Memo to the Files, Subject: Human Experimentation

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fo : The Files DATE: April22, 1964 PROM : Edwin R. Render, Office of SUBJECT: HUMAN EXPERIMENTATION This office is in receipt of a n ORINS proposal t o conduct an experiment using as subjects some inmates atthe Brushy Mountain State Prison.This experiment will initially involve the ingestion of small tracer doses of radioactive substances by the subjects,notto exceed the maximum permiss i ble exposure for occupation ally exposed persons. Samples of the subjects ' urine and feces will be collected and analyzed by ORINS after the isotopes have been administered. Prisoners are considered desirable subjects for several reasons. They are i n good health, Being prisoners,they will be available for study over the entire period. ORINS does not wish to use hospital patients for the following reasons: (1) illnesses cause abnormal responses; (2) many of the patients receive diagnostic or therapeutic doses of isotopes so large as to interfere with counting of small tracer doses; and (3) patients either die' or recover and go home. Out patients are considered undesirable by ORINS because some are employed and do not wish to leave work and others live too far away for frequent studies. ORINS does not wish to use staff members for several reasons including : (1) some employees might feel some obligation to "volunteer"; and (2) ORINS does not wish to establish a policy of using employees i n such experiments. ORINS does not anticipate any serious difficulty in obtaining volunteers if some benefit is given the prisoners. It is expected that the prisoners will be advised of the nature of - the experiment and will be completely free to volunteer or a to refuse. The content of the agreement between ORINS and u1 the prisoners is not made clear from the file,but the writer - was advised that the agreement will be a contract in which -t the prisoners promise to participate in the experiment a s QD subjects and ORINS would incur a detriment such as giving the E SUbSctb a thorough physical examination. Legal consideration

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should not be problematical,since ORINS describes the risk incurred as slight or negligible, so the consideration can be small i n amount. The file also indicates that the prisoners will be free to terminate their participation at any time. This paper is concerned with non-negligence tort liability of ORINS or AEC inthe event a prisoner is injured during the course of the experiment. fli c ted injury will not be treated here It is only concerned with damages based on a strict liability theory. This paper will deal with this problem on the assumption that the contract between ORINS and the prisoners contains a promise by the prisoner not to sue for non-negligent injuries. The problem of a negligently in - I n approaching this problem three starting points are used. First,a considerable body of law has developed in malpractice actions against doctors which is to the effect that the physician experiments on patients at their own peril. These cases will be analyzed and their applicability to a clinical ex peri - ment will be considered. Second, the problem is approached, using as a starting point, an analysis of the legal status of prisoners.Third,there is some Federal law which might be applicable to this case. THE RESEARCRER'S LEGAL STATUS By way of introduction some general rules should probably be developed inthe context of the malpractice action against treat a person that he exercise the degree of skill and care ordinarily possessed by reputable members of the profession inhis community. Thus: (1) the doctor must not be negli - gent or he must use due care ; and (2)the amount of care required is established by the fictitious reasonable and prudent doctor practicing in the same camnunity and under the same or similar circumstances. Reasonable and prudent doctors do not experiment on their patients, hence, the rule that a doctor experiments on patients a this own peril. The rules respecting human experimentation were The law imposes upon a doctor undertaking t o A s one might expect, counsel for the research and medical professions have a low regard for this kind of analysis of the problem and the rules of law which have come into

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existence as the result of it. The medical profession regards human experimentation as both necessary and desirable if conducted i n accordance with certain safeguards. On the necessity of human experimentation it has been observed t h a t "at some point in any medical research,therefore,the investigation must be performed on human beings, if that research is toful - mentation on Human Beings" 1 1 7 Science, 203, 205 (1953). Another writer states: "Man cannot and should not be excluded from the roster of laboratory animals. For some investigations, notably in the field of mental health and emotional disorder or sensation and pain, he may be the only apt subject. " Ladimer, "Human Experimentation," 257 New Eng.J. of Med. 1 8 (1957). The policy of the law regarding medical research should be t o encourage the development of the medical sciences to the greatest possible extent consistent with western notions of personal "The purpose of law should be t o encourage the greatest amount and highest quality of clinical research possible ... and t o help both the investigator and the patient overcome apparent conflicts. The law,therefore, should be written and interpreted in a forward-looking and constructive manner; it should not prohibit long lists of specific activities, presume dishonesty on the part of the investigator,police the details of experimentation, or provide a series of legalistic blockades so intricate that the path to progress becomes an obstacle course." Sch reiner, ' Xi ability in Use of Investigation al The strict prohibition against experimentation is said to have originated in Slater v. Baker, 95 Eng. Rep. 860 (1767). I n this case the plaintiff suffered a broken leg which was set, but did not heal properly. The defendant re fractured the leg i n an attempt to straighten it. witha novel device invented by the defendant and the use of this device constituted a departure from the established method of treatment. The court found there was no necessity for the departure from the established practice and accordingly held the doctor liable. One writer i n commenting on this case states that it really does not lay down a "no experimentation rule " but rather that the case hoIds that the doctor may not experiment on the patients without their consent. The re fracture was accomplished

