FDA Proposes Rule That Would Apply Investigator Disqualification Agencywide

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Regulations governing disqualification of investigators from clinical trials involving products overseen by the Food and Drug Administration would be expanded under a proposed rule published in the April 13 Federal Register (76 Fed. Reg. 20575).

The proposed change would apply the disqualification of a clinical investigator across all FDA centers to prevent a researcher who has been found in flagrant violation of agency regulations in a drug study, for example, from participating in a clinical trial involving a medical device or a biological product.

“It seems like a no-brainer, but it's not in the regulation,” Joanne R. Less, director of the FDA Office of Good Clinical Practice, said during an April 6 conference in mentioning the proposed rule change.

Under the existing regulations, the agency does not have the authority to disqualify an investigator across all FDA centers and divisions. An investigator ineligible to receive a certain test article (for example, drugs, devices, or new animal drugs) under a commissioner's decision still may conduct clinical investigations that support applications for a research or marketing permit for other categories of products regulated by FDA, the proposed rule said.

“This proposal is based in part upon recommendations from the Government Accountability Office, and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA,” theFederal Register notice said. That September 2009 GAO report, FDA's Regulations Allow Disqualified Clinical Investigators to Conduct Trials for Other Medical Products, concluded that “it is critical for FDA to have the authority to take action to prevent clinical investigators who engaged in serious misconduct from doing so again, whether in research that involves drugs, biologics, or devices”.

A GAO report released in March 2010 concluded that FDA must improve its oversight of the Office of Criminal Investigations (OCI) and establish performance measures to assess whether OCI is achieving the agency's desired results.

The proposed changes would affect all FDA regulations addressing the disqualification of a clinical investigator, and include measures to harmonize regulatory language among the different centers (21 C.F.R. Parts 16, 312, 511, and 812).

While an investigator who is disqualified by a commissioner's decision from conducting drug studies could go on to work on device studies, the notice said, there is little, if any, evidence that an investigator disqualified from receiving one type of test article in the past later conducted a clinical investigation studying a different type of test article.

New Database Would Be Used.

To track investigators who would be affected by the expanded scope of the proposed rule, FDA said it developed an agency-wide database, updated in real time. The database lists all clinical investigator disqualification matters. The agency also posts disqualification actions on its website at http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ComplianceEnforcement/default.htm.

Although already applicable, FDA is proposing to add explicit provisions to make it clear that the definition of “clinical investigator” includes a sponsor-investigator.

FDA proposed that any final rule that it may issue based on this proposal take effect 30 days after the date of publication in the Federal Register.

Comments on the proposed rule are due July 12, and may be submitted electronically at http://www.regulations.gov; faxed to (301) 827-6870; or mailed to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Md. 20852. All submissions must include the agency name and docket number (FDA-2011-N-0079) and/or the RIN number (0910-AG49).

The full text of the proposed rule is available at http://www.gpo.gov/fdsys/pkg/FR-2011-04-13/pdf/2011-8786.pdf.