On November 13, 2012, OHRP released an announcement in relation to Superstorm Sandy and IRB operations. You can read the 2012 OHRP announcement here: “Effects of Superstorm Sandy on IRB Operations.”
This guidance states that, generally, storm-related disruptions to human subjects protections programs are not unanticipated problems involving risks to subjects or others that need to be reported.
Quorum’s interpretation is that study interruptions due to natural disasters are not generally reportable. In addition to OHRP’s announcement, missed visits or disruptions to scheduled research do not usually fall within Quorum’s current guidance on what would be reportable.
- Study visit(s) or study procedure(s) conducted out of timeframe are generally considered non-reportable minor Protocol Deviations
- Adverse events that, in the PI’s judgment, are not related to the study are not reportable
Since the majority of deviations are likely to be missed visits and the corresponding AEs would likely be related to the circumstances created by the storm, Quorum believes the OHRP guidance is reasonable and encourages sites and sponsors to follow the above guidelines for reporting.
Please note that some sponsors may still want the deviations and SAEs reported. In the case of deviations for out-of-window visits/procedures, sites are encouraged to submit a single protocol deviation report covering several events/participants.
At this time, the FDA has not issued similar guidance.
If you have further questions please contact Quorum at SiteSupport@QuorumReview.com or (877) 472-9883.