Reportable Events

Federal regulations for the Protection of Human Subjects require that investigators notify the IRB when specific research-related events occur.  These regulations also require that IRBs have written processes for notifying federal agencies (OHRP and, as applicable, FDA) of NIH IRB or RCRC  (IRB) determinations including unanticipated problems, serious and/or continuing noncompliance, and any suspension or termination of IRB approval. NIH investigators are expected to know which events require expedited reporting via submission of a Reportable New Information (RNI) form in PROTECT.

Prompt reporting of possible unanticipated problems to the NIH IRB helps ensure that appropriate steps are taken to protect other subjects from a similar harm.  IRB review of such events may also result in need for investigators to take additional steps to mitigate possibility of similar future risk. The IRB may require an update to the consent form and notification of existing subjects about a newly identified risk. Review of unanticipated problems in an expedited manner also allows the IRB to consider whether the risk/benefit analysis of the research continues to be acceptable.

Major deviations and noncompliance unrelated to the protocol also require prompt reporting to the NIH IRB.  Major deviations are those that have, or may have the potential to, negatively impact, the rights, welfare, or safety of the subject, or to substantially negatively impact the scientific integrity or validity of the study. They may be intentional or unintentional and can represent a deviation on the part of the investigator or the participant. Noncompliance means failure of an investigator to follow the applicable laws, regulations, or institutional policies governing the protection of human subjects in research, or the requirements or determinations of the Institutional Review Board (IRB), whether the failure is intentional or not.  If either a major deviation on the part of an investigator or noncompliance unrelated to the specific also rises to the level of serious or continuing noncompliance, reporting by OHSRP to the relevant federal agencies is required.

The information below has links to the relevant NIH polices that provide information regarding investigators’ responsibilities for reporting research related events to the IRB in PROTECT. Links to additional resource materials are also provided. Please submit any questions you have about reporting research related events to the IRB to the OHSRP Compliance and Training mailbox at OHSRPCompliance@od.nih.gov.

Additional Guidance and Resources:

• OHRP Reporting to OHRP: Unanticipated Problems (2020)
• OHRP Unanticipated Problems Involving Risks & Adverse Events Guidance (2007)
• FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection
• “Reporting research related events or new information to the IRB.” (Chapter 9). In NIH Investigator Manual for Human Subjects Research

Presentations:

• OHSRP Education Series presentation: Reporting Research Events and Non-compliance in Human Subjects Research (2019) (Slides and Videocast)