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IRB Consent Form Templates

A collection of informed consent, assent, and debriefing templates that can be used for your human participant research study.

General Consent Form Templates

Social and Behavioral Research Projects (last updated 03/16/2023)

Biomedical Research Projects (last updated 07/18/2022)

Consent Form Templates for Specific Biomedical Procedures

MRI and fMRI

Blood Collection by Finger Stick

Blood Collection by Venipuncture

Oral Consent Template

Guidance for Protocols Involving Oral Consent

Debriefing Template

Guidance and Template for Debriefing Participants

Studies Involving Children (Assent/Permission Forms)

Parent-Guardian Permission for Studies Involving Children

Sample Parental Notification Form

Sample Child Assent Form

Performance Release for Minors

Performance Releases

Performance Release for Adults

Sample Consent Forms

Consent form templates.

These consent form templates have been posted for your reference.  When completing and IRB submission in IRBIS, please fill in the application and use the consent form builder specific to your project.  For more information, please find instructions here .

Summary of Changes to the Regulations for Informed Consent:  Revised Common Rule Changes to Informed Consent and Waiver Requirements

Summary of Changes to Consent Documents:

• Informed Consent Documents – Version 2.0 Summary of Changes
• Informed Consent Documents – Version 2.1 Summary of Changes
• Informed Consent Documents – 10/26/2020 Summary of Changes
• Informed Consent Documents – 4/10/2023 Summary of Changes

Concise Summary examples can be found here .

Guidance on the use of plain language in consent forms:

• Clinical Research Glossary
• Webinar: The Promise of Plain Language: Launching a Glossary to Support Participant Understanding of Clinical Research – Recording & Slides

There are a few additional forms that are not provided online and may be accessed below.  As needed, these should be completed and uploaded to your IRB application.

Foreign Language Consent Forms

COVID-19 Related Forms:

• Spanish-IRB-COVID Information Sheet
• Spanish COVID Consent Letter v2
• Spanish COVID Informational Sheet Translation Certificate

Informed Consent Short Form (for a single subject who may be illiterate, or otherwise unable to read the consent form — used when full consent form has to be read or translated for subject).

• Informed Consent Short Form Guidance
• Simplified Chinese

HIPAA Templates

• Sample HIPAA Authorization Template
• Sample HIPAA Authorization Template in Spanish ( Certification )

Sample consent and permission forms

General consent form to participate in research (DOC)

Two stage project consent form (DOC)

Parent permission form for research with child (DOC)

Child assent form (DOC)

Multiple consent form including audio-recording and quotations (DOC)

Photo and video consent form (DOC)

Video-recording consent form (DOC)

Re-contact agreement form (DOC)

Post-debriefing consent form (DOC)

The Research Compliance Office (RCO) will be closed during Stanford’s Winter Closure from Monday, December 23, 2024, through Friday, January 3, 2025, and will resume operations on Monday, January 6, 2025.

Medical Research: Forms & Consent Templates

Main navigation.

This section contains all of the forms and consent templates that apply to investigators from:     • School of Medicine (SoM)    • Veteran's Affairs (VA) Hospital 

*Please note that when creating a protocol for IRB submission, these investigators need to select the Medical eProtocol Application category.

If you have questions or are having trouble accessing these forms, please contact IRB Education ( email or call 650-724-7141).

The consent/assent form should be in a language that is understandable to someone without a medical or scientific background. Please use the Microsoft Readability Statistics tool as needed when writing your consent form.

See  consent template updates  for recent changes.

Short Form Consent Templates can be found HERE .

Other Forms:

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Explore downloadable templates, including standard consent and assent templates, as well as several specialty templates, for use in specific types of research situations. You can search and bookmark any template in Research A-Z.

Obtaining the consent of a subject is a process that goes far beyond asking for a signature on a document. Potential participants must understand the nature of the study, the risks, discomforts, inconveniences, and potential benefits involved if they are to make an informed decision. We ensure respect for persons by providing information needed for thoughtful consent for a voluntary act.

