Testing Emergency Medical ProceduresWithout the Consent of the Patient
A physician who specializes in the research and development of cardiac resuscitation technology wants to know the ethical and halakhic issues involved in testing without consent. In many cases, the consent of the patient cannot be obtained prior to his or her cardiac arrest. Obtaining surrogate consent is not always practical, since the patient may well die without immediate treatment. There is a great need to test new emergency therapies, since current survival rates under standard manual cardiopulmonary resuscitation (CPR) are dismal. On the other hand, the critical condition of a small percentage of patients might actually be worsened prior to stopping these tests, despite ongoing supervision. (Rabbi Joseph A. Edelheit, Minneapolis)
Jewish tradition has much to say concerning the practice of medicine. It also addresses the issue of individual consent, whether and under what circumstances a person is entitled to refuse medical care, as well as the distinction between proven and yet-to-be proven (experimental) methods of treatment. As Reform Jews, meanwhile, we are the heirs and the creators of a stream of Jewish tradition which places great positive value upon both scientific progress and personal autonomy. Taken together, these teachings and affirmations pull us toward opposite and contradictory conclusions when we face this difficult question. Yet we shall need to consider all of them as we seek to forge a consistent and satisfying Jewish ethical message.
The practice of medicine is understood as a mitzvah, a religious requirement under Jewish law. Thus, despite the fact that the Talmud speaks of a “permit” (reshut) rather than a duty to heal1 and despite various indications in the sources of a negative attitude toward medicine and physicians,2 most authorities regard medicine as the primary means by which we fulfill the commandment to save life (pikuach nefesh).3 This duty applies to one’s own life as it does to the lives of others;4 it would follow that a person is not entitled to refuse lifesaving medical treatment. The sixteenth-century authority R. David ibn Zimra drew just this conclusion when he condemned as a “pious fool” a person who refused to violate the Shabbat in order to prepare medication. “This is no act of piety but of suicide. He is therefore compelled to do what the physicians prescribe.”5 Contemporary authorities concur that the patient “must do as the doctor orders.”6 On this basis we could argue that traditional Jewish law requires a patient to accept CPR and that emergency medical personnel are entitled to administer the therapy even if the patient is incapable of expressing consent.
The difficulty with this argument is that the CPR method under discussion is experimental in nature. The doctors, that is, are not yet certain as to its therapeutic effects. And under Jewish law, a patient is under no obligation to accept medical treatment whose efficacy is doubtful or untested.7 Moreover, as the she’elah indicates, the condition of “a small percentage of patients” might actually worsen under the use of this therapy rather than the more conventional methods of CPR. The doctors therefore cannot necessarily presume the patient’s consent before testing this therapy upon him or her. To proceed with the test upon a person who has no moral obligation to accede to it and who, if conscious, might well refuse consent, is to invite strenuous objection on ethical grounds. By what authority do we ignore the patient’s right to make an informed choice to accept–or reject- -medical treatment? And what statement do we as a community make concerning our own values when we arrogate this right to ourselves? We Jews, who remember all too well the experiments conducted by Nazi “scientists” upon the inmates of concentration camps, surely recoil at the specter of a scientific establishment which turns human beings into involuntary subjects of experimentation.
On the other hand, we liberals have historically placed great faith and trust in the power of reason and science to improve the human condition. We therefore cannot ignore the critical importance of scientific experimentation to the advancement of medicine. The very institution of “modern medicine” whose achievements we praise and upon which we rely to protect our lives is largely the product of testing and experimentation, much of it upon human subjects. In many cases there is no alternative to testing upon humans. For example, the current, “accepted” methods of CPR could only have attained that status because they were tested and perfected upon human beings who were experiencing cardiac emergency. Should we place severe restraints upon physicians’ ability to test new and promising emergency procedures, we may prevent them from developing the tools needed to save countless lives in the future.
The dilemma is this: the patient has no moral obligation to accept treatment that is potentially dangerous and whose lifesaving–i.e., medical–properties are doubtful. At the same time, it is precisely by testing such treatments upon human subjects, who in cases of emergency are usually unable to express their desires, that doctors learn how to save lives, to fulfill the commandment of pikuach nefesh, to do “medicine” at all. Is there an answer that strikes a proper balance between the legitimate concern for patient autonomy and the equally legitimate needs of medical science?
No such answer is to be found in the responsa of contemporary halakhic authorities. We think, however, that one can be derived through a consideration of the Jewish law on scientific experimentation on humans. The answer consists of three parts: first, that persons are allowed to subject themselves to controlled and careful scientific experimentation; second, that there exists in some cases a general ethical duty to submit to experimentation; and third, that in certain emergency situations physicians may within reasonable limits administer an experimental remedy to the patient.
