EthicsProtecting research subjects under the waiver of informed consent for emergency research: Experiences with efforts to inform the community*,**
Introduction
Informed consent offers a means of protecting human participants in biomedical research. However, obtaining informed consent might not be feasible in certain clinical settings because of altered mental status and the urgency of intervention (eg, cardiopulmonary resuscitation [CPR]). In an effort to permit clinical research in emergency settings when informed consent is not feasible while simultaneously protecting the rights and interests of the patients who are the proposed participants in such research, a federal rule permitting a waiver of informed consent under restricted conditions was promulgated in 1996. For such a waiver to be obtained, the institutional review board (IRB) responsible for the review, approval, and continuing review of the study must document that numerous criteria have been satisfied.1 Among these criteria are community consultation and public disclosure before initiating proposed research.
Under the community consultation requirement, the input of communities in which the research will be conducted and from which patients will be drawn must be considered by the IRB before approving the study. As noted in draft guidelines published by the US Food and Drug Administration (FDA), community input is to be gathered during consultation sessions that (1) promote comprehension of both the proposed study and the waiver of informed consent through discussion with community members and (2) elicit community opinions and input.2 Specific issues to be considered when designing such community consultation efforts are outlined elsewhere.2, 3, 4
Under the public disclosure requirement to obtain a waiver, communities in which the study will be conducted and from which participants will be drawn must be notified of the intention to conduct the research and of the nature of the research.1 We sought to describe and analyze efforts aimed at meeting the public disclosure requirement.
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Materials and methods
We performed a qualitative content analysis of docket 95S-0158, the FDA's repository for mandatory documentation (eg, photocopies of announcements, transcripts of community meetings) of efforts made to fulfill the public disclosure requirement for obtaining a waiver of informed consent for emergency research. This report represents a review of docket contents as of November 1999, which includes information about 4 separate studies (Table 1).Study Description* A
Results
Information about 4 different studies was included in the docket. Study A had 22 participating hospitals, study B had 9 hospitals, study D had 4 hospitals, and study C had 1 hospital.
One-way communications were the predominant type of public disclosure activity, with local newspapers and institutional publications the most commonly used media (Table 2).Type of Communication No. of Hospitals Using 1-Way Communications Study A (22) Study B (9) Study C (1) Study D (4) Press
Discussion
Our review highlights some important concerns for future efforts at meeting the public disclosure requirement for obtaining a waiver of informed consent for emergency research, specifically the need for broad community involvement, providing and announcing mechanisms of advance refusal, and justice with respect to race and ethnicity.
If 2-way communications are used as part of the public disclosure process, 3 issues should be considered. First, participating institutions might have catchment
Acknowledgements
We thank Bonnie M. Lee (Health Issues Analyst, FDA Office of Regulatory Affairs and co-author, CFR 50.24: Exception from informed consent requirements for emergency research) and Robert L. Wears, MD, MS (University of Florida Health Sciences Center, Jacksonville, Department of Emergency Medicine) for their comments and guidance. This study began as course work for a Masters of Health Sciences in Clinical Research at Duke University School of Medicine.
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Dr. Shah is currently with the Department of Orthopedic Surgery, Boston Medical Center, Boston, MA.
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Address for reprints: Jeremy Sugarman, MD, MPH, Center for the Study of Medical Ethics and Humanities, 108 Seeley G. Mudd Building (DUMC 3040), Duke University Medical Center, Durham, NC 27710; 919-668-9000, fax 919-668-1789; E-mail [email protected].