• Tips for Preparing

NOTE: On April 15, 2024 IRBMED issued a revised Standard Template , as well as revised versions of the eligibility, survey, and blood draw Specialty Templates containing updates relating to the new HSIP compensation policy. Consent documents submitted on or after June 1 st must be created in the newly revised template. See Research A-Z for more information.

Informed consent is an ongoing process that begins with recruitment and continues through the completion of the study.

The first step is to provide potential subjects with general information about the nature of the study and why they might be suited to participate. The recruitment flyers, websites, and phone scripts are part of this process. All recruitment materials must be reviewed by an IRB prior to implementation.

Once someone indicates interest in joining a study, details should be presented by a study team member who is knowledgeable about both the study and informed consent.

• Provide information about the research in language the subject can understand. Encourage questions and query for understanding. Note that for children (see Guidance about children ) and for those who do not understand written English language documents, this requires additional steps (which require IRB approval). See the IRBMED's guidance for non-English speaking/reading subjects .
• Provide an explanation of the difference between treatment and research.
• Provide time for subjects to consider all options. The riskier the study, the more time that is usually required.
• Provide answers to all of the subject's questions before the decision is made.
• Provide documentation about the research (including calendars, instructions, etc.) that the subject can refer to later. A copy of the consent document must be provided to the subject (or the subject’s legally authorized representative) and the original signed consent document should be retained in the study records. Note that the regulations do not require the subject's copy to be a signed copy, although a photocopy with signature(s) is preferred. All materials provided to subjects need IRB approval.
• Provide on-going opportunities to re-affirm consent throughout the study. Remind the subject about important information. Provide new information as it becomes available. Ask the subjects if they still want to participate. Document these interactions.

At each study visit encourage subjects to ask questions and raise concerns. Thus, informed consent becomes an ongoing, interactive process, rather than a one-time information session. Following good clinical practice (GCP) these discussions should be recorded in the subjects' records.

Important note for UMHS studies: A copy of the complete (every page) signed consent form should be placed in the UM medical record of subjects, particularly when the research intervention may affect other treatment or care (in most cases this means scanning the document into MiChart; click here for instructions). However, doing so may not be appropriate in all cases (for example if identification of the subject as a study participant might put the subject at risk of criminal prosecution or harm to reputation).

Web Resources

• Office of Human Research Protections (OHRP)
• National Cancer Institute, 'A Guide to Understanding Informed Consent'
• Food and Drug Administration (FDA)

The informed consent document is an important tool in the informed consent process. The goal is to have a document, understandable to the subjects or their legal representatives, that explains what will happen to them as part of the study, when it happens, and why.

Target readability levels of consent forms should be between 6th and 8th grade. Examples of this level are found in the popular press, e.g. Newsweek or USA Today. Computer programs that analyze grade level, like the Flesh Kincaid method, are useful tools but cannot be relied upon in whole because informed consent documents often use words of a higher level (like the name of a procedure) that you will also explain in lay terms.

The sections below, Tips and Examples of protocol language ‘translated’ to subject-friendly language, are to assist you in achieving an understandable document. Also refer to the UM library system's plain language medical dictionary for more lay terms. Refer to the Education page for information about the IRBMED workshop, Informed Consent 201.

Special thanks to the Center for the Advancement of Clinical Research for contributions in the material below.

