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The HIPAA Privacy Rule and research consent documents
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David Wendler, Ph.D. NIH, David Shalowitz
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dwendler{at}nih.gov David Wendler, et al.
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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. Conflict of Interest:None declared |
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David A. Gorelick, MD, PhD National Institute on Drug Abuse
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dgorelick{at}mail.nih.gov David A. Gorelick
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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. Conflict of Interest:None declared |
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King K. Holmes, MD, PhD University of Washington
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worthy{at}u.washington.edu King K. Holmes
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Congratulations for this well reasoned contribution. Conflict of Interest:None declared |
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