Using the Exception from Informed Consent Regulations in Research

Abstract

This article reflects the proceedings of a breakout session, “Using the Regulations in Research” at the 2005 Academic Emergency Medicine Consensus Conference, “Ethical Conduct of Resuscitation Research.” There have been two organized studies, and a number of anecdotal reports, describing the decline in cardiac arrest resuscitation research in the United States since the implementation of the Final Rule. Paradis and colleagues found that the volume of human cardiac arrest research published in the United States was significantly less in a four-year period after the Final Rule was adopted as compared to the earlier period. Nichol and colleagues reported that both the absolute number of US-based randomized cardiac arrest trials and the proportion of US-based trials (vs. foreign trials, based on the mailing address of the first author) decreased by about 15% annually. Despite the concern about a negative impact, there are at least five published trials, one in progress and one in planning that have been or are being conducted under the regulations. Those completed include the Diaspirin Cross-Linked Hemoglobin, Public Access Defibrillation, Multicenter Vest CPR, Brain-CPR, and Pre-Hospital Treatment of Status Epilepticus trials. Reports of how investigators met the regulations and their experience in doing so are reviewed. A summary table of the federal regulations is provided. Participants discussed what additional information and research about using the regulations would be helpful for the promotion of quality resuscitation and emergency care research in the United States. Areas suggested for further investigation include: impact on the quality as well as quantity of such research; current level of understanding of the regulations by investigators, regulatory/IRB personnel and potential subjects (the general public); costs incurred: additional time required for preparation, approval and conducting community consultation and public disclosure; impact on research on non–life-threatening conditions; value and cost of a registry; use of a standard reporting template for issues regarding meeting the requirements in individual clinical trials; whether more specific guidance would be helpful or restrictive; what constitutes effective community consultation and public disclosure; and whether titration of community consultation and public disclosure based on the risk of the proposed intervention to subjects is feasible and acceptable.