Baruch Human Research Protection Program (HRPP) Office (formerly IRB)
Submitting Revisions to the IRB
Administrative Revisions - This revision is usually requested before an IRB application is accepted into IRB Manager. The administrator may request substantive revisions to the protocol (such as revisions in the IRB application questions or substantive changes to attached documents) or may request non-substantive revisions (such as attaching CITI certificates, questionnaires, or informed consent documents). The administrator will reject the application so that a PI can revise their application and resubmit the application with the revisions requested. The PI will be notified of all rejections via IRB Manager email notification. The administrator will indicate (in the notes area of each question or document attachment section) what needs to be attached in order to for your application to be approved into IRB Manager. Please note that administrative approval of the application only pertains to approval to the hold for revisions stage not final IRB approval of a protocol.
Hold for Revisions - This stage occurs after the administrator approves the application for IRB review. This step allows the PI to make substantive revisions to the application per IRB instructions if substantive revisions are requested.
After a protocol has been reviewed by the IRB, the IRB will request either substantive or non-substantive revisions.
Substantive Revisions - Substantive revisions are major revisions made to an application (i.e. description of research plan, data protection, etc.). If a substantive revision is requested, the administrator will reject the application so that the PI can make the requested revisions.
Summary of Revisions - When substantive changes are requested, the PI must submit a memo (summary of revisions) listing each revision requested and describing all changes made to the application. This summary should also include the location in the application (i.e question number) where revisions have been made. The IRB will not accept a revised application without receiving a summary of revisions memo.
If the PI is a student, then the faculty advisor will receive a notification from IRB Manager once the student has resubmitted their application. Faculty Advisors must approve the revised application by typing in his or her password in order for the application to be forwarded to the IRB for review. Please click here for faculty advisor instructions.
Non-Substantive Revisions - Non-Substantive revisions are minor revisions such as document revisions (i.e. consent, debrief, and recruitment forms). These revisions can be emailed to the chair cc'ing the IRB Administrator.