• Use one of the IRBMED provided templates (above).
• Review the IRBMED template instructions (above). Alternate text for many sections is provided in the instructions to tailor the document appropriately for the type of study being described. The federally required elements of consent are also provided.
• Use multiple consents tailored for each study group in unblinded studies where different subject groups undergo significantly different procedures or schedules.
• Use subheads within sections that require extensive detail.
• Use a logical order for the topic within each section. For example, in the risk section, begin with research related risks that are expected, likely, and serious. Conclude with rarely expected risks and convey the likelihood.
• Insert hard page breaks if the page breaks at a place that makes it hard for the reader to follow such as right after a subhead.
• Do not use text smaller than 12 point.
• Use at least 1.5 spacing between paragraphs.
• Discuss only one or two ideas per paragraph.
• Keep paragraphs short.
• Avoid compound sentences.
• Use shorter, simpler words whenever they can convey appropriate meaning.
• Define or explain medical terms, procedures, and technical or complex words.
• Use U.S. measurements for metric measurements, or both. State 2 teaspoons rather than 10 MLs.
• Use regular time not military time. For example, say 1 p.m. rather than 1300 hours.
• Do not use exculpatory language, that is, language that indicates somebody (the researchers or UM) is free from blame.
• Write in the ‘second person,’ For example, instead of "The patient will be asked some questions about her medical history, then she will have a small amount of blood drawn,” state, "You will be asked some questions about your medical history, then a small amount of your blood will be drawn."
• Do not imply ‘cut and paste’ protocol sections or include elaborate details of the procedures of the protocol.
• Do not include highly scientific objectives or hypotheses that are of little relevance to the participants. These may bias your results or confuse participants.
• Consider what the participant would want to know.

Examples of protocol language versus subject-friendly language text

IRBMED has full accreditation by they Association for the Accreditation of Human Research Protection Programs, Inc.

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Consent, Assent, and Screening Templates

Biomedical Research Consent Templates

Minimal Risk Research Consent Templates (Expedited or Exempt)

These templates are appropriate for social, behavioral, and educational ("SBER") research that does not include any biomedical procedures.

• Study Information Sheet (no signature)
• Consent Form (includes signature)
• Consent Form for Federally Funded Research
• Parent Permission Form (parents provide permission for child to participate)
• Parent Consent Form (parents complete research procedures themselves)
• Oral Consent Script Outline
• Sample Debriefing Script

Biomedical Research Informed Consent Templates

• Biomedical Research Consent Template
• Consent Template for Expanded Access Research
• Right to Try Consent Template
• Humanitarian Use Device Consent Template

Child and Adolescent Assent Templates

• Child Assent Template (Age 7-12)
• Adolescent Assent Template for Non-Treatment Studies (Age 13-17)

Addendum Consent Templates

• Addendum Consent Template for Non-Treatment Studies  (for new procedures, risks)
• Addendum Consent Template for Treatment Studies  (for new procedures, risks)

Screening Scripts

• Screening Script for non-Treatment Studies
• Screening Script for Treatment Studies

Consent Standards and Sample Language

• Social, Behavioral & Educational ("SBER") Consent form Standards and Template Language
• Biomedical Research Consent Form Standards and Sample Language

Comprehension Tools

• PRISM Readability Tool Kit
• Self-Certification of Surrogate Decision Makers for Potential Research Subject's Participation in UC Research  (For use  only  in studies the IRB has reviewed and explicitly approved for surrogate consent)
• Decision-Making Capacity Assessment Tool  (for potential subjects who may have cognitive impairments)

Other References

• Research Participant Bill of Rights/Experimental Subjects Bill of Rights  - available in 34 languages
• Conducting Risk-Benefit Assessments
• Obtaining and Documenting Informed Consent  (v. 07-28-11)
• Requesting Waivers and Exceptions to Informed Consent  (v. 07-28-11)
• Child Assent and Permission by Parents or Guardians  (v. 09-06-11)
• The Use of Legally Authorized Representatives or Surrogate Consent  (v. 06-21-10)
• Recruitment and Screening Methods and Materials  (v. 09-05-11)

We appreciate your suggestions for improving templates and/or adding sample language to the standards documents. Please email  OHRPPEQI@research.ucla.edu to provide your feedback.

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Home » Informed Consent in Research – Types, Templates and Examples

Informed Consent in Research – Types, Templates and Examples

Table of Contents

Informed Consent in Research

Informed consent is a process of communication between a researcher and a potential participant in which the researcher provides adequate information about the study, its risks and benefits, and the participant voluntarily agrees to participate. It is a cornerstone of ethical research involving human subjects and is intended to protect the rights and welfare of participants.

