Forms

Download and fill out the applicable forms from the list below, then go to our online submission system ESTR (irb.harvard.edu), sign in with your HUID, and click on Create New Study. Fill out the online pages and upload these forms in the appropriate places.

For help with navigating ESTR, see the ESTR Study Submission Guide. 

 

INITIAL REVIEW

These forms are for use in an initial IRB submission.
CUHS Protocol Template Use this form to provide a research description in your initial submission for approval of research with human subjects .
HRP-213 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. 
Continuing Review Progress Report / Study Closure Template This template may also be required to provide further detail 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.

SUPPLEMENTAL FORMS

 
Financial Interest Disclosure Form The Principal Investigator is responsible for submitting this form for any member of the study staff with a financial interest related to the research. 
Non-Harvard Study Personnel Form This form is for reporting study staff only if they do not have a Harvard ID. Be sure to attach human subjects training certificates for these staff. 
IRB Cede Request Form For multi-site studies: use this form in conjunction with a request via ESTR that CUHS enter into a reliance agreement with another IRB.
Individual Investigator Agreement (IIA) 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.

CONSENT, ASSENT AND PERMISSION TEMPLATES

These templates are the most general starting point and can be filled in for any type of non-exempt minimal risk research.

Adult Consent Form Template

 
Parental or Guardian Permission Template  

Child Assent Form Template

Short Form Consent Form Template