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Hospital/clinical ethics committees' notion: an overview

Fatemeh hajibabaee.

1 PhD Candidate in Nursing, Faculty of Nursing & Midwifery, Tehran University of Medical Sciences, Tehran, Iran;

Soodabeh Joolaee

2 Associate Professor, Center for Nursing Care Research, Iran University of Medical Sciences,Tehran, Iran; Iranian Academy of Medical Sciences, Tehran, Iran;

Mohammad Ali Cheraghi

3 Associate Professor, School of Nursing & Midwifery, Tehran University of Medical Sciences, Tehran, Iran;

Pooneh Salari

4 Associate Professor, Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences, Tehran, Iran;

Patricia Rodney

5 Associate Professor, School of Nursing, University of British Columbia, Vancouver, Canada.

Hospital ethics committees (HECs) help clinicians deal with the ethical challenges which have been raised during clinical practice. A comprehensive literature review was conducted to provide a historical background of the development of HECs internationally and describe their functions and practical challenges of their day to day work. This is the first part of a comprehensive literature review conducted between February 2014 and August 2016 by searching through scientific databases. The keyword ethics committee, combined with hospital, clinic, and institution, was used without a time limitation. All original and discussion articles, as well as other scientific documents were included. Of all the articles and theses found using these keywords, only 56 were consistent with the objectives of the study. Based on the review goals, the findings were divided into three main categories; the inception of HECs in the world, the function of HECs, and the challenges of HECs. According to the results, the Americas Region and European Region countries have been the most prominent considering the establishment of HECs. However, the majority of the Eastern Mediterranean Region and South-East Asia Region countries are only beginning to establish these committees in their hospitals. The results highlight the status and functions of HECs in different countries and may be used as a guide by health policymakers and managers who are at the inception of establishing these committees in their hospitals.

Introduction

Owing to the new knowledge obtained from medical studies and the diversity of not only lifestyles, but also moral and religious values in modern societies, medical involvement and decision-making processes associated with healthcare are becoming more and more complicated. Moreover, noticeable economic pressure is being experienced by healthcare systems throughout the world, as awareness of ethical implications in medicine has been raised through public political and medico-legal discussions about patient independence, euthanasia and assisted dying ( 1 ). Csikai has noted that as complicated ethical issues have drawn widespread public attention and fulfilled the need to have protected patients' rights in the health care setting, the need for formal ethics committees has been recognized by most institutions ( 2 ). Much significance has been acquired by ethics committees in the hospital setting due to the developments in medical technology ( 2 ) around the late 20 th century. Over the past 30 years, having hospital ethics committees (HECs) has been encouraged or assigned to hospitals in many countries ( 3 ), whereas such committees have not been extensively present in the healthcare settings of developing countries ( 4 ).

Support has been provided to clinicians by HECs when they have met ethical challenges in their clinical practice ( 5 , 6 ). These committees have made much progress in regards to doctors, nurses, and other health experts becoming acutely aware of the ethical decisions they have to make ( 4 ). A healthcare ethics committee or hospital ethics committee is characterized as a body of persons established by a hospital or health care institution and assigned to consider, debate, study, take action on, or report on ethical issues that arise in patient care ( 7 ). Over time, HECs have moved toward democratic processes of discussion by which ethical processes are advocated with the consideration of the benefit of patients, their families, and health care team members ( 6 ).

HECs have made considerable progress in many countries since the 1980s ( 8 ) and are now well established in many countries ( 9 , 10 ).

An ethics committee consult is periodically called by nurses, to help patients and to get assistance in solving ethical dilemma. Preparation before asking for an ethics consultation is critically taken into account ( 5 ).

Ethical issues must be taken into consideration even more in nursing ( 11 ) and nurses should be educated on ethical issues through ongoing education programs, in-service programs, patient care conferences, and academic courses ( 12 ). Moreover, those who serve on an ethics committee have a personally and professionally rewarding experience due to the service provided for staff, patients, and families ( 5 ). The title “hospital ethics committee” can be utilized interchangeably with “patient care advisory committee”, "healthcare ethics committee", "clinical ethics committee", "institutional ethics committee", and "hospital clinical ethics committee" ( 3 , 7 ). HECs are responsible for providing ethics consultations. They also evaluate the results of consultations when the consultant is an individual ethicist instead of a board of ethicists ( 13 ). Most published literature has reported policy review, education, and consultation as the leading roles of these committees ( 14 ). More and more, organizational ethical issues, such as the allocation of resources, are being addressed by the HECs ( 6 ).

Ethics committees consist of members from many various disciplines in the health care setting. A holistic examination of a patient’s or their family’s situation that might involve a complicated ethical dilemma is possible through an interdisciplinary view of the issue ( 2 ). The various perspectives of nurses, chaplains, physicians, social workers, lawyers, and others brings variety to the debate and serves the patient in the best way possible ( 7 ). Committee members should be diverse in terms of their culture and skills, experiences, and knowledge. Variety inspires debates to obtain new information and consider alternative ideas ( 15 ), which is regarded as a prerequisite to culturally safe and ethically sound discussions ( 6 ). In order to prevent parochialism, a number of health professional members should be recruited from outside the institution ( 4 ). The committee members "should be inclined to learn about clinical ethics, receptive to various ideas and viewpoints, able to deal with emotionally charged topics and interpersonal disagreements, and capable of tolerating vagueness” ( 16 ). In general, the success of any HEC is dependent on the commitment and devotion of its members. As a matter of fact, there is increasing attention to the competencies needed for individuals engaged in ethics committees, especially ethics consultants ( 17 ).

Numerous studies have applied different methods to examine the performance and various dimensions of HECs in different countries in recent years, and have revealed similarities and differences. HECs still do not exist or have not been appropriately established in some developing countries, and few studies have been performed in this regard in these countries. Thus, it appears necessary to conduct studies that can provide guidelines for the establishment and operation of HECs through presenting an integrated comprehensive image of the process of development and performance of such committees.

The three main goals of this review included to describe the history and development of HECs in the world [countries classified according to World Health Organization (WHO) Regional Offices], explain the function of HECs, and to discuss the challenges of their practice.

Initially, world literature was reviewed, and then, analyzed and compared to formulate an appropriate guideline to establish committees with favorable structure and performance in countries where the establishment of ethics committees in hospitals has been newly planned. Consequently, this is the first part of a comprehensive literature review conducted between February 2014 and August 2016 by searching through scientific databases such as PubMed, Ovid, Scopus, Web of Science, and Google Scholar. The keyword ethics committee was used in combination with hospital, clinic, and institution. All original and discussion articles, as well as other scientific documents were included without a time limitation.

In the present study, countries with published studies on the history and procedures related to HECs development in English were included. The countries were classified according to WHO Regional Offices. This study was derived from the first author’s PhD thesis performed in Iran where HECs have lately been developed.

Among all the articles and theses which were found with these keywords, only 56 were consistent with the objectives of this study. There were 5 theses, 18 quantitative studies, 3 qualitative studies, 21 discussion articles, 5 editorials, 1 commentary, 2 comparative studies, and 1 review study. Based on the ‎review goals, the findings were divided into three main categories; the history and development of HECs in the world, the function of HECs, and the challenges of HECs.

History and development of hospital ethics committees

Of the documented literatures published on the history of HECs in different countries, 22 belong to western countries and began around 1985 ( 5 , 7 , 9 , 13 , 14 , 18 - 33 ). The history and process of the development of HECs in western countries are provided in this section based on the year the committees were established.

