Protecting research subjects under the waiver of informed consent for emergency research: experiences with efforts to inform the community.

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 decision making 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.