dards that would enable different individuals, or different residencies, to use the same coding s y s t e m are n o t described. Consequently, the problems the authors have encountered and their d e m o n s t r a t i o n of the i m p o r t a n c e of a tracking system for monitoring resident experience suggest that ABEM and ACEP should develop a Core Content that is tied to a relevant clinical coding system and, perhaps, one that is more focused to the emergency medicine practice experience.

VARIABILITY IN RESIDENT EXPERIENCE Langdorf et al have demonstrated that in their program PGI, II, and III level residents progress in the rate of speed at which they evaluate patients, and their data support the principle of a resident evaluation s y s t e m w i t h specific goals and objectives for each year of residency training. 2 If one assumes that the coding inconsistencies were uniformly distributed between residents, there is no question that the clinical encounters experienced in the emergency department varied from resident to resident. Therefore, if a standardized coding system could be developed, the tracking of resident experiences could be one way to assess resident training. The impact of nonED rotations in this residency program was not demonstrated, but in fact could be considerable. Consequently, a coding system should be used to assess the impact of nonED rotations as well, and could help determine the optimal a m o u n t of time necessary for each type of nonED rotation. Another problem for this type of analysis is the variability a m o n g emergency medicine residency programs. Some programs schedule more ED time in the early years while others do not.

U n q u e s t i o n a b l y , the a u t h o r s have d e m o n s t r a t e d t h e variability in the ED experiences of their residents. Without a similar evaluation of nonemergency medicine rotations, however, it is impossible to determine whether the overall clinical experience is sufficient. Of course, an emergency medicine residency curriculum is a total that is greater than the s u m of its parts: lectures, seminars, rounds, laboratory sessions, free-flowing discussions on the floor, as well as individual patient m a n a g e m e n t . A more precise identification of clinical experiences, however, is a good start to better curriculum evaluation. I believe the authors' recommendation that each program set up its own monitoring system is an excellent one, but at this point premature because neither the CCS, LOT, nor ICD-9 codes provide adequate reference points for the emergency m e d i c i n e clinical experience. Ideally, the ABEM-ACEP Core Content should be adapted to function as a clinical coding reference point. If this could be accomplished, longitudinal comparisons w i t h i n a residency as well as between residencies would be possible. Judith E Tintinalli, MD, FACEP Emergency Medicine Residency Program Director William Beaumont Hospital Royal Oak, Michigan

1. Sorlie PD, Gold EB: The effect of physician terminology preference on coronaryheart disease mortality: An artifact uncovered by the 9th revision ICD. Arn J Public Health 1987;77:148-152. 2. Tintinalli JE: Emergency department evaluations utilizing results-oriented performance standards (ROPS) (abstract). Ann EmergMed 1988;17: 417.

Physician Ethics in Human Research: The Role of Medical Publications Approximately 50 years ago the world was engulfed in a devastating war. This war was calamitous n o t only be ~ cause of the horrors faced by the combatants and the in~ flictions delivered on civilian populations, but also be o cause of the unprecedented manipulation of medical sci~ ence by concentration camp physicians and scientists purportedly w i t h the aim of advancing medical knowledge. These individuals twisted medicine into a horrible travesty of the helping profession, antithetical to everything that the healing arts had previously exemplified. The perpetrators of these despicable activities, some of w h o m are still sought, were tried as war criminals. M a n y of the war criminals were tried in Nuremberg, Germany. The defense used by most of the defendants, including those involved in the diabolical h u m a n experimentation, was that they were merely following orders or serving a subsidiary role in the research. This was unacceptable, both to the court sitting in judgment and to the 19:7 July 1990

court of world opinion. Both found that an individual's acts, whether they be in wartime or in peacetime, m u s t be, in the end, decided by the morality of the individual conscience. As a result of both the trials and the horrors exposed during and after the trials, the Nuremberg Code came into being. The Code stresses that moral responsibility is a personal, rather than social, p h e n o m e n o n . ~ It dictates the guidelines that m u s t be followed if e x p e r i m e n t a t i o n on h u m a n beings is to be undertaken. These guidelines state that "no experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects. ''2 It goes on to charge scientists with the responsibility to personally terminate a study if, at any stage, there is a risk to the patient. The American Medical Association's Ethical Guidelines

