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MEDICAL RESEARCH AND EXPERIMENTATION 
ON HUMAN SUBJECTS: GENERAL PRINCIPLES

 Explanation of Terms and Procedures 

Some medical interventions "are designed solely to enhance the well-being of an individual patient or client" and "have a reasonable expectation of success." (1) In contrast, medical research "designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships)." (2) Similarly, medical experimentation "refers to relatively untested and usually more innovative medical and surgical procedures which…are applied…primarily as a means of contributing to the common good in the interests of humanity through anticipated progress in medical science." (3) A procedure is deemed experimental "because it has not been accepted by the medical community as a standard treatment for a specific disease or disorder, or for a subclass of patients, e.g., infants, the elderly." (4) 

Policy 

Medical research and experimentation involving human subjects is permissible provided that certain conditions are met. These conditions include (but are not necessarily limited to) the following: 

1)    Whenever possible, research and experimentation on living human beings is preceded by other types of nonhuman research and experimentation. 

2)      A human subject cannot be used merely to gain medical knowledge which will serve the common good. However, provided that his/her substantial integrity (i.e., psychophysical integrity) is preserved, a subject may undertake an experimental procedure which carries risk as a way of making a personal contribution to the progress of medicine and the common good. 

3)    In the case of a subject suffering from a disease, participation in research and experimentation should normally be for the benefit of the patient himself or herself. 

4)    The subject or his/her proxy decisionmaker must give his/her free and informed consent to participation in research and experimentation. In cases of nontherapeutic research and experimentation, a proxy decisionmaker can give consent only if the experiment entails no significant risk to the person's well-being.  Further, in instances of proxy decisionmaking, the greater the person's incompetency and vulnerability, the greater the reasons must be to perform any research and experimentation, especially when it is nontherapeutic in nature. 

5)    Consent to participation in research and experimentation must be in accordance with the rights an individual has over his/her body. Thus, when there is reason to believe that experimental procedures will entail for the subject serious injury, impairment of health, destruction or mutilation (5) of bodily parts or functions, grave dangers, death, or the destruction or considerable lessening of his/her freedom, consent cannot legitimately be given. 

6)    Researchers who themselves participate in experiments as subjects are bound by the same principles and restrictions as other individuals. 

 

Sources of Policy 

The first condition for legitimate research and experimentation was articulated by Pius XII in an address to the First International Congress of Histopathology (1952): 

In the field of science, it is an obvious law that the application of new methods to the living person must be preceded by research on the dead body or the laboratory model, and by experimenting on animals. Sometimes, however, this procedure is shown to be impossible, inadequate, or, in practice, unable to be followed. (6) 

It was reiterated by John Paul II in the context of drug testing in an address to two congresses of physicians and surgeons (1980): 

Pharmacologico-clinical research may not be initiated unless all precautions have been taken to assure that the intervention will not be positively harmful. To this end, the preclinical phase of research must provide the broadest possible documentation of the possible toxicological effects of the drug. (7) 

Responding to abuses which occurred during World War II, Pius XII set out the condition that a human subject cannot be used merely to gain medical knowledge for the common good in the aforementioned address to the First International Congress of Histopathology: 

Can the public authority, whose function it is to care for the common good, give the doctor the power to make experiments on the individual in the interests of science and the community, in order to invent and try out new methods and processes when these experiments infringe on the right of the individual to dispose of himself?...

 

The great postwar trials have brought to light a frightful quantity of documents testifying to the sacrifice of the individual to "medical interests of the community." In these acts are found testimonies and reports which show how, with the assent, and sometimes even by formal command of the public authority, certain centers demanded a regular supply of men from concentration camps for their medical experiments. We learn how men were delivered up to the centers; so many men, so many women, so many for this experiment, so many for that...

