Thursday, December 27, 2012

Clarifying an IRB’s Review of a Clinical Investigators’ Qualifications


On November 28, 2012, the Food and Drug Administration (“FDA”) issued draft guidance outlining an Institutional Review Board’s (“IRB”) responsibility for evaluating the qualifications of clinical investigators that are subject to Investigational New Drug (“IND”) regulations. The new guidance clarifies the role IRBs play in reviewing the qualifications of an investigator, which is separate from the sponsor’s obligation to ensure investigators are “qualified by training and experience as appropriate experts.” See 21 CFR 213.53(a); 21 CFR 812.43(a). 

Under 21 CFR 56.107 and 21 CFR 56.111, an IRB must ascertain  the acceptability of the proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice as well as determine that research satisfies the criteria for approval.  In order to properly fulfill these requirements, the IRB needs information about an investigator’s qualifications.

According to the FDA’s draft guidance, the amount and type of information needed to fulfill this responsibility depends upon the nature and risks of the research as well as the IRB’s previous experience with the investigator. For example, an IRB’s “previous experience with an investigator or institution” may enable the IRB to “readily determine that the principle investigator is appropriately qualified.” In such cases, the IRB may simply contact the chair at a faculty member’s university or the credentialing office at a hospital to confirm the investigator’s qualifications.

Where an IRB has little to no knowledge of the investigator or institution, however, additional steps will likely be needed. This may include reviewing the investigator’s and sub-investigators’ resumes, verifying professional associations and licensing, a review of the applicant’s past publications, and checking with the FDA’s compliance and enforcement websites. Moreover, for research involving higher risks, vulnerable subjects, or novel technologies or techniques, a thorough assessment of an investigator’s training and experience usually becomes necessary. This is also the case for research that is outside an investigator’s area of expertise or in a sponsor-investigator clinical trial.

While this specific guidance is still only in the comment stage as of the time of this article, it does represent current FDA expectations of an IRB’s review process according to researchers with experience in front of IRBs. Thus, an IRB would be wise to follow the practices set forth in this FDA guidance document and institute appropriate procedures should they fall short of this guidance.

To comment on the FDA’s guidance, go to http://www.regulations.gov or submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.