Unanticipated Problems

PIs are required to promptly report a summary of each unanticipated problem using the Unanticipated Problem Form (Appendix F) and available online at https://utdirect.utexas.edu/vr/Adverse.WBX.

The University defines an unanticipated problem as any of the following:

• An actual unforeseen harmful or unfavorable occurrence to participants or others that relates to the research protocol (injuries, side effects, deaths);
• An unforeseen development that potentially increases the likelihood of harm to participants or others in the future;
• a problem involving data collection, data storage, privacy, or confidentiality;
• a participant complaint about approved research procedures;
• New information about a research study (e.g., a publication in the literature, interim findings, safety information released by the sponsor or regulatory agency, or safety monitoring report) that indicates a possible change in the risks of the research;
• Changes in approved research initiated without review and approval to eliminate apparent immediate hazards to the participant.

The University defines an "unanticipated problem involving risks to participants or others" as an event that was (1) unforeseen, (2) related to the research procedures, (3) either caused harm to participants or others, or placed them at increased risk of harm.

The process for reporting an unanticipated problem is as follows:

1. Reporting responsibilities of the PI:
   1. Within 5 days of knowledge of the unanticipated problem, the PI is asked to submit the Unanticipated Problem Form to the office.
   2. Expected adverse events (adverse events described in the risks section of the consent form) are to be reported in the annual continuing review application.
2. Reviewing and reporting responsibilities of the ORS:
   1. Unanticipated problems not involving risks to participants or others (foreseen, not related to the research procedures, and did not cause harm to participants or others, or place them at increased risk of harm):   The Chair, ORS Director, and HRP Program Coordinator will confer to determine if the reported unanticipated problem is (1) an unanticipated problem, and (2) if the potential exists for the unanticipated to involve risks to participants or others.   For those unanticipated problems failing to meet (2) ORS will work with the PI and work towards a satisfactory and reasonable resolution for all parties.   In the event the unanticipated problem cannot be administratively adjudicated, the unanticipated problem will be referred to the full for review.   ORS will formally report back to the PI all submitted unanticipated problem reports determined to be not unanticipated problems.
   2. Unanticipated problems potentially posing risk to participants or others (or those reports not administratively adjudicated) are placed on the appropriate agenda for the review.
      1. The Unanticipated problem form is distributed to all members in advance of the meeting.   All members will be provided with a copy of the report.   The primary reviewer will be provided with a copy of the report, the protocol with all approved modifications, and currently approved consent documents.
      2. The votes to determine whether the unanticipated problem represents an unanticipated problem involving risks to participants or others.
      3. The votes to take one of the following actions:
         1. Accept the actions taken by the PI to report and resolve the incident;
         2. Notifying current participants when information about the unanticipated problem might affect their willingness to continue to take part in the research;
         3. Alter the continuing review schedule;
         4. Peer review monitoring
         5. Approve with explicit changes:
            • Notification of previous subjects;
            • Modification of consent and/or protocol;
         6. Suspension of some or all research activities
         7. Approve the study for a shorter period of time (e.g. 6 months versus 12 months);
         8. Terminate - the study for cause.
   3. If the determines that the unanticipated problem represents an unanticipated problem involving risks to participants and others, the follows the Reporting Policy found in Section 2.0.6 for procedures taken when reporting unanticipated problems that involve risk to participants or others.

Additional Reporting Requirements:  

1. If a sponsor funds or supports the study, then the PI is responsible for notifying the sponsor .   For any studies under FDA jurisdiction, it is the PI and / or sponsor's responsibility to notify the FDA within 24 hours.
2. Similarly, if the study is a multi-site project, and the unanticipated problem occurs at a site other than The University, then the sponsor is required to inform investigators of unanticipated problems or reactions that occur at other sites. When PIs are informed of unanticipated problem(s) in sponsor safety memos or other correspondence, then the PI must notify the using the Unanticipated Problem Form (Appendix F or http://www.utexas.edu/research/rsc/humansubjects/
   forms.html ). Reports to the should be submitted as promptly as possible after receipt of the report from the sponsor.
3. Note that notifying the does not relieve the PI from his/her responsibility to notify the sponsor and / or FDA (as applicable).