 
     Insofar as, in the cases mentioned, the moral justification of the intervention is based on the mandate of the public authority, and therefore from the subordination of the individual to the community, of the individual good to the social good, it rests on a mistaken application of the principle. It must be pointed out that man, as a person, in the final reckoning, does not exist for the use of society; on the contrary, the community exists for man. (8)

The same idea has been reiterated by John Paul II in an address to two congresses of physicians and surgeons (1980), with added clarification about the way in which an individual may legitimately contribute to the common good through medical experimentation: 

Except in special cases, the essential purpose of the patient in cooperating with the experiment is the improvement of his or her health. Any such experiment derives it primary justification from the way it serves the interests of the individual, not of the collective.

 

This does not mean, however, that, provided his or her own substantial integrity is preserved, the patient may not legitimately accept a share of risk as a way of making a personal contribution to the progress of medicine and thus to the common good. Medical science exists in the community as a force that is meant to liberate human beings from the infirmities which encumber them and from the psychic and somatic weaknesses that lay them low. Such a gift of oneself, within the limits set by the moral law, can, therefore, be a highly meritorious proof of love and an occasion for spiritual growth of such magnitude as to offset the dangers of a possible physical diminution that is not substantial in kind. (9)

 

This statement from John Paul II also puts forth the third condition for legitimate research and experimentation. 

The fourth condition is based on the Ethical and Religious Directives for Catholic Health  Care Services, directive no. 31: 

No one should be the subject of medical or genetic experimentation, even if it is therapeutic, unless the person or surrogate first has given free and informed consent.  In instances of nontherapeutic experimentation, the surrogate can give this consent only if the experiment entails no significant risk to the person's well-being.  Moreover, the greater the person's incompetency  and vulnerability, the greater the reasons must be to perform any medical experimentation, especially nontherapeutic. (10)

 

The fourth and fifth conditions are also delineated by Pius XII in his address to the First International Congress of Histopathology: 

First of all, one must suppose that the doctor, as a private person, cannot take any measure or try any intervention without the consent of the patient. The doctor has only that power over the patient which the latter gives him, be it explicitly, or implicitly and tacitly. The patient, for his part, cannot confer rights which he does not possess. The decisive point, in this problem, is the moral legitimacy of the right which the patient has at his own disposal. This is where is marked out the moral frontier for the doctor who acts with the consent of the patient.

 

As far as the patient is concerned, he is not absolute master of himself, of his body, or of his soul. He cannot, therefore, freely dispose of himself as he pleases. Even the motive for which he acts is not by itself either sufficient or determining. The patient is bound by the immanent purposes fixed by nature. He possesses the right to use, limited by natural finality, the faculties and powers of his human nature. Because he is the beneficiary, and not the proprietor, he does not possess unlimited power to allow acts of destruction or of mutilation of anatomic or functional character...

 

The patient has not the right to involve his physical and psychic integrity in medical experiments or researches, when these interventions entail, either immediately or subsequently, acts of destruction, or of mutilation and wounds, or grave dangers.

 

Furthermore, in exercising his right to dispose of himself, of his faculties and organs, the individual must observe the hierarchy of the scale of values,--and within an identical order of values, the hierarchy of individual goods, to the extent demanded by the laws of morality. So, for example, man cannot perform upon himself or allow medical operations, either physical or somatic, which beyond doubt do remove serious defects or physical or psychic weaknesses, but which entail at the same time permanent destruction of, or a considerable and lasting lessening of freedom, that is to say, of the human personality in its particular and characteristic function... (11) 

Pius XII also makes explicit that these conditions bind proxy decisionmakers: 

What We have already said is true also of the legal representatives of anyone incapable of disposing of himself and of his affairs: for example, children who have not arrived at the age of reason, the feeble of mind, the insane. Such legal representatives, appointed by a private decision or by public authority, do not possess over the body and the life of their subordinates any other rights than they themselves would have, if they were capable of it, and to the same extent. They cannot then give the doctor permission to dispose of them outside these limits. (12)

 

In an address to the Congress of the World Medical Association (1954), Pius XII is again found to state the fifth condition as well as presenting the sixth one: 

