research informed consent form template

• Find My GCO
• IACUC applications (Cayuse Animal Management System)
• IBC Applications (eMUA)
• IRB Applications (RASS-IRB) External
• Institutional Profile & DUNS
• Rates and budgets
• Report external interests (COI)
• Join List Servs
• Ask EHS External
• Research Development Services
• Cornell Data Services External
• Find Your Next Funding Opportunity
• Travel Registry External
• RASS (Formerly Form 10 and NFA) External
• International research activities External
• Register for Federal and Non-Federal Systems
• Disclose Foreign Collaborations and Support
• Web Financials (WebFin2) External
• PI Dashboard External
• Research metrics & executive dashboards
• Research Financials (formerly RA Dashboard) External
• Subawards in a Proposal
• Proposal Development, Review, and Submission
• Planning for Animals, Human Participants, r/sNA, Hazardous Materials, Radiation
• Budgets, Costs, and Rates
• Collaborate with Weill Cornell Medicine
• Award Negotiation and Finalization
• Travel and International Activities
• Project Finances
• Project Modifications
• Research Project Staffing
• Get Confidential Info, Data, Equipment, or Materials
• Managing Subawards
• Animals, Human Participants, r/sNA, Hazardous Materials, Radiation
• Project Closeout Financials
• Project Closeout
• End a Project Early
• Protecting an Invention, Creation, Discovery
• Entrepreneurial and Startup Company Resources
• Gateway to Partnership Program
• Engaging with Industry
• Responsible Conduct of Research (RCR)
• Export Controls
• Research with Human Participants
• Research Security
• Work with Live Vertebrate Animals
• Research Safety
• Regulated Biological Materials in Research
• Financial Management
• Conflicts of Interest
•   Search

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 )

As the nation’s largest public research university, the Office of the Vice President for Research (OVPR) aims to catalyze, support and safeguard U-M research and scholarship activity.

The Office of the Vice President for Research oversees a variety of interdisciplinary units that collaborate with faculty, staff, students and external partners to catalyze, support and safeguard research and scholarship activity.

ORSP manages pre-award and some post-award research activity for U-M. We review contracts for sponsored projects applying regulatory, statutory and organizational knowledge to balance the university's mission, the sponsor's objectives, and the investigator's intellectual pursuits.

Ethics and compliance in research covers a broad range of activity from general guidelines about conducting research responsibly to specific regulations governing a type of research (e.g., human subjects research, export controls, conflict of interest).

eResearch is U-M's site for electronic research administration. Access: Regulatory Management (for IRB or IBC rDNA applications); Proposal Management (eRPM) for the e-routing, approval, and submission of proposals (PAFs) and Unfunded Agreements (UFAs) to external entities); and Animal Management (for IACUC protocols and ULAM).

Sponsored Programs manages the post-award financial activities of U-M's research enterprise and other sponsored activities to ensure compliance with applicable federal, state, and local laws as well as sponsor regulations. The Office of Contract Administration (OCA) is also part of the Office of Finance - Sponsored Programs.

Ethics & Compliance

• eResearch IRB NextGen Project
• Class Assignments & IRB Approval
• Operations Manual (OM)
• Authorization Agreement Process
• ORCR Policies and Procedures
• Self-Assessment Tools
• Resources and Web Links
• Single IRB-of-Record (sIRB) Process
• Certificate of Confidentiality Process
• HRPP Education Resources
• How to Register a Clinical Trial
• Maintaining and Updating ClinicalTrial.gov Records
• How to Report Clinical Trial Results
• Research Study Participation - FAQ
• International Research
• Coordinated Services & Practices (CSP)
• Collaborative Research: IRB-HSBS sIRB Process
• Data Security Guidelines
• Research Incentive Guidelines
• Routine fMRI Study Guidelines
• IRB-HSBS Website Directory and Guidance
• Waivers of Informed Consent Guidelines
• IRB Review Process
• IRB Amendment Process
• Continuing Review Process
• Incident Reporting (AE/ORIO)
• IRB Repository Application
• IRB-HSBS Education
• Newsletter Archive

You are here

• 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

Informed consent guidance.

