According to federal regulations, investigators are responsible for obtaining prior approval from the IRB for any modifications to approved research, including modifications to the informed consent process and document. The only exception to this requirement is a change necessary to eliminate apparent immediate hazards to subjects (45 CFR 46.103(b)(4)).
When submitting an amendment, use the appropriate sample cover letter printed on your department’s letterhead. The amendment needs to be provided to the IRB office in hard copy, with original signatures. Be sure to consider the points in the cover letter and make sure they are addressed in your submission so your amendment can be processed quickly and efficiently:
1) When should I submit an amendment / modification for a study?
Any modifications to a research study require IRB approval before the requested change can be implemented. Here are some examples of when amendments must be submitted to the IRB for review and approval:
Changes to the research team (adding or removing research team members)
Revisions to study documents
Revisions to study procedures
Revisions to the study payment plan
Revisions to recruitment material
Newly developed recruitment material
Addition of collaborators, etc.
Updates in study contact information (for example: coordinator telephone number)
Amendments/modifications received from the study Sponsor/CRO
Any other changes to the study
Please do not hesitate to contact the IRB office at 617-636-7512 if you have any questions about when to submit an amendment for your study.
2) What do I need to submit for an amendment / modification?
A tracked copy of any study documents that are being revised
A clean copy (the proposed new version) of the revised study documents
Any new study documents you are submitting for review
Submit a paper copy of your amendment to the IRB Office (Box 817, or drop off to 15 Kneeland St. Tupper 1, 1st floor Street Entrance).
Note: Be sure to update the version date and/or version number on each revised document.
3) Do I need to submit anything to the IRB if there are changes in the research team for my study?
Yes, the addition and removal of research team members requires IRB review and approval before new research team members can start working on the study. All research team members must be up to date with their mandatory research education (CITI, and GCP, as applicable), and the PI must have their completed Conflict of Interest (COI) Form on file (and submitted to the IRB, if needed).
If study documents require revisions as a result of the change(s) in research team, please submit an Amendment Cover Letter along with tracked and clean versions of the revised study documents to the IRB Office (Box 817, or drop off to 15 Kneeland St. Tupper 1). (Be reminded to make changes on the most recent IRB approved version of documents, and to update the version date – if there is another modification pending IRB review and approval, contact the IRB for instructions.)
If no study documents require revisions as a result of the change(s) in research team, please submit a Change in Research Team Cover Letter to the IRB Office (Box 817, or drop off to 15 Kneeland St. Tupper 1).
Please Note: If you are requesting a change in Principal Investigator (PI), the cover letter must be signed in original ink by both the former PI and the newly proposed PI.
4) I want to amend my study, but the continuing review (CR) / administrative annual review (AAR) for my study is due. Can I submit an amendment along with my CR/AAR?
Yes! You can submit amendments with your CR/AAR submission. Please note though, that amendments will be reviewed at the time of CR/AAR (which can be as long as one month after you submit the CR/AAR). Therefore, if an amendment is urgent please let the IRB know and the amendment may be reviewed before the CR/AAR, if possible.
5) What is the turnaround time for IRB review of a protocol amendment?
If an amendment requires convened IRB review, it will be placed on the next available IRB meeting agenda. Convened IRB meetings take place two times per month. The meeting dates and submission deadlines are available here.
If the amendment is eligible for review under expedited procedures, it will be reviewed in order of receipt. Depending on the number of submissions received and the quality of the submission, an amendment submission is generally reviewed within 7 to 10 business days of receipt.
Note: If your amendment submission is incomplete, or there are any issues with the submission, the review may take longer than 10 days.
6) I reached my subject enrollment limit for my study. Can I request an increase in enrollment?
Yes, you can request an increase in enrollment at the time of continuing review or as an amendment at any time during the study. Be sure to submit your request before you reach your enrollment limit so you do not over-enroll subjects. All requests to increase in enrollment must be approved by the IRB.
7) I received validated informed consent forms (ICFs) back from the IRB with my approval letter. Are these the ICFs that I need to use to consent subjects?
Yes, only validated ICFs should be used to consent subjects. These are the ICFs with the IRB validation stamp in the bottom right-hand corner of the document. Be sure to archive old versions of ICFs to avoid non-compliance.
Note: Re-consent is not required every time you amend the ICF. Be sure to check the approval letter from the IRB to see if previously enrolled subjects need to be re-consented to the new information.