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, firstname.lastname@example.org.
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.
Table. Comparison of HIPAA Authorization Requirements and U.S. Federal Research Consent Requirements
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King K. Holmes
University of Washington
May 2, 2006
Congratulations for this well reasoned contribution.
David A. Gorelick
National Institute on Drug Abuse
May 28, 2006
The HIPAA Privacy Rule and research consent documents
To the Editor: Shalowitz and Wendler (1) provide some helpful suggestions for reducing the length and complexity of research consent documents that also comply with Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule requirements. However, I believe that one of their recommendations is not as straightforward as they present.
Shalowitz and Wendler (1) suggest that research consent documents incorporate the HIPAA requirement that revocation of authorization (i.e., consent to research participation) be in writing. They acknowledge that written revocation of consent is not a requirement of the federal regulations for human research subject protection (45 CFR 46), but do not address how adding a requirement for written withdrawal might influence the voluntariness of continued research participation. One can easily construct scenarios for biomedical research in which only oral communication is possible or practical for at least a certain time interval. For example, the subject might be lying enclosed within a scanning device for several hours. A requirement for written, rather than oral, withdrawal might force subjects to temporarily continue participation after they had decided to withdraw, at least until the procedure was completed and writing was possible again. This seems to contradict the spirit, if not the letter, of 45 CFR 46.
My impression is that current clinical research practice is to promptly honor oral requests from subjects to withdraw from research participation, or to at least suspend further procedures pending a fuller discussion with the subject. A brief review of several IRB web sites found none that required written withdrawal from research participation. Imposing such a requirement is one recommendation that would not enhance human research subject protection.
Reference 1. Shalowitz D & Wendler D. Informed consent for research and authorization under the Health Insurance Portability and Accountability Act privacy rule: An integrated approach. Ann Int Med 2006;144:685-688.
June 29, 2006
We agree with Dr. Gorelick that the right to withdrawal from research participation is a vital safeguard, and investigators should respect research participants' decision to withdrawal, no matter how it is expressed. We did not mean to suggest otherwise. Rather, we recommended that, when applicable, research participants should be informed that the HIPAA Privacy Rule allows investigators to continue to use individuals' protected health information until they withdrawal their authorization for such use in writing.
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: 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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