Federal regulations require investigators to report unanticipated problems, complications or complaints to the IRB in a timely fashion. The Department of Health and Human Services defines an adverse event as "an undesirable and unintended, though not necessarily unexpected, result of therapy or other intervention."
The scope of the definition includes any "unanticipated problems involving risks to subjects or to others" in medical and non-medical research alike.
Under these federal requirements, investigators must report to the IRB in writing the nature of the problem within five working days of the occurrence. In addition, any injury or physical or emotional harm to a participant must be reported immediately to the IRB. Other examples include, but are not limited to, a breach in confidentiality or privacy, problems with recruitment and/or the consent form process, noncompliance with federal regulations or IRB policies, complications or complaints occurring during the research, or any other problem that presents changes in the risk-benefit ratio and affects the rights, welfare and safety of subjects. A separate report must be filed for each incident summarizing the problem or difficulty encountered along with a statement by the investigator indicating whether a change in the protocol and/or consent form is warranted and whether, in the investigator's opinion, the adverse event was related to the research activity. Adverse event report forms are available from the Kenyon IRB Forms page.
Following receipt of an adverse event report, the IRB will review the information to determine whether any further actions, beyond any changes or amendments to the protocol that are proposed by the investigator, are warranted. The IRB reserves the right to review and approve all the proposed changes and determine whether the study should be continued as originally approved, modified, or discontinued. Further, the IRB is required to report to the Provost and any Sponsoring Agency, all adverse events that caused injury to human subjects or other major effects that involved unanticipated risks or problems; investigators must also comply with any reporting requirements in the protocol itself or as stipulated by the Sponsoring Agency in grant documents or agency regulations.