The United States

Review committees were formed in the US following requests for the approval of all decisions about abortion in the 1960s ( 20 ). Due to the limited number of dialysis machines in the 1970s, a number of committees were developed to determine patients’ priority in access to hemodialysis ( 20 , 21 ). Since HECs (also known as heath care ethics committees) were developed in the 1980s in the US, most available data on these committees are obtained from the American literature ( 5 , 22 ). While only 1% of hospitals in the US had HECs in 1983, this rate increased to over 90% by 2001 ( 23 ). In 1984, the development of these committees was endorsed by the American Medical Association and the American Hospital Association. Their tasks were considered to be encompassing several areas and guiding hospital policy, but the key and most groundbreaking goal was to make recommendations in individual cases ( 34 ). There has been dynamic discussion over how valuable these committees truly are ( 35 ). Today, HECs are the primary mechanisms for managing ethical issues in clinical care in the USA ( 36 , 37 ).

Limited HECs existed in Canada before the 1980s ( 13 , 18 ). In 1986, the Guide to Accreditation of Health Care Facilities indicated the need for multidisciplinary ethics committees for the resolution of biomedical issues ( 38 ). Two national surveys of Canadian HECs in 1984 and 1989 reported that, respectively, 18% and 58% of the hospitals in the country had a HEC ( 18 , 39 ). Today, however, the exact conditions of HECs in Canada are not known ( 13 ). Moreover, a study in 2010 found that 85% of the surveyed Canadian hospitals had HECs ( 13 ).

European Region

Netherlands

In the Netherlands, HECs were established in the early 1970s. For almost 20 years, however, they were mostly mixed committees. They started as bottom-up enterprises and have maintained their nature ever since ( 24 ). It has also been reported that ethics advice on clinical issues can be provided by HECs in the Netherlands ( 40 ).

The growth of bioethics and ethics committees in France differs greatly from that in other countries ( 25 ). Two major movements in France led to the formation of ethics committees in the 1980s. The first was a political movement which resulted in the development of a permanent national ethics committee called “ Comité Consultatif National d’Ethique ” (CCNE). The second, a professional movement, facilitated the formation of local ethics committees. During 1983-93, the CCNE focused on three major topics including medically assisted procreation and the embryo, research on human beings, and genetics ( 25 ).

United Kingdom

Among the European countries, United Kingdom was one of the pioneers in this regard. A number of local reasons, including institutional response to particular problematic cases and clinicians’ concern about the ethical aspects of clinical practice, were involved in the development of the first clinical ethics committees in the UK ( 22 ). One of the first HECs was created at what is now called Barts and The London NHS Trust, incorporating the formerly independent St. Bartholomew's and The Royal London Hospitals, The London Chest Hospital, and the Queen Elizabeth Hospital for Children. This HEC, which began its work in 1995, is now an integral feature of professional life within the trust and is a sub-committee of the trust's Clinical Governance Committee, working closely with the Medical Director. The terms of reference of the HEC emphasize two important dimensions ( 41 ). First, the committee acts proactively in the development of coherent and practical ethico-legal policies and provision of recommendations for the traditional issues commonly faced in clinical settings and mentioned in the literature related to medical ethics and law. The HECs’ second function is reactive and involves the provision of relevant advices on particular ethico-legal issues discussed by clinical colleagues ( 42 ).

In Slovakia, in June 1992, the ‘‘Guidelines on Establishment and Work of Ethics Committees in Health Care Facilities and Biomedical Research Institutions’’ ( 43 ) were elaborated by the Central Ethics Committee, and published in the form of the Ministry of Health's recommendations. The guidelines provided detailed directions regarding the formation and responsibilities of local ethics committees ( 24 ).

A law passed in 1994 obliged all general and psychiatric hospitals in Belgium to develop a local ethics committee to handle the responsibilities of both Research Ethics Committees (RECs) and HECs. This seems to be the origin of ethics committees in charge of both research and clinical ethics ( 26 ). In 2000, however, the Belgian Court of Arbitration excluded ethics consultation from the HEC-related tasks. Since the Belgian HECs are controlled on a national scale, all hospitals have their own ethics committee responsible for a large number of committee tasks ( 43 ).

In 1996, a group of hospital clinicians, politicians, and health authorities, along with the Norwegian Medical Association launched an initiative in Norway which led to the development of the first HECs in the country. As a result, there is at least one ethics committee at any of the 23 hospital trusts providing 4.9 million Norwegians with specialized and hospital-based healthcare services ( 44 ).

The establishment of a HEC is mandatory in all hospitals registered in the Christian Association of Hospitals in Germany ( 22 ). According to a new study in Germany, the percentage of hospitals with HECs was found to be 86.4% ( 45 ).

Among European countries, Croatia achieved the legal requirements for the establishment of ethics committees around 1997. The 1997 "Law on the Health Protection" obliges all healthcare institutions in Croatia to create an ethics committee. Each committee should have 5 members including 2 individuals who are not involved in the field of medicine ( 28 ). In Croatia, a top-down approach was adopted for the development of ‘‘mixed’’ ethics committees, i.e., a combination of HECs and RECs, in healthcare institutions ( 24 ). Ethics committees were established in almost half (46%) of all healthcare institutions in the country (except drugstores and homecare provision centers) 6 years after the reinforcement of the Law on the Health Protection in Croatia (in 2006). Most of these committees (89%) consist of 3 medical professionals and 2 experts in other fields. Moreover, while 49% of the committees were mainly involved in the analysis of research protocols, a small percentage of them provided standing orders, professional guidelines, or other related documents ( 28 ).

In Lithuania, HECs, called medical ethics commissions, are established based on the Health Care System Law of the Republic of Lithuania and the Model Guidelines for Medical Ethics Commissions (released by the Ministry of Health in 1997). The Health Care System Law of the Republic of Lithuania was passed by the Parliament in the early 1990s and obliged all large healthcare institutions to create a specific HEC. The Lithuanian National Bioethics Committee was then established in response to the need for an organization to manage and support these HECs. The Model Guidelines for Medical Ethics Commissions provided details on the mission, functions, establishment, and composition of HECs ( 24 ).

Although ethics committees exist in university hospitals in Turkey, so far, these committees have had no advantages over pharmaceutical RECs. Due to the need for HECs to resolve the ethical issues faced by not only doctors, but also patients, the senate of Kocaeli University Medical Faculty in Turkey approved the establishment of a HEC on November 13, 2000 ( 46 ). Demir and Buken stated: "In Turkey, The introduction of HECs is relatively recent and the number of committees is limited" ( 10 ).

There were no documents of existing HECs in Polish hospitals until 2007 ( 43 ). We could not find any legal or ethical regulation concerning HECs. Medical ethics committees of medical councils or chambers of physicians and dentists, working at national and regional levels, are the only committees in Poland which handle issues related to medical ethics and have similar functions (but not exactly) to those of HECs. However, they have limited effects on the development of healthcare policies and clinical decision-making. In 1990, the first General Medical Assembly, the highest authority of the Polish Chamber of Physicians and Dentists (PCHPD), recommended the establishment of the Medical Ethics Committee of the Supreme Medical Council ( 43 ). Nevertheless, not many hospitals in Poland currently have HECs and the existing committees usually fail to provide the required structure, services, and workload ( 29 ).

Western Pacific Region

Despite their ongoing development in Australia, HECs and other ethics support services are generally not accessible by all institutions ( 47 ). The Committee at John Hunter has published their experience ( 48 ), but there are not many documents about Australian HECs. In New South Wales and other parts of Australia, public hospitals are supposed to focus on providing clinical ethics support as a priority ( 49 ).

Chinese Medical Association (CMA) set up the HEC as one of its branches in 1988. The Regulation of Hospital Ethical Committees in China was issued at the sixth conference of medical ethics in Chengdu in 1991, and then, revised by the CMA in 1995 ( 50 ). In 2007, the Ministry of Health of China published a review of methods used in biomedical research involving humans. Today, all medical institutions and hospitals in the country have an ethics committee whose main function is to ensure respect for principles of autonomy, beneficence, and justice ( 50 ).

