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 HRP-502—Template Consent Document 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 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 HRP-502 and HRP-502a—Additional Consent Language.

Use the bulleted template found within HRP-502—Template Consent Document when conducting studies that involve minimal risk, are less complex and require less than three pages of consent language. This template 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 HRP-502 and HRP-502a—Additional Consent Language. Examples of the bulleted consent can be found in HRP-502a.

Use the guidance and examples found in HRP-502—Template Consent Document and HRP-502a—Additional Consent Language to craft a child assent document 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 documents only if the child participant is capable of providing assent (either verbal or written).

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 guidance and examples are provided in both HRP-502 and HRP-502a. Additional language for parental permission is provided in HRP-502a.

Use a consent addendum 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. HRP-502a—Additional Consent Language includes examples. HRP-502—Template Consent Document can be shortened to align with these changes.

Researchers who intend to deposit human subjects data into data repositories should add language found in HRP-502a—Additional Consent Language to the informed consent.

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 HRP-502a—Additional Consent Language to add additional GUID specific language to your informed consent.

For Brown University research studies that involve the use HRP-502a—Additional Consent Language to add additional language to the consent forms to provide important information to participants about MRI scans and safety procedures. 

Use the provided authorization language found in HRP-502a—Additional Consent Language when seeking a participant’s consent to use protected health information (PHI) for the purpose of your research.