IRB Director Perspectives: Reportable Events
Reportable Events: What should be reported to the IRB?
By: Sanjur Brooks, DPS, MA
The institutional review board (IRB) is an independent board federally mandated to review and monitor research involving intervention and/or interactions with human participants while ensuring the protection of their rights and welfare as research participants. Researchers, regardless of risk level, must submit their research protocol to the IRB approval for all research involving human participants, whether living individuals, data, or specimens.
However, once a researcher receives their IRB approval, that does not mean that the IRB and researcher no longer engage with each other. In fact, the IRB-Researcher relationship should be solidified by keeping the IRB abreast of its progression and IRB must conduct regulator monitoring of the study and maintain oversight. One form of protocol communication is submitting reportable events to the IRB in a timely manner.
The timeframe for reporting to the IRB is dependent on the nature of the reportable event. Thus, a good rule of thumb for the researcher to follow is to always put the rights, safety, and welfare of the participants first and mitigate the harms immediately, then report the nature of the event and the corrective action to the IRB.
In general, things to report are reportable events that pertain directly to participants’ safety while actively enrolled in the study. Reportable Events include, but are not limited to:
- Reportable events that are unexpected in terms of nature, severity, or frequency,
- Reportable events related or possibly related to research participation
- Reportable events that suggest the research will put participants or others at a greater risk of harm than previously known
If a researcher is unsure if the reportable event should be reported to the IRB, or the period for reporting these events to the IRB, the researcher should follow up with a staff member of the IRB for further guidance.
References
Advarra. (2022). Reporting to the IRB: What Does and Does Not Need to be Reported
Straut, T., & Schmalfuss, C. (2014). SAEs, UAPs, and Deviations: The What, When, Where, and How of Reporting Events to the VA Central IRB. Office of Research & Development.
Categories Education and Training