1. Scientific Experimentation Upon Human Subjects. May a person volunteer to serve as a subject in a scientific experiment? A factor which argues for a prohibitive answer is the Talmudic tradition which forbids a person from inflicting physical injury upon his or her body.8 Maimonides cites this rule as halakhah, but it is significant that he limits the prohibition to injury caused “by way of contempt” for the body.9 How he derived this limitation is not clear; some suggest that, since physical injury can be financially compensated and that an injured person is entitled to waive the damages, the Rambam rules that the person is similarly entitled to inflict self-injury when that act is the source of some benefit.10 The contemporary halakhic debate concerning cosmetic surgery revolves around this point. Those who permit cosmetic surgery argue that, while an individual is ordinarily forbidden to inflict self-injury, the benefits which may accrue from an improved appearance demonstrate that the procedure is not undertaken out of “contempt”. That conclusion can obviously be debated; this Committee, among others, has expressed serious reservations over the supposed “benefits” of cosmetic surgery.11 On the other hand, careful and legitimate medical experimentation holds the promise of increasing our fund of the kind of knowledge that may one day cure terrible diseases and save countless lives. Surely this constitutes an acceptable warrant for an individual to waive the prohibition against self- injury in order to submit to scientific experiment.
2. The Ethical Duty to Submit to Experimentation. This “right” to volunteer as a subject in a scientific experiment can also be expressed in the language of obligation. It is well-known that the tradition holds the preservation of life (pikuach nefesh) to supercede virtually all other commandments12 and that we have a positive duty to rescue those whose lives are endangered when we can do so.13 Indeed, that we are commanded (rather than merely permitted) to practice medicine is based on this recognition of an obligation to save the lives of others.14 We would not suggest on the basis of this teaching that every person is required to volunteer as a subject in a scientific experiment, any more than we would conclude that the commandment to practice medicine obliges every person to become a physician. Rather, just as a person who does possess medical knowledge is said to have an ethical duty to use that knowledge to treat disease and to save lives, it can be argued that one who has the opportunity to participate in an experiment or study directed at the advancement of medicine has something of an obligation to do so. This may be especially true in our case, where the individual has no choice but to receive CPR and where the experimental therapy, which must be tested upon humans, has the potential of saving numerous lives which would be lost under current procedures of resuscitation.
The difficulty with this argument is that, while Jewish law requires me to save the life of another, it does not obligate me to endanger my own life to do so. The very text which establishes the duty of pikuach nefesh declares that we are to perform the mitzvot so as to “live by them” and not place our lives in jeopardy.15 Thus, while I am commanded to save a drowning person, I am not obliged to make the attempt if in doing so I place my own life at risk.16 The predominant halakhic position extends this to instances of less-than-mortal risk: I am not required–and perhaps am forbidden–to assume potential danger (safek sakanah) in order to rescue a person whose life is in clear and present danger (vadai sakanah).17 According to this view, there is no duty to submit to a scientific experiment, even one that could result in the discovery of life-saving information, so long as there is any significant degree of risk involved. On the other hand, this view is not unanimous: some authorities hold that the halakhah does not prohibit an individual from entering into a situation of potential danger in order to rescue a person facing vadai sakanah.18 It is, moreover, quite possible that the predominant view is in error and that the Talmudic and other sources upon which it is based do not forbid–and perhaps require–an individual to enter into safek sakanah to save another in clear and present danger.19
Our own conception of individual moral responsibility leads us to favor the latter, more stringent position. Most of us, we think, would prefer to live in a community whose members, rather than insisting rigidly upon their personal safety at all costs, are prepared to assume a limited degree of risk to save the lives of their neighbors. This is not, we stress, a call for an ethic of self-sacrifice; we do not believe that all people must live according to the terms of midat chasidut, a saintly standard of behavior. On the contrary: we would argue that the proposed standard is an eminently reasonable one that lies well within the reach of normal human beings. It represents the minimal level of care and concern for the lives and welfare of others below which an ethical community is scarcely imaginable. This standard, if not the dominant view among halakhists, is thus both arguably the more accurate interpretation of the sources and certainly the more exalted expression of Jewish thought. Under its terms, an individual would be permitted to volunteer as a subject in an experiment aimed at discovering life-saving information so long as whatever risk he or she assumes by participating is less than vadai sakanah. Indeed, in some cases, where the potential for saving life is both real and vital, participation in such an experiment could well take on the status of a moral duty.
