In addition, no Indigenous or gender diverse researchers participated in the study. Given the ethical issues and systemic injustices that many people from these groups face in Canada (Drolet & Goulet, 2018 ; Nicole & Drolet, in press ), research that gives voice to these researchers would be relevant and contribute to knowledge development, and hopefully also to change in research culture.

Further, although most of the ethical issues discussed in this article may be transferable to the realities experienced by researchers in other countries, the epistemic injustice reported by Francophone researchers who persist in doing research in French in Canada – which is an officially bilingual country but in practice is predominantly English – is likely specific to the Canadian reality. In addition, and as mentioned above, recruitment proved exceedingly difficult, particularly amongst researchers. Despite this difficulty, we obtained data saturation for all but two themes – i.e., exploitation of students and ethical issues of research that uses animals. It follows that further empirical research is needed to improve our understanding of these specific issues, as they may diverge to some extent from those documented here and will likely vary across countries and academic research contexts.

Conclusions

This study, which gave voice to researchers, REB members, and ethics experts, reveals that the ethical issues in research are related to several problematic elements as power imbalances and authority relations. Researchers and research assistants are subject to external pressures that give rise to integrity issues, among others ethical issues. Moreover, the current context of social acceleration influences the definition of the performance indicators valued in academic institutions and has led their members to face several ethical issues, including social, distributive, and epistemic injustices, at different steps of the research process. In this study, ten categories of ethical issues were identified, described and illustrated: (1) research integrity, (2) conflicts of interest, (3) respect for research participants, (4) lack of supervision and power imbalances, (5) individualism and performance, (6) inadequate ethical guidance, (7) social injustices, (8) distributive injustices, (9) epistemic injustices, and (10) ethical distress. The triangulation of the perspectives of different members (i.e., researchers from different disciplines, REB members, research ethics experts, and one research assistant) involved in the research process made it possible to lift the veil on some of these ethical issues. Further, it enabled the identification of additional ethical issues, especially systemic injustices experienced in research. To our knowledge, this is the first time that these injustices (social, distributive, and epistemic injustices) have been clearly identified.

Finally, this study brought to the fore several problematic elements that are important to address if the research community is to develop and implement the solutions needed to resolve the diverse and transversal ethical issues that arise in research institutions. A good starting point is the rejection of the corollary norms of “publish or perish” and “do more, faster, and better” and their replacement with “publish quality instead of quantity”, which necessarily entails “do less, slower, and better”. It is also important to pay more attention to the systemic injustices within which researchers work, because these have the potential to significantly harm the academic careers of many researchers, including women researchers, early career researchers, and those belonging to racialized groups as well as the health, well-being, and respect of students and research participants.

Acknowledgements

The team warmly thanks the participants who took part in the research and who made this study possible. Marie-Josée Drolet thanks the five research assistants who participated in the data collection and analysis: Julie-Claude Leblanc, Élie Beauchemin, Pénéloppe Bernier, Louis-Pierre Côté, and Eugénie Rose-Derouin, all students at the Université du Québec à Trois-Rivières (UQTR), two of whom were active in the writing of this article. MJ Drolet and Bryn Williams-Jones also acknowledge the financial contribution of the Social Sciences and Humanities Research Council of Canada (SSHRC), which supported this research through a grant. We would also like to thank the reviewers of this article who helped us improve it, especially by clarifying and refining our ideas.

Competing Interests and Funding

As noted in the Acknowledgements, this research was supported financially by the Social Sciences and Humanities Research Council of Canada (SSHRC).

