For all consent forms, informed consent must be written at an eighth grade reading level or lower and presented in lay language. Instructions in each document are marked in shaded brackets. Additional language to be used if applicable (e.g., an intervention, a study funded by the FDA) is presented in italics, also in shaded brackets. All plain text without shading should be included without modification in your consent document. ​​Brackets, shading and italics should be removed by researchers from the final versions of the assent form.

Use the standard template when conducting studies that involve greater than minimal risk, multiple procedures or a clinical trial; are more complex; or require more than three pages of consent. Using the standard template will ensure that the basic elements of informed consent are included in your document. You should also use this template if your study is already approved but requires a more detailed consent form than the bulleted form. ​

Additional language about study design, research population and funding is provided in a separate guidance document.

• Standard Consent Template for Adults (18+)
• Additional Consent Language
• Example Standard Consent Form

Use the bulleted template when conducting studies that involve minimal risk, are less complex and require less than three pages of consent language. This form is also useful if you want a consent process for eligibility screening, or if you will be receiving consent online or verbally (by phone or in person).

Additional language about study design, research population and funding is provided in a separate guidance document.

• Bulleted Consent Template for Adults (18+)
• Example Bulleted Consent Form (PDF)
• Additional Bulleted Consent Language

Use one of the child assent templates when conducting studies that involve children ages 7-17 as participants to ensure that the basic elements of informed consent are included in your document, at an appropriate reading level. Use these templates only if the child participant is capable of providing assent (either verbal or written).

There are two age level templates: Ages 7-12 or fifth grade reading level, and ages 13-17 or seventh grade reading level. Text can be adjusted based on reading level but should always be written in lay language that is appropriate for your child participants. 

Parent permission templates are provided in both a standard format, for more complex studies, and bulleted format, for when a short consent form is more appropriate. Additional language for parental permission is provided in a separate guidance document.

• Child Assent Template (Ages 7-12)
• Child Assent Template (Ages 13-17)
• Example Child Assent Form (Ages 7-12)
• Example Child Assent Form (Ages 13-17)
• Standard Parent Permission Template
• Bulleted Parent Permission Template
• Additional Parent Permission Language

Use the consent addendum template if you need additional consent for new activities or procedures from participants already enrolled in a study. This includes currently active participants or those who participated in a completed study and gave permission to be re-contacted for future procedures in the same study.

• Consent Addendum
• Example Consent Addendum: Active Participants
• Example Consent Addendum: Completed Participants

Researchers who intend to deposit human subjects data into data repositories should use these templates as an addendum to the informed consent process.

• Research Data Management
• Data Repository Assent Template (Ages 7-14)
• Data Repository Consent Template (Ages 15+)
• Data Repository Parent Permission Template

GUID Data Repository Consent Forms

Researchers who are funded by specific agencies in the National Institutes of Health (NIH) are now required to deposit de-identified human subjects data into federal repositories using special codes called Globally Unique Identifiers (GUIDs). If an award has this requirement, use these templates as an addendum to your informed consent process.

• GUID Data Repository Assent Template (Ages 7-14)
• GUID Data Repository Consent Template (Ages 15+)
• GUID Data Repository Parent Permission Template
• Data and Safety Monitoring
• Creating an NIH Data Management and Sharing Plan

For Brown University research studies that involve the use of the MRI Research Facility, use these forms to provide important information to participants about MRI scans and safety procedures. The text of these forms should not be modified, with the exception of the shaded brackets that may be tailored for study specifics.

• MRI Research Facility
• MRI Research Facility Assent Template (Ages 7-14)
• MRI Research Facility Consent Template (Ages 15+)
• MRI Research Facility Parent Permission Template

Use the provided authorization form when seeking a participant’s consent to use protected health information (PHI) for the purpose of your research.

• HIPAA Research Rule Guidance
• Authorization to Use PHI in Research Form