consent form example for research

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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 )

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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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)