In Japan, 20 (25.6%) medical organizations developed an ethics committee in 1998, and this rate increased to 29 (50.0%) in 2003 ( 50 ). A recent study on 4000 hospitals in Japan reported 51.1% of the surveyed hospitals to have an ethics committee. Moreover, 16.8% of the hospitals were working on developing their HECs ( 51 ).

When faced with ethical dilemmas in university hospitals, residents and physicians in Korea have very limited access to clinical ethicists or active hospital ethics committees to consult with ( 52 ). According to a study in Korea, only 3.4% of the surveyed residents had discussed their ethical issues with an attending faculty member or a hospital ethics committee. The participating residents tended to resolve their ethical conflicts on their own (15.1%) or by asking for advice from their colleagues or senior residents (44.9%) or the hospital’s ethics committee (0.7%) ( 52 ).

New Zealand

A total of 15 Health and Disability Ethics Committees have been established in New Zealand. These committees are currently working based on the national guidelines ( 53 ). These committees are accredited by the Health Research Council Ethics Committee for the ethical review and approval of research ( 4 ).

The Report of the Inquiry into National Women’s Hospital (1988) concluded that the ethical review of research proposals and other issues should be performed by independent ethics committees consisting of 50% lay people (not involved in health professions) and also chaired by a lay person ( 53 ).

Eastern Mediterranean Region

In the previous two decades, there have been remarkable movements in the field of bio-medical ethics in Iran, mainly in the educational, research, and policy-making aspects ( 54 ). The regulations and guidelines for the HECs were established by the Iranian Ministry of Health and Medical Sciences in 2000. Based on a national study for identifying the priorities of medical ethics in Iran, the constitution of HECs was one of 10 priorities ( 55 ); however, HECs are not yet working as strong as other hospital committees. The results of a study conducted in one of the major cities in Iran indicates that HECs are functioning as combined committees (85.7%) entitled ethics committee and religious principles. These committees are chaired by doctors (42.8%), hospital directors (2.5%), hospital managers (14.28%), and nurses (14.2%) in different educational hospitals ( 56 ).

In this review, very few documents were found regarding other countries in the Middle East Region. This might be because of the language limitation, since our search was conducted only in English documents. The review indicated that while HECs in most developed countries are well established and active, in some developing countries, even if they exist, there is a gap in their activating strategies. In some cases they are only a grand name on the list of different hospital committees and do not perform any specific tasks.

Functions of hospital ethics committees

Slowther et al. stated: "The healthcare ethics committees were born out of a grass-root process in American hospitals" ( 57 ). Three domains or functions must be covered by HECs in their ordinary work. First, the HEC needs to educate its members, hospital staff, and also patients about ethical issues. The second function of an HEC is to cooperate in the development and revision of various hospital policies and guidelines to facilitate service provision by hospital personnel. The third function of a HEC is the task of ethical case analysis ( 58 ).

The committees have a variety of responsibilities including the resolution of clinicians’ ethical issues, provision of ethical training to their members (at least one individual) and individuals from other institutions, and cooperation in the formulation of institutional policies related to clinical ethical issues. Although a committee may perform only one of the mentioned tasks, most existing committees are involved in all of them ( 4 ).

The function and constitution of these committees are different from RECs, the purpose of which is considered the ethical review of research on human subjects ( 4 ). One or more of the following three functions may ordinarily be performed by the HECs in the United States ( 59 ): ( 1 ) providing ethical consultations upon the requests from clinicians or sometimes patients and their families. The main goals of an ethics consultation in hospital ethics committees is presented in table 1 ; ( 2 ) Assisting in the formulation of hospital policies and guidelines by presenting the required ethical input; and ( 3 ) training the health personnel of the institution ( 22 ).

The main goals of ethical consultation in hospital ethics committees ( 9 )

In Norway, individual patient cases are normally debated in the HEC, not with ethics consultant teams or individual consultants, as is often the case in many other countries ( 27 ). The procedures for case discussions suggested in the HEC manual are defining the ethical problem(s), describing all facts, identifying the values and pertinent laws at risk, identifying and discussing probable solutions of the case, conclusion, and follow-up and evaluation. The manual puts more emphasis on the patient’s situation, values, and interests which are to be given a central place in the committee’s work ( 30 ). A study in Norway indicated that between 1 and 8 seminars for hospital employees during the last 2 years with, altogether, 4,400 participants had been arranged by 30 of the 31 HECs. To elaborate on the ethical guidelines, 26 of the HECs had become involved. The topics of the guidelines were end-of-life issues (including not attempting resuscitation and caring for the relatives), patient autonomy issues/involuntary treatment, prioritization issues, confidentiality, communication with patients on Facebook and cultural issues/language problems ( 30 ).

In Croatia, the implementation of ethical principles of the medical profession, approval of research activities (protocols) within the healthcare institution, supervision of drug and medical device trails, supervision of organ procurement from deceased persons, and resolution of other ethical issues in the health institution are undertaken by the ethics committees ( 28 ). Table 2 shows the suggested functions for hospital ethics committees.

Suggested functions for hospital ethics committees ( 60 )

The challenges of hospital ethics committees

Challenges of HECs can be divided into three main categories based on the reviewed literature.

Clarifying and maintaining their position inside the institution

Although HECs may have a multiplicity of goals and functions, one of the challenges that all HECs share is clarifying and maintaining their position inside their respective institution. HECs in Europe have to protect the interests of both individuals and the organization while maintaining a critical independence ( 8 ).

Convincing professionals of the necessity of engaging patients and their families in the decision making process

Persuading health professionals of the significance of engaging patients and their families in medical decision-making is also a challenge. In fact, when a discussion about the hospitals’ "do not resuscitate policy" was started, some committee members and other clinicians involved in the initial development of the policy disagreed with the disclosure of information and the engagement of patients and their families in "do not resuscitate" decisions. Finally, the committee agreed on a policy that ensured the patients’ right to be involved in making such decisions, unless exceptional conditions were present. Recent media publicity has supported the committee's point of view ( 31 ).

Educational challenges

In the educational setting, a major challenge was to convince the staff, especially the junior medical staff, of the equal significance of ethical issues and clinical teaching. In fact, medical students are more focused on acquiring factual clinical knowledge than on discussing the ethical issues they face ( 31 ).

According to a recent national survey in the US, 81% of the 519 surveyed hospitals and 100% of hospitals with over 400 beds provided ethics consultation services. Despite these noticeable rates, there is still ongoing debate about educating bioethicists, the objectives of ethics consultation, methods of evaluating consultation outcomes, and the best approach toward ethics consultation ( 9 ).

Developing more objective methods for the evaluation of effectiveness and providing the required ethical education for the members of such committees can be considered as the future challenges in this field. The relationships between these committees and the national structure and guidelines for ethics committees in some countries, such as New Zealand, need further attention. In fact, particular requirements for ethical approval of research projects may not be relevant when individual clinical situations are concerned ( 4 ).

A multiplicity of concerns has been raised about HECs. HECs can damage the doctor-patient relationship which is a delicate and vital component of health care, decrease doctors’ professional autonomy, and gradually undermine their responsibility and authority to act in the best interest of their patients ( 61 ).

They may either limit the patients’ freedom of choice or neglect (rather than protect) their interests by attracting attention to various competing interests, e.g., the interests of the hospital and its personnel.

By adding an extra layer to the overburdened administrative bureaucracy of hospitals, HECs may decrease the already insufficient time available for clinical care. They may also raise unnecessary moral and even political disputes ( 32 ). Finally, in an attempt to protect themselves, HECs may act (e.g., perform analyses and provide recommendations) with extreme caution ( 33 ).

Conclusions

According to the results, the Americas Region and European Region countries such as United States, Canada, and Netherlands have been the most prominent considering the establishment of HECs. Nevertheless, the majority of Eastern Mediterranean Region countries and South-East Asia Region countries are only beginning to establish these committees in their hospitals. The major functions of HECs were ethics consultation, education about ethical issues, and policy-making. Based on the reviewed literature, challenges of the HECs can be divided into the 3 main categories of elucidating and establishing their position within the institution, persuading professionals of the importance of participating patients and families in decision-making, and challenges related to providing education.