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Al-Hidabi, Abdulmalek, M. D., & The, P. L. (2018). Multiple Publications: The Main Reason for the Retraction of Papers in Computer Science. In K. Arai, S. Kapoor, & R. Bhatia (eds), Future of Information and Communication Conference (FICC): Advances in Information and Communication, Advances in Intelligent Systems and Computing (AISC), Springer, vol. 886, pp. 511–526
Allaire, S., & Deschenaux, F. (2022). Récits de professeurs d’université à mi-carrière. Si c’était à refaire… . Presses de l’Université du Québec
Aristotle . Aristotle’s Nicomachean Ethics. Chicago: The University of Chicago Press; 2012. [ Google Scholar ]
Bahn S. Keeping Academic Field Researchers Safe: Ethical Safeguards. Journal of Academic Ethics. 2012; 10 :83–91. doi: 10.1007/s10805-012-9159-2. [ CrossRef ] [ Google Scholar ]
Balk DE. Bereavement Research Using Control Groups: Ethical Obligations and Questions. Death Studies. 1995; 19 :123–138. doi: 10.1080/07481189508252720. [ PubMed ] [ CrossRef ] [ Google Scholar ]
Beauchemin, É., Côté, L. P., Drolet, M. J., & Williams-Jones, B. (2021). Conceptualizing Ethical Issues in the Conduct of Research: Results from a Critical and Systematic Literature Review. Journal of Academic Ethics , Early Online. 10.1007/s10805-021-09411-7
Berg, M., & Seeber, B. K. (2016). The Slow Professor . University of Toronto Press
Birchley G, Huxtable R, Murtagh M, Meulen RT, Flach P, Gooberman-Hill R. Smart homes, private homes? An empirical study of technology researchers’ perceptions of ethical issues in developing smart-home health technologies. BMC Medical Ethics. 2017; 18 (23):1–13. doi: 10.1186/s12910-017-0183-z. [ PMC free article ] [ PubMed ] [ CrossRef ] [ Google Scholar ]
Blais, J., & Drolet, M. J. (2022). Les injustices sociales vécues en camp de réfugiés: les comprendre pour mieux intervenir auprès de personnes ayant séjourné dans un camp de réfugiés. Recueil annuel belge d’ergothérapie , 14, 37–48
Bogdan, R. C., & Biklen, S. K. (2006). Qualitative research in education: An introduction to theory and methods . Allyn & Bacon
Bouffard C. Le développement des pratiques de la génétique médicale et la construction des normes bioéthiques. Anthropologie et Sociétés. 2000; 24 (2):73–90. doi: 10.7202/015650ar. [ CrossRef ] [ Google Scholar ]
Bronfenbrenner, U. (1979). The Ecology of Human development. Experiments by nature and design . Harvard University Press
Bruhn JG, Zajac G, Al-Kazemi AA, Prescott LD. Moral positions and academic conduct: Parameters of tolerance for ethics failure. Journal of Higher Education. 2002; 73 (4):461–493. doi: 10.1353/jhe.2002.0033. [ CrossRef ] [ Google Scholar ]
Clark, A., & Sousa (2022). It’s time to end Canada’s obsession with research quantity. University Affairs/Affaires universitaires , February 14th. https://www.universityaffairs.ca/career-advice/effective-successfull-happy-academic/its-time-to-end-canadas-obsession-with-research-quantity/?utm_source=University+Affairs+e-newsletter&utm_campaign=276a847f 70-EMAIL_CAMPAIGN_2022_02_16&utm_medium=email&utm_term=0_314bc2ee29-276a847f70-425259989
Colnerud G. Ethical dilemmas in research in relation to ethical review: An empirical study. Research Ethics. 2015; 10 (4):238–253. doi: 10.1177/1747016114552339. [ CrossRef ] [ Google Scholar ]
Davison J. Dilemmas in Research: Issues of Vulnerability and Disempowerment for the Social Workers/Researcher. Journal of Social Work Practice. 2004; 18 (3):379–393. doi: 10.1080/0265053042000314447. [ CrossRef ] [ Google Scholar ]
DePoy E, Gitlin LN. Introduction to Research. St. Louis: Elsevier Mosby; 2010. [ Google Scholar ]
Drolet, M. J., & Goulet, M. (2018). Travailler avec des patients autochtones du Canada ? Perceptions d’ergothérapeutes du Québec des enjeux éthiques de cette pratique. Recueil annuel belge francophone d’ergothérapie , 10 , 25–56
Drolet MJ, Girard K. Les enjeux éthiques de la recherche en ergothérapie: un portrait préoccupant. Revue canadienne de bioéthique. 2020; 3 (3):21–40. doi: 10.7202/1073779ar. [ CrossRef ] [ Google Scholar ]
Drolet MJ, Girard K, Gaudet R. Les enjeux éthiques de l’enseignement en ergothérapie: des injustices au sein des départements universitaires. Revue canadienne de bioéthique. 2020; 3 (1):22–36. [ Google Scholar ]
Drolet MJ, Maclure J. Les enjeux éthiques de la pratique de l’ergothérapie: perceptions d’ergothérapeutes. Revue Approches inductives. 2016; 3 (2):166–196. doi: 10.7202/1037918ar. [ CrossRef ] [ Google Scholar ]
Drolet MJ, Pinard C, Gaudet R. Les enjeux éthiques de la pratique privée: des ergothérapeutes du Québec lancent un cri d’alarme. Ethica – Revue interdisciplinaire de recherche en éthique. 2017; 21 (2):173–209. [ Google Scholar ]
Drolet MJ, Ruest M. De l’éthique à l’ergothérapie: un cadre théorique et une méthode pour soutenir la pratique professionnelle. Québec: Presses de l’Université du Québec; 2021. [ Google Scholar ]
Drolet, M. J., & Ruest, M. (accepted). Quels sont les enjeux éthiques soulevés par la recherche scientifique? In M. Lalancette & J. Luckerhoff (dir). Initiation au travail intellectuel et à la recherche . Québec: Presses de l’Université du Québec, 18 p
Drolet MJ, Sauvageau A, Baril N, Gaudet R. Les enjeux éthiques de la formation clinique en ergothérapie. Revue Approches inductives. 2019; 6 (1):148–179. doi: 10.7202/1060048ar. [ CrossRef ] [ Google Scholar ]
Fédération québécoise des professeures et des professeurs d’université (FQPPU) Enquête nationale sur la surcharge administrative du corps professoral universitaire québécois. Principaux résultats et pistes d’action. Montréal: FQPPU; 2019. [ Google Scholar ]
Fortin MH. Fondements et étapes du processus de recherche. Méthodes quantitatives et qualitatives. Montréal, QC: Chenelière éducation; 2010. [ Google Scholar ]
Fraser DM. Ethical dilemmas and practical problems for the practitioner researcher. Educational Action Research. 1997; 5 (1):161–171. doi: 10.1080/09650799700200014. [ CrossRef ] [ Google Scholar ]
Fraser, N. (2011). Qu’est-ce que la justice sociale? Reconnaissance et redistribution . La Découverte
Fricker, M. (2007). Epistemic Injustice: Power and the Ethics of Knowing . Oxford University Press
Giorgi A, et al. De la méthode phénoménologique utilisée comme mode de recherche qualitative en sciences humaines: théories, pratique et évaluation. In: Poupart J, Groulx LH, Deslauriers JP, et al., editors. La recherche qualitative: enjeux épistémologiques et méthodologiques. Boucherville, QC: Gaëtan Morin; 1997. pp. 341–364. [ Google Scholar ]
