Modifications to Research Already IRB Approved
IRB review and approval is required before implementing any new recruitment procedures (advertisements, flyers, etc); changes to the consent process or forms; research methods, procedures, apparatus, stimuli, measures, locations or any other aspect of an approved research protocol.
Instructions for submitting modifications
Modifications to an already approved protocol does not require a new application. When a modification is required, the lead investigator is instructed to email the IRB (firstname.lastname@example.org).
- Type "Modification Request" in the subject line of the email;
- Include in the body of the email the title of the proposal, the level of review (exempt, expedited, or full review), the date of the original submission and/or approval date, along with an explanation of the changes being made;
- Attach to the email message any modified or new materials. Original copies of signature-bearing documents are to be sent to the Institutional Review Board, PO Box 2000, Miller Building Room 402, Cortland, NY 13045. Remember that most changes to procedure will require a change to the consent form(s), and if modified, is to be attached to the email; also,
- If the change is being made because a new risk was identified, share this information with the IRB at the time the modification request is being made. This information will allow the IRB to ensure that the protocol is still classified appropriately. Furthermore, this new knowledge will assist the IRB in our ongoing efforts to improve our human research protection program, and it may help another investigator at some point in the future.
If the change is minor or the change is being made to an exempt or expedited protocol, the IRB will reply to your request as soon as possible. Please allow at least two weeks for this level of review. If the proposal was initially reviewed by the Full Board, the IRB will likely be required to refer the change to the Full Board for their review and approval. Submit changes as soon as possible, as this process can take up to four weeks. Note that an approved modification will not alter the one-year protocol termination date.