The authors of this study tried to present an integrated image of the development of HECs and their performance and challenges around the world. Since the inception of these committees was in Western countries, the findings of this study may be used as a guide by health policymakers and managers who are only beginning to establish these committees in their hospitals. Moreover, health service providers in countries, where there is still no report about activities of HECs or these committees do not act efficiently, do not have any information about the performance of such committees. Therefore, the results of this study help health service providers become familiar with the status of these committees in different countries and their main functions.

There is a need for further research addressing the real gaps and some of the institutional challenges of HECs and evaluating the functions of HECs.

• Open access
• Published: 29 July 2021

Health care ethics programs in U.S. Hospitals: results from a National Survey

• Marion Danis   ORCID: orcid.org/0000-0002-4749-4568 1 ,
• Ellen Fox   ORCID: orcid.org/0000-0001-9029-7052 2 ,
• Anita Tarzian   ORCID: orcid.org/0000-0002-0237-5311 3 &
• Christopher C. Duke   ORCID: orcid.org/0000-0003-3022-6257 4  

BMC Medical Ethics volume  22 , Article number:  107 ( 2021 ) Cite this article

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As hospitals have grown more complex, the ethical concerns they confront have grown correspondingly complicated. Many hospitals have consequently developed health care ethics programs (HCEPs) that include far more than ethics consultation services alone. Yet systematic research on these programs is lacking.

Based on a national, cross-sectional survey of a stratified sample of 600 US hospitals, we report on the prevalence, scope, activities, staffing, workload, financial compensation, and greatest challenges facing HCEPs.

Among 372 hospitals whose informants responded to an online survey, 97% of hospitals have HCEPs. Their scope includes clinical ethics functions in virtually all hospitals, but includes other functions in far fewer hospitals: ethical leadership (35.7%), regulatory compliance (29.0%), business ethics (26.2%), and research ethics (12.6%). HCEPs are responsible for providing ongoing ethics education to various target audiences including all staff (77.0%), nurses (59.9%), staff physicians (49.0%), hospital leadership (44.2%), medical residents (20.3%) and the community/general public (18.4%). HCEPs staff are most commonly involved in policy work through review of existing policies but are less often involved in development of new policies. HCEPs have an ethics representative in executive leadership in 80.5% of hospitals, have representation on other hospital committees in 40.7%, are actively engaged in community outreach in 22.6%, and lead large-scale ethics quality improvement initiatives in 17.7%. In general, major teaching hospitals and urban hospitals have the most highly integrated ethics programs with the broadest scope and greatest number of activities. Larger hospitals, academically affiliated hospitals, and urban hospitals have significantly more individuals performing HCEP work and significantly more individuals receiving financial compensation specifically for that work. Overall, the most common greatest challenge facing HCEPs is resource shortages, whereas underutilization is the most common greatest challenge for hospitals with fewer than 100 beds. Respondents’ strategies for managing challenges include staff training and additional funds.

Conclusions

While this study must be cautiously interpreted due to its limitations, the findings may be useful for understanding the characteristics of HCEPs in US hospitals and the factors associated with these characteristics. This information may contribute to exploring ways to strengthen HCEPs.

Peer Review reports

Hospitals are complex organizations that grapple with numerous ethical issues related to patient care, population health, professional practice, employee relations, business relations, and organizational ethics. Depending on their ownership, mission, and affiliations, some hospitals also need to be concerned with government ethics, public administration ethics, faith-based ethics, research ethics, and the ethics of educating trainees.

Over the past 40 years, ethics scholars, professional organizations, and oversight organizations have recognized that the breadth of ethical issues that health care organizations face are not fully encompassed by exclusive attention to the clinician-patient relationship; they have called for more attention to the range of ethical issues that are faced by health care organizations [ 1 , 2 , 3 , 4 ].

U.S. hospitals have tended to address this wide range of ethical issues through an expanding patchwork of committees and offices. For example, within a given hospital, clinical ethics issues are often handled by an ethics consultation service or ethics committee while business and management issues are handled by compliance officers and human resources staff and research ethics issues are handled by an institutional review board (IRB). These entities tend to operate in relative isolation from each other, instead of working together to identify and address areas of overlap and gaps [ 5 ].

Yet in more recent years, there has been a call for U.S. health care institutions to move beyond the traditional patchwork model to adopt a unified programmatic approach that integrates the various “subspecialties” of health care ethics such as clinical ethics, organizational ethics, and research ethics [ 6 ]. The American Society for Bioethics and Humanities (ASBH) has explicitly endorsed “the trend toward integrating ethics across all subspecialties in an organization” [ 6 ]. One prime example of such an integrative approach to ethics is the IntegratedEthics™ model from the U.S. Department of Veterans Affairs National Center for Ethics in Health Care [ 5 ], which replaces the traditional, siloed, ethics committee approach with a single, overarching ethics program that coordinates and manages the organization’s provision of ethics services across the full range of content domains. Other ethics models that address a wide range of ethical issues that health care organizations encounter include the Southern California region of Kaiser Permanente, whose bioethics program integrates with many programs including quality management and compliance [ 7 ], and the Catholic Health Association (CHA)/Ascension model [ 8 ], which integrates with leadership and numerous institutional committees such as human resources (IRB), and patient relations. The cross-cutting and comprehensive nature of these programs is reflected in their mission statements. For example, the aim of the CHA/Ascension model is “to promote and support the identity and integrity of an organization and those within it; and the aim of the VA’s IntegratedEthics model is “to support, maintain, and improve ethics quality in health care” at three levels. Notably, none of these integrated ethics programs focuses exclusively on clinical ethics (i.e., the identification, analysis, and resolution of values conflicts or uncertainties that arise in the provision of health care in clinical settings) [ 9 , 10 ]. Rather, they all address other ethics issues, such as those relating to resource allocation, advertising, relationships with employees, and human subjects research. Nor do these programs focus on individual decisions and actions alone; they are also concerned with the organizational systems, processes, environment, and culture [ 5 ].

Integrated ethics programs are “integrated” in three ways. First, whereas in many hospitals, ethics-related activities are carried out by various individuals and programs (such as ethics committees, leadership, and IRBs) in relative isolation from each other, integrated ethics programs have an integrative “umbrella” structure—i.e., a unified, coordinated programmatic approach. Second, whereas traditional ethics support services tend to focus on specific content areas, such as clinical ethics or research ethics, integrated ethics programs are comprehensive or at least very broad in scope, including many if not all types of ethical issues facing the organization. Third, whereas traditional ethics support services tend to focus on a narrow range of activities (e.g., ethics consultation, staff education, and policy review), integrated ethics programs employ many different strategies to accomplish their goals and integrate with other programs and individuals throughout the organization.

Despite the recent trend toward integrated programmatic approaches to ethics in health care organizations, prior empirical studies of health care ethics in U.S. hospitals have focused on a single programmatic structure, activity, or model. For example, there have been studies of clinical ethics consultation services [ 11 , 12 , 13 , 14 ], hospital ethics committees [ 15 , 16 , 17 , 18 ], clinical ethics policy [ 19 ], ethics and compliance programs [ 20 ], research ethics committees [ 21 ], and research ethics consultation [ 22 ]. But to our knowledge, no prior study has examined the full range of officially sanctioned entities within a hospital that support health care ethics—in other words, health care ethics programs (HCEPs).

