Implementing the Food and Drug Administration's Final Rule for Waiver of Informed Consent in Certain Emergency Research Circumstances

In 1996, the Food and Drug Administration released its Final Rule for Waive r of Informed Consent in Certain Emergency Research Circumstances (the Fina l Rule). The Department of Health and Human Services (DHHS) also released a n update of its regulations related to waiver of informed consent in emerge ncy research. These new regulations allow resuscitation research to proceed with a waiver of informed consent under very narrow and specific clinical research circumstances. Waiving informed consent for research participation has profound ethical and scientific implications. However, in unpredictabl e life-threatening clinical situations for which current therapy is unprove n or unsatisfactory, patients usually are unable to consent on their own be half to participate in clinical trials of potentially beneficial but experi mental interventions. Because of the time-dependent nature of most resuscit ation interventions, it is usually not feasible to identify and contact the legally authorized representative who can speak on behalf of the patient w ithin the presumed therapeutic window of the intervention under investigati on. For such clinical trials to proceed, a waiver of informed consent is us ually necessary. Patients who are critically ill or injured and unable to p rovide meaningful prospective informed consent because of their current lif e-threatening condition are vulnerable and require additional protections b eyond those for research subjects who can speak on their own behalf. The Fi nal Rule and the DHHS-updated regulations incorporate a number of additiona l patient safeguards that must occur if a clinical trial is to proceed with waiver of informed consent. Specific means of adequately meeting these req uirements are not described in the regulations. Although this was intention al on the part of the federal regulators so that individual protocols and r esearch environments would direct the development of these patient safeguar ds, the lack of specific guidance has led to confusion on the appropriate i mplementation of the new regulations. This article reviews some of the key concepts of the Final Rule, with suggestions on their purpose and meaning. It also reviews the studies that have been approved to date to proceed with waiver of informed consent, and offers suggestions for the process of impl ementing the requirements of the Final Rule for research involving patients who are unable to give prospective informed consent.