First-ever FDA guidance on transferring research oversight from one IRB to another

On May 23, the US Food and Drug Agency (FDA) released its Guidance for IRBs, Clinical Investigators and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another IRB (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM398613.pdf). Despite newsworthy events involving transfer of IRB oversight based on research subject deaths and institutional decisions to outsource IRB review dating as far back as 1996, it seems that the highly-publicized shutdown of a commercial IRB in 2009 (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149565.htm), has driven this first such guidance. Note that FDA Guidance consists of suggestions on what should be done (but isn’t required).

The 17-page, 48-footnote document amplifies the substantial flexibility already in the regulations, and offers options for managing important issues. Although protection of human subjects without lapse is paramount, options are offered for how to support these protections, such as communication among key stakeholders (e.g. clinical investigator, transferring and receiving IRBs, sponsor, CRO, DSMB, FDA), timing of transfer, transfer mechanics, storage and retention of documents, the receiving IRB’s formal and informal review, and other matters. This guidance will be helpful to institutions considering IRB transfer; independent IRBs with a substantial transfer experience already have detailed procedures to smoothly transfer protocols from another IRB to their own.

Although not stated by FDA, the primary drivers for transfer today are: 1) Consolidation of healthcare facilities creating one system that would have multiple/duplicative IRBs, if not for transfer; 2) Regulatory concerns arising at institutions with local IRBs (either due to increased workload or noncompliance);  3) Growing recognition by healthcare and academic medical center leadership that oversight of multicenter clinical trials by their local IRB provides no human subject protections value if the research has already been reviewed by an accredited independent IRB. Interestingly, the guidance reiterates FDA’s encouragement of reliance on central IRBs for multicenter clinical trials (http://www.fda.gov/RegulatoryInformation/Guidances/ucm127004.htm).

The guidance notes that there are times when an investigator proposes to transfer research to an IRB that is not the sponsor’s primary choice, and suggests that the sponsor and investigator make arrangements to utilize a more IRB acceptable IRB. This is surprising, not only because under FDA regulations, the investigator has the responsibility for securing IRB approval (21CFR312.66), but also because institutions (through bylaws and a desire for consistency) often constrain oversight to one IRB or only a few. In such cases, sponsors may be left with little choice but to accept the investigator’s choice of IRB (as they did before transfer), or close the site.

Stuart Horowitz, PhD, MBA, is President, Institutions & Institutional Services, at WIRB-Copernicus Group.

 

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