FDA Finalizes IRB Transfer Guidance With Minimal Changes
Posted 22 May 2014 | By
The US Food and Drug Administration (FDA) has announced the release of a final document intended to instruct sponsors, clinical investigators and institutional review boards (IRB) about how to transfer the oversight of clinical trials to a new IRB.
The guidance, Considerations When Transferring Clinical Investigation Oversight to Another Institutional Review Board, was first released in draft form in June 2012 by FDA and the US Department of Health and Human Services’ Office for Human Research Protections (OHRP), both of which oversee clinical trials in the US. (The difference: FDA oversees private clinical trials, while OHRP oversees government-run clinical trials).
The guidance contained a recommended eight-step process for transferring an IRB:
- Identify those studies for which IRB oversight is being transferred.
- Ensure availability and retention of pertinent records.
- Establish an effective date for the transfer.
- Conduct a review of research by the receiving IRB, where appropriate.
- Confirm or establishing the date for the next continuing review.
- Determine whether the consent form needs to be revised.
- Notify the key parties.
- Update IRB registration information.
FDA notes in a 22 May 2014 Federal Register announcement that the guidance document has largely been left as-is, but contains a few changes.
In particular, new IRBs are now supposed to notify the sponsor of any decisions to suspend or terminate study approval. FDA also modified one section to recommend the use of a letter "to provide currently enrolled subjects with any changes in contact information," commonly used to report injuries or inquire about subject rights.
Other changes were largely editorial in nature or intended to clarify reporting requirements, FDA said.
Federal Register Announcement