Reports of Unanticipated Problems

Investigators or the study team must report possible unanticipated problems to the HRPP in writing.  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 problems 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.

A report of a possible unanticipated problem involving risks to participants or others will be immediately forwarded by HRPP staff to the IRB Chair if the HRPP staff believes that immediate intervention may be required to protect participants or others from serious harm. Upon receipt of a report of a possible unanticipated problem from someone other than the investigator or study staff, the IRB director or HRPP staff will notify the PI on the study when appropriate.

Review by HRPP and IRB Chair

  1. The IRB chairperson, and/or other experienced individuals designated by the IRB chairperson, receives and reviews the report of the event considered to be an unanticipated problem.  The IRB chairperson (or designee) will make the final determination as to whether the event is to be regarded as an unanticipated problem.  All events determined to be unanticipated problems will be reported to the relevant regulatory agencies and institutional officials, as necessary, according to the procedures in this document.

  2. Unanticipated problems for which no modifications to the protocol or informed consent process/documents are needed, as determined by the IRB chairperson (or designee), may be:

    (a) filed in the IRB records without further review by the convened IRB
    (b) at the discretion of the IRB chairperson (or designee) referred to the rest of the IRB members for review and further action, as appropriate, at a convened meeting.

    For external adverse events, if the central monitoring entity or the PI did not propose any modifications to the protocol or informed consent process/document, but the IRB chairperson (or designee) believes that modifications are needed in response to the external adverse event(s), the IRB chairperson (or designee) requests in writing that the PI discuss the proposed modifications with the study sponsor or coordinating center and submit a response or necessary modifications for review by the IRB. These modifications then are handled in accordance with procedures below.

    The IRB or the IRB chairperson (or designee) has authority to require submission of more detailed contextual information by the PI, the sponsor, the study coordinating center, or DSMB/DMC about any adverse event occurring in a research protocol as a condition of the continuation of the IRB’s approval of the research.

  3. Unanticipated problems for which modifications to the protocol or informed consent process/documents are needed, either as requested by the PI or determined by the IRB chairperson (or designee), will be handled as follows:

    (a) If all proposed modifications represent minor changes, the IRB chairperson (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: (i) filed in the IRB records without further review by the convened IRB or, (ii) at the discretion of the IRB chairperson (or designee), referred to the rest of the IRB members for review and further action, as appropriate, at a convened meeting.

    (b) If any of the proposed modifications represent more than a minor change, or if the IRB chairperson (or designee) determines for any reason that he or she should not approve the proposed modifications under an expedited review procedure, the proposed modifications must be forwarded to the other IRB members for review at a convened meeting.

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