What pertains to the doctor with regard to his patient is equally applicable to the doctor with regard to himself. He is subject to the same broad moral and juridical principles as govern other men. He has no right, consequently, to permit scientific or practical experiments which entail serious injury or which threaten to impair his health to be performed on his own person; and to an even lesser extent is he authorized to attempt an operation of experimental nature which, according to authoritative opinion, could conceivably result in mutilation or suicide. This also applies, moreover, to male and female nurses, and to anyone who feels himself disposed to offer his person as a subject for therapeutic research. He cannot expose himself to such experimentation. (13) 


1. National Commission for the Protection of Human Subjects of Biomedical and Behavioral

Research, The Belmont Report  (Washington, DC: Government Printing Office, 1978), p. 2, cited in A.M. Capron, "Human Experimentation" in Robert M. Veatch (ed.), Medical Ethics (Boston: Jones & Bartlett, 1989), p. 132. 

2. Ibid., p. 3, cited in Capron, "Human Experimentation," p. 132. 

3. Orville N. Griese, Catholic Identity in Health Care: Principles and Practice (Braintree, MA: Pope John Center, 1987), p. 321. 

4. Ibid., p. 486. 

5. "The use of the word 'mutilation' as it occurs in theological writings calls for a brief explanation. The word is found as a technical term with a meaning not quite the same as that associated with its ordinary usage. ...The English derivative: mutilation, entered the clinical vocabulary with a more specific meaning and is defined by Dorland's Medical Dictionary as: 'the act of depriving a limb, member or important part; deprival of an organ.' The medical-moral definition is simply: 'the removal of an organ or the suppression of its function.'" Thomas J. O'Donnell, S.J., Medicine and Christian Morality, 2nd ed. rev. (New York: Alba House, 1991), pp. 75-6. 

6. Pius XII, "The Intangibility of the Human Person," Allocution to the First International Congress of Histopathology, Sept. 13, 1952 in The Human Body: Papal Teachings (Boston: Daughters of St. Paul, 1960), p. 207. 

7. John Paul II, "A Patient is a Person," Address to Two Congresses of Physicians and Surgeons, Oct. 27, 1980 in The Pope Speaks 26/1 (Spring 1981): 1-5 at 4. 

8. Pius XII, "The Intangibility of the Human Person," pp. 202-4. 

 9. John Paul II, "A Patient is a Person," p. 4. The principles are articulated in the context of a discussion of drug research, but it is explicitly stated that they "can be applied to other areas of medicine" (ibid.). 

10. Reprinted in Grise, Catholic Identity in Health Care: Principles and Practice, p. 486. 

11. Pius XII, "The Intangibility of the Human Person," pp. 198-9. For the condition of consent, see also John Paul II, "A Patient is a Person," p. 4. 

12. Pius XII, "The Intangibility of the Human Person," p. 201. 

13. Pius XII, "Moral Problems in Medicine," Allocution to the Eighth Congress of the World Medical Association, Sept. 30, 1964 in The Human Body: Papal Teachings, p. 315.


COMMENTARY
MEDICAL RESEARCH AND EXPERIMENTATION ON HUMAN SUBJECTS: GENERAL PRINCIPLES
 

Past Abuses with Research and Experimentation on Human Subjects 

The Nuremberg trials following World War XII brought to light medical research and experimentation conducted by the Nazis which was abusive of human subjects. The following are examples of the types of experiments conducted: 

At the Ravensbrueck concentration camp, experiments were conducted to test the effectiveness of the drug sulfanilamide. Cuts were deliberately made on the bodies of people; then the wounds were infected with bacteria. The infection was worsened by forcing wood shavings and ground glass into the cuts. Then sulfanilamide and other drugs were tested for their effectiveness in combatting the infection.

 

At the Dachau concentration camp, healthy inmates were injected with extracts from the mucous glands of mosquitos to produce malaria. Various drugs were then used to determine their relative effectiveness.

