In November 2012, the FDA published a draft guidance, entitled “IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites and the Determination of Whether an IND/IDE is Needed,” which outlines recommendations for the role/responsibilities of IRBs. However, the Association of Clinical Research Organizations (ACRO), the Association of Clinical Research Professionals (ACRP) and The Biotechnology Organization (BIO) expressed concern that the new draft guidance may confuse the responsibilities of IRBs and trial sponsors, as described in a recent article on in-pharmatechnologist.com. The groups suggest that the roles of the IRB outlined in the guidance overlap with the responsibilities of the sponsor of the clinical investigation. Therefore, the groups recommend that the FDA’s final guidance encourage coordination and consultation between IRBs and study sponsors to avoid inefficiencies or additional regulatory problems. To read the full article on in-pharamtechnologist.com, click here. To read the FDA draft guidance, click here.
What are your thoughts on the topic? Does the draft guidance suggest responsibilities outside the IRB domain?