New FDA Guidance Seeks To Smooth Transfers Of Clinical Study Oversight

By Nick Otto

Institutional review boards (IRBs) assuming clinical trial oversight from another IRB should provide sponsors an opportunity to address any concerns the receiving IRB has with the study before termination or suspension, according to finalized draft guidance released by the FDA on Friday.

Such an opportunity will give sponsors the chance to minimize study disruptions, address any human subject protection issues, and reduce regulatory burdens when investigators and sponsors transfer clinical trial oversight between IRBs.

The guidance also recommends investigators/sponsor use a letter to inform enrolled subjects of any changes to contact information, subject rights, and research-related injuries due to the IRB transfer. Spelling out the process, the FDA includes an eight-step recommended approach to transferring IRBs:

1. Identify studies where IRB oversight is being transferred.
2. Ensure availability and retention of pertinent records.
3. Establish an effective date for the transfer of oversight, including records, for the clinical investigation.
4. Conduct a review by the receiving IRB, where appropriate, before it accepts responsibility for the study.
5. Confirm or establish the date for the next continuing review.
6. Determine whether the consent form needs to be revised.
7. Notify the key parties.
8. Update IRB registration information.

The Secretary’s Advisory Committee on Human Research Protections says transfers between IRBs have become increasingly common since 1996, and lauded the FDA in comments on the 2012 draft guidance, noting it is “an important practice among IRBs, and they are flexible documents that will serve to aid  IRBs and institutions in conducting transfers of research activities.”

The FDA also recommends documenting the IRB transfer process in a written agreement between the original and receiving IRBs. The agreement should address important steps, such as ensuring the availability and retention of pertinent study records and determining whether consent forms need to be revised, the guidance notes.

Additionally, should IRB transfers occur within the same institution, the FDA notes the process may be expedited and simplified, as some of the aforementioned steps may be skipped, such as conducting an initial review.