research consent form

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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 )

• Privacy Policy

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

Informed Consent in Research – Types, Templates and Examples

Table of Contents

Informed consent is a cornerstone of ethical research, ensuring that participants are fully aware of the nature, purpose, risks, and benefits of the study before agreeing to participate. This article explores the concept of informed consent, its types, the components of an informed consent form, and provides practical examples and templates to guide researchers.

Informed Consent in Research

Informed consent is a process through which researchers obtain voluntary agreement from participants to partake in a study after providing comprehensive information about the study’s objectives, procedures, risks, benefits, and their rights. It ensures that participants make informed decisions about their involvement.

For example, in a clinical trial for a new medication, participants must be informed about the experimental nature of the treatment, potential side effects, and their right to withdraw at any time.

Importance of Informed Consent

• Ethical Responsibility : Informed consent upholds the principle of autonomy, ensuring participants have control over their involvement.
• Legal Compliance : It protects researchers and institutions from legal challenges by documenting participant agreement.
• Trust and Transparency : Establishing trust between researchers and participants ensures ethical integrity and fosters collaboration.

Types of Informed Consent

Informed consent can take various forms depending on the study’s nature and the participants involved. Below are the main types:

1. Written Consent

Participants provide their agreement by signing a detailed consent form. This is the most common form, used in studies involving significant risks or complex procedures.

• Example : A participant signs a form before joining a psychological study that includes interviews and personality assessments.

2. Verbal Consent

Verbal consent is used in situations where written documentation may not be practical or necessary. Researchers typically record verbal consent.

• Example : In field studies conducted with illiterate populations, verbal consent may be obtained and documented via audio recordings.

3. Implied Consent

Implied consent is inferred from a participant’s actions, such as completing a questionnaire or survey. While practical for low-risk studies, researchers should still provide an explanation of the study.

• Example : Participants completing an anonymous online survey indicate implied consent by submitting their responses.

4. Passive Consent

Passive consent involves notifying participants or guardians about the study and assuming consent unless they explicitly opt out. This is typically used in educational or observational research.

• Example : Parents receive a letter about a study being conducted in their child’s classroom and are asked to notify the school if they do not want their child to participate.

5. Proxy Consent

A legal representative or guardian provides consent on behalf of individuals who cannot consent for themselves, such as minors or individuals with cognitive impairments.

• Example : A parent signs a consent form allowing their child to participate in a study on childhood nutrition.

Components of an Informed Consent Form

A well-designed informed consent form includes several key components to ensure clarity and comprehensiveness:

1. Study Title and Introduction

• Clearly state the study’s name and provide a brief overview.
• Example : “Study Title: Exploring the Impact of Online Learning on Student Performance.”

2. Purpose of the Study

• Explain why the study is being conducted and its significance.
• Example : “The purpose of this study is to understand how online learning influences academic performance among high school students.”

3. Procedures

• Describe what participants will do, how long the study will last, and any tools or methods used.
• Example : “Participants will attend weekly online classes for six months and complete pre- and post-class assessments.”

4. Risks and Benefits

• Detail any potential risks (physical, psychological, or social) and the expected benefits.
• Example : “There are minimal risks, such as mild stress from the assessments. Benefits include contributing to the improvement of online education strategies.”

5. Confidentiality

• Explain how participant data will be protected and used.
• Example : “All data will be anonymized and stored securely. Only the research team will have access.”

6. Voluntary Participation

• Emphasize that participation is voluntary and participants can withdraw at any time without penalty.
• Example : “You may choose to stop participating at any point without affecting your relationship with the institution.”

7. Contact Information

• Provide contact details for the research team and ethical review board for questions or concerns.
• Example : “For questions about the study, contact Dr. Jane Smith at [[email protected]]. For ethical concerns, contact the Institutional Review Board at [phone number].”

8. Signature Line

• Include spaces for participant and researcher signatures, as well as the date.

Templates for Informed Consent

Template 1: general informed consent form.

Study Title : [Insert Title] Researcher : [Name and Affiliation] Purpose of the Study : [Briefly explain] Procedures : [Detail activities and duration] Risks and Benefits : [Describe risks and benefits] Confidentiality : [State how data will be managed] Voluntary Participation : [Explain the right to withdraw] Contact Information : [Provide details] Signature :

• Participant: _______________ Date: _
• Researcher: _______________ Date: _

Template 2: Verbal Consent Script

“Hello, my name is [Researcher Name]. I am conducting a study on [Topic]. Participation in this study involves [briefly describe procedures]. There are minimal risks, such as [state risks], and potential benefits, including [state benefits]. Your participation is voluntary, and you can withdraw at any time without penalty. Do you agree to participate in this study?”

