On November 9, 2022, the Department of Health and Human Services Office for Human Research Protections (OHRP) published a new Guidance clarifying the requirements for reporting incidents to OHRP. Questions about OHRP reporting requirements frequently arise when an incident (an unanticipated problem involving risk to subjects or others; serious or continuing non-compliance with federal human subjects research regulations or the requirements of the IRB; or any suspension or termination of IRB approval) occurs in research that is not conducted or supported by a federal agency (e.g. industry sponsored clinical trials).
OHRP’s new guidance clarifies that OHRP reporting is not required for incidents that occur in non-federally supported research conducted by institutions holding a Federalwide Assurance (FWA), where the institution does not “check the box” on its FWA to apply the Common Rule and therefore does not submit to OHRP oversight for all of its research, including research that is not federally supported. This new Guidance includes a helpful flow chart for determining whether OHRP reporting is required.
The Guidance also includes clarification regarding the time frame for “promptly” reporting incidents to OHRP. Prompt reporting of serious incidents may require reporting within days; while it may be sufficient to report less serious incidents within a few weeks. Depending on the circumstances of a reportable incident, institutions may submit an initial incident report to OHRP which indicates that a follow-up report will be made either by a specific date or after an investigation has been completed or a corrective action plan has been implemented.
Finally, the Guidance describes OHRP’s process and timeframes for reviewing and responding to incident reports and describes how OHRP uses information in incident reports to analyze trends.
Institutions that hold an FWA should (1) review their FWA and relevant institutional and IRB policies regarding protocol deviations, non-compliance and OHRP reporting; and (2) provide IRB and research staff training to ensure their policies and practices are consistent with federal requirements and to avoid potentially over-reporting incidents to OHRP.