Giorgini V, Mecca JT, Gibson C, Medeiros K, Mumford MD, Connelly S, Devenport LD. Researcher Perceptions of Ethical Guidelines and Codes of Conduct. Accountability in Research. 2016; 22 (3):123–138. doi: 10.1080/08989621.2014.955607. [ PMC free article ] [ PubMed ] [ CrossRef ] [ Google Scholar ]
Glaser, J. W. (1994). Three realms of ethics: Individual, institutional, societal. Theoretical model and case studies . Kansas Cuty, Sheed & Ward
Godrie B, Dos Santos M. Présentation: inégalités sociales, production des savoirs et de l’ignorance. Sociologie et sociétés. 2017; 49 (1):7. doi: 10.7202/1042804ar. [ CrossRef ] [ Google Scholar ]
Hammell KW, Carpenter C, Dyck I. Using Qualitative Research: A Practical Introduction for Occupational and Physical Therapists. Edinburgh: Churchill Livingstone; 2000. [ Google Scholar ]
Henderson M, Johnson NF, Auld G. Silences of ethical practice: dilemmas for researchers using social media. Educational Research and Evaluation. 2013; 19 (6):546–560. doi: 10.1080/13803611.2013.805656. [ CrossRef ] [ Google Scholar ]
Husserl E. The crisis of European sciences and transcendental phenomenology. Evanston, IL: Northwestern University Press; 1970. [ Google Scholar ]
Husserl E. The train of thoughts in the lectures. In: Polifroni EC, Welch M, editors. Perspectives on Philosophy of Science in Nursing. Philadelphia, PA: Lippincott; 1999. [ Google Scholar ]
Hunt SD, Chonko LB, Wilcox JB. Ethical problems of marketing researchers. Journal of Marketing Research. 1984; 21 :309–324. doi: 10.1177/002224378402100308. [ CrossRef ] [ Google Scholar ]
Hunt MR, Carnevale FA. Moral experience: A framework for bioethics research. Journal of Medical Ethics. 2011; 37 (11):658–662. doi: 10.1136/jme.2010.039008. [ PubMed ] [ CrossRef ] [ Google Scholar ]
Jameton, A. (1984). Nursing practice: The ethical issues . Englewood Cliffs, Prentice-Hall
Jarvis K. Dilemmas in International Research and the Value of Practical Wisdom. Developing World Bioethics. 2017; 17 (1):50–58. doi: 10.1111/dewb.12121. [ PubMed ] [ CrossRef ] [ Google Scholar ]
Kahneman D. Système 1, système 2: les deux vitesses de la pensée. Paris: Flammarion; 2012. [ Google Scholar ]
Keogh B, Daly L. The ethics of conducting research with mental health service users. British Journal of Nursing. 2009; 18 (5):277–281. doi: 10.12968/bjon.2009.18.5.40539. [ PubMed ] [ CrossRef ] [ Google Scholar ]
Lierville AL, Grou C, Pelletier JF. Enjeux éthiques potentiels liés aux partenariats patients en psychiatrie: État de situation à l’Institut universitaire en santé mentale de Montréal. Santé mentale au Québec. 2015; 40 (1):119–134. doi: 10.7202/1032386ar. [ PubMed ] [ CrossRef ] [ Google Scholar ]
Lynöe N, Sandlund M, Jacobsson L. Research ethics committees: A comparative study of assessment of ethical dilemmas. Scandinavian Journal of Public Health. 1999; 27 (2):152–159. doi: 10.1177/14034948990270020401. [ PubMed ] [ CrossRef ] [ Google Scholar ]
Malherbe JF. Compromis, dilemmes et paradoxes en éthique clinique. Anjou: Éditions Fides; 1999. [ Google Scholar ]
McGinn R. Discernment and denial: Nanotechnology researchers’ recognition of ethical responsibilities related to their work. NanoEthics. 2013; 7 :93–105. doi: 10.1007/s11569-013-0174-6. [ CrossRef ] [ Google Scholar ]
Mills, C. W. (2017). Black Rights / White rongs. The Critique of Racial Liberalism . Oxford University Press
Miyazaki AD, Taylor KA. Researcher interaction biases and business ethics research: Respondent reactions to researcher characteristics. Journal of Business Ethics. 2008; 81 (4):779–795. doi: 10.1007/s10551-007-9547-5. [ CrossRef ] [ Google Scholar ]
Mondain N, Bologo E. L’intentionnalité du chercheur dans ses pratiques de production des connaissances: les enjeux soulevés par la construction des données en démographie et santé en Afrique. Cahiers de recherche sociologique. 2009; 48 :175–204. doi: 10.7202/039772ar. [ CrossRef ] [ Google Scholar ]
Nicole, M., & Drolet, M. J. (in press). Fitting transphobia and cisgenderism in occupational therapy, Occupational Therapy Now
Pope KS, Vetter VA. Ethical dilemmas encountered by members of the American Psychological Association: A national survey. The American Psychologist. 1992; 47 (3):397–411. doi: 10.1037/0003-066X.47.3.397. [ PubMed ] [ CrossRef ] [ Google Scholar ]
Provencher V, Mortenson WB, Tanguay-Garneau L, Bélanger K, Dagenais M. Challenges and strategies pertaining to recruitment and retention of frail elderly in research studies: A systematic review. Archives of Gerontology and Geriatrics. 2014; 59 (1):18–24. doi: 10.1016/j.archger.2014.03.006. [ PubMed ] [ CrossRef ] [ Google Scholar ]
Rawls, J. (1971). A Theory of Justice . Harvard University Press
Resnik DB, Elliott KC. The Ethical Challenges of Socially Responsible Science. Accountability in Research. 2016; 23 (1):31–46. doi: 10.1080/08989621.2014.1002608. [ PMC free article ] [ PubMed ] [ CrossRef ] [ Google Scholar ]
Rosa, H. (2010). Accélération et aliénation. Vers une théorie critique de la modernité tardive . Paris, Découverte
Sen, A. K. (2011). The Idea of Justice . The Belknap Press of Harvard University Press
Sen, A. K. (1995). Inegality Reexaminated . Oxford University Press
Sieber JE. Empirical Research on Research Ethics. Ethics & Behavior. 2004; 14 (4):397–412. doi: 10.1207/s15327019eb1404_9. [ PubMed ] [ CrossRef ] [ Google Scholar ]
Sigmon ST. Ethical practices and beliefs of psychopathology researchers. Ethics & Behavior. 1995; 5 (4):295–309. doi: 10.1207/s15327019eb0504_1. [ PubMed ] [ CrossRef ] [ Google Scholar ]
Swazey JP, Anderson MS, Lewis KS. Ethical Problems in Academic Research. American Scientist. 1993; 81 (6):542–553. [ Google Scholar ]
Swisher LL, Arsalanian LE, Davis CM. The realm-individual-process-situation (RIPS) model of ethical decision-making. HPA Resource. 2005; 5 (3):3–8. [ Google Scholar ]
Tri-Council Policy Statement (TCPS2) (2018). Ethical Conduct for Research Involving Humans . Government of Canada, Secretariat on Responsible Conduct of Research. https://ethics.gc.ca/eng/documents/tcps2-2018-en-interactive-final.pdf
Thomas SP, Pollio HR. Listening to Patients: A Phenomenological Approach to Nursing Research and Practice. New York: Springer Publishing Company; 2002. [ Google Scholar ]
Wiegand DL, Funk M. Consequences of clinical situations that cause critical care nurses to experience moral distress. Nursing Ethics. 2012; 19 (4):479–487. doi: 10.1177/0969733011429342. [ PubMed ] [ CrossRef ] [ Google Scholar ]
Williams-Jones B, Potvin MJ, Mathieu G, Smith E. Barriers to research on research ethics review and conflicts of interest. IRB: Ethics & Human Research. 2013; 35 (5):14–20. [ PubMed ] [ Google Scholar ]
Young, I. M. (2011). Justice and the Politics of difference . Princeton University Press