To address this gap in knowledge regarding hospital-based HCEPs in the US, we included questions regarding ethics programs in a national survey of ethics consultation in US hospitals [ 23 ]. Because ethics consultation services are often part of HCEPs, certain characteristics of ethics consultation services cannot be meaningfully studied without studying the broader ethics program. For example, budgets and staffing are often allocated to ethics programs, to cover various ethics-related activities, and not to ethics consultation services separately. While the survey was largely focused on ethics consultation, this report examines the broader context of HCEPs beyond ethics consultation.

The broader study of which this analysis is a part [ 23 ] replicates many of the methods from a prior national study of health care ethics consultation in U.S. hospitals [ 11 ]. A full description of the methods is provided in the publication of the broader study and is accompanied by the survey instrument [ 23 ].

Survey instrument

A HCEP was defined in the survey questionnaire as follows:

For this survey, health care ethics program is defined as an officially sanctioned entity within a hospital that supports health care ethics by providing ethics-related services such as ethics policy development or ethics education. Services may be performed by one or more designated individual(s), committee(s), office(s), or other organizational structure(s). A health care ethics program may or may not provide ethics consultation.

This definition was intended to include all organized programmatic health care ethics activities regardless of how they were labeled, performed, or structured. To reinforce the idea that a HCEP is not necessarily limited to clinical ethics but can encompass a variety of other content areas, we began the survey with a question about scope that immediately followed the definition of a HCEP. Specifically, we gave a list of ethics-related functions (clinical ethics, business ethics, research ethics, regulatory compliance, ethical leadership, other) and asked respondents to select which functions their HCEP included.

Next respondents were asked a series of multiple-choice questions about the education activities, policy activities, and other activities of their HCEP. To examine their educational role, they were asked to select the target audiences to which their HCEP was responsible for providing ongoing ethics education. To examine their policy work, they were asked whether their HCEP participates in leading and/or assisting others in the development of new policies and/or the periodic review of existing policies. Regarding other activities, they asked whether their HCEP includes an ethics representative positioned at the executive leadership level in the organization, provides ethics representation to other hospital committees, leads large-scale quality improvement initiatives related to ethics, and is actively engaged in community outreach.

Respondents were also asked about their HCEP’s staffing, work hours, financial compensation of staff, source of funding, and reporting relationship through numeric response, numeric range, and multiple-choice questions. To characterize the staffing of HCEPs, respondents were asked how many individuals in total performed either paid or unpaid work for the hospital’s HCEP in the last year (including ethics consultation and other ethics activities). Respondents were then asked to estimate the average number of hours per week that each of these individuals devoted to HCEP work in the last year (< 1, 1–4, 5–9, 10–19, 20–29, 30–39, or ≥ 40 h/week). They were also asked how many of these individuals who worked for the HCEP received salary support (or equivalent financial compensation such as a consulting fee or a dedicated percentage of their salary) specifically for HCEP work. Respondents were then asked to estimate the total number of FTEs in salary support (or equivalent financial compensation) provided for HCEP work at their hospital. FTE was defined as follows: “FTE stands for Full-Time Equivalent. 1.0 FTE means the equivalent of one full-time salary; 0.1 FTE means the equivalent of 4 h per week.” Respondents were asked to provide an estimate even if they did not know the exact number. To determine the source of funding, respondents were asked to indicate how this salary support (or other financial compensation) for HCEP work was funded by estimating the percentage for each of the following funding categories: hospital, multi-hospital health care system that includes the hospital, university or school, patient billing, or other.

To determine the HCEP’s reporting relationship, respondents were asked which hospital administrator or senior leader had oversight responsibility for health care ethics. To clarify the meaning of oversight responsibility the following explanation was provided: “This person is not the person who leads or manages the ethics program, but rather a person at a higher leadership level in the hospital. This person would typically receive periodic reports about the ethics program and would potentially intervene if there were big problems with the program.” To further characterize the program’s relationship with this hospital administrator, respondents were asked to rate on a scale of 0 to 10 the administrator’s level of awareness about the hospital’s health care ethics activities.

Finally, to explore the challenges faced by HCEPs, respondents were asked to give detailed and specific answers to the following open-ended questions: What do you think is the #1 greatest challenge relating to the hospital’s health care ethics program right now? What do you think would help the hospital to overcome or manage that challenge? The full survey is published elsewhere [ 23 ].

Respondents in hospitals that reported not having an ethics consultation service were asked, “Is there some other individual, committee, office or other structure within your hospital that supports health care ethics by providing ethics-related services such as ethics policy development or ethics education?” These hospitals, which were considered to have a HCEP, were invited to take a different version of the survey that included 23 of the primary questions from the full survey Footnote 1 and seven contingency questions from that survey. Footnote 2

Survey sample

The survey sample was drawn from the pool of all general hospitals that participated in the 2016 American Hospital Association Annual Survey of Hospitals [ 24 ]. The random sample, stratified based on bed size category, included 600 hospitals. Survey respondents at each hospital were identified and contacted using a standardized protocol and script as described elsewhere [ 23 ].

Data were analyzed using SAS, version 9.3 . Data were weighted by bed size category to adjust for the stratified sample using the degrees-of-freedom method to make inferences about the entire population of U.S. general hospitals [ 25 ]; Descriptive statistics were used to describe survey measures. We used a series of one-way ANOVAs with contrasts and chi-squares to evaluate the associations between hospital characteristics and specific survey measures. All contrasts used the Scheffé method of adjustment for multiple comparisons [ 26 ]. We used a two-sided probability of 0.05 as the criterion for statistical significance. Results are presented as weighted percentages extrapolated from completed responses to the survey.

In addition to analyzing the survey responses, we calculated the number of content areas that were included within the scope of the hospital’s HCEP (possible score range 0–5), the number of educational target audiences to which the HCEP was responsible for providing ongoing ethics education (possible score range 0–7), the number of types of policy work in which the HCEP participated (possible range 0–4), and the number of other activities performed by the HCEP (possible range 0–4). We also constructed a variable for “total workload,” which was estimated from the aggregated number of person-hours per week that were devoted to (paid or unpaid) HCEP work in the last year by all of the individuals who performed work for the hospital’s HCEP combined. For each of the numeric ranges specified for the average number of hours per week devoted to HCEP work by individuals, we multiplied the number of individuals whose hours per week fell in that range by the midpoint in that range, then summed the results across all numeric ranges. For example, if a hospital indicated that 1 person devoted between 5 and 9 h per week and a second person devoted ≥ 40 h per week, the total workload would be calculated as follows: (1 × 7) + (1 × 40) = 47 h per week.

Some responses to questions regarding average hours per week, number of individuals who received financial compensation, and FTEs did not seem plausible as explained below. For these questions, one author reviewed results to identify potentially implausible responses; these were eliminated if two other authors agreed with doing so. We report results both with and without these implausible responses.

Content analysis

Responses to open-ended questions regarding the HCEP’s greatest challenge and proposed strategies to overcome this challenge were coded using content analysis as follows. Following a reading of responses, a coding scheme was developed by a research assistant. It was then reviewed and revised by one of the authors. Codes were then assigned to responses by these two individuals and reviewed by a second author. Any disagreement regarding assigned codes was reconciled by deliberation. The weighted percentage of respondents in each hospital category who provided open-ended responses matching the assigned codes was calculated. Examples of open-ended responses were selected for inclusion in this manuscript as illustrative of these codes.

Study hospitals

Among the 600 sampled hospitals, one closed before data collection; 462 participated and completed all or part of the study for a response rate of 77.1%. Among these participating hospitals, 438 had an ethics consultation service and were eligible for the version of the online survey designed for hospitals with ethics consultation services; 365 completed some or all of this online survey. An additional 16 of the 462 participating hospitals had a HCEP but no ethics consultation service so were eligible for the modified version of the online survey; of these 16, seven completed at least one question on that survey, but only one hospital answered any of the questions reported in this paper beyond reporting that they had a HCEP. The remaining eight of the 462 participating hospitals had no ethics consultation service and no HCEP so were not eligible for either online survey. Here we report data regarding the prevalence of HCEPS based on the 462 participating hospitals, and data about the characteristics of HCEPs based on the 372 hospitals that completed all or part of either online survey. There were no significant differences between sampled hospitals and participating hospitals, or between hospitals that took the online survey and all participating hospitals, for any of the hospital characteristics, as reported elsewhere [ 23 ].

