Improved methods of Cardiopulmonary resuscitation at the scene, public access defibrillation, and hypothermia to protect the brains of patients surviving cardiac arrest are the newest and yet not-so-new methods of treating cardiac arrest. Improving CPR to improve survival to hospital and neurologically intact survival requires more research, but those studies are currently being hampered by regulations that are often poorly understood by local institutional review boards, the federally mandated groups that review human research in medical schools and research institutions.

To improve those efforts, the American Heart Association Emergency Cardiovascular Care Committee and the Council on Cardiopulmonary, Perioperative and Critical Care recently issued recommendations on improving the rules under which emergency research can be undertaken. The American College of Emergency Physicians and the Society for Academic Emergency Medicine both endorsed the recommendations that were designed to clarify the U.S. Food and Drug Administration’s rules for conducting emergency research, which must often take place without direct consent of the patient. (Circulation 2007;116:1855.)

Henry Halperin, MD, a professor of medicine at Johns Hopkins University School of Medicine and the director of the Johns Hopkins Hospital CPR Team, led the writing team for the AHA group, and he said his participation came from his own experiences during a CPR trial in the 1990s. I saw the whole evolution of the process. Initially, they used to allow deferred consent. That was felt inadequate for many reasons. Then there was a moratorium on CPR studies around 1993. Around 1996, the FDA came up with the new guidelines that recognized that the research was important. Uniformly, we felt it was important to have this research done because the outcome from CPR was so dismal, he said.

Because the patient whose heart has stopped cannot consent to research and family member consent is difficult to obtain in only a few minutes, the agency came up with an exception to informed consent that required community consultation and public disclosure of the research. The rules for how to consult the community and to let the public know about the research were vague, however.

There is an infinite number of ways to do community consultation and public disclosure, said Dr. Halperin. Knocking on everyone’s door is impossible, he said, adding that the community has to decide if there should be announcements in the newspaper, public meetings, a web site, or numbers that the public can call.

The ambiguity left individual institutional review boards in a quandary. The AHA group in its paper sought to give concrete examples and recommendations about how to fulfill the FDA requirements in an expeditious fashion. It turns out that not all CPR studies are created equal, said Dr. Halperin. Some carry more risk than others. If you are studying two devices or drugs that are already approved by the FDA for use in cardiac arrest, the incremental risk of doing this study would be small over using either drug or device outside of research. We felt those kinds of studies should be low risk, and require less scrutiny and consequently less community consultation and public disclosure than if you were studying drugs or devices that were not yet approved. The chances of harm are greater with a higher risk study.

The road map suggested by the AHA identifies four levels of risk: minimal, low, intermediate, and high. The AHA suggests that minimal risk studies require no community consultation or public disclosure, although a minimum level of public disclosure should be considered. Low-, intermediate-, and high-risk studies require increasing levels of consultation or disclosure under the recommendation.

Cardiac arrest is difficult to study because it is an infrequent event and requires a time-dependent intervention, said Kennon Heard, MD, an assistant professor of surgery in emergency medicine at the University of Colorado at Denver and Health Sciences Center. You have to have a lot of resources to study it without considering the barriers because of the consent and other administrative issues. It makes it even more difficult. The public doesn’t understand that no one wants to do research that is outside what people find acceptable. However, the public also needs to understand that the cost is that we have not significantly improved outcomes from cardiac arrest. We are making small incremental steps. The outcomes are not dramatically better than they were 20 years ago.

SoRelle, Ruth MPH

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Emergency Medicine News:Volume 30(1)January 2008p 18-19