Protocol Modifications
Once your study gets initial IRB approval, any new changes to the study, including the protocol, consent forms, study tools, recruitment materials, or translated documents, are considered modifications (MOD). You must submit these modifications to the IRB for review. The NIH IRB must approve the changes before you can implement them or use any updated materials, unless the change is needed to eliminate an immediate hazard to a participant.
Once your study gets initial IRB approval, any new changes to the study, including the protocol, consent forms, study tools, recruitment materials, or translated documents, are considered modifications (MOD). You must submit these modifications to the IRB for review. The NIH IRB must approve the changes before you can implement them or use any updated materials, unless the change is needed to eliminate an immediate hazard to a participant.
As the Principal Investigator (PI) and study team, you are responsible for submitting all modifications to the IRB in a timely manner.
There are 2 types of Modifications you can submit in PROTECT. One is “study team members” only, the second is “other parts of the study”. You may select both types in the same action or submit them separately.
MOD to Study Team members
When you add study team members, they must be up to date with required training as per NIH policy:
If their training isn't complete or updated in PROTECT, and you submit the modification (MOD) to the IRB Office (IRBO), the IRB Coordinator will send the submission back to your study team.
When changing the Principal Investigator (PI), follow these steps:
Submit a Statement or Memo
In the MOD submission, the new PI should add a comment that they agree with taking over the responsibilities as PI of the study. Alternatively, a memo from the new PI could be uploaded with the MOD. This should confirm that the new PI agrees to take on the role and is responsible for the study's oversight.
Update Documents
- Protocol and Consent Form (CF): Update these documents with the new PI's information.
- Recruitment Materials: Update these if applicable.
Notify and Re-consent Subjects
- Notification: Inform active subjects if the study is still enrolling or in active follow-up
- Plan: The notification plan may vary based on the study status and how often subjects are seen
- Re-consent at Next Visit: If the next visit is within a reasonable time frame, have subjects sign the revised consent form
- Information Letter: Send an information letter if appropriate
- Verbal Notification: Use a verbal script to inform subjects if appropriate
When changing the study coordinator or contact, follow these steps:
- Update the consent form (CF), recruitment materials with new coordinator or contact name and contact information
- Include a plan for notifying/re-consenting the subjects.
- Notification: Inform active subjects if the study is still enrolling or in active follow-up
- Plan: The notification plan may vary based on the study status and how often subjects are seen
- Re-consent at Next Visit: If the next visit is within a reasonable time frame, have subjects sign the revised consent form
- Information Letter: Send an information letter if appropriate
- Verbal Notification: Use a verbal script to inform subjects if appropriate
MOD to other parts of the study
For any modifications to previously approved research, complete the MOD smartform in PROTECT, and update any fields that have changed.
Ensure the protocol, consent documents, and all supplemental documents are in a clean Microsoft Word format. Word documents are required so that the changes can be compared within PROTECT.
PROTECT will convert all Word documents to a PDF format when the submission is approved.
In rare cases, you can attach a PDF document instead of a Word document, such as when a sponsor provides only a PDF version of a protocol. In those cases, you may submit a clean copy and tracked PDF of the document instead of the Word version.
Additionally, there are a few languages that cannot be converted to PDF in PROTECT. For the following languages only, submit a clean PDF of the translated consent (do not submit the Word version):
- Amharic
- Gujarati
- Kannada
- Sinhalese
- Tigrinya
Document Submission in PROTECT
- When you submit documents within PROTECT, make sure each electronic file has a consistent format. This includes naming folders and files correctly to ensure that required information is maintained and easily accessible.
- It's not enough to just add or attach your file. You must also name the document in PROTECT according to IRBO naming conventions. This helps keep everything organized and easy to find.
- Updates to version dates:
- Expedited Review: You can keep the same version date that you initially included when you submitted the MOD until the expedited designated reviewer approves it. Note: There may be exceptions based on the study sponsor's requirements.
- Full Board Review: If your submission is reviewed by the full board, you must update the version date each time the document is revised in response to stipulations from the full board.
- For guidance on submitting updated IBs and package inserts, see the document below.
Ancillary Review
Before submitting a MOD in PROTECT, ensure that any necessary ancillary reviews have been completed. These reviews are managed by entities other than the IRB, and their requirements are set by those entities.
For any questions about these ancillary reviews, contact the relevant office directly.
Next Steps Once the IRB receives the MOD Submission
The NIH IRBO is responsible for screening all submissions to determine whether the modification will be reviewed by the convened IRB (Full Board) or if it meets the regulatory criteria for expedited review and will be routed to a Designated Reviewer.
| Expedited | Full Board |
|---|---|
| Minimal Risk (MR) | Greater than Minimal Risk (GTMR) |
| Analyst Pre-review | Analyst Pre-Review |
| Reviewed by Chair/Chair Designee | Reviewed and Approved by Convened Board |
Review Process
Full Board Review: If the proposed change to the research adversely impacts the risk/benefit ratio or if the changes are more than minor, the modification will be sent to the full board for review. This can include research that was previously expedited.
Expedited Review: If the proposed change to the research is a minor change that does not adversely impact the risk/benefit ratio, it may be eligible for expedited review.