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Compliance In Focus
Posted by John Lehmann on Fri, Jun 15, 2012

New FDA Guidance: Transferring IRB Oversight in Clinical Trials

Institutional Review Boards (IRBs), sometimes called Ethic Committees, are responsible for reviewingNEW FDA Guidance (2) and approving research studies involving human subjects. The rules that govern IRBs are clearly laid out in 21 CFR 56 which contains the general standards for the composition, operation, and responsibility of an IRB that reviews clinical investigations regulated by the FDA. The IRB has the authority to:

  • Approve research
  • Require modifications in research
  • Disapprove research
  • Require additional elements of informed consent are provided
  • Waive the requirement for a signed informed consent

But most importantly, the IRB’s purpose is to protect patients by performing rigorous research reviews, and ensuring the rights, safety and well-being of potential subjects are safeguarded.

A new draft guidance titled “Considerations When Transferring Clinical Investigation Oversight to Another IRB” was released by FDA. The guidance covers the best practices and regulatory responsibilities of IRBs, Clinical Investigators, and Sponsors when oversight of a clinical trial is transferred to an alternate IRB. This specifically relates to clinical studies that have already received IRB approval.

The guidance outlines steps to bear in mind when transferring clinical oversight to another 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

It’s also noted in the press-release this was a combined effort of federal agencies as part of an on-going goal to standardize the regulatory requirements for human subject research. The FDA worked with the Office for Human Research Protections (OHRP) and plans to continue the joint effort to develop the final guidance.

What are your thoughts on this new guidance? Do you have anything else that should be added to the list when switching IRBs? Share your recommendations below!

Photo Credit: Crinity

Topics: New FDA Guidance, IRB Oversight, 21 CFR 56, FDA

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