science

Modification

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 46.108(a)(3), 21 CFR 56.108(a)(4)).

Submission Requirements

Modifications must be submitted through eIRB. A full step-by-step guide for submitting modifications and/or updating the research team can be found here.

Find the active study in the “IRB” tab under “Active.” You can search by IRB number or PI name.

If you are submitting a change in study team member information, select “Study team member information”. If you are making any other changes (including changes to study documents), select “Other parts of the study”. If both, you must select both.

You will need to answer questions in the submission smart form about the current enrollment status and provide a brief summary of the changes you are making. You will then be able to modify the smart form for the study and upload any revised or new documents.

Common Questions About Modifications

1) When should I submit a 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 modifications 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, locations, etc.
  • Increasing the number of subjects you plan to enroll
  • 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 or IRBoffice@tuftsmedicine.org if you have any questions about when to submit a modification for your study.

2) What do I need to submit for a modification?

  1. A tracked copy of any study documents that are being revised
  2. If your study previously included clean copies of your study documents, please include a clean copy (the proposed new version) of the revised study documents. If you want to upload only one version of the document moving forward, remove both the older tracked and clean copies and upload just the revised tracked document as a brand new separate document with a different name (do not use replace function).
  3. Any new study documents you are submitting for review

Note: Be sure to update the version date and/or version number on each revised document.

3) Do I need to submit anything in eIRB 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 choose “Study team member information” AND “Other parts of the study” on the Modification Scope page, and upload tracked and clean (if applicable) versions of the revised study documents. (Be sure 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, choose “Study team member information” only and enter each current team member.
  • See the Step-by-Step Guide to Submitting a Change in Research Team for more instructions.

Please Note: If you are requesting a change in Principal Investigator (PI), you will need to change the PI in the Smart Form. To do this:

  1. Confirm with the current PI and the new PI that they agree to the change.
  2. If the current PI is no longer available, contact the IRB office. You will need to provide documentation from the Department Chair / Division Chief in order for the IRB to make this change.
  3. For studies with a Sponsor, confirm with the Sponsor that the Sponsor agrees to the change.
  4. In eIRB, choose Modification/Update (or Modification and Continuing Review if this change occurs at the time of Continuing Review)
  5. Choose “Other parts of the study” (or both “Other parts of the study” and “Study Team Member Information” if you are changing the PI as well as updating the list of research team members)
  6. Fill out the Modification Information page with the current study enrollment status, how you will notify any currently enrolled subjects of the changes you are making, and include a summary of the modifications and rationale for making the changes (ex: Previous PI left the institution and we are changing the PI. Previous PI and sponsor confirm the change).
  7. On the “Basic Study Information” page, update question #6 “Local Principal Investigator” to the new PI.
  8. Upload study documents that are being revised to reflect the PI change, e.g., protocol, informed consent form, etc.
  9. On the “Local Site Documents” page upload the Research Financial Interest Disclosure forms.
  10. Click Continue and then Finish. This will return you to the main study page. If you are ready to submit these changes, on the left side of the page under the blue buttons, hit “Submit”.

4) I want to amend my study, but the continuing review (CR) for my study is due. Can I submit a modification along with my CR?

Yes! You can submit combined Modification/CR submissions. Please note though, these combined modifications will be reviewed at the time of CR (which can be as long as one month after you submit the CR).

Therefore, if a modification is urgent please submit a modification separately from the CR, as combined Modification/CR submissions can only be approved as a unit (i.e. we cannot partially approve the Modification portion before the CR is approved).

Note: This restriction doesn't apply when modifying a participating site with its own Site page. See the Step-by-Step Guide to Modifying a Participating Site for instructions.

5) What is the turnaround time for IRB review of a protocol modification?

If a modification 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 modification is eligible for review under expedited procedures, it will be reviewed in order of receipt. Depending on the number of submissions received and the nature of the submission, a modification submission is generally reviewed within 7 to 10 business days of receipt.

Note: If your modification submission is incomplete, or there are any issues with the submission, the review may take longer.

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 a modification 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 enrollment must be approved by the IRB.

7) The informed consent forms (ICFs) were finalized and stamped with a validation stamp when my modification was approved. 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 revise the ICF. Be sure to include a proposed plan that specifies whether re-consent is necessary, and then check the approval letter from the IRB to see if previously enrolled subjects need to be re-consented to the new information.