Several federal initiatives (NHLBI/PULSE and NIH/Resuscitation Outcomes Consortium (ROC)) support infrastructure development for multi-center clinical studies to improve outcome from cardiac arrest. One barrier to conducting resuscitation research is that victims of sudden cardiac arrest or major injury cannot give informed consent for research. OHRP and FDA regulations uphold principles inherent in the ethical conduct of research and allow research using an emergency exception to informed consent (21 CFR 50.24). Local IRBs often struggle with interpretation of these rules which can deprive society of new knowledge and treatments. ? ? For example, one major university IRB declined to review any research using the exception to informed consent because of difficulties in interpreting the rules. Despite the emergency exception to informed consent rules, the quantity of resuscitation research taking place in the US is declining. Consequences of this are potentially enormous and include the relocation of important research to other countries as well as significant limitations to the advancement of medical care with major potential benefit to individuals and society. The topic is of intense public interest, and was recently highlighted by Sen. Grassley in letters to the FDA. The ROC of NHLBI is now struggling with these issues as develops its clinical research program. ? ? The National EMS Research Agenda is an ongoing project supported by the National Highway Traffic Safety Administration (NHTSA) and EMS for Children, conducted through the National Association of EMS Physicians. The EMS Research Agenda documents appraise infrastructure requirements for successful EMS research, suggest scrutiny of the informed consent process in emergency situations and recommend educating investigators and IRBs about existing regulations.1-3 NHTSA has funded the development of a consensus document concerning ethical issues inherent in consent for research in emergency situations with emphasis on providing guidance for investigators and IRB members about current rules as well as feedback to regulators on the feasibility of implementing those regulations. We propose to hold a conference involving regulatory and research stakeholders in Washington, DC to further the development of this document. The goal is to encourage collaborative development of specific consent strategies as well as appropriate clarifications to the regulations in 21 CFR 50.24 to reduce impediments to research while adequately protecting subjects. The final document will be distributed to IRBs and submitted for publication in a peer review journal as well as posted on the NHTSA web site and NIH web sites as appropriate. ? ? ? ?
