Adverse Events

Problems involving risk to participants, including animals, may occur during the course of your research study and require appropriate and timely responses. They include physical and psychological harms to humans and animals.

Adverse events include but are not limited to:

  • An event or problem that affects the safety and welfare of study participants.
  • An unexpected problem, complication, or death resulting from the research procedures described in the IRB-approved protocol and related or possibly related to participation in the research study.
  • Any change in U.S. Food and Drug Administration safety labeling or withdrawal of a drug, device, or biologic agent used in an IRB–approved research study due to adverse events or unanticipated problems.
  • Accidental or unintentional change to or noncompliance with the IRB-approved protocol without prior sponsor and IRB approval.
  • Any breach in confidentiality that caused harm or places study participants or others at a greater risk of harm (including physical, psychological, economic, or social), such as a data breach.
  • Any unanticipated incident that seriously affects the health or safety of laboratory animals.
  • Any unanticipated loss of animal life.
  • Any work-related injury to persons involved in animal research or any other person that requires more than minor medical intervention.

Federal regulations governing the use of humans in research state the institution that granted local approval to conduct the study must have "written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Department or Agency head, of any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB" (Code of Federal Regulations, 2009).

The definition of "prompt" and "unanticipated problems" can leave you questioning what and when to report. "Clearly, any unanticipated problem involving 'risk' that ultimately results in harm to the subject and is related to a research intervention encompasses a reportable AE" (Prentice, Epperson, Kratochvil, & Gordon, 2002).

When an unanticipated event occurs, you must initially decide whether the event is related to the research, can be categorized into a series of similar events resulting in a need to change the protocol and/or consent form, or is serious enough to require reporting to the local IRB. If it is serious, you must immediately report the event. If you have any doubt about whether a problem involved risk, TSNRP urges seeking guidance from the local IRB. When in doubt, ask!

Local IRB policies vary, and differences occur within the same military service. The principal investigator is responsible for each study site, each site's IRB policies, and each study investigator. Keep a copy of the policies for all sites in the study file. All investigators must know and follow local IRB policies. The principal investigator is responsible for the accurate documentation, investigation, and follow-up of all possible study–related adverse events.

If an adverse event occurs on your TSNRP study, follow your local IRB's instructions for reporting the event. Additionally, fax TSNRP a copy of the local IRB's notification within 24–48 hours of the event; the notification will be forwarded for secondary IRB review at USUHS.

More Information

Sources

Code of Federal Regulations. (2009). Title 45-Public Welfare; Part 46-Protection of Human Subjects.

National Institutes of Health. (1999). Guidance on reporting adverse events to institutional review boards for NIH-supported multicenter clinical trials.

Prentice, E., Epperson, K., Kratochvil, C., & Gordon, B. (2002). IRB review of adverse events. In R. Amdur & E. Bankert (eds.), Institutional review board: Management and function (pp. 297–300). Boston: Jones and Bartlett.