Research without consent : Current status, 2003 - 26/08/11
Address for reprints: Michelle H. Biros, MD, MS, Department of Emergency Medicine, Hennepin County Medical Center, 701 Park Avenue South, Minneapolis, MN 55415; 612-347-5683, fax 612-904-4241Abstract |
In November 1996, regulations developed by the US Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) went into effect to allow certain emergency and resuscitation human subjects research to proceed without prospective informed consent. These new regulations brought harmonization to the requirements of the 2 federal agencies charged with research oversight and ended a moratorium that had essentially shut down resuscitation research for almost 4 years. However, the FDA's emergency exception from informed consent and the HHS's waiver of informed consent have been used infrequently. Many perceived obstacles to implementation of the regulations have been described, including the additional regulatory burden for investigators and institutional review boards, the extra expense and time required to adequately fulfill the regulatory requirements, and the reluctance of institutional review boards to allow these studies to move forward because of concerns about potential legal ramifications. Regardless of the arguments advanced, these regulations are essentially the only current regulatory options that have been provided for research without consent. This article presents a brief history of the development of the FDA's Final Rule, a summary of its requirements and its use so far, and suggestions for its implementation. Some strategies to allow the resuscitation research community to suggest fine tuning of the regulations are suggested in hopes that research requiring an exception from informed consent is allowed to proceed in a manner acceptable to regulators, is stringent in patient protection, and yet is sensitive to the practical aspects of performing resuscitation research.
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 | The FDA's Final Rule on Exception From Informed Consent for Emergency Research (21 CFR §50.23) was based on the recommendations advanced by the Coalition of Acute Resuscitation and Critical Care Researchers, which was a creation of the specialty of emergency medicine. A number of key individuals were involved from the start and, to the best of my knowledge, have never been formally acknowledged. These individuals include Jeff Runge, MD, Chris Doherty, JD, Sue Fish, PharmD, Roger Lewis, MD, PhD, and Bonnie Lee, Associate Director for Human Subjects Protection Policy, FDA. Without the active (and mostly voluntary) involvement of these dedicated individuals, we would undoubtedly still be struggling to do resuscitation research. They deserve our sincere appreciation regardless of our current feelings regarding the Rule, and I personally thank them on behalf of the emergency resuscitation research community. I also thank Bonnie Lee and Roger Lewis for their helpful comments on parts of this manuscript. The author reports this study did not receive any outside funding or support. |
Vol 42 - N° 4
P. 550-564 - ottobre 2003 Ritorno al numero
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