FDA Draft Guidance Seeks Clarity on IRBs' Clinical Research Oversight Responsibilities

A new draft guidance published by the US Food and Drug Administration (FDA) aims to clarify the responsibilities of institutional review boards (IRBs) in the oversight of investigators, research sites and investigational authority of sponsors.

The draft guidance, IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites and the Determination of Whether an IND/IDE is Needed, aims to clarify the roles of IRBs, which are charged with overseeing the design, enrollment, data collection and conduct of clinical trials. At the core of their concerns is the minimization of potential harms to human patients relative to the expected benefits.

In particular, the guidance-set to replace Question 56 in FDA's 1998 guidance on IRBs-looks at three aspects of the clinical trials process: whether the clinical investigators conducting or overseeing the trial are sufficiently qualified, whether the research facility used to conduct the clinical research is adequate, and whether the research has appropriately sought out either an investigational new drug (IND) exemption or investigational device exemption (IDE) from federal law.

FDA currently has authority over the interstate commerce of healthcare products, and in particular those intended to treat specific diseases. The movement of any drug or medical device without an approved or cleared marketing application is therefore banned.  Makers of investigational devices, however, may get around this by obtaining exemptions from FDA-in the case of drugs and devices, INDs or IDEs-which allow them to send their devices out for investigational and research purposes. Not all trials require the exemption (e.g. those testing already-approved products), but FDA said it wanted to provide clarity for IRBs on when they are absolutely necessary for a trial to be in compliance with federal regulations.

The guidance also notes that FDA worked in conjunction with the Department of Health and Human Services' (DHHS) Office for Human Research Protections (OHRP). The two agencies have recently started to work together more closely. In June 2012, the two agencies put together a harmonized draft guidance regarding the transfer of clinical trials oversight between different IRBs. While the two agencies provide oversight for research subject protections in similar areas, because their regulatory processes are distinct, their approaches can become disharmonized.

FDA's new draft guidance also comes just as OHRP is preparing to overhaul its human subject protections, including the Common Rule.

In an unusual step, FDA said it will consider not only the public comments submitted directly regarding the draft guidance, but also all relevant comments submitted to OHRP regarding its advanced notice of public rule making (ANPRM) on the Common Rule as well.

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[Editor's note: The draft guidance is now available here.]