Ethical Aspects of Cardiopulmonary- Cerebral Resuscitation Research Michael Eliastam, MD, MPP, Moderator* / Peter Safar, MDt / Michael Shapiro, MA, JD* / Samuel Gorovitz, PhD§

[Ethical aspects of cardiopulmonary-cerebral resuscitation research depend on the perceptions of the individual con- cerned. Comments by a clinician, a legal scholar, and a philosopher on a variety of related issues broaden our un- derstanding of this controversial topic. Eliastam M, Safar P, Shapiro M, Gorovitz S: Ethical aspects of carch'opulmonary- cerebral resuscitation research. Ann Emerg Med September 1984 (Part 2);13:874-875. Key words: cardiopulmonary-cere- bral resuscitation; ethics.]

Introduction The concluding session of the 1984 Winter Symposium

was a panel discussion of ethical problems and issues relat- ing to resuscitation research. The panel consisted of a clini- cian, Peter Safar, MD, PhD; a legal scholar, Michael Shapiro, PhD; and a philosopher, Samuel Gorovitz, PhD. Michael Eliastam, MD, MPP, prepared this summary of their re- marks.

The Clinician Peter Safar,/OLD: Is resuscitation a worthwhile venture? It is, in fact, in opposition to natural selection. Resuscitation promotes "survival of the unfit," probably a bad outcome for the species. In fact, natural selection is and should be repugnant to the individual physician.

To place resuscitation research in perspective, it's inter- esting to note that research on the dying process is far be- hind research on the birthing process. Research appears to be beneficial because, while taking some risk, good results often are accomplished. Research should be conducted along many lines, because often unexpected and conflicting results are obtained. In large clinical trials, for example, brain fimction cannot be sustained after prolonged cerebral ischemia-anoxia, but in laboratory experiments individual neurons have been shown to recover biochemical and elec- trical function after much longer ischemic periods.

The treatment of experimental laboratory animals is cur- rently under debate, and it is my opinion that current prac- tices of animal research are, in fact, acceptable on the basis of extending the laws of nature that each species lives off on the philogenetic ladder. On the related subject of pain expe-

From the Emergency Department, Stanford University Hospital, Stanford, California;* the Resuscitation Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania;t The Law Center, University of Southern California, Los Angeles;* and the Department of Philos- ophy, University of Maryland, College Park.§ Address for reprints: Michael Eliastam, MD, MPP, Stanford University Hospital, Emergen- cy Department, P-1016, 300 Pasteur Drive, Stanford, California 94305.

rienced during experiments in animals, studies have shown that 20% to 80% of pain may be perceptual. Man has not addressed the perceptual side of pain adequately, and doing so would reduce the adverse effects on animals. I suggest that captivity is the major issue in animal research, for the conditions under which animals are held are not natural to them, and thus animals bred specifically for research might do better. I advocate the participation of nonphysicians and nonresearchers in the development of processes for the pro- tection of animals in research, and I strongly oppose legisla- tive action in this area.

A review of the history of cardiopulmonary resuscitation reminds us that scientific evidence establishing effective airway opening mechanisms was achieved through addi- tional radiographs taken at the time of unrelated surgery. Documentation of effective artificial ventilation techniques was accomplished using human volunteers - - surgeons in training - - who were paralyzed and ventilated to test vari- ous techniques. Closed-chest cardiac compressions, long known and tried in 1890 on chloroformed patients, was re- introduced in the late 1950s by anesthesiologists who, be- cause of the high incidence of myocardial depression from recently introduced anesthetic drugs, were familiar with this technique from animal experiments. Similar advances, such as electrical defibrillation and the use of mechanical ventilators, came about in human beings as a result of ani- mal experimentation.

On the issue of protection of patients, researchers have occasionally transgressed reasonable boundaries, as, for ex- ample, in the studies of syphilis in the South many years ago when treatment was withheld from groups of patients without their consent. It is my impression that this is un- common and does need policing, but that regulation pro- duces unwarranted delays.

At the Resuscitation Research Center of the University of Pittsburgh we have attempted to develop a protocol for brain ischemia research, and that process has been difficult. Currently federal regulatory bodies have no consistent pol- icy enabling resuscitation research to be conducted.

