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Streamlining the Clinical Research Enterprise
  1. Bernard A. Schwetz,
  2. Adrian S. Dobs
  1. 1Senior Advisor for Science, U.S. Food and Drug Administration, Rockville, Md (B.S.), and Professor of Medicine and Director, Clinical Research Unit, The Johns Hopkins University School of Medicine, Baltimore, Md.
  1. Drs. Schwetz and Dobs are members of the Clinical Research Roundtable. For a complete list of the Clinical Research Roundtable membership, visit the following Institute of Medicine web site:
  2. Address correspondence to: Bernard Schwetz, D.V.M., Ph.D., Senior Advisor for Science, U.S. Food and Drug Administration, 14-71 Parklawn Bldg., 5600 Fishers Lane, Rockville, MD 20857; email: bschwetz{at}

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Recently, researchers have witnessed a vast change regarding the protection of research participants in the clinical research environment. Although federal regulations (particularly the “Common Rule”1) governing human participant research have not changed substantially since 1981, the level of enforcement and the implementation of those regulations have increased dramatically. For example, in June 2000, the Office of Human Research Protections (OHRP) was created within the U.S. Department of Health and Human Services (DHHS) to succeed the Office for Protection from Research Risks. In the 10 years preceding this announcement, Office for Protection from Research Risks had issued 40 determination letters noting violations of a research institution's multiple project assurance.2During the first 18-month period of OHRP's existence, however, 289 determination letters were issued.3The increased enforcement of compliance activity within DHHS, as well as the escalating legal environment, has increased institutional anxiety concerning clinical research.4Whereas clinical researchers previously had modest institutional oversight procedures, these procedures have increased substantially in the form of multiple Institutional Review Boards (IRBs),5conflict-of-interest committees,6scientific oversight committees, and other entities.

Recent accounts of adverse events—including deaths—among patients enrolled in clinical studies have created a public demand for increased protection of patient safety and greater regulation of research institutions.7-9The increased oversight burden threatens to compromise the efficiency of the clinical research enterprise, however, and there is a perception in the clinical research community that regulations are onerous, which may serve as a disincentive for physicians and students who are contemplating careers in clinical research.10The desire to maximize both efficiency and participant protection ranks high on the priority list of many clinical researchers. As such, in a June workshop conducted by the Clinical Research Roundtable (CRR), the issue “Streamlining the Clinical Research Enterprise” was discussed with regard …

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