On entrepreneurs, ethics, and leadership

EDITORIALS The Ethics of Emergency Medicine Research Borak and Veilleux, in their article "Prophylactic Lidocaine: Uncertain Benefits in Emergency Settings" in this issue of Annals, have identified the major problem in prehospital and emergency department research today. The question is not whether lidocaine should be given prophylactically to those patients with suspected myocardial infarctions, as the title suggests, but rather whether one can do adequate research in emergency medicine on critically ill patients in light of all the governmental regulation of informed consent. Federal regulations have never been more comprehensive or stringent than they are now. In addition, the development of institutional review boards (IRBs) has added to the confusion due to their lack of uniformity in decision making, which is primarily caused by their lack of understanding of prehospital and emergency care. The authors discuss the ethical dilemma that faces the contemporary researcher, but I disagree with their conclusions that research today must "lead to prohibiting ethical conflicts" and that the only course of action is to circumvent the ethical barriers to produce effective research. The authors state that, "The central ethical problem relates to the inability to obtain informed consent from patientsubjects within the timeframe and clinical context dictated by urgent and life-threatening health crises." Abramson, Meisel, and Safar 1 recently stated an alternative to the classic informed consent, and argued convincingly for applying the emergency exception to the informed consent requirement for clinical research. This new FDA regulation 2 states that an emergency exception may be made if the following criteria are met: 1. The human subject is confronted by a life-threatening situation; 2. Informed consent cannot be obtained from the subject because of inability to communicate with, or obtain legally effective consent from, the subject; 3. Time is not sufficient to obtain consent from the subject's legal representative; or 4. There is available no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject. As a further safeguard, if the emergency exception is used, an independent physician must certify its necessity within five days. This researcher currently, has an application pending approval before an IRB. The protocol is for a double-blind study for the use of bretylium in out-of-hospital countershock refractory ventricular fibrillation. The IRB has had the protocol under advisement for four months, and has not had a serious discussion on it. A review of prehospital cardiac arrests in Tampa-Hillsborough County, Florida, has revealed several facts. Harrison, 3 in a review of countershock

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refractory cases of ventricular fibrillation, found that even though the protocol followed the ACLS recommendations for the use of lidocaine for repeated episodes of ventficular fibrillation, only 53% of the patients did, in fact, receive lidocaine. Of even more interest is that there was no statistical difference in the response of those who received lidocaine and those who did not. In the new Textbook of Advanced Cardiac Life Support, 4 bretylium is recommended for countershock refractory ventficular fibrillation, although there is little clinical documentation of its efficacy. In our own review of bretylium use, s we found that bretylium was used in less than 15% of all potential cases. Thus we have presented a dilemma to the IRB: If lidocaine was used 50% of the time in refractory ventricular fibrillation and the results show that there was no statistical difference, and now bretylium is recommended with little scientific justification, can a system that used bretylium 15% of the time nonrandomly increase its use to 50% of the time randomly? To put this question philosophically, can an optional mode of treatment that is FDA approved for a specific use, is used by some physicians in the community for a specific purpose, is not used by other physicians, and has never been definitely proven to be of value by scientific studies, be withheld from some and given to others in emergency situations in a randomized fashion without obtaining informed consent rather than given in a nonrandomized fashion as is now being done (E. E. Harrison, personal communication, 1982)? Research in the prehospital and emergency department settings is difficult - - if not impossible - - today. But the need for this research is critical. Only through clinical investigation can we solve the difficult decisions we face every day.

Brent D. Amey, MD Tampa, Florida 1. Abramson NS, Meisel A, Safar P: Informed consent in resuscitation research. JAMA 246:2828-2830, 1981. 2. Protection of Human Subjects: Informed Consent, Dept. of Health and Human Services, Food and Drug Administration. Federal Register 46:8951, 1981. 3. Harrison EE: Lidocaine in prehospital countershock refractory ventficular fibrillation. Arm Emerg Med 10:420-423, 1981. 4. Mclntyre KM, Lewis AJ (eds): Textbook of Advanced Cardiac Life Support. Dallas, American Heart Association, 1981, p II-4, II-6. 5. Amey BD, Harrison EE: The use of bretylium tosylate in prehospital Ventricular fibrillation. Ann Emerg Med, submitted for publication.

Annals of Emergency Medicine

11:9 September 1982