3. Emergency Experimental Treatment Without the Patient’s Consent. The case at hand, however, is no ordinary experiment. By foregoing the accepted methods of cardiopulmonary resuscitation in order to test new ones, medical professionals may well be withholding life-sustaining care from a patient in critical condition. Remember, too, that the survival chances of a small percentage of patients will worsen under these experimental procedures. Their use might therefore place a patient in a situation of vadai sakanah, and while self- sacrifice may be admirable, Jewish tradition does not suggest that an individual must undertake mortal danger in order to save the life of another.20 Is there an ethical rationale which would ever permit the testing of new methods of CPR in the absence of a patient’s consent?
It might be useful to compare our question to the employment of randomized clinical trials (RCTs) in medical experimentation. In these trials, subjects/patients are randomly assigned to different therapies or placebos in an effort to keep variables other than the differing treatments from distorting the results of the study. While this method offers great scientific value, it poses serious ethical problems. The physician’s primary responsibility, after all, is to the health of the patient; is this responsibility not violated when the patient is given a placebo instead of the treatment that the other subjects receive? The answer clearly is “yes” if we know that by including the patient in the experiment we lessen his or her chances for recovery. On the other hand, those who favor RCTs respond that these methods are ethical, provided they are utilized only when there is genuine doubt as to the efficacy of existing therapies, whether standard or experimental, so that “no patient…will receive a treatment known to be less effective or more dangerous than another available alternative.”21
Let us translate this discussion into the Jewish vernacular. It is a mitzvah to heal, to practice medicine. Under the terms of this requirement, physicians are obligated to provide the accepted and recognized medical therapies to patients who come to them, and patients, in turn, are obliged to accept them. A placebo is not therapeutic; it does not qualify as refu’ah, medical treatment. We are, of course, aware that belief in the efficacy of the placebo may, in some cases, contribute to the patient’s healing. In our case, however, the experimental method of CPR is by no means a placebo. It is in fact a new technique which offers great promise in the saving of life. Nor is it obvious that the experimental method is less therapeutic to the patient than the standard methods. As the she’elah points out, though the condition of some patients might deteriorate under the use of the experimental method, the survival rates under current methods are in any event “dismal”. Given the unsatisfactory nature of current therapies, there would seem to be no reason to conclude that the new method is, in general, less therapeutic or medically efficacious than the standard one.
Our conclusion, then, is that emergency lifesaving therapies such as the one under discussion may in certain cases be tested upon patients without their express consent. This is because in those cases the experimental therapies qualify as legitimate medicine (refu’ah) which an individual is obligated to accept in fulfillment of the mitzvah of pikuach nefesh, the saving of life. These therapies are legitimate medicine under the following conditions:
1. The physicians are reasonably certain that the experimental therapy is neither significantly more dangerous nor less efficacious than the standard therapies. This “reasonable certainty”22 applies to the individual patient as well as to the population as a whole: if there is reason to suspect that this individual will fare worse under the experimental therapy, he or she must receive the standard treatment.
2. The medical personnel on the scene immediately discontinue the test once it becomes evident that the experimental method is not achieving the desired result. The strictest supervision must be maintained, for the life of this patient takes priority at all times over the potential lifesaving knowledge that can be gleaned by the test.
We add a final caveat. As we stated above, society ignores at its moral peril the requirement that patients be informed of their medical treatment and that they consent to it. While in some situations, such as this one, informed consent is difficult or impossible to obtain in advance, medical professionals must undertake every effort to educate the community as to the state of technology in various medical fields, the need for further research, and the therapeutic options available to physicians in specific situations. For we know that a medical establishment which does not meet the duty of disclosure to the public will soon lose the confidence of the public and, necessarily, its ability to function as an instrument of healing.
