The written report should contain the following:

1. Detailed information about the possible unanticipated problems, including relevant dates
2. Any corrective action, planned or already taken, to ensure that the possible unanticipated problem is corrected and will not occur again
3. An assessment of whether any participants or others were placed at risk as a result of the event or suffered any physical, social, or psychological harm and any plan to address these consequences
4. Any other relevant information
5. Any other information requested by the HRPP

The convened IRB will review the report of the incident considered to be an unanticipated problem. 

All incidents determined to be unanticipated problems will be reported to the relevant regulatory agencies and institutional officials, as necessary, according to federal regulations.

No Modifications Needed

Unanticipated problems for which no modifications to the protocol or informed consent process/documents are needed, as determined by the convened IRB, may be filed in the IRB records without further review.

Modifications Needed

For external adverse events, if the central monitoring entity or the PI did not propose any modifications to the protocol or informed consent process, but the IRB chair (or designee) believes that modifications are needed, the IRB chair (or designee) will request in writing that the PI discuss the proposed modifications with the study sponsor or coordinating center and submit a response or necessary modifications for IRB review.

The IRB, IRB chair or their designee has authority to require as a condition of the continuation of their approval that the PI, study coordinating center or Data Safety Monitoring Board (DSMB) submit more detailed contextual information about any adverse event occurring in a research protocol.

Minor Changes

If all proposed modifications represent minor changes, the IRB chair (or designee) may review and, if appropriate, approve the modifications under an expedited review procedure. The related report of the external adverse event may be filed in the IRB records without further review by the convened IRB or, at the discretion of the IRB chair (or designee), referred to the rest of the IRB members for review and further action, as appropriate, at a convened IRB meeting.

Substantial Changes

If any of the proposed modifications represent more than a minor change, or if the IRB chair (or designee) determines for any reason that they should not approve the proposed modifications under an expedited review procedure, the proposed modifications must be forwarded to the convened IRB.

If the IRB chair (or designee) determines that modifications in addition to those proposed by the PI are needed in response to an external adverse event, the IRB chair (or designee) will request in writing that the PI submit a response or the necessary additional modifications for review by the IRB.