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EDITORIALS

for Clinical Investigation later echoed this s t a t e m e n t when it stated that "In conducting clinical investigation, the investigator should demonstrate the same concern and caution for the welfare, safety and comfort of the person involved as is required of a physician who is furnishing medical care to a patient independent of any clinical investigation. ''3 The Declaration of Helsinki, adopted by the 18th World Medical Assembly in 1964, and later revised in 1975, also reaffirms the responsibility of the individual physician toward the patient. It states that "It is the mission of the medical doctor to safeguard the health of the people ... Doctors should abstain from engaging in research projects involving h u m a n subjects unless they are satisfied that the hazards involved are believed to be predictable. Doctors should cease any investigation if the hazards are found to outweigh the potential benefits." Also cited is the Declaration of Geneva's statement that for the physician, "the health of m y patient will be m y first consideration.,,4 Aside from the personal responsibility of the physicianresearcher, the Helsinki document also introduced the concept of "a specially appointed independent committee for consideration, c o m m e n t and guidance" of research procedures involving human subjects. 4 In the United States, the spirit of these documents has been entered into federal guidelines mandating the presence of an operating institutional review board (IRB). This body m u s t prospectively review research involving humans at any facility receiving federal funding for research through the Department of Health and H u m a n Services. s IRBs are now common in all major medical facilities, both public and private. Their track record in reviewing h u m a n research is regarded as excellent. 6 However, until recently, it was not the norm for medical journals to require a statement concerning IRB approval before publishing an article on research involving h u m a n subjects. This is no longer the case. Yet another, perhaps more disturbing, trend seems to be appearing. Recently, out of the many articles I review for scientific journals, several manuscripts dealing with human research, for this and other journals, touched a nerve. Both the journals and the authors spanned a variety of m e d i c a l s p e c i a l t i e s and i n c l u d e d n o n p h y s i c i a n researchers. The one thing that tied all of these particular articles together was that I questioned whether the authors' study was ethical to perform. Several points were raised in each case to support the following questions. Was it appropriate to do this research under the constraints of the study? Were the patients' health, as well as their rights, being protected? Had these concerns been thought through by the authors? These issues have also been brought up in other major medical journals. 7 Not being the purveyor of absolute truth, for this or any other universe, I was expecting merely a reply that contained a rationale for performing the study as they did. Because the study was a fait accompli, it was unrealistic to expect any change in past behavior. But perhaps a suitable explanation of m y ethical questions could have been 146/829

given in these papers' discussion section to enlighten others. Rather than answer m y ethical queries, the authors, in each instance, replied that the IRB had approved their study. All clinicians, especially those in emergency medicine, know that nearly any case can be presented by slanting information so that a desired outcome (admission, surgery, procedure) is strongly suggested. This also m a y happen within the IRB.S-t 1 These bodies, although often well versed in science and well intentioned, are not expert in every medical field. They are present to guarantee only a first-pass screening through which grossly inappropriate studies involving h u m a n subjects cannot proceed. They are not meant to give the definitive statement on the ethical viability of any particular human research study. To use IRB approval as justification when questions are raised about the morality of a study is very similar to the defenses used at Nuremberg - and just as specious. The Declaration of Helsinki specifically r e c o m m e n d s that "Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication. ''4 It is now time for all medical journals to require, in addition to a statement of IRB approval, a personal statement of ethical appropriateness of any clinical study by the physicians involved. No matter what internal or external regulatory agency gives its imprimatur for a research activity, it still remains the researcher's primary responsibility to ensure that the research being done conforms to the norms and bioethical standards of the international medical community. It is the individual physician-researcher who involves patients in studies. It is the individual physician-researcher who must assure not only himself, but the entire community, that the patient is not an object being poorly used for the greater good of mankind.

Kenneth V Iserson, MD, MBA, FACEP Section of Emergency Medicine University of Arizona College of Medicine Tucson 1. Monagle JP: Medical Ethics. Rockvill¢, Maryland, Aspen Publishers, 1988, p 127-139. 2. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law. Washington, DC, GPO, vol 2, no 10, 1949. 3. American Medical Association: Ethical Guidelines for Clinical Investigation. Current Opinions of the Council on Ethical & Judicial Affairs. Chicago, 1989, p 4-5 (adopted by A/VIA 1966). 4. World Medical Assembly: Declaration of Helsinki. Helsinki, Finland, 1964; Revised, Tokyo, Japan, 1975. 5. Protection of Human Subjects. 45 CFR 46, Revised 1983. 6. National Commission for the Protection of H u m a n Subjects: Report and Recommendations: Institutional Review Boards, DHEW Nos [OS) 78-0008 and (OS] 78-0009, 1978. 7. Shahar E: Dexamethasone and acute mountain sickness (letter]. N Engl [ Med 1990;332:1395. 8. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research: Implementing Human Research Regulations. Washington, DC, US Government Printing Office, 1983, p 37-38.