BT. Baba Kamma 85a, from Exo. 21:19. See II Chronicles 16:12 and Isaiah 38:3, and BT. Berakhot 10b and Pesachim 56a on the latter; BT. Berakhot 60a and Rashi, s.v. she’ein darkan shel benei adam; BT. Kiddushin 82a (M. Kid. 4:14) and Rashi, s.v. tov shebarof’im. For a general statement of this position, see Ramban on Lev. 26:11. Ramban, Torat Ha’Adam, Chavel ed. (Jerusalem, 1964), pp. 41-42. He notes that the prohibitions against work on Shabbat and Yom Kippur are set aside in cases when life is in danger and that we customarily rely upon a physician’s diagnosis to determine when danger exists. His words are embodied in the Tur and the SA, YD 336. Maimonides, by contrast, learns the mitzvah of medical practice from Deut. 22:2 and the Talmudic discussion in BT. Sanh. 73a (Rambam, Commentary on M. Nedarim 4:4). See our responsum 5754.14, above p. , for a detailed discussion. Lev. 18:5 and BT. Sanh. 74a: a person may violate almost any commandment in order to save his own life. The Rambam adds that, should he in such a case choose instead to follow the commandment and thereby lose his life, he is guilty of suicide (Yad, Yesodey HaTorah 5:1). Resp. Radbaz, v. 1, # 1139. R. Eliezer Yehudah Waldenberg, Resp. Tsits Eliezer, v. 5, Ramat Rachel, ch. 20; R. Ovadyah Yosef, Resp. Yechaveh Da`at, v. 1, # 61. R. Ya`akov Emden, Mor uKetzi`ah 328; R. Moshe Raziel in Techumin 2 (1981), 335-336. M. Baba Kamma 8:6 (90b); BT. Baba Kamma 91a-b. The Talmud cites here the familiar midrash (on Num. 6:11) concerning the nazir, who is regarded as a “sinner” because he denies himself the legitimate pleasures of wine: “if such a person is a `sinner’, then kal va-chomer is one who inflicts physical pain upon himself a `sinner'”. Yad, Hilkhot Chovel uMazik 5:1. Thus, in pietistic communities where physical means of atonement are practiced a person may hire another to administer the beatings; Shulchan Arukh of R. Shneur Zalman of Liady, CM, Hikhot, Nizkey HaGuf, no. 4. See R. Simchah Hakohen Kook in Sefer Asya, v. 3 (1983), 292. See our responsum 5752.7, “On the Permissibility of Cosmetic Surgery”, above p. , and the literature cited therein. Lev. 18:5; BT. Yoma 85b and Sanhedrin 74a; Yad, Hilkhot Yesodey HaTorah 5:1; SA, YD 157:1. Lev. 19:16; BT. Sanhedrin 73a; Yad, Hilkhot Rotseach 1:14; SA, CM 426:1. The authorities are divided as to the source of the commandment to heal. Nachmanides locates it in Ex. 21:19 and Lev. 18:5 (Torat Ha’Adam, Chavel ed., 41-42), while Maimonides relies upon Deut. 22:2 and BT. Sanhedrin 73a (Commentary to M. Nedarim 4:4). Lev. 18:5; BT. Yoma 85b and Rashi s.v. deShmuel. Minchat Chinukh, mitzvah 237, #. 2. We might also cite the famous passage concerning the two wanderers in the desert (BT. Baba Metsi`a 62a). The law is generally thought to follow R. Akiva, who rules that the traveller holding the container of water is not obliged to share the water with his fellow, since “your life takes precedence over his.” See, in general, Aaron Kirschenbaum, “The `Good Samaritan’ and Jewish Law,” Dine Israel 7 (1976), 46 and 51, and the essay by Avraham Avidan in Torah shebe`al Peh 16 (1974), 129-134. Sources include Bayit Chadash, Tur CM 426; Sefer Me’irat Eynayim, CM 426, n. 2; Shulchan Arukh of R. Shneur Zalman of Liady, Hilkhot Nizkey HaGuf, part 5; R. Naftali Zvi Yehudah Berlin, Ha`amek HaShe’elah, she’ilta 147, end; and R. Eliezer Yehudah Waldenberg, Resp. Tsits Eliezer 9, no. 17, ch. 5. Arukh HaShulchan, CM 426, n. 4; Torah Temimah to Lev. 19:16, n. 10. See also R. Yosef Karo, Beit Yosef, CM 426 and Kesef Mishneh, Hilkhot Rotseach 1:14. For a detailed version of this argument see Journal of Reform Judaism 36 (Winter 1989), 53-65. This statement needs some qualification. Some authorities, for example, do not apply this rule to a situation of wartime, where soldiers are indeed required to endanger themselves for the good of their comrades and of the nation; see Avidan (above, n. 17), 131ff. Then there is the position of R. Avraham Yitzchak HaKohen Kuk, who holds that in cases of communal emergency the individual Jew must be prepared to sacrifice his life on behalf of his people; Resp. Mishpat Kohen, # 142-144. Tom L. Beauchamp and James F. Childress, Principles of Biomedical Ethics (New York, 1989), 351. It is not our province to define “reasonable certainty” with statistical precision. Any measure we adopt (say, a less-than-five-percent chance that the experimental treatment will prove less effective or more dangerous than the standard one) would be in some sense an arbitrary one. As is the case with all general legal standards, the parameters of “reasonable certainty” are set through a process of reasoned evaluation by those charged with making the decision. In this case, a medical judgment must be rendered by medical experts. If, in their informed opinion, the standard of “reasonable certainty” is met, then our answer applies. On the function of “expert medical opinion” in halakhic judgment, see SA OC 618 and Mishnah Berurah ad loc.
If needed, please consult Abbreviations used in CCAR Responsa.