Ethics
Protecting research subjects under the waiver of informed consent for emergency research: Experiences with efforts to inform the community*,**

https://doi.org/10.1067/mem.2003.14Get rights and content

Abstract

Study objectives: The US Food and Drug Administration (FDA) and Department of Health and Human Services created a method for obtaining a waiver of informed consent to permit research in emergency settings when patients are not competent. One of the requirements to obtain a waiver is public disclosure about the research. We describe approaches used to meet the public disclosure requirement. Methods: We performed a qualitative content analysis of the FDA's repository for mandatory documentation of public disclosure efforts as of November 1999. Data from 4 studies were analyzed: 2 multi-institutional trials involving trauma and 2 smaller trials involving cardiac arrest. These efforts included both 1-way communications, such as announcements, and 2-way communications, such as focus groups and public meetings. Participation in and common concerns expressed during 2-way communications were noted, as was evidence of mechanisms of advance refusal and the collection of quantitative data on public opinion. Results: One-way communications were the predominant method of disclosure. Many 2-way communications were not directed toward lay persons. Those that were often involved fewer than 15 participants. Concerns regarding inability to refuse study participation, racial biases affecting study design and execution, and ambiguity with regard to how community input would be used in study decisionmaking were raised in several 2-way communications. A minority of participating hospitals announced mechanisms of advance refusal or collected quantitative data on public opinion concerning proposed research. Conclusion: Initial experience with obtaining a waiver of informed consent for emergency research suggests that community involvement and specific public concerns should be carefully considered in future applications for such a waiver. [Ann Emerg Med. 2003;41:72-78.]

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.

Section snippets

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).

. Trials included in docket 95S-0158.

StudyDescription*
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).

. One-way communication efforts.

Type of CommunicationNo. 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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    Institutions serving a more limited number of media outlets, or smaller geographic service area, may wish to consider paid advertising as a viable strategy. As with other published accounts of public disclosure and community consultation [3,7,8,10], the community meetings we held solely to disseminate and discuss information on the study drew sparse attendance. To inform communities of upcoming meetings, we relied on press releases and the informational website.

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*

Dr. Shah is currently with the Department of Orthopedic Surgery, Boston Medical Center, Boston, MA.

**

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].

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