Library of Congress
Research Guides
Science & Technology

Technical Reports & Standards Collection Guide

Introduction.

Technical Reports Collections
Standards Collection
American Documentation Institute (ADI)
Office of Scientific Research and Development (OSRD) Collection
Synthetic Rubber Project
Technical Translations (TT) Series
Locating Technical Reports and Standards
Research Assistance and Reproductions
Online Resources and Databases
Using the Library of Congress
Jennifer Harbster, Head, Science Section, Researcher Engagement & General Collections Division
Sean Bryant, Reference Librarian, Researcher Engagement & General Collections Division
Ashley Fielder, Librarian for Medicine and Life Science. Science Section, Researcher Engagement & General Collections
Created: September 22, 2023

Last Updated: May 7, 2024

Science & Technical Reports : Ask a Librarian

Have a question? Need assistance? Use our online form to ask a librarian for help.

Owl above door to center reading room on fifth floor. Library of Congress John Adams Building, Washington, D.C.

Get connected to the Library’s large and diverse collections related to science, technology, and business through our Inside Adams Blog. This blog also features upcoming events and collection displays, classes and orientations, new research guides, and more.

The Library of Congress is completing a project to update and modernize Library reading room websites. As a part of the process, “The Technical Reports and Standards Collection” is in the process of being updated and migrated to this new platform. The process has not yet been completed and the guide remains subject to change.

Researchers with questions about the collection are encouraged to contact a science or business librarian using the Ask-a-Librarian: Science and Technical Reports or Ask a Librarian: Business online form, by phone, at (202) 707-5639, or in person, at the reference desk, in the Science and Business Reading Room, on the fifth floor of the Library's John Adams Building.