Prevalence of HCEPs

Based on participants’ responses, an estimated 97.1% of hospitals had a HCEP. The prevalence of HCEPs did not vary significantly by hospital bed size, ownership category, academic affiliation, or urban/rural location (see Table 1 ).

Scope of HCEPs

In almost all hospitals (97.0%), the scope of the hospital’s HCEP included the clinical ethics functions of the hospital. In a minority of hospitals, the HCEP scope included the hospital’s ethical leadership functions (35.7%), regulatory compliance functions (29.0%), business ethics functions (26.2%), and research ethics functions (12.6%). The only significant difference across hospital categories with regard to these functions was the percentage of hospitals whose HCEPs included research ethics, as shown in Table 1 .

The mean number of content areas included in the scope of hospitals’ HCEPs was 2.3 (median 2, range 0 to 5). The HCEP included one content area in 43.6% of hospitals, two in 25.1%, three in 18.2%, four in 6.7%, and all five in 5.1%. The mean number of content areas varied significantly based on level of academic affiliation and hospital location (see Table 2 ).

Activities of HCEPs

HCEPs were responsible for providing ongoing ethics education to the following target audiences: all staff in 77.0% of hospitals, nurses in 59.9% of hospitals, staff physicians in 49.0% of hospitals, leadership/management in 44.2% of hospitals, other non-clinical staff in 40.2% of hospitals, medical residents in 20.3% of hospitals, and the community/general public in 18.4% of hospitals. These percentages did not vary significantly across hospital categories except for medical residents and staff physicians as shown in Table 3 . The HCEP was responsible for one target audience in 36.8% of hospitals, two or three in 18.3%, four or five in 29.9%, and six or seven in 14.0%. The mean number of target audiences was 3.1 (median 3, range 1–7). The number of target audiences varied significantly based on level of academic affiliation and hospital location (see Table 2 ).

HCEPs participated in the following types of policy work: leading the development of new policies (52.2%), assisting others who were leading the development of new policies (57.4%), leading periodic review of existing policies (75.5%), and assisting others who were leading the periodic review of existing policies (55.1%). These percentages varied based on hospitals characteristics as shown in Table 4 . The mean number of types of policy work was 2.4 (median 2, range 1–4). The HCEP participated in one type of policy work in 26.2% of hospitals, two types in 35.2%, three types in 10.9% and all four types in 27.7%. This number of types of policy work varied significantly based on level of academic affiliation and hospital location (see Table 2 ).

HCEPs engaged in a variety of other activities besides education and policy work. The HCEP included an ethics representative positioned at the executive leadership level in the organization in 80.5% of hospitals, provided ethics representation to other hospital committees in 40.7% of hospitals, was actively engaged in community outreach in 22.6% of hospitals, and led large-scale quality improvement initiatives relating to ethics in 17.7% of hospitals. These activities varied based on hospital characteristics and shown in Table 4 . The mean number of other activities was 1.6 (median 1, range 1–4). The HCEP performed one other activity in 61.5%, two other activities in 19.7% of hospitals, three other activities in 14.7%, and four other activities in 4.1%. The number of other activities varied significantly based on level of academic affiliation and hospital location (See Table 2 ).

Staffing, workload, and compensation

The mean number of individuals who performed work (paid or unpaid) for HCEPs in the prior year was 11.0 (range 0–110, median = 8). The mean number of individuals who spent, on average, less than 1 h per week was 8.0; the number who spent 1–4 h per week was 3.0, the number who spent 5–9 h per week was 0.4, the number who spent 10–19 h per week was 0.3, the number who spent 20–29 h per week was 0.2, the number who spent 30–39 h per week was 0.05, and the number who spent 40 or more hours per week was 0.1. Only 5.9% of hospitals had one or more individuals who worked full-time for the HCEP; 4.9% had one, 0.3% had two, 0.2% had three, 0.4% had 4, and 0.3% had 5. The total number of individuals who performed work for HCEPs varied based on hospital characteristics as shown in Table 5 .

The mean calculated total workload—i.e., the total number of person-hours per week devoted to paid or unpaid HCEP work in the last year by all the individuals who performed work for the HCEP combined—was 29.1 person-hours (range 0.5–1595.0, median = 9). Differences across hospital categories are shown in Table 5 .

The mean number of individuals who received salary support or equivalent financial compensation such as a consulting fee or a dedicated percentage of their salary specifically for HCEP work was 1.6 (range 0–21, median = 0). In 61.6% of hospitals, the respondent indicated that no individuals received financial compensation specifically for HCEP work; in 16.7% of hospitals, one individual received compensation specifically for ethics; in 6.5% of hospitals two individuals received compensation specifically for ethics; in 5.0% of hospitals, three received compensation specifically for ethics; and in 10.2% of hospitals, four or more individuals received compensation specifically for ethics.

The mean estimate for the total number of FTEs in salary support or equivalent financial compensation provided to these individuals for HCEP work was 0.3 (range 0–15, median = 0). The estimated total FTE was 0 in 76.3% of hospitals, between 0 and 1.0 in 17.1% of hospitals, between 1.1 and 2.0 in 4.5% of hospitals, and 3 or more in 2.1% of hospitals.

In some cases, responses to the questions pertaining to these last three variables—workload, the number of individuals receiving financial compensation for HCEP work, and the total number of FTE—were deemed implausible, either because the responses were extreme outliers, or because the responses to these questions were inconsistent with each other. An example of an outlier response is one hospital where 42 individuals were reported to each spend between 20 and 29 h per week on HCEP work, while no individuals spent fewer than 20 h or more than 29 h per week. An example of an inconsistent response is one hospital where seven people were reported to each spend less than one hour per week on HCEP work and no one spent more than one hour per week, yet one person received salary support specifically for HCEP work and the total FTE for HCEP work was estimated to be two.

Removing such implausible responses had no effect on the results for workload. However, for both the number of individuals receiving financial compensation and for total estimated FTE, the results changed somewhat once implausible responses were removed. Specifically, for the number of individuals receiving financial compensation, for 23 of 251 respondents, responses were deemed implausible. Once these implausible responses were removed (N = 228), the results were as follows. The mean number of individuals who received salary support or equivalent financial compensation such as a consulting fee or a dedicated percentage of their salary specifically for HCEP work was 0.6 (range 0–21, median = 0). In 71.1% of hospitals, no individuals received financial compensation specifically for HCEP work; in 16.0% of hospitals, one individual received financial compensation; in 7.2% of hospitals two received compensation; in 2.4% of hospitals, three received compensation; and in 3.3% of hospitals, four or more individuals received compensation. The number of individuals receiving financial compensation varied based on bed size, academic affiliation, and urban/rural location as shown in Table 4 , which summarizes the data after implausible answers were removed.

For estimated FTEs, 17 of 204 responses were deemed implausible. Based on the plausible responses only (N = 188), the mean estimated FTE was 0.2 (range 0–7, median = 0). Estimated FTE was 0 in 83.0% of hospitals, between 0.001 and 1.0 in 11.4% of hospitals, between 1.1 and 2.0 in 3.8% of hospitals, and 3 or more in 1.4% of hospitals. Estimated FTE varied based on bed size, academic affiliation, and location as shown in Table 5 .

When we analyze the staffing and workload of HCEPs and extrapolate from responses regarding the total number of individuals who performed paid or unpaid work for hospitals, we estimate that, in aggregate, approximately 32,000 individuals performed work for US hospital HCEPs in the year prior to the survey.