Types of Informed Consent in Research

There are different types of informed consent in research , which may vary depending on the nature of the study, the type of participants, and the context. Some of the common types of informed consent in research include:

Written Consent

This is the most common type of informed consent, where participants are provided with a written document that explains the study and its requirements. The document typically includes information about the purpose of the study, procedures involved, risks and benefits, confidentiality, and participant rights. Participants are asked to sign the document as an indication of their willingness to participate.

Oral Consent

In some cases, oral consent may be used when a written document is not practical or feasible. Oral consent involves explaining the study and its requirements to participants verbally and obtaining their consent. This method may be used for studies with illiterate or visually impaired participants or when conducting research remotely.

Implied Consent

Implied consent is used in studies where participants’ actions are taken as an indication of their willingness to participate. For example, a participant may be considered to have given implied consent if they show up for a scheduled appointment for the study.

Opt-out Consent

This method is used when participants are given the opportunity to decline participation in a study. Participants are provided with information about the study and are given the option to opt-out if they do not wish to participate. This method is commonly used in population-based studies or surveys.

Assent is used in studies involving minors or participants who are unable to provide informed consent due to cognitive impairment or disability. Assent involves obtaining the agreement of the participant to participate in the study, along with the consent of a legally authorized representative.

Informed Consent Format in Research

Here’s a basic format for informed consent that can be customized for specific research studies:

• Introduction : Begin by introducing yourself and the purpose of the study. Clearly state that participation is voluntary and that participants can withdraw at any time without penalty.
• Study Overview : Provide a brief overview of the study, including its purpose, methods, and expected outcomes.
• Procedures : Describe the procedures involved in the study in clear, concise language. Include information about the types of data that will be collected, how they will be collected, and how long the study will take.
• Risks and Benefits : Outline the potential risks and benefits of participating in the study. Be honest and upfront about any discomfort, inconvenience, or potential harm that may be involved, as well as any potential benefits.
• Confidentiality and Privacy : Explain how participant data will be collected, stored, and used, and what measures will be taken to ensure confidentiality and privacy.
• Voluntary Participation: Emphasize that participation is voluntary and that participants can withdraw at any time without penalty. Explain how to withdraw from the study and who to contact if participants have questions or concerns.
• Compensation and Incentives: If applicable, explain any compensation or incentives that will be offered to participants for their participation.
• Contact Information: Provide contact information for the researcher or a representative from the research team who can answer questions and address concerns.
• Signature : Ask participants to sign and date the consent form to indicate their voluntary agreement to participate in the study.

Informed Consent Templates in Research

Here is an example of an informed consent template that can be used in research studies:

Introduction

You are being invited to participate in a research study. Before you decide whether or not to participate, it is important for you to understand why the research is being done, what your participation will involve, and what risks and benefits may be associated with your participation.

Purpose of the Study

The purpose of this study is [insert purpose of study].

If you agree to participate, you will be asked to [insert procedures involved in the study].

Risks and Benefits

There are several potential risks and benefits associated with participation in this study. Some of the risks include [insert potential risks of participation]. Some of the benefits include [insert potential benefits of participation].

Confidentiality

Your participation in this study will be kept confidential to the extent allowed by law. All data collected during the study will be stored in a secure location and only accessed by authorized personnel. Your name and other identifying information will not be included in any reports or publications resulting from this study.

Voluntary Participation

Your participation in this study is completely voluntary. You have the right to withdraw from the study at any time without penalty. If you choose not to participate or if you withdraw from the study, there will be no negative consequences.

Contact Information

If you have any questions or concerns about the study, you can contact the investigator(s) at [insert contact information]. If you have questions about your rights as a research participant, you may contact [insert name of institutional review board and contact information].

Statement of Consent

By signing below, you acknowledge that you have read and understood the information provided in this consent form and that you freely and voluntarily consent to participate in this study.

Participant Signature: _____________________________________ Date: _____________

Investigator Signature: ____________________________________ Date: _____________

Examples of Informed Consent in Research

Here’s an example of informed consent in research:

Title : The Effects of Yoga on Stress and anxiety levels in college students

Introduction :

We are conducting a research study to investigate the effects of yoga on stress and anxiety levels in college students. We are inviting you to participate in this study.