Technical Reports

Technical reports are designed to quickly alert researchers to recent findings and developments in scientific and technical research. These reports are issued for a variety of purposes:

to communicate results or describe progress of a research project
to convey background information on an emerging or critical research topic
to provide lists of instructions or procedures for current practices
to determine the feasibility of a technology and recommend if research should be continued (and how to evaluate any further progress made)
to detail technical specifications (materials, functions, features, operation, market potential, etc.)

Technical reports first appeared in the early part of the 20th century. The U.S. Geological Survey (USGS) published a series of professional papers beginning in 1902, and the National Advisory Committee for Aeronautics (NACA) issued its first report in 1915. But, the format gained importance during World War II, emerged in the postwar era, and remains, to this day, a major tool for reporting progress in science and technology, as well as in education, business, and social sciences research. The names given to series of these publications vary, but are often such generic terms as "technical reports," "working papers," "research memoranda," "internal notes," "occasional papers," "discussion papers" or "gray (or grey) literature." In the physical and natural sciences, "technical report" seems to be the preferred designation. For reports dealing with business, education, and the social sciences, on the other hand, the terms "working paper," "occasional paper," and "memorandum" are often the designations of choice. Other, more specific types of technical reports include "preprints" and "reprints." Preprints generally are versions of papers issued by researchers before their final papers are published by commercial publishers. Preprints allow researchers to communicate their findings quickly, but usually have not been peer reviewed. Reprints are typically released to heighten awareness of the research being conducted in a particular field or at a single institution. The term, "technical report" encompasses all of these designations.

Since many of these publications are intended to provide just a temporary snapshot of current research in a particular field or topic, they may contain the some of following distinctions:

Rapid communication of new research results
Dissemination to a targeted audience.
Detailed methodologies, in order to facilitate review of research results by others
No peer review, though there is often another selection process for publication (grant, contract, or institutional affiliation)
Not published by typical commercial publishers (instead reports are issued or sponsored by government agencies, professional associations, societies, councils, foundations, laboratories, universities, etc.)
Corporate authorship, where present, is typically emphasized

Unfortunately, uncertain availability, limited print runs, and decentralized distribution patterns with little bibliographic information are also often characteristics of this literature.

The Federal Government issues many different types of technical reports. An overview of some of these can be found in a May 2001 GAO report, " Information Management: Dissemination of Technical Reports ." Government issued or sponsored reports contain an additional characteristic - they may be subject to distribution restrictions linked to their classification status. Although references to classified reports may be found in technical reports literature, the security status or limited distribution of reports may make them unavailable to the general public and to the Library as well, as the Library holds only titles in the public domain. Those interested in locating such materials can consult the U.S. Department of Justice's Freedom of Information Act site for guidance in obtaining these reports.

To enable them to be identified and located, technical reports are assigned report codes by agencies or organizations involved in their production or distribution. These codes may be referred to as "accession numbers," "agency report series numbers," "contract numbers," "grant numbers" or by other names, and include dates and individual report numbers. Typically, reports are assigned multiple codes and these codes help to identify the sponsoring agency, the organization performing the research or the organization disseminating the report. Most technical reports held by the Library of Congress are not cataloged, and, for these reports, one or more report codes is required for Library staff to check the collections for a report or to locate and retrieve it. For more information about the current Standard Technical Report Number format (STRN) see ANSI/NISO Z39.23- 1997 (S2015) Standard Technical Reports Number Format and Creation .

Standards are specifications which define products, methods, processes or practices, and are known to have existed as early as 7000 B.C., when cylindrical stones were used as units of weight in Egypt. According to Office of Management and Budget (OMB) Circular A-119 , as revised in 2016, the term "standard" or "technical standard" refers to:

common and repeated use of rules, conditions, guidelines or characteristics for products or related processes and production methods, and related management systems practices;
the definition of terms; classification of components; delineation of procedures; specification of dimensions, materials, performance, designs, or operations; measurement of quality and quantity in describing materials, processes, products, systems, services, or practices; test methods and sampling procedures; or descriptions of fit and measurements of size or strength; and
terminology, symbols, packaging, marking or labeling requirements as they apply to a product, process, or production method.

Technical standards are not "professional standards of personal conduct; or institutional codes of ethics." (p. 15).

Standards are typically generated by governments or by professional associations and organizations interested in or affected by the subject matter of particular standards. For example, U.S. government standards mandated by the Fair Packaging & Labeling Act (FPLA) have standardized the labeling required for packaging in which consumer commodities is sold. Standards set the basis for determining consistent and acceptable minimum levels of reliability and safety, and are adhered to either voluntarily or as mandated by law. For a more complete overview, see the NIST report " The ABC's of Standards Activities " by Maureen A. Breitenberg (2009).

The Library of Congress standards collection includes military and other federal standards, industry standards, and a few older international standards from Russia, China, and South Africa. Material from the collection is available in various formats, including digital, print, and microform materials. The majority of the Library's standards collection held in the Science Section's Technical Reports and Standards Collection. The collection remains largely uncatalogued, and as a result, most items from this collection are not discoverable in the Library's online catalog. Inquires on Library holdings can be sent to the Science Section using the Science and Technical Reports Ask-a-Librarian form . Some standards, however, are housed in the Library's general collections and discoverable by searching the online catalog -- the ASTM standards are one example. Other standards are in custody of appropriate specialized research centers, such as the Law Library , which maintains OSHA standards and some building codes.

