Modifications

Click on a form/document name in the table below to open the individual form. Save the form to your computer desktop and reopen it before completing.

Modification Submission Forms	Instructions
Modification of Approved Human Research	This form is no longer in use.  Instead, log into ESTR: irb.harvard.edu to “Create Modification/CR” and follow prompts.
Change to Principal Investigator	This form is no longer in use.  Instead, log into ESTR: irb.harvard.edu to “Create Modification/CR” and follow prompts.  Note that under “Modification Scope” this would not be considered an update to ”Study team member information,” but rather to ”Other parts of the study.”
Exemption Request	To request changes to a previously exempt protocol, log into ESTR: irb.harvard.edu to “Create Modification/CR” and follow prompts (this process is identical for non-exempt human research applications). If you do not see your previous exemption in ESTR, contact QIP.
Not Human Subjects Research Determination Request	Submit this form and in Section A indicate a “clarification” to request changes to a previously determined Not Human Subjects Research protocol. Then, log into ESTR: irb.harvard.edu to “Create Modification/CR” and follow prompts (upload the Not Human Subjects Determination Request within the Smartform Section: Study Scope. For further explanation of what qualifies as Human Subjects Research, open this form.  If you do not see your previous exemption in ESTR, contact QIP.