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.

Informed Consent Templates (2018 Common Rule)

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.

(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

Other Templates

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) 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.

• Brief protocol for exempt research including data management and security questionnaire

Child Assent and Parental Permission

• Child assent ages 3-6
• Child assent 7-11
• Parent permission
• Child assent 12-14

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

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

• Human Subjects Protections

Informed Consent Templates

As part of our continued efforts to improve the IRB application and review process, we have developed new ICF templates that address the issues identified by our stakeholders:

• Different templates have been created for  different types of studies  (SBER, Biomed, etc.).
• Guidance language has been added to each template to  reduce confusion  about which template to use, as well as how to complete sections.
• The  Key Information  section has been simplified.
• An  Assent Template  has been created, with guidance included to identify applicable populations.
• All language utilized is at the  8th grade reading level , and has been improved to promote clarity of instructions.
• The template has been  shortened and simplified  to facilitate completion.
• All  signatures have been moved  to the end of the document.

These new and improved ICF templates replace all previous versions posted to our site as of May 17th, 2023; any new intakes  initiated  within WRG-HS as of June 12th, 2023, must utilize these new templates.

• WCM Assent Template
• WCM Biomedical Informed Consent Template
• WCM Humanitarian Use Device Informed Consent Template
• WCM Informed Consent Addendum Template
• WCM Intermediate-Size Investigational Treatment Informed Consent Template
• WCM Pregnant Partner Non-Subject Informed Consent Template
• WCM Pregnant Partner Research Subject Informed Consent Template
• WCM Repository Informed Consent Template
• WCM SBER Informed Consent Template
• WCM Single Patient Investigational Treatment Informed Consent Template

Make sure your Informed Consent Form is a readable document!

See our Guidance Document on how to prepare a readable consent form .

See our list of Medical Terms in Lay Language for use in Informed Consent Forms.

Refer to the  Program for Readability in Science & Medicine (PRISM) Readability Toolkit

Refer to the MRCT Research Glossary for easy-to-understand clinical research definitions.

Frequently Asked Questions (FAQs)

Will i have to start using these new consents today.

Any new studies initiated in WRG-HS starting 6/12, must use the new ICF templates.

Do I have to transition my existing study consent(s) to these new templates?

Any existing study using the previous consent templates can continue to use their IRB-approved consent. Any new studies initiated in WRG-HS starting 6/12, must use the new ICF templates.

Do these new ICF templates need to be used under a ceded/sIRB study with an external IRB as the IRB of record?

Studies with an external IRB are expected to use consent forms provided by the lead IRB. Once the externally reviewed ICF is provided to the WCM IRB, we will conduct a local context review to confirm any required language (i.e. research-related injury, NYS Genetic testing requirements, etc.). The new WCM ICF templates are available as a resource if needed, but not required for externally reviewed studies.

If I am updating my protocol and the change requires an update to the ICF, will I need to use the new ICF templates?

You can continue to use the same ICF.

Weill Cornell Medicine Human Research Protections 575 Lexington Avenue New York, NY 10022 Phone: (646) 962-8200

Human Subjects Division

• [email protected]
• 206.543.0098

Consent Templates

About this page.

The UW IRB provides the UW research community with a variety of consent templates that align with regulatory and policy requirements and best practices as described in our main Consent guidance and guidance on Designing the Consent Process .

The first two templates, marked with an asterisk, are the templates most non-exempt studies will choose from. The other templates may apply to particular types of studies or activities.

Using our templates is not required . We encourage researchers to use the guidance on Designing the Consent Process to create consent forms and processes that are: (1) written from the perspective of the subject population being enrolled, emphasizing the Key Information that is mostly likely to assist those subjects with deciding whether to enroll; and (2) designed and presented in a way that facilitates comprehension and understanding.