 

At Buchenwald, numerous healthy people were deliberately infected with the spotted-fever virus merely for the purpose of keeping the virus alive. Over 90% of those infected died as a result.

 

Also at Buchenwald, various kinds of poisons were secretly administered to a number of inmates to test their efficacy. Either the inmates died or they were killed at once so that autopsies could be performed. Some experimental subjects were shot with poisoned bullets.

 

At Dachau, to help the German Air Force, investigations were made into the limits of human endurance and existence at very high altitudes. People were placed in sealed chambers, then subjected to very high and very low atmospheric pressures. As the indictment put its, "Many victims died as a result of these experiments and others suffered grave injury, torture, and ill-treatment." (1) 

            Further, between 1930 and 1945 human experiments in biological warfare and physical responses to infection were conducted by Japan using prisoners of war and through field trials on mainland China. Although American officials had knowledge of these experiments, a decision was made not to prosecute the Japanese in return for the Japanese sharing with the Americans the information they had gained about biological warfare. (2) 

In addition to such complicity with improper experimentation, morally and legally questionable research projects have been conducted within the United States itself. A prime example is the Tuskegee Syphilis Study conducted under the auspices of the U.S. Department of Public Health: 

From 1932 to 1970, a large but undetermined number of black males suffering from the later stages of syphilis were examined at regular intervals to determine the course their disease was taking. The men in the study were poor and uneducated and believed that they were receiving proper medical care from the state and local public health clinics. As a matter of fact, they were given either no treatment or inadequate treatment, and at least forty of them died as a result of factors connected with their disease. Their consent was never obtained, and the nature of the study, its risks, and the alternatives open to them were never explained. It was known when the study began that those with untreated syphilis have a higher death rate than those whose

 

condition is treated, and although the study was started before the advent of penicillin

(which is highly effective against syphilis), other drugs were available but were not used in ways to produce the best results. When penicillin became generally available, it still was not used.

 

The Tuskegee Study clearly violated the Nuremberg Code, but it was not stopped even after the War Crimes trials. It was reviewed in 1969 by a USPH ad hoc committee, and it was decided that the study should be phased out in 1970. The reasons for ending the study were not moral ones. It was simply believed that there was nothing much of scientific value to be gained by continuing the work. (3)

 

            From the 1940s to the 1960s chemical testing involving e.g., mescaline and LSD was conducted by American military and intelligence agencies. Experiments took place without the knowledge and consent of the subjects and sometimes resulted in death. (4) Also the subject of controversy have been the Willowbrook hepatitis experiments which involved retarded children in a state institution (5), and an experiment involving the injection of live cancer cells into patients at the Jewish Chronic Disease Hospital. (6) 

Such abusive practices have led to the formulation of codes of research ethics, such as the Nuremberg Code (7), the Declaration of Helsinki of the World Medical Association (8), and the Policy for the Protection of Human Research Subjects from the U.S. Department of Health and Human Services. (9) Within the United States institutional review boards (IRBs) have been formed to review and approve proposed research projects as a condition for funding from the Department of Health and Human Services. (10) 

 

Ecclesiastical Statements on Medical Research and Experimentation 

The 1994 revision of the Ethical and Religious Directives for Catholic Health Care Services includes five directives pertaining to medical research and experimentation.  One directive encourages Catholic health care institutions, especially teaching hospitals, to "promote medical research consistent with its mission of providing health care and with concern for the responsible stewardship of health care resources." (11)  Two directives deal with the issue of informed consent (12), and two others concern research and experimentation in the case of embryos and fetuses. (13)  Additional principles guiding medical research and experimentation can be disengaged from occasional papal statements. These principles are not unlike criteria articulated in nonecclesiastical codes of research ethics. 

Since there is no official Church document on medical research and experimentation specifically, the principles found in ecclesiastical statements should probably not be regarded as an exhaustive list of ethical principles to be followed in conducting and participating in research and experimentation.

