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Maintaining :: Undesirable events :: Reporting requirements

Reporting Requirements

Adverse Event and Unexpected Events

OHRP recognizes that there adverse events are a normal part of conducting a study and while they should be recorded and monitored as part of the data collection process, they don’t necessarily need to be reviewed by the IRB and OHRP. OHRP does define three categories where reporting an adverse event is necessary:

  1. Adverse events that are serious, unexpected, and related or possibly related to participation in the research.
  2. Serious adverse events that are expected in some subjects, but are determined to be occurring at a significantly higher frequency or severity than expected.
  3. Other unexpected adverse events, regardless of severity, that may alter the IRB’s analysis of the risk versus potential benefit of the research and, as a result, warrant consideration of substantive changes in the research protocol or informed consent process/document.

Essentially, if the resulting event changes the level of risk that was previously approved by the Board, the Board and researcher needs to revisit the protocol’s procedures and recommend appropriate changes to accommodate the new level of risk. These changes could include changes to the protocol, consent forms, and other documents used in the study. If the protocol received an expedited review or was exempted in the initial review (because the protocol was considered minimal risk at the time), a change in risk may require that the protocol receive full board review for any future reviews. In addition, the Board has the authority to terminate or suspend approval for a study if they feel that the risk to participants is too great for the study to continue.

Noncompliance Events

Noncompliance events that change the probability of harm to a participant must be reported to the IRB, even if a participant was not harmed as a result of the problem.

The Reporting Undesirable SBS Research Events form (RUSRE form) is designed to help you determine if you need to report an undesirable event to the IRB-SBS. See Procedures for more information.

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