About the Science Section

Part of the Science & Business Reading Room at the Library of Congress, the Science Section is the starting point for conducting research at the Library of Congress in the subject areas of science, medicine and engineering. Here, reference specialists in specific subject areas of science and engineering assist patrons in formulating search strategies and gaining access to the information and materials contained in the Library's rich collections of science, medicine, and engineering materials.

Next: Technical Reports Collections >>
Last Updated: Jul 3, 2024 11:51 AM
URL: https://guides.loc.gov/technical-reports

Title Page Setup

A title page is required for all APA Style papers. There are both student and professional versions of the title page. Students should use the student version of the title page unless their instructor or institution has requested they use the professional version. APA provides a student title page guide (PDF, 199KB) to assist students in creating their title pages.

Student title page

The student title page includes the paper title, author names (the byline), author affiliation, course number and name for which the paper is being submitted, instructor name, assignment due date, and page number, as shown in this example.

Title page setup is covered in the seventh edition APA Style manuals in the Publication Manual Section 2.3 and the Concise Guide Section 1.6

Related handouts

Student Title Page Guide (PDF, 263KB)
Student Paper Setup Guide (PDF, 3MB)

Student papers do not include a running head unless requested by the instructor or institution.

Follow the guidelines described next to format each element of the student title page.


Paper title	Place the title three to four lines down from the top of the title page. Center it and type it in bold font. Capitalize of the title. Place the main title and any subtitle on separate double-spaced lines if desired. There is no maximum length for titles; however, keep titles focused and include key terms.
Author names	Place one double-spaced blank line between the paper title and the author names. Center author names on their own line. If there are two authors, use the word “and” between authors; if there are three or more authors, place a comma between author names and use the word “and” before the final author name.	Cecily J. Sinclair and Adam Gonzaga
Author affiliation	For a student paper, the affiliation is the institution where the student attends school. Include both the name of any department and the name of the college, university, or other institution, separated by a comma. Center the affiliation on the next double-spaced line after the author name(s).	Department of Psychology, University of Georgia
Course number and name	Provide the course number as shown on instructional materials, followed by a colon and the course name. Center the course number and name on the next double-spaced line after the author affiliation.	PSY 201: Introduction to Psychology
Instructor name	Provide the name of the instructor for the course using the format shown on instructional materials. Center the instructor name on the next double-spaced line after the course number and name.	Dr. Rowan J. Estes
Assignment due date	Provide the due date for the assignment. Center the due date on the next double-spaced line after the instructor name. Use the date format commonly used in your country.	October 18, 2020 18 October 2020
	Use the page number 1 on the title page. Use the automatic page-numbering function of your word processing program to insert page numbers in the top right corner of the page header.	1

Professional title page

The professional title page includes the paper title, author names (the byline), author affiliation(s), author note, running head, and page number, as shown in the following example.

Follow the guidelines described next to format each element of the professional title page.


Paper title	Place the title three to four lines down from the top of the title page. Center it and type it in bold font. Capitalize of the title. Place the main title and any subtitle on separate double-spaced lines if desired. There is no maximum length for titles; however, keep titles focused and include key terms.
Author names	Place one double-spaced blank line between the paper title and the author names. Center author names on their own line. If there are two authors, use the word “and” between authors; if there are three or more authors, place a comma between author names and use the word “and” before the final author name.	Francesca Humboldt
Author names	When different authors have different affiliations, use superscript numerals after author names to connect the names to the appropriate affiliation(s). If all authors have the same affiliation, superscript numerals are not used (see Section 2.3 of the for more on how to set up bylines and affiliations).	Tracy Reuter , Arielle Borovsky , and Casey Lew-Williams
Author affiliation	For a professional paper, the affiliation is the institution at which the research was conducted. Include both the name of any department and the name of the college, university, or other institution, separated by a comma. Center the affiliation on the next double-spaced line after the author names; when there are multiple affiliations, center each affiliation on its own line.	Department of Nursing, Morrigan University
Author affiliation	When different authors have different affiliations, use superscript numerals before affiliations to connect the affiliations to the appropriate author(s). Do not use superscript numerals if all authors share the same affiliations (see Section 2.3 of the for more).	Department of Psychology, Princeton University Department of Speech, Language, and Hearing Sciences, Purdue University
Author note	Place the author note in the bottom half of the title page. Center and bold the label “Author Note.” Align the paragraphs of the author note to the left. For further information on the contents of the author note, see Section 2.7 of the .	n/a
	The running head appears in all-capital letters in the page header of all pages, including the title page. Align the running head to the left margin. Do not use the label “Running head:” before the running head.	Prediction errors support children’s word learning
	Use the page number 1 on the title page. Use the automatic page-numbering function of your word processing program to insert page numbers in the top right corner of the page header.	1

IMAGES

FREE 11+ Research Ethics Templates in PDF
Ethics Committee Report 11.19.pdf
Manual for Research Ethics Committees: Centre of Medical Law and Ethics
The Research Ethics Committee at the Faculty of Medicine
(PDF) Reporting Ethics Committee Approval in Public Administration Research
(PDF) Ethical Research in Palliative Care: a guide through the Human

