Federal Agencies Team Up to Issue Draft Guidance on IRB Transfers
Posted 11 June 2012 | By
The US Food and Drug Administration (FDA) has released a draft guidance intending to instruct sponsors, clinical investigators (CIs) and Institutional Review Boards (IRBs) on best practices for transferring clinical trial oversight to a new IRB.
The proposed guidance harmonizes regulatory interpretations between FDA and the US Department of Health and Human Services' Office for Human Research Protections (OHRP). The agencies said in a Federal Register statement they plan to continue working closely in the development of final guidance.
FDA explains there are numerous regulatory responsibilities coming into effect when a previously-approved clinical investigation is transferred from one IRB to another IRB. In particular, the draft guidance discussed eight steps to be taken during the transfer process:
- 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.
While FDA explains the list is not intended to be "exhaustive," barring extraordinary circumstances the items should encompass the majority of situations.
The draft guidance is scheduled to be published in the 12 June 2012 edition of the Federal Register and placed online on FDA's website.
FDA - Draft Guidances for Institutional Review Boards, Clinical Investigators, and Sponsors: Considerations when Transferring Clinical Investigation Oversight to Another Institutional Review Board