There is a fear that aggressive resuscitation will lead to an increase in the number of vegetative survivors, but that fear is unfounded. Data clearly show that the number of pa- tients in persistent vegetative state has not increased. Re- suscitation research must be accompanied by research on outcome prognostication. Promising possibilities include evaluation of cerebrospinal fluid enzymes, the use of brain CT scanning, and studies of brain metabolic rate. Finally, every hospital should establish procedures for "letting die." The recently published guidelines for treatment of hope-

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ETHICAL ASPECTS OF CCPR Eliastam et al

lessly ill patients is a landmark event representing the abil- ity of informed members of society to formulate jointly a set of guidelines that are helpful to clinicians, other health professionals, patients, and families.

The Legal Scholar Michael Shapiro, MA, JD: Any problem that has a funda- mental value conflict will not go away. Several significant problems exist in the area of biomedical research.

First, a physician has an obligation to his individual pa- tient, and must have a clear understanding of experimental therapy as opposed to standard therapy. This is made more complex by the issue of patient autonomy and the physi- cian's responsibility to respect this, as well as the question of the extent of the physician's obligation to benefit future patients while attempting to provide the best possible care to the immediate patient.

Randomized clinical trials are widely believed to be es- sential for medical research. I disagree, and recommend that they be used only in special cases. The definition of statis- tical significance (eg, P < .05) is arbitrary, and more patients might benefit if the number were changed. I believe that when physicians make choices involving randomized clinical trials, they often are obliged to ignore the benefits of the specific patient while placing the interest of the group at a higher priority. Common law requires that physi- cians behave reasonably, but allows the possibility that it may be reasonable to follow a less-well-accepted treatment, even if endorsed only by a small but reasonable minority.

On the issue of consent in randomized, controlled trials I think disclosure of randomization should be done, even if it frightens the patient. I doubt fear will reduce participation. There are, of course, other difficult issues in clinical trials. Already mentioned is the issue that a trial may disrupt the physician's personal relationship with the patient. Most physicians have an intuitive opinion on whether the experi- mental or control therapy is better. Should data be released to patients during the trial, or withheld until the end? The generally accepted level of statistical significance is purely arbitrary, whether these trials are unethical or even un- lawful. I think that the law covering the obligation of a phy- sician to a specific patient may require revision to allow the trials to continue.

In my view existing medicolegal rules of malpractice sug- gest that randomized trials are outside the boundaries of reasonable practice. The emergency exception, which is used extensively, covers consent only for the intervention and not for randomization. Patients might consent to treat- ment, but not to randomization. In my opinion, the necessi- ty for and the legality of randomized clinical trials is not

self-evident, and I urge further examination of these issues.

The Philosopher Samuel Gorovitz, PhD: In light of my colleagues' com- ments, I must first remind everyone that it represents an assault when a physician does something to a patient, and special justification is needed each time. Physicians per- form "felonious assault" when they operate on, feed poison (as most current medications could be described) to, and stick tubes into patients.

Accepting that physicians have a desire to do good, usu- ally this should not be in conflict with the patient, and should not violate the patient's autonomy. At times, how- ever, one should override a person's autonomy, as in the ex- ample of the child running into the street in front of a speeding car and being saved by someone snatching it out of the car's way. Physicians practice in the gray zone between individual autonomy and general welfare.

Informed consent derives from the sociopolitical culture, and is very variable. One example is the problem of the shortage of transplantable kidneys: in France a dead person is considered a potential donor unless that person has spe- cifically expressed a desire not to be one, but in the United States one must actively state his willingness to be a donor before organs may be taken. The Soviet Union considers everyone a donor, regardless of his or her wishes. Specific areas of research generate fundamental and very complex political issues and generate great public debate. What is dearly seen by one group as much-needed research may be regarded by another as "not natural" and to be avoided. The history of in vitro fertilization research is an example of the latter.

While I agree with Dr Safar that violation of reasonable research criteria is rare, even rare violations must not be tolerated. Protective mechanisms must be constructed for the exceptional or unexpected case. I disagree with the argu- ment that the medical profession can and should police it- self, for there is no clear body of law for easy application by physicians. Further, the situation is remarkably unstable, with values in tension and varying over time. I believe there is a great need for these matters to be reviewed by someone from outside with a broader perspective. Physicians, like other people, are motivated by a mixture of factors, and it is naive to imagine they are motivated solely by the patient's interest and the public good.

I strongly oppose the concept of deferred consent, for it is impossible to obtain deferred consent once the experiment has started. Thus the patient is not giving consent, but rather is receiving delayed information. This issue should be addressed realistically and the process labeled accurately.

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