We also provide example consent forms to accompany the templates. The examples demonstrate some of the many ways consent can be presented, depending on what is most appropriate for the study population.

Review the guidance on Required Signatories for information about who should sign the consent form when documentation of consent is required.

If you wish to use the short form and the translation you need is not posted here, email [email protected] .

• *No Separate Key Information Consent Template (2,000 words or less)
• *Separate Key Information Consent Template (more than 2,000 words)
• Assent Template
• Emergency or Compassionate Use Consent Template
• Exempt Research Consent Template
• HIPAA Authorization Template
• HIPAA Authorization, Pregnant Partner Template
• Short Form Certificate of Translation
• Short Form Consent Template (Amharic)
• Short Form Consent Template (Arabic)
• Short Form Consent Template (Cambodian)
• Short Form Consent Template (Chinese)
• Short Form Consent Template (English)
• Short Form Consent Template (Farsi)
• Short Form Consent Template (French)
• Short Form Consent Template (Hindi)
• Short Form Consent Template (Japanese)
• Short Form Consent Template (Korean)
• Short Form Consent Template (Lao)
• Short Form Consent Template (Oromo)
• Short Form Consent Template (Punjabi)
• Short Form Consent Template (Russian)
• Short Form Consent Template (Samoan)
• Short Form Consent Template (Somali)
• Short Form Consent Template (Spanish)
• Short Form Consent Template (Tagalog)
• Short Form Consent Template (Tigrinya)
• Short Form Consent Template (Ukrainian)
• Short Form Consent Template (Vietnamese)

University of Washington Office of Research

Or support offices.

• Human Subjects Division (HSD)
• Office of Animal Welfare (OAW)
• Office of Research (OR)
• Office of Research Information Services (ORIS)
• Office of Sponsored Programs (OSP)

OR Research Units

• Applied Physics Laboratory (APL-UW)
• WA National Primate Research Center (WaNPRC)

Research Partner Offices

• Corporate and Foundation Relations (CFR)
• Enivronmental Health and Safety (EH&S)
• Grant and Contract Accounting (GCA)
• Institute of Translational Health Sciences (ITHS)
• Management Accounting and Analysis (MAA)
• Post Award Fiscal Compliance (PAFC)

Collaboration

• Centers and Institutes
• Collaborative Proposal Development Resources
• Research Fact Sheet
• Research Annual Report
• Stats and Rankings
• Honors and Awards
• Office of Research