COMMENTS

Ethics Committees: Structure, Roles, and Issues
Abstract. An Ethics Committee (EC) is an independent body composed of members with expertise in both scientific and nonscientific arenas which functions to ensure the protection of human rights and the well-being of research subjects based on six basic principles of autonomy, justice, beneficence, nonmaleficence, confidentiality, and honesty.
In Pursuit of Ethical and Inclusive Research: What Ethics Committees
Human Research Ethics Committees (HRECs) are rightfully concerned about the potential for research to cause harm, with rigorous ethical oversight aiming to ensure high standards of autonomy, non-maleficence, beneficence, and justice in research. ... This paper begins by familiarising the reader with the broader context of human research ethics ...
The role of research ethics committees: Friend or foe in educational
Research ethics committees may be perceived as a friend; they have a legitimate and useful role to play by offering advice, ... In conclusion, and to respond to the title of this paper, contemporary educational researchers regard research ethics committees as friends, when best practice is taking place and when researcher and ethics committees ...
Human Research Ethics Committees: Examining their Roles and ...
Examining Human Research Ethics Committees 39 research ethics review and governance, the overall process and underlying principles are very similar, at least across developed Western countries. There is a suf-ficient common conceptual base in research ethics for this Australian data to be relevant and meaningful for other settings.
Relevance and Challenges of Ethics Committees
This article explores the role of ethics committees in ensuring ethical research and innovation, which is essential for maintaining trust in science and innovation. The paper argues that the ...
Relevance and Challenges of Ethics Committees
This article explores the role of ethics committees in ensuring ethical research and innovation, which is essential for maintaining trust in science and innovation. The paper argues that the ethics infrastructure must function at the levels of research and innovation...
Research ethics committees: A forum where scientists, editors, and
Ideally, research ethics committees should have a multidisciplinary membership that reaches beyond the science, and also includes ethicists and patients concerned with the contextual aspects of research that impact methodology, data privacy, and the application of the research across populations. 9 The Chair at the helm of these committees is ...
Ethics Committees: Structure, Roles, and Issues
Abstract. An Ethics Committee (EC) is an independent body composed of members with expertise in both scientific and nonscientific arenas which functions to ensure the protection of human rights and the well-being of research subjects based on six basic principles of autonomy, justice, beneficence, nonmaleficence, confidentiality, and honesty.
Research made simple: ethics committee approval
Research ethics committees. RECs came to prominence in the second half of the 20th century. The internationally recognised Declaration of Helsinki— first adopted in 1964, but amended several times since then—states all researchers need to secure REC approval before commencing research involving human participants, in order to safeguard the health and well-being of those involved.2 RECs can ...
Ethical review of action research: the challenges for researchers and
In this paper the authors, one a research ethicist and one an experienced action researcher, will consider the challenges faced when seeking ethical approval for AR. This paper will consider these challenges from the perspective of both the researcher and the research ethics committee (REC). Whilst these experiences are drawn from the Health ...
Ethics Committees: Structure, Roles, and Issues
This review is focused on the types of research articles that need EC approval, the submission process, and exemptions, and highlights the constitution of ECs, their duties, the review process and the assessment of the risk-benefit of the proposed research including privacy issues. An Ethics Committee (EC) is an independent body composed of members with expertise in both scientific and ...
Behind the scenes of research ethics committee oversight: a qualitative
Research cites shortcomings and challenges facing research ethics committees in many regions across the world including Arab countries. This paper presents findings from qualitative in-depth interviews with research ethics committee (REC) chairs to explore their views on the challenges they face in their work with the oversight of research involving human populations.
Research Ethics: Sage Journals
Research Ethics. Research Ethics is aimed at all readers and authors interested in ethical issues in the conduct of research, the regulation of research, the procedures and process of ethical review as well as broader ethical issues related to research … | View full journal description. This journal is a member of the Committee on Publication ...
Human Research Ethics Committees: Examining Their Roles and Practices
Abstract. Considerable time and resources are invested in the ethics review process. We present qualitative data on how human research ethics committee members and health researchers perceive the ...
How do we know that research ethics committees are really working? The
The Increasing Role of REC Review. REC review is a cornerstone of international guidelines on research with human participants. For example, the Council for International Organizations of Medical Sciences (CIOMS) states that "all proposals to conduct research involving human subjects must be submitted for review and approval to one or more independent ethical and scientific review committees []."
The Structure and Function of Research Ethics Committees in ...
According to international guidelines [1,2] and several nations' laws [], research with humans requires independent ethics committee review.In the United States, committees are called institutional review boards (IRBs) []; elsewhere they generally are called research ethics committees (RECs).Committees are designed to: provide third party review, thereby minimizing conflicts of interest ...
Principles of research ethics: A research primer for low- and middle
In other countries, these committees may be called Human Research Ethics Committees (HREC) or have other titles. Several articles discuss the evolution of HRECs in sub Saharan Africa [9,10]. ... Data should only be accessible to the research team. Surveys and other paper documents must be kept in a locked cabinet or drawer in a secure room ...
The role of research ethics committees: Friend or foe in educational
The results indicated that contemporary educational researchers regard research ethics committees as friends when researcher and reviewer are transparently engaged in a shared endeavour. When this shared endeavour breaks down, for a variety of reasons—including apparently unreasonable demands or mutual misunderstanding—the research ethics ...
(PDF) The Structure and Function of Research Ethics Committees in
This paper outlines the roles and responsibilities of investigators and ethics committees in clinical research with reference to internationally accepted guidelines for ethical research.
Ethical Dilemmas in Qualitative Research: A Critical Literature Review
They are expressed in ethical codes and guidelines used by Research Ethics Committees (RECs), which are the instances that regulate research conducted with human beings. ... The reflection on the researcher's role and his/her influence on the research field was the theme of the paper by Råheim et al. (2016). During two years, a group of six ...
Ethical Considerations in Research
Revised on May 9, 2024. Ethical considerations in research are a set of principles that guide your research designs and practices. Scientists and researchers must always adhere to a certain code of conduct when collecting data from people. The goals of human research often include understanding real-life phenomena, studying effective treatments ...
NeurIPS
The Neural Information Processing Systems Foundation is a non-profit corporation whose purpose is to foster the exchange of research advances in Artificial Intelligence and Machine Learning, principally by hosting an annual interdisciplinary academic conference with the highest ethical standards for a diverse and inclusive community.
Ethical Issues in Research: Perceptions of Researchers, Research Ethics
Introduction. Research includes a set of activities in which researchers use various structured methods to contribute to the development of knowledge, whether this knowledge is theoretical, fundamental, or applied (Drolet & Ruest, accepted).University research is carried out in a highly competitive environment that is characterized by ever-increasing demands (i.e., on time, productivity ...
Technical Reports & Standards Collection Guide
The names given to series of these publications vary, but are often such generic terms as "technical reports," "working papers," "research memoranda," "internal notes," "occasional papers," "discussion papers" or "gray (or grey) literature." In the physical and natural sciences, "technical report" seems to be the preferred designation.
Title Page Setup
For a professional paper, the affiliation is the institution at which the research was conducted. Include both the name of any department and the name of the college, university, or other institution, separated by a comma. Center the affiliation on the next double-spaced line after the author names; when there are multiple affiliations, center ...
Procedural ethics for social science research: Introducing the Research
Existing databases including ClinRegs, Health Research Web, European Network of Research Ethics Committees (EUREC) and the Research Ethics Guidelines International Online Navigation Map (REGION) emphasize practical information that a northern-based researcher might need to abide by ethics regulations at home or abroad; they are concerned with ...
Start Taiwan Takeover Preparations as Soon as Possible
They suggest Beijing set up a "Central Taiwan Work Committee" to research and prepare "post-takeover" policies on a variety of issues - including currency conversion, education systems, military integration, and customs, among others - based on a solid understanding of existing policies and institutions in Taiwan.
PDF Ethical Statement Templates
4. Our institution does not require ethics approval for reporting individual cases or case series. 5. The IRB determined that the protocol is considered exempt because *REASON* on *DATE*. 6. This research did not require IRB approval because *REASON*. Informed Consent 1. Written informed consent was obtained for anonymized patient information to be

