Forms

When preparing an IRB submission, whether it's for a new study, a continuation, a modification or a closure, below you can read about which forms and templates you may need.

 

To download these documents, please access the ESTR Library.

 

INITIAL IRB SUBMISSION

 

  • HRP-503-HUA Protocol Template - Use this form to provide a research description in your initial submission for approval of research with human subjects.

 

  • HRP-213-FORM-Not Human Subjects Research Determination Request - Use this form to apply for a formal determination that your activities do not constitute research with human subjects. You may use IRB Worksheet HRP-310 for reference.

 

CONTINUING REVIEW (Renewal) AND CLOSURE

 

The main information for continuing review or closure is submitted directly into ESTR – there is no additional form that is required.

 

  • HRP-5xx-Summary of Study Progress Template - If you are submitting a continuing review for a Full Committee study or when requesting closure, you may use this optional form to provide further details on study progress.

 

MODIFICATIONS

 

There are no separate forms; instead, information is entered directly into ESTR. You must also upload all documents that are relevant to the modification.

 

CONSENT, ASSENT AND PERMISSION TEMPLATES

 

In most cases, you'll be required to provide a consent process for research participants. These templates are the most general starting point and can be filled in according to the type of research that you are conducting.

 

  • HRP-502-HUA Adult Consent Form Template - for expedited and convened IRB research with individuals who are considered adults.

 

  • HRP-502a-HUA Child Assent Form Template - for expedited and convened IRB research with individuals who have not attained the legal age for consent to participate in research, under applicable law of the jurisdiction in which the research will be conducted. Generally, the law considers any person under 18 years old to be a child.

 

  • HRP-502b-HUA Parental or Guardian Permission Template - for expedited and convened IRB research with parents or guardians of those considered a ‘child’.

 

  • HRP-502c-HUA Exempt Research Consent Script – for exempt research with individuals who are considered adults.

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  • HRP-507-HUA Short Form Consent Template - for the unexpected involvement of individuals with limited English proficiency. If you expect to enroll more than one participant with limited English proficiency or if your study is being conducted internationally, you are expected to translate all study documents provided to participants into the appropriate language(s) and not use this form.

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  • HRP-502d-HUA GDPR Notification for Participants.docx – for use with studies that include individuals located in the European Economic Area. Note that this notification is only for research that began prior to May 25, 2018 will involve the collection of new data for the same research purpose as the pre-May 25, 2018 data, such that the new data collection falls within the scope of the terms of the original consent obtained. For all other research involving individuals located in the EEA, please use the informed consent form according to your research (see above) as these forms include a “GDPR Addendum” located at the end of the form.

 

SUPPLEMENTAL FORMS

 

  • HRP-220-FORM-Non-Harvard Study Personnel Form - Use this form to report study staff only if they do not have a Harvard ID. Be sure to attach human subjects training certificates for these staff.

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  • HRP-221-FORM-Financial Interest Disclosure Form - The Principal Investigator must submit this form for any member of the study staff with a financial interest related to the research.

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  • HRP-225-FORM-Individual Investigator Agreement - Use this form to request the addition of a researcher on your project who is neither affiliated with a Harvard University Area school nor under another institution’s IRB.