This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Contact me when this article is cited  Related Content  • Related article  • Related letters  • Similar articles in JAMA  Topic Collections  • Medical Practice  • Medical Ethics  • Radiation Therapy  • Statistics and Research Methods  • Alert me on articles by topic  Social Bookmarking   What's this?

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati     What's this?

RELATED ARTICLE

Influence of the HIPAA Privacy Rule on Health Research
Roberta B. Ness and for the Joint Policy Committee, Societies of Epidemiology
JAMA. 2007;298(18):2164-2170.
ABSTRACT | FULL TEXT  

RELATED LETTERS

Health Research and the HIPAA Privacy Rule
Samuel J. Tilden
JAMA. 2008;299(11):1259.
EXTRACT | FULL TEXT  

Health Research and the HIPAA Privacy Rule
Ruth R. Faden, Anna C. Mastroianni, and Jeffrey P. Kahn
JAMA. 2008;299(11):1259-1260.
EXTRACT | FULL TEXT  

Health Research and the HIPAA Privacy Rule—Reply
Roberta B. Ness
JAMA. 2008;299(11):1260.
EXTRACT | FULL TEXT