On April 30, 2010, the Office for Human Research Protections (OHRP) published a letter responding to a medical center's question regarding the use of a central institutional review board (IRB). The letter explained that OHRP and the Food and Drug Administration (FDA) now have similar positions on the use of a central IRB. The FDA's March 2006 guidance document, Using a Centralized IRB Review Process in Multicenter Clinical Trials, states that "[t]he Agency hopes that sponsors, institutions, [IRBs], and clinical investigators involved in multicenter clinical research will consider the use of a single central IRB (centralized IRB review process), especially if using centralized review could improve the efficiency of IRB review." OHRP's April 30, 2010, letter assured the medical center that OHRP fully agrees with the FDA's position on the benefits of relying on a single central IRB for multicenter research. The letter explains that OHRP no longer holds the view, cited in its prior guidance documents, favoring local IRB review over review by a central IRB. Although it does indicate that the central IRB should have appropriate knowledge of the "local context."
OHRP further stated that despite the fact that it is still considering whether to pursue a notice of proposed rulemaking to enable it to hold IRBs and the institutions or organizations operating the IRBs directly accountable for meeting certain regulatory requirements, OHRP is taking steps to enhance oversight of central IRBs. For example, OHRP's recent compliance evaluations have begun taking into consideration the compliance history of central IRBs, in addition to local IRBs.
Comments on the content of its response letter maybe submitted to OHRP by email at [email protected]. Please include the phrase "April 30, 2010, letter regarding central IRB review" in the subject field. Comments may also be submitted by paper to: Office for Human Research Protections, 1101 Wooten Parkway, Suite 200, Rockville, MD 20852.