In hospitals where salary support or other financial compensation was provided for HCEP work, it was funded by the hospital in 72.9% of hospitals, by a multi-hospital health care system that includes the hospital in 23.3% of hospitals, by a university or school in 0.9% of hospitals, through patient billing in 0.4% of hospitals, and by some other source for 2.5% of hospitals.

Reporting relationship

The hospital administrator or senior leader who had oversight responsibility for health care ethics was the Chief Executive Office in 28.4% of hospitals, the Chief Medical Officer in 23.8% of hospitals, the Chief Nursing Officer in 18.7% of hospitals, the Chief Operating Officer in 4.7% of hospitals, and some other individual in 24.4% of hospitals. The mean rating for the hospital administrator’s level of awareness about the hospital’s health care ethics activities was 8.1 on a scale from 0 to 10 (where 0 = not at all aware and 10 = extremely aware).

Greatest challenges facing ethics programs

Of the 372 respondents who completed some part of the online survey, 232 wrote in responses describing their HCEP’s #1 greatest challenge. The greatest challenges fell into 5 categories: resource shortages (including time, money, staff, recruitment, and training); underutilization of the ethics support services (i.e., staff were unaware of the service, did not understand the role of the service, did not appreciate its possible benefits, or did not identify a need for the service); lack of clarity about the ethics program’s scope, goals or purpose; lack of support from organizational leaders; and other challenges. See Table 6 for a summary of the percentages of hospitals reporting these challenges and sample quotes for each category. Hospitals with 1–99 beds were much more likely to report underutilization (50%) as their greatest challenge than hospitals with 500 + beds (16.5%) ( p  < 0.01). Similarly, non-teaching hospitals (44.3%) and rural hospitals (38.9%) were much more likely to report underutilization as their greatest challenge than major teaching hospitals (9.0%), and urban hospitals (19.6%) ( p  < 0.0001). Meanwhile, large hospitals, major teaching hospitals, and urban hospitals were more likely to list resource shortages as their greatest challenge (63.3% of hospitals with 500 + beds vs. 42.9% of hospitals with 1–99 beds; 69.5% of major teaching vs. 47.9% of non-teaching hospitals; 55.6% urban vs. 44.4% rural hospitals), although the differences for resource shortages were not statistically significant. While resource shortages was the most commonly reported greatest challenge overall, underutilization was the most commonly reported greatest challenge in hospitals with fewer than 100 beds.

Strategies for overcoming challenges

Responses regarding what the respondent thought would help their hospital overcome or manage their greatest challenge fell into 8 categories: additional resources (for more time, staff, or other needs); training for staff; increased leadership buy-in; publicity or marketing; quality improvement efforts; data to demonstrate the value of the program; regional or national support or mandate; or some other solution that fell outside of these categories. See Table 7 for percentages of hospitals reporting each of these categories and sample quotes. Government hospitals were more likely to mention training as a solution than were for-profit hospital (Federal government (0.45), non-federal government (0.62), for-profit (0.18), p  < 0.01).

This nationwide survey of a random sample of US hospitals serves to describe the characteristics of HCEPs in US hospitals beyond ethics consultation. The characteristics we studied were: prevalence, scope, activities (education, policy, other activities), staffing, workload, financial compensation for program staff, reporting relationship, the #1 greatest challenge, and potential solutions.

Limitations

We wish to note several limitations before putting the study in context and considering its implications. We should acknowledge that we may have overestimated the percentage of hospitals that have HCEPs since hospitals without such a program may have been less likely to have a “best informant” and therefore less likely to have participated in the study. However, there were no significant differences between participating hospitals and non-participating hospitals for any of the demographic variables examined in this study [ 23 ]. Another limitation is that among hospitals that said they had a HCEP, only one hospital without an ethics consultation service responded to the questions reported in this study. Thus while this study was designed to provide information on HCEPS in hospitals that provide ethics consultation as well as those that do not provide ethics consultation, the results provide almost no information about hospitals in the latter category. A further limitation relates to the completion of the survey by a single respondent or “best informant” at each hospital. Since in many hospitals, various ethics-related activities are carried out in silos in relative isolation from each other [ 5 ], the survey respondent may not have been aware of the full range of activities of their HCEP, especially if the program was not well integrated. An added challenge is that unlike EC, which has widely accepted definitions and standards, there are no widely accepted definition or standards for HCEPs. While we stipulated a definition for “health care ethics program” in the survey, the term has only recently been gaining in usage and acceptance with the trend towards adopting integrated ethics programs. In this survey, because we wanted to capture the full range of organized entities that support health care ethics, we deliberately defined HCEPs in a broad and general way. As such, the term was almost certainly interpreted differently by various respondents. Lastly, a limitation of the paper relates to the questions on salary support/compensation and our concerns about the validity of these results, because of both the number of non-respondents and the number of implausible responses observed for these questions.

Prevalence, scope, and activities of HCEPs

Having acknowledged these limitations, we believe these data serve as the first systematically conducted survey of the state of HCEPs in US hospitals. It represents a starting point for further research and may serve to set a bar for future work. As such, we reflect on the study findings and their implications. The 97% prevalence of HCEPs in US hospitals is not surprising, considering that by 1999, 93% of hospitals had institutional ethics committees. We expected the prevalence of HCEPs to be quite high since HCEPs were defined to encompass all organized health care ethics activities including but not limited to ethics committees.

With regard to scope of HCEPs, our findings show that in almost all hospitals, HCEPs include the hospital’s clinical ethics functions, while other functions such as ethical leadership, research ethics, regulatory compliance, and business ethics were included in the scope of the HCEP in only a minority of hospitals. We should note that there are two possibilities for why hospitals do not report that the scope of their HCEP includes a particular function or content area: either that function is not carried out under the umbrella of the HCEP, or that function is not carried out at the hospital at all—at least not in an organized way. For example, a hospital might have an internal or external IRB that addresses aspects of research ethics but is separate from the hospital’s HCEP, or alternatively, the hospital might have no organized mechanism for addressing research ethics at all, which would likely be the case if they did not conduct research. While historically, most clinical research was conducted in academic medical centers, which comprise approximately 5% of hospitals in the U.S. [ 27 ], there has been a trend in favor of community hospitals conducting research [ 28 ], and now most health care facilities have at least one IRB [ 29 ]. In this study 12.6% of hospitals indicated that research ethics functions were within the scope of their HCEPs, but there may have been other hospitals that addressed research ethics separately from their HCEP.

With regard to the other content areas (ethical leadership, business ethics, regulatory compliance), only a minority of hospitals report that they are included in their HCEPs. While there is little doubt that all hospitals encounter ethical issues relating to all three of these content areas, it is unclear whether hospitals formally address ethics in these areas through programs or structures separate from their HCEPs, or not at all. As an example, all hospitals must meet regulatory compliance requirements [ 28 ]. Guidance from the U.S. Department of Health and Human Services Office of the Inspector General states that “it is imperative for hospitals to establish and maintain effective compliance programs” [ 30 ]. So, while only 29% of respondents reported that this activity resided with their HCEP, compliance activities are highly likely to be going on elsewhere in the hospital. Compliance programs are often called “Compliance and Ethics” programs, mirroring U.S. Sentencing Commission Guidelines for Organizations [ 31 ]. But it is unclear the extent to which compliance programs integrate both compliance-based and values- or integrity-based approaches to ethics [ 32 ].

HCEPs were much more likely to engage in certain activities compared to others. Most hospitals’ HCEPs were responsible for providing ongoing ethics education to all staff and to nurses, while a minority of hospitals were responsible for educating other target audiences. In terms of policy work, HCEPs most commonly reviewed existing policies and less often participated in developing new policies or assisting others in policy review. Most HCEPs had a representative in executive leadership, but less than half had representatives on other committees, led large-scale quality improvement initiatives relating to ethics, and engaged in community outreach.