© 2024 University of Washington | Seattle, WA

• About Research & Innovation
• Advanced Cardiovascular Care
• Health Equity
• Inflammation
• Maternal and Fetal Medicine
• Musculoskeletal Care
• Neuroscience
• Opioid & Pain
• Research Centers
• Departments
• About the Office of Research
• Funding & Proposal Development
• Regulatory Review & Compliance
• Research Project Management
• Cores & Resources
• Education & Training
• Peter Arvan Lab
• Antiphospholipid Syndrome Research Labs
• J. Michelle Kahlenberg Lab
• John Varga Lab (ScleroLab)
• Mulholland Lab
• Raghavendran Lab
• ALS Center of Excellence
• Institute for Heart & Brain Health
• Center for Basic & Translational Science
• Center for Bioethics and Social Sciences in Medicine
• Biomedical Research Core Facilities
• IT Route Map
• Clinical Research Route Map
• Commercialization Route Map
• Great Minds, Greater Discoveries
• Research Scouts
• Meet the ROMS Team
• ROMS Fellowship Application Information
• Working with a ROMS Fellow
• Pandemic Research Recovery
• Research Climate Council
• Support for Outstanding Research
• Research News Trivia
• Frequently Asked Questions (FAQ)
• Billing Calendar & Study Applications
• CRAO Frequently Asked Questions (FAQ)
• Pre-Onboarding Considerations
• Access Biospecimen
• Biospecimen Processing
• Biospecimen Inventory
• Regulatory & Governance
• Equipment & Instrumentation
• Central Biorepository Pricelist
• CBR Frequently Asked Questions (FAQ)
• Clinical Trials Support Units
• Clinical Research Coordinator Career Ladder
• Clinical Trials Management Systems: Accounts & Support
• Research Pharmacy
• Off-Campus Clinical Research
• Statistical Support for Large-Scale Clinical Trials
• MCRU Services
• MCRU Lab Study Team Guidelines
• MCRU Frequently Asked Questions (FAQ)
• Michigan Medicine Site Profile
• CTSO Frequently Asked Questions (FAQ)
• Self-Serve Data Tools
• Custom Data Request
• Data & Biospecimen Sharing
• Student Access to Patient Data
• FFMI fastPACE
• Frankel Cardiovascular Center Innovation Program
• Rogel Cancer Center Innovation Program
• Global Health Commercialization Competition
• Biomedical Innovation 101
• Certificate in Biomedical Innovation & Entrepreneurship
• Fast Forward Medical Innovation Fellowship Program
• Biotech Career Development Program
• Drug Discovery & Development Course
• Innovation Studio
• Oncology Drug Discovery & Development (3D) Workshop
• FFMI fastPACE Train-the-Trainer
• Intellectual Property in the Academic Setting
• Academic Drug Discovery
• Medical Device Regulation
• Idea to Impact Webinar Series
• 6 Tips for Customer Discovery
• Interacting with Industry
• Ask the Experts: A Biomedical Innovation Forum
• Business Development
• Michigan Biomedical Venture Fund
• R01 Boot Camp
• Facility & Resource Profile Templates
• BMRC Bridging Support Program for Biomedical Research
• Medical School Limited Submissions
• Budgeting & Costs
• NIH Specifics, Tips & Tricks
• Grant Routing Deadlines
• Proposal Review Checklists
• Department Contacts
• Authorized Signers
• Research Data Analytics
• Grant Processing Advisory Committee (GPAC)
• Post-Award Advisory Committee (PAAC)
• Grants Frequently Asked Questions (FAQ)
• Board Nominations Sought
• Informed Consent & Assent Templates
• IRBMED Seminar Series
• Information for IRB Members
• Information for Study Subjects
• SignNow Electronic Signature Service
• IRBMED Frequently Asked Questions (FAQ)
• IRBMED Contacts & Roster

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.

We transform lives through bold discovery, compassionate care and innovative education.

• Diversity, Equity & Inclusion
• News & Stories
• Find a Doctor
• Conditions & Treatments
• Patient & Visitor Guide
• Patient Portal
• Clinical Trials
• Research Labs
• Cores and Resources
• Programs & Admissions
• Our Community
• Departments, Centers & Offices
• About the Medical School

Global Footer Secondary Navigation

Human Research Protection Program Office of Research Regulatory Support

Informed consent templates.

Informed consent templates have been developed to assist researchers in developing a consent form for a research study. The template is only a guide to help researchers and may be subject to change. Please note that IRB members may still request changes to your document.

The revised Common Rule implements January 21, 2019 for new studies. Several templates have been updated to incorporate the revised Common Rule requirements (noted below).  Please use the updated templates.  To view more detailed information about the revised Common Rule changes, please visit the  Revised Common Rule webpage .

• HRP-502 - Template - Minimal Risk Consent Document  (Word 28 KB) ( updated for revised Common Rule )
• HRP-507 - Template - Consent Document - Short Form  (Word 17 KB) ( updated for revised Common Rule )
• HRP-517 - Template - Biomedical Consent Document  (Word 36 KB) ( updated for revised Common Rule )
• HRP-518 - Template - Social Science - Behavioral Consent Document  (Word 33 KB) ( updated for revised Common Rule )
• HRP-519 - Template - Genomics Consent Document  (Word 43 KB) ( updated for revised Common Rule )
• HRP-520 - Template - Consent Document for Exempt Research  (Word 30 KB)
• HRP-521 - Template - Assent Document  (Word 17 KB)
• HRP-522 - Template - Parental Permission Document  (Word 22 KB)
• HRP-523 - Template - Telephone Script Consent Document  (24 KB) ( updated for revised Common Rule )
• HRP-524 - Template - Screening Consent Document  (Word 26 KB)
• HRP-525 - Template - Consent Language when using Experimetrix  (Word 17 KB)
• HRP-526 - Template - Consent Language when using Sona  (Word 18 KB)
• HRP-543 - Template - MRI Screening Form Pregnancy  (Word 18 KB)

