OHRP sent out an email update this morning regarding Superstorm Sandy’s potential disruption of IRB operations. The following actions are recommended for institutions and IRBs affected by Sandy:
- Refer oversight of research to unaffected IRBs, if possible
OHRP acknowledges that in this situation, it may be impossible for an IRB to prevent the expiration of approval, or to notify investigators that research activities should be suspended due to the expiration of approval. If a study involves research interventions that are deemed to be in the best interests of participants, those interventions may continue after IRB approval expires.
- Make reasonable attempts to suspend or refer research to another IRB
OHRP says that it will use “available flexibility” in evaluating an affected institution’s failure to either suspend research due to expiration of approval, or conduct a continuing review in time to prevent expiration of approval. Affected IRBs that cannot resume normal operations should perform – and document! – due diligence in identifying and pursuing one of these two options for each expiring study. It should also be assumed that 45 CFR 46 still applies in its entirety, to include limitations on the use of expedited review procedures.
- Participants may be temporarily referred to other facilities to receive research interventions
OHRP anticipates that in most cases, these facilities will not be considered to be engaged in the research, which means they will not be required to obtain an FWA or seek IRB approval. The 2008 guidance anticipates situations in which a study participant needs to receive care at a facility that is not otherwise participating in the research.
Even if a facility is engaged, the best interests of participants should govern decisions regarding the provision of research interventions.
- Events related to this storm do not necessarily have to be reported to OHRP.
OHRP states, “In general, disruptions of human subjects protections programs by this storm do not constitute unanticipated problems involving risks to subjects or others, serious or continuing noncompliance, or suspension or termination of IRB approval. Therefore, these events need not be reported to OHRP as such.”
The most important words in this statement are the words in general. Although OHRP has presumably fielded a large number of questions to date, it’s impossible to anticipate every scenario that may arise. Affected organizations may still need to contact OHRP for advice regarding specific situations, some of which are likely to be reportable.