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The Files - 4 - April 22, 1964 canmentator cbemed that the patient was treated in a negligcntmamer. Bowker, "Legal Liability to Volunteers in Testing New Drugs," 88 Caned. Med. Ass. J. 745 (1963). Betbitas it may, the case has come to stand for the proposition that a doctor experiments on his patients a this own peril. Carter v. Blake, 60 Barb. 488 (N.Y. 18711,was a lawsuit in which the doctor did not use a sling to support a dislocated elbow and did not instruct the patient in the care required minor departure from the established practice, was held to constitute unlawful experimentation. I n hoLding for the - plaintiff the court said "it i s incumbent L for the doctor / t o conform to the treatment established... any deviation shall be deemed sufficient to charge the surgeon with negligence." The court observed that any other rule would involve experimentation taking the place of skill and " the reckless experiment a list,the place of the educated, experienced The failure to prescribe the sling,although a I n Jackson V. Burnham, 39 Pac. 577 (Colo. 18951, a physician was held liable for unwarranted experimentation when he i n - correctly diagnosed phimosis of the penis as an ulceration of the urinal canal and treated it with a flax seed poultice. Gangrene set in,requiring amputation. The Colorado Supreme Court, upholding the patient when the physician appealed, concluded: "There must be some criterion by which t o test the proper mode ...if a physician sees fitto experiment with some other mode, he should do so a this peril. " In Alle n-v. Voje, 89 N.W. 924 (Wis. 19021, the patient had a pelvic inflammation, and was placed i n an unsanitary nursing home. The doctor failed to diagnose localized pus and failed t o remove a n ovary. This case involved negligence ifa malpractice suit ever did. The court so found, but nevertheless offered the following: 'We have little doubt that,if the first case of vaccination had -proved disastrous and injured the patient,the physician should have been held liable. Nor do we believe that a physician of standing and loyalty to his patients will subject them t o mere experiment, the safety and virtue of which has not been established by experience of the profession,

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The Files - 5 - April 22, 1964 save possibly when the patient is i next rem is, and fatal results substantially certain unless the experiOther cases involving alleged experimentation upon patients Statements were found ina few widely scattered cases which may indicate some judicial dissatisfaction with the abovestated "no experimentation rule. " Inthe Canadian case of Bail lis 1. Boulanger, 4 Dom. L. Rep. 1083 (19241, it was held that a doctor could use an ultraviolet lamp on a patient even though the device was relatively new. The court pointed out that the physician was obligated to use great care. An English case gave some indication that all human experimentation was not bad i n 'We should be doing a disservice to the community a t large ifwe were t o impose liability on hospitals and doctors for everything that happens t o go wrong. Doctors would be led to think more of their own safety than of the good of their patients.Initiative would be stifled and confidence shaken." In a Scottish case in which it was alleged that the doctor deviated fran normal methods of practice and experimented on the patient the court stated : "Such a deviation is not necessarily evidence of negligence. Indeed, i f it were so, all inducement to progress in medical science would then be destroyed." See Bowker, "Legal Liability to Volunteers in Testing New Drugs", 88 Canad. Med. Ass.2. 745 (1963). similar statement was found i n Mendelson v. Ginder,lBO N.Y. Supp. 2d 879 (19581,where it was said that "a departure from the approved dental method in general use is not i n and of itself negligence per se." It appears obvious that there are valid bases of dist in - gui shing all the cases discussed above from a program such as that proposed by ORINS. All of these cases are characteri zed by an unskillful deviation from established medical practices,in most of them the defendant showed a flagrant

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lack of consideration for the health and welfare of the patients.A second distinction which may be made between the decided cases and the proposed program of ORINS is that in all the cases discussed the patient came to the doctor for the purpose of obtaining treatment of then existing illnesses.In all the cases the physicians were employed to cure or treat and presumably not one of the patients consulted the doctors for the purpose of subjecting himself toan experiment. Inthe ORINS case the basic reason for entering the relationship with the prisoners would be for the purpose of conducting an experiment and presumably the prisoners would be so informed. Lawyers who advise doctors and research institutes are virtually unanimous in their opinions that the case of a n organized research effort is different from the experiment ation cases which have been decided. that no case exists in which a bona fide clinical experiment, comparable to that proposed by ORINS, has been held to const it ute unlawful experimentation and subject to the strict liability malpractice rule. These people in advising their clients on how t o conduct a program involving human ex peri - mentation have stated what they consider to be a standard by which the research conduct will be judged as well as enumerating specific rules to follow in conducting ex peri - ments involving humans. The test of liability as seen by these people is quite similar tothe test in regular mal - practice suits.In the typical case involving alleged human experimentation the issue is usually whether the doctor followed the established method of treatment for the illness.Inthe treatment case the emphasis i s on what the doctor did,andif he followed the established practice he will not be held liable. It i s contended that in research a citi vite s liability should be determined by the method or manner i n which the doctor conducts the experiment. Thus, if the research program follows the accepted standards for performing research involving human beings,then liability will not be imposed. They uniformly assert The most frequently cited set of rules dealing with the utilization of humans as experimental subjects is found inthe Trials of War Criminals Before Nuremberg Military Tribunals (Medical Case). In this case a group of Allied jurists including American judges with the advice of leaders

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The Files - 7 - April 22, 1964 of the medical profession propounded a set of rules by which the German medical profession should have conducted itself i n human experimentation programs. Although it is argued by some that these rules are not binding on American courts,they have been acknowledged t o be t h e best statement of governing standards. They are quoted next : "1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to consent; should be so situated as t o be able to exercise free power of choice, without the intervention of any element of force,fraud,deceit,duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the subject matter involved as to enable him t o make a n understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known t o him the nature,deviation, and purpose of the experiment; the method and means by which it isto be conducted; all inconveniences and hazards reasonably t o be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. "The duty and responsibility for ascertaining the quality of consent rests upon each individual who initiates,directs,or engages i n the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity. " 2 . The experiment should be such as to yield fruitful results for the good of society, unprocurable by o t h e r methods or means of study, and not random and unnecessary in nature. ' "3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or …