More Information About the Revised Common Rule (2018 Requirements)

The revised Common Rule requires several changes to the informed consent document. Included below is guidance and help information on these requirements. To view more detailed information, please visit the Revised Common Rule Informed Consent Requirements webpage . 

• Guidance for the New Informed Consent Requirement for a Concise and Focused Presentation of Key Information (80KB)

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.

Forms & Consent Templates

Main navigation, consent templates.

The IRB recommends the use of the consent templates to help researchers meet the legal requirements for consent.

See the Informed Consent Process page for more information about the consent process .  

Medical (SoM)

• School of Medicine (SoM)
• Lucile Packard Children's Hospital (LPCH)
• Stanford Hospital and Clinics (SHC)
• Veteran's Affairs (VA) Hospital
• Psychology fMRI studies

Social & Behavioral Research (Non-Medical)

• Engineering
• Humanities & Sciences

The IRB uses these checklists and forms to review protocols for compliance with regulations, policies and guidance:

Staff Checklists

• Exemption Eligibility

 Protocol Checklists:

• Protocol - Medical
• Protocol - Expedited (initial review)
• Protocol - Chart Review (initial review)
• Protocol - Nonmedical
• Protocol - sIRB Checklist
• SCRO Renewal Review Checklist
• Research Involving VA Studies ; see  Reviewing Veterans Affairs (VA) Research  for additional requirements
• Exemption from IRB Review: Emergency Use of a Test Article
• Single Patient IND/IDE

Other Federal Agency Requirements:

• Dept. of Defense (DoD)
• Dept. of Education (ED)
• Dept. of Energy (DOE)
• Dept. of Justice (DOJ)
• Environmental Protection Agency (EPA)

Informed Consent:

• Informed Consent  (medical: clinical studies)
• Informed Consent  (medical: expedited/minimal risk)
• Informed Consent  (nonmedical: surveys, social, behavioral, education research)

Continuing Review:

• Continuing Review - FULL/EXPEDITED

Reviewer Checklists :

• Privacy Policy

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

You may also like

How to Cite Research Paper – All Formats and...

Data Collection – Methods Types and Examples

Delimitations in Research – Types, Examples and...

Research Paper Format – Types, Examples and...

Research Process – Steps, Examples and Tips

Research Design – Types, Methods and Examples

Informed consent

Information and guidance for researchers, what is informed consent.

Informed consent is one of the founding principles of research ethics. Its intent is that human participants can enter research freely (voluntarily) with full information about what it means for them to take part, and that they give consent before they enter the research.

Consent should be obtained before the participant enters the research (prospectively), and there must be no undue influence on participants to consent. The minimum requirements for consent to be informed are that the participant understands what the research is and what they are consenting to.  

There are two distinct stages to a standard consent process for competent adults:

• Stage 1 (giving information) : the person reflects on the information given; they are under no pressure to respond to the researcher immediately.  
• Stage 2 (obtaining consent): the researcher reiterates the terms of the research, often as separate bullet points or clauses; the person agrees to each term (giving explicit consent) before agreeing to take part in the project as a whole. Consent has been obtained.

Researchers should ensure that they comply with the General Data Protection Regulation (GDPR) during and after the consent process, especially if they will be collecting 'special category' (ie sensitive) data or personal data in the course of their research (also refer to the advice on consent in research involving children ).  See also the guidance on data protection and research and the data protection checklist for use when preparing an application for ethical review.

