In reply:

Abstract

I would like to thank Dr. McRae and Dr. Weijer for their comments regarding my article. We are in agreement about the need to carefully examine the current regulations and to continue to push for refinement, guidance, and explanation of the basis of these requirements. I also agree that the initiative should come from resuscitation researchers. I must, however, reiterate that such an effort will take time, and we have a lot of research to do while we are waiting. That said, we must acknowledge that the Final Rule is the regulatory mandate we must currently follow. It is all we have right now. We can allow it to subvert, divert, or extinguish our research efforts, or we can use our best judgment and creativity to meet its requirements. The Exception from Informed Consent (please refer to my original article1.Biros M. Research without consent: current status.Ann Emerg Med. 2003; 42: 550-564Abstract Full Text Full Text PDF PubMed Scopus (77) Google Scholar regarding the difference between “Waiver of” and “Exception from” informed consent) is at times vague in its requirements. However, this was intentional on the part of the writers, who hoped that individual researchers and institutional review boards would apply their knowledge of the local community, the local investigators' strength and weaknesses, and the local value of the knowledge obtained by the research to creatively develop patient-specific and community-specific approaches to fulfill the regulations. I suspect their thinking was somewhat naive and that many of the questions researchers have were never anticipated, but the latitude the lack of specific guidance provides us can be used to our advantage, if we are willing and able to exert the extra effort. As suggested by Dr. McRae and Dr. Weijer, the value of community consultation has not yet been shown, nor has its effectiveness, even when well done.2.McClure K.B. DeIorio N.M. Gunneis M.D. et al.Attitudes of ED patients and visitors regarding emergency exception from informed consent in resuscitation research, community consultation, and public notification.Acad Emerg Med. 2003; 10: 352-359Crossref PubMed Google Scholar However, I do not believe that the “failure to articulate a moral basis for community consultation” is a major difficulty with the application of the Final Rule. The moral construct on which it was based may not be crystal clear, but when one thinks it through, what is more admirable and morally sound than asking the community what it thinks of research they may be entered into, without their knowledge or consent, at a time when they have become vulnerable to potential exploitation by virtue of a critical clinical situation they cannot control? The problem instead, I believe, centers around the extra energy, time, and money to perform community consultation. Maybe we also fear its results. In any case, I think we should view the Final Rule as a means of proceeding with resuscitation research when consent cannot be obtained for subject participation. Hopefully, these regulations will evolve as we acquire more experience with them and as we conduct relevant research aimed at determining the validity of the various concepts they entail. In the meantime, I hope we do not let our research efforts stall as we wait for the slow process of evolution.