Current Edition

New FDA Guidance Clarifies the Transfer of Clinical Research Projects to a New Institutional Review Board

On May 23, 2014, the US Food and Drug Administration (FDA) finalised its recommendations on transferring IRB oversight by the publication of the ‘Guidance for Institutional Review Boards, Clinical Incestigators and Sponsors: Considerations When Transferring Clinical Incestigation Oversight to Another Institutional Review Board (IRB)’. Alejandra Muntanola of Thomson Reuters looks into the guidance document that was developed as part of the regulatory harmonisation efforts between the FDA and OHRP. The Code of Federal Regulations (CFR) Title 45- Part 46: Protection of Human Subjects provides a regulatory basis for policies that protect individuals in investigative clinical trials.….pdf