Extent of integration of HCEPs

Our findings pertaining to the scope and activities of HCEPs provide some preliminary insights into the degree to which HCEPs are integrated. Integrated ethics programs, by their nature, have a unified, coordinated structure; are comprehensive or at least very broad in scope, and utilize a variety of different strategies to integrate with other programs and individuals throughout the organization. In this survey we did not examine the extent to which HCEPs are unified or coordinated structurally, but we did ask questions about the breadth of HCEPs scope and activities. With respect to scope, we note that while in most hospitals the HCEP’s scope was rather narrow, in that it included only one or two of the listed content areas, in 11.8% of hospitals, the scope was broad, in that they included four or five of these areas. We also note that the mean number of content areas varied based on level of academic affiliation, suggesting that HCEPs in academic medical centers tend to be broader in scope.

We observed a similar pattern for HCEPs’ breadth of activities. In most hospitals the HCEP was responsible for educating only a few of the listed target audiences, but in 14.0% of hospitals the HCEP educated six or seven. In most hospitals the HCEP participated in only one or two of the listed types of policy work, but in 27.7% the HCEP participated in all four. And in most hospitals the HCEP performed only one of the other activities listed, but in 4.1% of hospitals, the HCEP participated in all four. For all of these variables—content areas, target audiences, types of policy work, and other activities, the mean number varied based on level of academic affiliation and location, suggesting that HCEPs in urban academic medical centers tend to be more integrated.

Staffing, workload, and compensation for HCEP work

In reflecting on the study results regarding compensation for HCEP work, we must take into account that, with respect to both the number of individuals who received financial compensation and the estimated number of FTEs, there were a number of non-respondents to these questions and a number of participants gave responses that were considered implausible. This suggests that respondents may not have been sure about how to answer these questions and/or may have misinterpreted their intent. Hence any interpretation must be cautious. Nonetheless, a few observations deserve mention.

First, we observe that the estimated number of individuals who performed work for HCEPs in US hospitals in the year prior to the survey was 32,000, compared with 27,000 who performed ethics consultation [ 23 ]. This would suggest that 84% of individuals who work for HCEPs perform ethics consultation.

Second, it appears that large hospitals, major teaching hospitals, and urban hospitals devoted significantly more resources to HCEPs than other hospitals, in term of individuals working for the HCEP, the number of person hours spent on HCEP work, the number of individuals receiving financial compensation specifically for HCEP work, and the total number of FTEs. With respect to financial compensation, the differences were particularly striking: for example, the mean number of FTEs for hospitals with 500 or more beds and for major teaching hospitals was 1.0, compared with 0 for hospitals with fewer than 100 beds and for non-teaching hospitals.

In interpreting these results, it is important to note that the survey asked only about individuals who received financial compensation specifically for HCEP work in the form of, for example, a consulting fee or a dedicated percentage of their salary. Employees who performed work for the HCEP as a volunteer service activity, as a “collateral duty,” or as part of their administrative or protected time may have been 100% compensated for their HCEP work in the sense that they performed it while “on the clock,” even though they did not receive any compensation specifically for their HCEP work. In addition, while percent effort distribution (in which professionals have portions of their time allocated to specific activities) is a common practice in academic medical centers, this may be an unfamiliar concept in non-academic settings. As a result, this study may have underestimated financial compensation in these hospitals.

Challenges and solutions

As we noted, while overall, a shortage of resources was the most commonly reported greatest challenge, in hospitals with fewer than 100 beds, the most commonly reported greatest challenge was underutilization. Responses categorized as underutilization included lack of staff awareness, understanding, or appreciation of the services offered by the HCEP, or lack of perceived need for the service. This finding of underutilization is consistent with the findings of a national survey of critical access hospitals conducted in 2007 [ 33 ]. In that survey, which included 381 hospital administrators, only 60% of these hospital administrators reported having an ethics committee or ethics consultation service and 28% did not see the need for such ethics support services despite their absence [ 33 ]. Is the challenge of underutilization at small hospitals concerning? It would seem to depend on whether health care professionals do in fact have the competence to address ethical concerns without collaborating with health care ethicists, and are doing so in a way that adequately and justly meets the needs of stakeholders at their hospitals. Our study cannot adequately determine whether that is the case, but it is an important issue to explore.

Given the complicated mission and organizational structure of hospitals, and the many stakeholders involved, hospital leaders have a daunting task in meeting their mission in an ethically sound manner. Our study shows that nearly all US hospitals have some sort of HCEP, but these programs vary widely in terms of scope, activities, staffing, workload, and compensation of staff. Only a minority of HCEPs are integrated ethics programs in that they apply a unified, coordinated programmatic approach to managing ethics that address a broad range of ethics content areas and employ a wide range of strategies to integrate with other parts of the organization. The greatest challenge facing HCEPs is lack of resources, except in small hospitals where the greatest challenge is underutilization. We hope that our results will inform further discussion about the appropriate role of HCEPs and the resources they require in facilitating the delivery of ethically sound patient care in hospitals.

Availability of data and materials

The datasets generated and analyzed during this study may be requested from the authors. Because some survey data may reveal identifying information regarding participating hospitals, access to some data may be restricted.

Q1, Q41, Q47A-B, Q49-50, Q15, Q61-73, Q75-7.

Q1, Q47A, Q61, Q71, Q41, Q72.

Abbreviations

American Society for Bioethics and Humanities

Catholic Health Association

Full time equivalent

Health care ethics program

Institutional Review Board

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Acknowledgements

The authors would like to thank the following Altarum employees for their help on this work: Gillian Beach, Gregory Becker, Cydny Black, Elizabeth Blair, Erin Butto, Danisha Herrod, Jim Lee, Christine Stanik. We would also like to thank Paula Goodman-Crews and Alexander Kon for their valuable contributions to the expert panel, and Lisa Lehmann for her early involvement in the project. Finally, we would like to thank the hundreds of individuals and hospitals that participated in cognitive interviewing, pilot testing, or the survey study.

Open Access funding provided by the National Institutes of Health (NIH). This work was supported by the Greenwall Foundation under a 2015 Making a Difference Grant and a 2018 President’s Award. Marion Danis’s salary was supported by the Department of Bioethics, a part of the intramural program at the National Institutes of Health. The funders had no role in data collection, analysis or reporting.

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Marion Danis

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Anita Tarzian

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Christopher C. Duke

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Contributions

EF, MD, AT, and CD made substantial contributions to the conception and design of the survey, interpretation of the data and preparation of the manuscript; EF and CD made substantial contribution to acquisition of the data. EF, CD and MD contributed to the analysis, of the data. All authors have approved the submitted version of the study. All authors have agreed both to be personally accountable for their own contributions and to ensure that questions related to the accuracy or integrity of any part of the work, were appropriately investigated, resolved, and the resolution documented in the literature. All authors read and approved the final manuscript.

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Correspondence to Marion Danis .

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This study was performed in accordance with relevant guidelines and regulations. The survey was reviewed and determined to be exempt from IRB review by the Chesapeake (now Advarra) IRB and the Office of Human Subjects Research Protection (OHSRP) at the National Institutes of Health. The OHSRP determination specified that Federal regulations for the protection of human subjects do not apply to this study. The OHSRP determination of Not Human Subjects Research is based on the interpretation of 45 CFR 46 under "Research Involving Coded Private Information or Biological Specimens" [ 34 ] and Guidance on Engagement of Institutions in Human Subjects Research [ 35 ]. The activity was designated EXEMPT, and was entered in the OHSRP database (Exempt #13456).

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Danis, M., Fox, E., Tarzian, A. et al. Health care ethics programs in U.S. Hospitals: results from a National Survey. BMC Med Ethics 22 , 107 (2021). https://doi.org/10.1186/s12910-021-00673-9

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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.

© 2023 The Korean Academy of Medical Sciences.

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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…

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