If you agree to participate, you will be asked to attend four yoga classes per week for six weeks. Before and after the six-week period, you will be asked to complete surveys about your stress and anxiety levels. Additionally, we will measure your heart rate variability at the beginning and end of the six-week period.

Risks and Benefits:

There are no known risks associated with participating in this study. However, the benefits of practicing yoga may include decreased stress and anxiety levels, increased flexibility and strength, and improved overall well-being.

Confidentiality:

All information collected during this study will be kept strictly confidential. Your name will not be used in any reports or publications resulting from this study.

Voluntary Participation:

Participation in this study is completely voluntary. You are free to withdraw from the study at any time without penalty.

Contact Information:

If you have any questions or concerns about this study, you may contact the principal investigator at (phone number/email address).

By signing this form, I acknowledge that I have read and understood the above information and agree to participate in this study.

Participant Signature: ___________________________

Date: ___________________________

Researcher Signature: ___________________________

Importance of Informed Consent in Research

Here are some reasons why informed consent is important in research:

• Protection of participants’ rights : Informed consent ensures that participants understand the nature and purpose of the research, the risks and benefits of participating, and their rights as participants. It empowers them to make an informed decision about whether to participate or not.
• Ethical responsibility : Researchers have an ethical responsibility to respect the autonomy of participants and to protect them from harm. Informed consent is a crucial way to uphold these principles.
• Legality : Informed consent is a legal requirement in most countries. It is necessary to protect researchers from legal liability and to ensure that research is conducted in accordance with ethical standards.
• Trust : Informed consent helps build trust between researchers and participants. When participants understand the research process and their role in it, they are more likely to trust the researchers and the study.
• Quality of research : Informed consent ensures that participants are fully informed about the research and its purpose, which can lead to more accurate and reliable data. This, in turn, can improve the quality of research outcomes.

Purpose of Informed Consent in Research

Informed consent is a critical component of research ethics, and it serves several important purposes, including:

• Respect for autonomy: Informed consent respects an individual’s right to make decisions about their own health and well-being. It recognizes that individuals have the right to choose whether or not to participate in research, based on their own values, beliefs, and preferences.
• Protection of participants : Informed consent helps protect research participants from potential harm or risks that may arise from their involvement in a study. By providing participants with information about the study, its risks and benefits, and their rights, they are able to make an informed decision about whether to participate.
• Transparency: Informed consent promotes transparency in the research process. It ensures that participants are fully informed about the research, including its purpose, methods, and potential outcomes, which helps to build trust between researchers and participants.
• Legal and ethical requirements: Informed consent is a legal and ethical requirement in most research studies. It ensures that researchers obtain voluntary and informed agreement from participants to participate in the study, which helps to protect the rights and welfare of research participants.

Advantages of Informed Consent in Research

The advantages of informed consent in research are numerous, and some of the most significant benefits include:

• Protecting participants’ autonomy: Informed consent allows participants to exercise their right to self-determination and make decisions about whether to participate in a study or not. It also ensures that participants are fully informed about the risks, benefits, and implications of participating in the study.
• Promoting transparency and trust: Informed consent helps build trust between researchers and participants by providing clear and accurate information about the study’s purpose, procedures, and potential outcomes. This transparency promotes open communication and a positive research experience for all parties involved.
• Reducing the risk of harm: Informed consent ensures that participants are fully aware of any potential risks or side effects associated with the study. This knowledge enables them to make informed decisions about their participation and reduces the likelihood of harm or negative consequences.
• Ensuring ethical standards are met : Informed consent is a fundamental ethical requirement for conducting research involving human participants. By obtaining informed consent, researchers demonstrate their commitment to upholding ethical principles and standards in their research practices.
• Facilitating future research : Informed consent enables researchers to collect high-quality data that can be used for future research purposes. It also allows participants to make an informed decision about whether they are willing to participate in future studies.