Where your research includes filming or photography, you should refer to specific guidance in the Photography and GDPR toolkit .

Written or oral consent – which process suits your project?

Which process to use depends on the research project (its context, design and participants), though an oral process is usually only appropriate where a written process is not feasible. Any consent process must be understandable to the participants concerned. Please see the sections below to find out about different processes which may be used depending on the context, as well as informed consent templates for each process.

Written informed consent process

A written process is used where:

• Reading and signing forms is not problematic.
• The research is complex or has multiple stages.
• First access to the research participants is by providing written information.

Though opinions differ about the legal force of signed consent forms, they provide extra proof that the terms of consent have been understood. This can be especially important when seeking consent for copyright over data, or for future uses of data. Also, future funders or regulators may want written proof of the terms of original consent.

For literate participants who are not put off by written information, a written process is often a straightforward way of communicating the 'research contract'.

Between the provision of information and obtaining consent, the participant should be given a reasonable amount of time to consider whether to consent and to ask questions, though the time given depends on the project design, the context of the research and the participants.

The written consent templates below can be adapted to suit your study.

Oral informed consent process

An oral consent process is where researcher and participant have a conversation to give information and obtain consent.  There is no paper form to sign. It is normally used:

• where literacy is a problem
• where there are cultural or political concerns with signing contract-like documents
• where either the researcher and/or the participant could be put at risk by existence of a paper record
• where time for consent is limited, eg a chance interaction between researcher and participant (although you should not use an oral process merely to correct poor planning of research)
• for research conducted via remote video conferencing software

It may also be more appropriate when interviewing elite participants as part of the research.

For all other research, how you arrange the oral process depends on how you will encounter your participants (for example email, phone, an on-the-street-meeting by chance). Between the information-giving and consent stage the participant should be given a reasonable amount of time to consider whether to consent, though this depends on the project design, the type of participants and the context of the research.

When obtaining oral consent, please ensure you are recording the consent process either using a recording device (for example audio recorder if you are conducting an interview that needs to be recorded) or, if participants do not agree to audio recording or if using or keeping audio records is unsafe, by using a researcher record of oral consent template or completing a written consent form on their behalf.

The oral consent templates below can be adapted to suit your study, but careful consideration is required to ensure that these are appropriate for the research and the participants.

Informed consent templates

Written informed consent process (including online surveys), template agreements, cases where 'implied consent' may be acceptable (for example online surveys).

Researchers should always aim to inform people fully and obtain appropriate consent. However, in some cases the research may be straightforward enough that a separate, deliberate process for obtaining consent is not needed. In these cases participants, by their actions, imply consent. This is seen most often in research:

BPG 06 Internet-mediated research

Template information sheet for online research

• where no participant personal details are obtained
• where the topic of research is very low risk and no special category data will be collected
• where participation is confined to one small task, eg completing a survey or simple pencil or computer task

Please note: consent cannot be inferred from inaction (eg failure to move away from a camera).  

When consent works against the aims of research

If your research employs deception, you will not be able to inform participants fully about your project’s true aims. In this case please check if you can fully apply the CUREC approved procedure on research involving the deception of participants . If the deception raises ethical concerns such that the application is not covered by this procedure please complete a CUREC 2 application form.

Some research settings evolve very rapidly (for example in conflict studies). Similarly, some research participants may only be revealed in time-poor or emergency settings (eg heart attack patients). This infringes on the standard information-giving stage of research. The vulnerability of participants in those settings may justify an expedited or fully waived consent process. Again it is important to describe the research setting clearly. You may need to complete a CUREC 2 application to the relevant committee in these cases: please check with your DREC or your IDREC .

Last updated Thursday 2 December 2021

Related links

• Where and how to apply for ethical review
• Committee information
• Research ethics FAQs and glossary
• Research integrity and ethics policy
• Ethics committee contacts