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9. Annas GJ: Judging Medicine. Clifton, New Jersey, Humana Press, 1988, p 331-333. 10. Veatch RM: Problems with institutional review hoards: Inconsistency.

JAMA 1982;248:179-180. 11. Benson PR: The social control of human biomedical research: An overview and review of literature. Soc Sci Med 1989;29:1-12.

Emergency Medicine Education and the HIV Epidemic The spread of human immunodeficiency virus (HIV} infection has already reached epidemic proportions and continues to expand. As of February 1989, more than 87,000 Americans had been diagnosed with acquired immune deficiency syndrome (AIDS).1 The US Public Health Service projects that there will be 365,000 diagnosed cases of AIDS and 263,000 cumulative deaths by 1992; from 1 to 1.5 million Americans are currently infected with HIV.2 Much has been written about the effect of the HIV epidemic on both undergraduate education and specialty education programs. Within emergency medicine, there are several levels at which the HIV epidemic poses a challenge to our education programs and both undergraduate and graduate trainees.

OCCUPATIONAL RISK Apprehensions regarding occupational transmission of HIV infection are a legitimate issue in emergency medicine education because students and residents assigned to the emergency department are on the front line in dealing with acute presentations of illness in an undifferentiated patient population. Patients often present with little time to undertake universal precautions, and treatment often requires extensive exposure to various body fluids. Furthermore, recent epidemiologieal work and clinical experience show that many ED patients are unaware of their seropositivity. Many students and residents may not be comfortable with the assimilation of personal risk into the conduct of their professional responsibilities at its extreme (ie, if high rates of nosocomially acquired HIV infection become a reality among ED personnel). The potential exists for the competitiveness of emergency medicine, as either a career choice or an elective educational experience, to suffer compared with other alternatives.

PREHOSPITAL CARE ISSUES Prehospital care issues in emergency medicine pertaining to the HIV epidemic are primarily twofold. First, standards and precautions in prehospital care may undergo change secondary to increasing numbers of HIV-positive patients requiring invasive prehospital intervention (eg, IV therapy, tamponade of bleeding, airway intervention, ventilation). Second, actual or potential liability of emergency medical services (EMS) systems and indirect liability to municipalities and national or state agencies that sponsor EMS systems may ultimately result in limitation or abolishment of the use of prehospital systems for the education of medical students and emergency medicine resi19:7 July 1990

dents. In addition, students and residents, fearing the acquisition of HIV infection, may choose not to participate in these educational activities.

PATIENT ISSUES Issues pertaining directly to undergraduate and graduate programs exist at several levels. HIV patients with acute complications may be both time and labor intensive, thus adding to often overwhelming ED caseloads and potentially diluting resident exposure to other types of cases as the epidemic expands in the 1990s. The uneasiness of physicians with these patients' lifestyles or prognoses (or often the outright rejection of HIV-positive patients by physicians) must be addressed in programs. This negativism may increase as AIDS patients lose their perception as "innocent victims" and are seen instead as suffering from a self-inflicted disease resulting from unsafe sexual or IV drug practices. Both the increased clinical caseload and the negativism toward AIDS patients have the potential to affect the quality of emergency medicine training programs. Further, the competitiveness of residency training programs in EDs with high volumes of HIV-related cases may suffer, in much the same way that the competitiveness of internal medicine training programs in such endemic areas have suffered. Lastly, an adequate but not overwhelming amount of didactic teaching must be devoted to the issues that arise in the care of these patients.

MORAL OBLIGATIONS The moral obligation for emergency physicians to care for HIV-infected patients must be acknowledged in our training programs and in our educational goals and objectives. If medicine in general (and emergency medicine in particular) is a profession and not a trade, devotion to moral ideals of selflessness, commitment to serving the ill, and acceptance of an element of personal risk in duty to patients {particularly during epidemics) are assumed and time honored. Medicine is a moral enterprise, and demonstration of this precept by faculty to residents and students in the care of these patients is incumbent. Our students must see emergency medicine practitioners on the front line with these patients, having resolved their tensions with their own personal risks in favor of the resultant benefits to emergently ill HIV patients. Similarly, e m e r g e n c y medicine residency programs must collectively clarify their own attitudes and approaches toward their HIV-infected patient population. Institutions must establish policies and procedures and de-

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Physician ethics in human research: the role of medical publications.

dards that would enable different individuals, or different residencies, to use the same coding s y s t e m are n o t described. Consequently, the pro...
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