David Shalowitz, AB; David Wendler, PhD
Acknowledgments: The authors thank John Barton, Lindsay Hampson, and Mary McCabe for their helpful comments on earlier versions of this manuscript.
Potential Financial Conflicts of Interest: Employment: D. Shalowitz (National Institutes of Health), D. Wendler (National Institutes of Health).
Requests for Single Reprints: David Wendler, PhD, Department of Clinical Bioethics, NIH Clinical Center, Building 10, Room 1C118, Bethesda, MD 20892; e-mail, email@example.com.
Current Author Addresses: Mr. Shalowitz and Dr. Wendler: Department of Clinical Bioethics, NIH Clinical Center, Building 10, Room 1C118, Bethesda, MD 20892.
Researchers have found that implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule is having a negative impact on clinical research. This impact traces, in part, to many research institutions complying with HIPAA by adding lengthy, complex language to their research consent documents. The addition of extensive language burdens institutional review boards and may undermine participants' understanding of the research in which they take part. Comparative analysis reveals, however, that the addition of lengthy text often is unnecessary. The U.S. federal requirements for informed consent for human subjects research and the HIPAA Privacy Rule's requirements for individual authorization overlap substantially. Hence, consent forms that satisfy the U.S. federal regulations for human subjects research need only minimal additional text to also satisfy the authorization requirements under the HIPAA Privacy Rule.
Shalowitz D, Wendler D. Informed Consent for Research and Authorization under the Health Insurance Portability and Accountability Act Privacy Rule: An Integrated Approach. Ann Intern Med. 2006;144:685–688. doi: https://doi.org/10.7326/0003-4819-144-9-200605020-00012
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Published: Ann Intern Med. 2006;144(9):685-688.
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