The guidance discusses the regulatory responsibilities of IRBs, clinical investigators, and sponsors when oversight of a previously approved, ongoing clinical investigation under FDA’s jurisdiction is transferred from one IRB to another IRB.
The transfer of review responsibility for a clinical investigation from one IRB to another “should be accomplished in a way that assures continuous IRB oversight with no lapse in either IRB approval or the protection of human subjects, and with minimal disruption of research activities,” the FDA says.
Such transfers of oversight may occur for a number of different reasons, such as cessation of IRB operations, consolidation of multiple IRBs into a single IRB, temporary inability of an IRB to meet its obligations, or as a result of IRB non-compliance.
The guidance provides recommendations concerning the transfer of IRB oversight from one IRB to another IRB that is not part of the same institution and recommends the transfer process be documented in a written agreement.
Such an agreement should address the studies that are being transferred; all pertinent records, such as the research protocol and significant amendments. Under FDA regulations, IRB records related to the review of a clinical investigation must be retained for at least three years after the completion of the research, and the records must be accessible for inspection and copying by FDA.
Other items worth considering in an agreement include the date for the transfer, whether consent forms need to be revised, notification of the key parties and an update of the IRB registration information.
The guidance also addresses the transfer of oversight from one IRB to another IRB operating within the same institution, the temporary transfer of clinical investigation oversight to another IRB that occurs as a result of a natural disaster or for other reasons, and the transfer of a clinical investigation to a new research site requiring IRB review.
The IRB guidance comes as the FDA has previously focused its efforts on IRB responsibilities in checking investigator qualifications, ensuring sites are up to code, and investigating whether an IND is necessary for a proposed trial.