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

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Informed Consent Templates

Use These Templates to Properly Inform Prospective Participants on Scope of Research

Informed consent is a cornerstone principal of ethical human subjects research. Researchers must ensure prospective participants receive information about the study, sufficiently detailed to facilitate a truly informed choice, in a manner that facilitates voluntary consideration of whether to participate. This ethical obligation exists for all research—exempt and non-exempt.

Federal regulations outline informed consent requirements for non-exempt research, including a list of information participants must receive (i.e.,  elements of informed consent ).  Using one of the templates below helps ensure that your consent form includes these elements.  The templates are only a guide.  Templates can and should be adapted to fit the study plans and needs of prospective participants. However,  all  of the consent elements must be included in your consent form unless your study is eligible for exempt review.

Consent forms must be carefully drafted to facilitate comprehension.   Detailed guidance  and  a checklist  are available to aid researchers.

An IRB-approval stamp will be applied to approved consent forms.  Please leave a 1 ½ inch margin at the top of the document to accommodate the stamp.  Avoid including unnecessary headings (e.g., Attachment or Appendix) on the consent form.  Researchers are strongly advised to copy/print the stamped consent form for use during the study—doing so assures the current IRB-approved version is used and assures participants that the study has been reviewed by the IRB.

I nformed Consent Form Template –Q & A Format  (UPDATED: 1.24.22)

Informed Consent Form Template –Standard Format  (UPDATED: 1.24.22)

Parental Informed Consent Form Template –Q & A Format  (UPDATED: 1.24.22)

Parental Informed Consent Form Template –Standard Format  (UPDATED: 1.24.22)

Informed Consent Addendum Template –use for re-consenting or to inform participants of new information  (UPDATED: 3.22.22)

For additional guidance about informed consent, see the following:

Consent Process  – guidance on developing a meaningful informed consent process

Assent Process  – guidance on obtaining assent from children

Elements of Informed Consent  – a detailed description of required consent elements and consent form considerations

Waivers or Alterations of Consent  – guidance on when consent requirements can be altered or waived

Retention of Signed Consent Forms  – guidance on retention of consent forms

Informed Consent for Exempt Research

Use of a formal informed consent form containing all the elements of consent is not required for research under exempt review.  However, researchers are ethically obligated to obtain the voluntary agreement of prospective participants before including them in research.  For more information and examples of consent forms appropriate for exempt research see  Informed Consent for Exempt Studies .

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• Human Subjects
• IRB Health Sciences and Behavioral Sciences (HSBS)

Informed Consent Guidelines & Templates

U-m hrpp informed consent information.

See the HRPP Operations Manual, Part 3, Section III, 6 e .

The human subjects in your project must participate willingly , having been adequately informed about the research.  

• If the human subjects are part of a vulnerable population (e.g., prisoners, cognitively impaired individuals, or children), special protections are required.
• If the human subjects are children , in most cases you must first obtain the permission of parents in addition to the consent of the children.

Contact the IRB Office for more information .

See the Waiver Guidelines  for information about, and policies regarding, waivers for informed consent or informed consent documentation. 

See the updated  Basic Informed Consent Elements document  for a list of 2018 Common Rule basic and additional elements. 

Informed Consent Process

Informed consent is the process of telling potential research participants about the key elements of a research study and what their participation will involve.  The informed consent process is one of the central components of the ethical conduct of research with human subjects.  The consent process typically includes providing a written consent document containing the required information (i.e., elements of informed consent) and the presentation of that information to prospective participants.  

In most cases, investigators are expected to obtain a signature from the participant on a written informed consent document (i.e., to document the consent to participate) unless the IRB has waived the consent requirement or documentation (signature) requirement .

• Projects which collect biospecimens for genetic analysis must obtain documented (signed) informed consent.
• It is an ethical best practice to include an informed consent process for most exempt research .   IRB-HSBS reviews, as applicable, the IRB application for exempt research, but not the informed consent document itself.  A suggested consent template for exempt research can be found below under the References and Resources section.  A companion protocol template for exempt research may be found in the feature box, Related Information (top right).