Relevance and Challenges of Ethics Committees

Cite this chapter

Similar content being viewed by others

Research Ethics Codes and Guidelines

Ethics and Integrity in Research: Disciplines and Professions

1 Introduction

2 Ethical Research: From Fragments to the Whole Research Process

3 What Do We Mean When We Talk About Ethics Committees?

4 What Should the Ethics Committee(s) Do?

5 Implementation of the Ethics Infrastructure

6 Conclusion

Acknowledgments

Author information

Corresponding author

Editor information

Rights and permissions

Copyright information

About this chapter

Download citation

Share this chapter

Save citation to file

Add to My Bibliography

Ethics Committees: Structure, Roles, and Issues

Conflict of interest statement

Similar articles

Publication types

LinkOut - more resources

Log in using your username and password

You are here

Statistics from Altmetric.com

Research ethics committees

What do RECs consider when scrutinising research protocols?

What happens after the REC review?

What can help get an REC application approved?

Steps to take when applying for REC approval

Read the full text or download the PDF:

Ethics Committees: Structure, Roles, and Issues

Figures and Tables from this paper

8 Citations

How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review

The Increasing Role of REC Review

Challenges for REC Review

Existing Oversight Mechanisms for RECs

Integrating Quality Assurance Principles into REC Assessment

Pre-publication history

Acknowledgements

Author information

Corresponding author

Additional information

Authors' contributions

Rights and permissions

About this article

Share this article

BMC Medical Ethics

The Structure and Function of Research Ethics Committees in Africa: A Case Study

Results of Our Case Study

History of research ethics committees.

Composition.

REC meetings.

Training of REC members.

Conflicts of interest.

Procedural and administrative issues.

REC review.

Challenges.

Suggestions.

Encouraging lessons.

Limitations of our case study.

Supporting Information

Acknowledgments

Have a language expert improve your writing

Ethical Considerations in Research | Types & Examples

Table of contents

Here's why students love Scribbr's proofreading services

Prevent plagiarism. Run a free check.

Research misconduct

Cite this Scribbr article

Is this article helpful?

Pritha Bhandari

Main Navigation

Registration