 

Principles Found in Ecclesiastical Statements 

(1) Whenever possible, research and experimentation on living human beings is preceded by other types of nonhuman research and experimentation. 

Specifically, Pius XII mentions "research on the dead body or the laboratory model" and "experimenting on animals." (14) This is comparable to a stipulation of the World Medical Association's Declaration of Helsinki that "Biomedical research involving human subjects…should be based on adequately performed laboratory and animal experimentation...". (15) Prior experimentation on animals is likewise mentioned in the Nuremberg Code. (16) 

Ethically appropriate and inappropriate uses of animals in research projects has become a major topic of debate. (17) Some ethicists attribute rights to animals, and some even go so far as to say that the use of animals in research projects violates their rights and ought to cease. (18) A middle ground on the use of animals in research and experimentation has been taken by Pope John Paul II. On the one hand, he has affirmed that "It is certain that animals are  at  the  service  of  man and can hence be the object of experimentation." (19) On the other hand, he cautions that animals "must be treated as creatures of God which are destined to serve man's good, but not to be abused by him." (20) Experiments "should be conducted with respect for the animal, not subjecting it to unnecessary suffering." (21) 

Pius XII also speaks of research "on the dead (human) body." (22) One must be judicious in interpreting this statement as contemporary technology has opened up possibilities not envisioned by Pius XII. For example, it is possible to sustain by technological means the vital functions of an individual who has suffered brain death. It has been proposed that such legally dead human beings be sustained specifically as subjects for medical research projects. (23) As pointed out by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, research on the brain-dead could have a disturbing effect on family members and violate commonly held convictions about respect for the dead. (24) Thus such a project should be approached cautiously. (25)

(2) A human subject cannot be used merely to gain medical knowledge which will serve the common good. However, provided that his/her substantial integrity (psychophysical integrity) is preserved, a subject may undertake an experimental procedure which carries risk as a way of making a personal contribution to the progress of medicine and the common good. 

The first clause of this criterion is a response to past abuses in research and experimentation, such as those described above. In the name of advancing knowledge, serious harm and even death have been deliberately inflicted on subjects. Individuals have been made subjects of research and experimentation without their consent, or have been kept ignorant of the true nature of the project in which they are participating. Such practices go against the intrinsic worth and dignity of the human person, and turn human beings into objects to be used. As stated in the World Medical Association's Declaration of Helsinki, "concern for the interests of the subject must always prevail over the interests of science and society." (26) 

The first clause is also a rejection of the utilitarian approach to justifying medical research and experimentation, which can allow the interests of an individual to be completely sacrificed for the sake of benefit to society.

 The second clause of this criterion brings up the issue of risk. In describing legitimate research and experimentation, ethicists typically work with a concept of proportionality between the risks and the benefits of the project, e.g., "The risk of suffering or injury must be proportionate to the good to be gained." (27) The notion of proportionality is embodied in several stipulations of the Declaration of Helsinki

Biomedical research involving human subjects cannot legitimately be carried out unless the importance of the objective is in proportion to the inherent risk to the subject.

 

Every biomedical research project involving human subjects should be preceded by careful assessment of predictable risks in comparison with foreseeable benefits to the subject or to others.

   

Physicians   should   abstain  from  engaging  in  research  projects  involving  human

subjects unless they are satisfied that the hazards involved are believed to be predictable. Physicians should cease any investigation if the hazards are found to outweigh the potential benefits. (28) 

The concept of proportionality is likewise included in the Nuremberg Code (29) and in the Policy for the Protection of Human Research Subjects developed by the U.S. Department of Health and Human Services. (30)

  

(3) In the case of a subject suffering from a disease, participation in research and experimentation should normally be for the benefit of the patient. 

