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Rational Protection of Subjects in Research and Quality Improvement Activities

The authors are members of the Committee on Psychopathology of the Group for the Advancement of Psychiatry. Dr. Goldman is a medical consultant with Blue Cross Blue Shield of Michigan, Detroit. Dr. Dixon is with the Department of Veterans Affairs (VA) Capitol Health Care Network Mental Illness Research, Education, and Clinical Centers (MIRECC), Baltimore. Dr. Adler is with the Department of Psychiatry, Tufts University School of Medicine, Boston. Dr. Berlant is in private practice in Boise, Idaho, and Kentfield, California. Dr. Dulit is with the Weill Medical College of Cornell, New York City. Dr. Hackman is with the Department of Psychiatry, University of Maryland School of Medicine, Baltimore. Dr. Oslin is with the Veterans Integrated Service Network 4, MIRECC, Philadelphia. Dr. Siris is with the Department of Psychiatry, Albert Einstein College of Medicine, New York City. Dr. Valenstein is with the VA Health Services Research and Development, Serious Mental Illness Treatment Research and Evaluation Center, Ann Arbor, Michigan. Send correspondence to Dr. Goldman at 55 West Maple Rd., Suite 206, Birmingham, MI 48009 (e-mail: bgold0914{at}comcast.net).

This Open Forum illuminates shortcomings with the basis for determining degree of oversight of health services research and quality improvement activities. Using a federally regulated definition of research rather than a direct appraisal of risk to patients can misallocate effort from activities with higher risk for patients to those with lower risk. The case of the Johns Hopkins multicenter study of central line safety checklists in intensive care units is cited. Definitions of research promulgated by the Office of Human Research Protection are reviewed, and an alternative model based on patient risk is proposed. Suggestions for how quality improvement work fits into the larger paradigm of research are made.

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Psychiatr Serv 2010 61: 109. [Full Text] [PDF]

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