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In Reply: Dr Tilden has further developed our concern that there are unnecessary bureaucratic obstacles to reviewing and conducting research. The federal Common Rule is designed to find a balance between legitimate concerns about privacy and the importance of reducing the regulatory burdens on medical record research. This is manifested by the creation of an exemption from coverage by the Common Rule for medical record research in which there will be no development for research purposes of additional records containing personal identifiers (46.101). For some other categories of medical record research, the Common Rule permits expedited review procedures, waivers, and alterations of the requirement for informed consent (46.116) and waiver of the requirement for a consent form (46.117). However, contemporary application of HIPAA requirements take back much of the relief from bureaucratic encumbrances intended by the regulations.

Dr Faden and colleagues clarify an historical point regarding the . . . [Full Text of this Article]

Robert J. Levine, MD
Yale School of Medicine
New Haven, Connecticut

Norman Fost, MD, MPH
ncfost@wisc.edu
University of Wisconsin School of Medicine and Public Health
Madison

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