Examples of Informed Consent in Research

Example 1: clinical research.

A clinical trial for a new drug requires participants to sign a detailed consent form. The form includes information about the drug’s experimental nature, potential side effects, and alternative treatments.

Example 2: Social Science Study

A researcher studying workplace dynamics provides participants with a consent form explaining the study’s purpose, the confidentiality of responses, and their right to withdraw.

Example 3: Educational Research

A school-based study on student performance sends parents a consent form to allow their children to participate. The form includes details about the assessments and privacy protections.

Challenges and Ethical Considerations

• Language Barriers : Ensure the consent form is available in a language the participant understands.
• Cultural Sensitivity : Adapt consent processes to align with cultural norms while maintaining ethical standards.
• Informed Decision-Making : Provide ample time for participants to review the information and ask questions.
• Vulnerable Populations : Take additional steps to ensure the informed consent process protects the rights and well-being of minors, elderly individuals, or those with disabilities.

Informed consent is an essential element of ethical research, safeguarding participant autonomy and fostering trust between researchers and participants. By understanding its types, components, and practical applications, researchers can create robust consent processes that ensure ethical compliance and enhance the credibility of their studies.

• Beauchamp, T. L., & Childress, J. F. (2019). Principles of Biomedical Ethics (8th ed.). Oxford University Press.
• Emanuel, E. J., Wendler, D., & Grady, C. (2000). “What Makes Clinical Research Ethical?” JAMA , 283(20), 2701–2711.
• OHRP (2023). “Informed Consent Tips.” Office for Human Research Protections. hhs.gov .
• Wiles, R. (2012). What Are Qualitative Research Ethics? Bloomsbury Publishing.
• World Medical Association (2013). Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects . WMA.

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

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U-M Research & Compliance

Informed Consent Guidelines & Templates

IRB-HSBS has posted updated informed consent and assent templates. See the  summary of changes  for details.  See the updated  Basic Informed Consent Elements document  for a list of 2018 Common Rule basic and additional elements. 

In this Section

Waivers of Informed Consent Guidelines

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).

Even in situations where the IRB may waive the documentation (signature) requirement (e.g., telephone interview, online survey), investigators are expected to present participants with the required key elements of informed consent and with a copy of the written consent document.

U-M HRPP Informed Consent Information

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

Willing Participation

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.

Waiver Guidelines

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

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.  

A statement that the project is research and participation is voluntary,

A summary of the research, including:

• List of procedures

Reasonable, foreseeable risks or discomforts

Reasonable, expected benefits

Alternative procedures or course of treatment, if any

Modified from www.citiprogram.com 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:

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

For guidance on using plain language, examples, and more, visit the Plain Language website .

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.

If you choose to create an informed consent document without utilizing an IRB-HSBS template, you  must ensure  that all required elements are included and that the recommended language (found in the templates) is utilized appropriately.

References and Resources

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.

IRB Health Sciences and Behavioral Sciences

2800 Plymouth Road Bldg. 520, Rm. 2144 Ann Arbor, MI 48109-2800

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

Related Information

Working with consent documents in an IRB Application

Uploading, Editing and Deleting Documents  in eResearch

Making Consent Document Changes

A suggested companion to the  Exempt Informed Consent Template  is the IRB-HSBS  Exempt Protocol Template .

Routine fMRI study?  See  fMRI Guidelines  to review study criteria and download the IRB-HSBS fMRI consent template.

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:

Eprotocol forms:.

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Sample Consent Forms

These consent forms were used in various NIH-funded research projects and have been approved by the relevant local IRBs. These completed forms are meant to complement the sample language found in the other sections. They are not provided as guidance or templates promoted by NHGRI, but as references to inform investigators and IRBs considering these issues. Consent forms should be tailored to each individual study.

Additional Resources

• The Global Alliance for Genomics and Health maintains sample consent clauses relevant to genomics research projects that may be helpful when developing consent forms.  
• The NIH Office of Human Subjects Research Protections has created a useful list of consent templates for NIH Intramural Researchers . These include consent templates that have been updated to comply with the Revised Common Rule, as well as older forms that might be useful in crafting consent language.   Note: these templates are not specifically for genomics projects .

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Last updated: March 16, 2022