Guidance regarding unanticipated problems and risks during the conduct of research.

Adverse events that are anticipated by the researcher must be discussed as part of the IRB proposal, and the possibility of such effects must be made known to study participants as part of the informed consent process. If expected adverse events occur during such research, no special reporting to the Office for Human Research Protections (OHRP) is required. There is no formal definition of adverse events in HHS regulations related to human research, but some guidance can be found here.

Adverse events that are unanticipated in their nature, severity, or frequency require immediate attention. Although such events are most likely to occur in medical experiments, they are not unknown in behavioral or psychological studies. Every researcher should be familiar with the definition of unanticipated adverse effects as outlined by the Office for Human Research Protections (OHRP). Particular attention should be paid to section 1 of this document. If the experimenter has reason to believe that an unanticipated adverse event may have occurred, the event should be reported to the IRB office. Such events may be (1) reported by the study participant, (2) observed by the experimenter, or (3) reported by a third party based on observation of study participants. Once the event is reported, the members of the IRB will work with the investigator to determine whether the event meets the criteria for reporting to the OHRP. The full text of the OHRP’s guidance on this subject may be found here.

If the researcher believes that an unanticipated adverse event has occurred, the following steps should be taken.

  1. The unexpected adverse event should be reported immediately to the IRB, which will then work with the investigator to determine whether the adverse event is or may be related to participation in the research project. If it can be established that the event is not due to participation in the project, then the report will be logged but no report to the OHRP is required.
  2. If it is determined that the event is or may be related to participation in the research project, then a report must be prepared and submitted to the OHRP within XXX hours.
  3. The report to the OHRP, if required, should include the following information.
    1. Name of the institution conducting the research
    2. Title of the project
    3. Name of the principal investigator on the proposal
    4. The research project number assigned by the IRB at the time of approval and the number of any federal awards funding the research
    5. A detailed description of the problem
    6. Actions the institution is taking or plans to take to address the problem. These may include any or all of the following
      1. Revise the protocol
      2. Suspend enrollment of new participants in the project
      3. Terminate the research
      4. Revise the informed consent document
      5. Inform already enrolled participants
      6. Increase monitoring of existing participants