A. Modifications

Any change in the conduct of a study must be reviewed and approved by the IRB prior to implementing the change.  The exception to this is when the change is necessary to eliminate apparent immediate hazards to subjects.  The investigator is required to notify promptly the IRB of any changes made without IRB approval to eliminate apparent immediate hazards to subjects using the Modification Form.  The convened IRB will review these modification forms to determine that any changes made by the investigator to eliminate apparent immediate hazards to the subjects were consistent with ensuring the subjects’ continued welfare.

Modifications include, but are not limited to:

1. Changes to study procedures,
2. Adding or removing investigators or research team members,
3. If a PI is leaving the institution, a new PI must be submitted and approved prior to the current PI’s departure.  A signed assurance document is required of a newly named PI of a research study.  If a PI is on extended leave from the institution, contact the HSO to discuss continued oversight of any open studies.
4. Changes to the title of the project,
5. Requests for additional subjects beyond the original approved number,
6. Change in funding sources,
7. Changes in how subjects are being recruited or followed-up,
8.  New or revised advertisements,
9. Changes to Informed Consent Documents, surveys, questionnaires, correspondence with potential or current subjects, or additional new items, protocol changes.
10. Modifications to an approved project should be submitted on a Modification/Update Form.  A modification may be submitted at the same time as a continuing review.  Instructions for the completion of these applications are contained within HawkIRB.

Modifications to an approved project that pose no additional risk to subjects i (e.g. changes in title, co-investigator(s), funding sources) are eligible for expedited review.  To be eligible for expedited review, the modification must maintain similar or increased safeguards to protect the subject.  Expedited modifications are reviewed and approved by the IRB chair or designee.  More extensive modifications, or modifications that pose additional risk to subjects, may require full board review.  In either case, revisions or clarifications may be required.  All modifications must be approved by the IRB prior to implementation (see exception noted above).

Once a PI has received a protocol amendment from a study sponsor, it is the PI's responsibility to submit the amendment in a timely manner for IRB review and approval.  Based on guidance from the FDA, potential subjects who meet eligibility criteria under a pending amendment to the protocol may not be enrolled until after the amendment is approved by the IRB.  Further, the FDA will hold the PI responsible for compliance with this requirement.  The sponsor does not have the authority to override this FDA regulation, and therefore, it is inappropriate for the PI to request "special permission" from the sponsor to implement any aspect of the amendment before IRB approval.  Rather, the PI should move as quickly as possible towards submitting the amendment for IRB approval.

For projects that have received Concept approval, to obtain approval for enrolling human subjects the investigator should submit a Modification/Update Form in HawkIRB.  In the Modification/Update Form, the investigator should change Question IV.1 to indicate that the project should receive Regular review.  This change will open up additional questions for the investigator to answer in order to complete the application.  An Informed Consent Document and any other materials, such as interview scripts or questionnaires, should be attached to the Modification/Update Form.