Informed consent documents

An  informed consent document  is typically used to provide subjects with the information they need to make a decision to volunteer for a research study.  Federal regulations ( 45 CFR 46.116 ) provide the framework for the type of information (i.e., the "elements") that must be included as part of the consent process.  New with the revised 2018 Common Rule is the requirement that the consent document begin with a "concise and focused" presentation of key information  that will help potential participants understand why they might or might not want to be a part of a research study.  

Key Information Elements

The image below displays the  five elements identified in the preamble to the revised Final Rule  as suggested key information.  

Note: Element number 5 (alternative procedures) applies primarily to clinical research.

General Information & Tips for Preparing a Consent Document

Reading level.

Informed consent documents should be written in plain language at a level appropriate to the subject population, generally at an 8th grade reading level .  A best practice is to have a colleague or friend read  the  informed consent document for comprehension before submission with the IRB application.  Always:

For guidance on using plain language, examples, and more, visit: http://www.plainlanguage.gov/

• Tailor the document to the subject population.
• Avoid technical jargon or overly complex terms.
• Use  straightforward  language that is understandable.

Writing tips

The informed consent document should succinctly describe the research as it has been presented in the IRB application.

• Use the second (you) or third person (he/she) to present the study details.  Avoid use of the first person (I).  
• Include a statement of agreement at the conclusion of the informed consent document. 
• The consent doucment must be consistent with what is described in the IRB application.

Document Formating for Uploading into eResearch

• Remove "track changes" or inserted comments from the consent documentation prior to uploading the document into the IRB application (Section 10-1) for review.
• Use a consistent, clearly identified file naming convention for multiple consent/assent documents.

Informed Consent Templates

IRB-HSBS strongly recommends that investigators use one of the informed consent templates developed to include the required consent elements (per  45 CFR 46.116 ), as well as other required regulatory and institutional language.  The templates listed below include the new consent elements outlined in the 2018 Common Rule.

References and Resources

PDF.  Lists the basic and additional elements required for inclusion or to be included, as appropriate to the research, in the informed consent documentation, along with the citiation number [e.g., _0116(b)(1)] within the revised Common Rule.  New elements associated with the 2018 Common Rule are indicated in bold text.

Strongly recommended for studies that involve the collection of biospecimens and/or genetic or genomic analysis, particularly  federally sponsored clinical trials that are required to post a consent document on a public website.  Last updated:  04/10/2024.

Informed Consent documents are not reviewed by the IRB for Exempt projects.  However, researchers are ethically bound to conduct a consent process with subjects.  This template is suggested for use with Exempt projects. Last updated 4/17/24

(Word) Blank template with 2018 revised Common Rule key information and other required informed consent elements represented as section headers; includes instructions and recommended language.  It is strongly advised that you modify this template to draft a project-specific informed consent document for your study for IRB review and approval.  Last updated: 04/10/2024

(Word) General outline to create and post a flyer seeking participation in a human subjects study.  Includes instructions.

(Word) Two sample letters for site approval cooperation between U-M and other institutions, organizations, etc.  Letters of cooperation must be on U-M letterhead and signed by an appropriate official.  These letters are uploaded into the Performance Site section of the eResearch IRB application.

For use by U-M Dearborn faculty, staff, and students conducting non-exempt human subjects research using subject pools. Last updated 4/10/24

For use by U-M Dearborn faculty, staff, and students conducting exempt human subjects research using subject pools

Researchers who will conduct data collection that is subject to the General Data Protection Regulation (GDPR) must use this template in tandem with a general consent for participation template/document.

• Child assent ages 3-6
• Child assent 7-11
• Parent permission
• Brief protocol for exempt research including data management and security questionnaire
• Child assent 12-14
• Introductory psychology subject pool general consent template
• Introductory psychology subject pool exempt consent template

IRB-Health Sciences and Behavioral Sciences (IRB-HSBS)

Phone: (734) 936-0933 Fax: (734) 936-1852 [email protected]

• Human Subjects Protections

New Consent Templates

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