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.

To request modifications, log in to ESTR  and go to the main study workspace and select “Create Modification”. From there, indicate the scope of the Modification: either Study Team Member Information, Other Parts of the Study, or both.

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 (click to download)

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.
Questions about what to submit? Please contact us.