Some types of medical research and experimentation (e.g., phase one testing of new drugs, the testing of vaccines) involve the use of healthy subjects. Many other types involve subjects who are themselves suffering from a disease. A distinction is drawn between therapeutic and nontherapeutic research and experimentation. Research and experimentation is considered therapeutic if it holds out a reasonable expectation of improving the health status of the patient-subject. Research and experimentation is classified as nontherapeutic if it is not expected to improve the health of the patient-subject, but will yield information and knowledge which will benefit other people. (31) 

In an address to two congresses of physicians and surgeons, John Paul XII has stated: 

Except in special cases, the essential purpose of the patient in cooperating with the experiment is the improvement of his or her health. Any such experiment derives its primary justification from the way it serves the interests of the individual, not of the collective. (32) 

The qualification except in special cases indicates that participation in nontherapeutic research and experimentation is not completely ruled out. However, the nontherapeutic exceptions are not spelled out. The import of the statement is that therapeutic research and experimentation is the norm when dealing with patients. 

In the spirit of placing the welfare of the patient first, some ethicists would add a further stipulation about patient participation in experimental medical treatment: It must be the case either that there is no proven treatment available, or that the standard treatment has failed, or that the particular status of the patient has ruled out the standard treatment, or that the experimental treatment represents a less radical or risky procedure than the standard treatment and does not preclude the later use of established modes of treatment. (33) 

Some research projects involve use of a control group which is given a placebo or upon which a sham intervention is used. In the case of research subjects who are themselves suffering from a disease, it is ordinarily morally wrong to give the control group nothing when a proven treatment is available. An alternative experimental design can be employed in which the effectiveness of a new form of treatment is compared with that of the standard treatment. While this alternative may be less satisfactory from a scientific point of view, it is preferable from a moral point of view. (34) Likewise, when dealing with research subjects who are themselves suffering from a disease, it is ordinarily morally wrong to continue to give a placebo to the control group when the new experimental treatment proves to work well. 

(4) The subject or his/her proxy decisionmaker must give his/her free and informed consent to participation in research and experimentation. 

Consent to participation in research and experimentation is a major theme in codes of research ethics. The first principle of the Nuremberg Code is that the "voluntary consent of the human subject is absolutely essential." (35) The World Medical Association's Declaration of Helsinki includes several stipulations regarding free and informed consent:

In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be informed that he or she is at liberty to abstain from participation in the study and that he or she is free to withdraw his or her consent to participation at any time. The physician should then obtain the subject's freely given informed consent, preferably in writing.

 

In the case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject in accordance with national legislation. (36)

 

The Policy for the Protection of Human Research Subjects developed by the U.S. Department of Health and Human Services not only states that "informed consent will be sought from each prospective subject or the subject's legally authorized representative" (37), but spells out in detail the nature of the information to be provided to potential research subjects. (38)  Similarly, the Ethical and Religious Directives for Catholic Health Care Services indicates elements which should be included in the process of obtaining free and informed consent:  

Free and informed consent requires that the person or the person's surrogate receive all reasonable information about the essential nature of the proposed treatment and its benefits; its risks, side-effects, consequences, and cost; and any reasonable and morally legitimate alternatives, including no treatment at all. (no. 27)   (39) 

Some research projects use a control group which is given a placebo or upon which a sham intervention is used. In fact, some projects are double-blind, that is, conducted in such a way that neither participants nor researchers know which subjects are being given the experimental treatment and which are being given a placebo. As part of the consent process for such projects, subjects should be told in advance that they may be in the position of receiving a placebo or sham intervention. This is particularly important in the case of subjects who are themselves suffering from a disease. 

Putting the concept of free and informed consent into practice is not without difficulty. The risks involved in a research project should be explained to potential subjects before they give their consent, but sometimes researchers themselves do not know all the risks which may be involved. (40) Researchers must take care to present information in language that is understandable to potential subjects. (41) And, even then, subjects may have difficulty grasping the full import of the information. For example, how can someone "appreciate the sensation of living for days with a multi-lumen intestinal tube passing through his mouth and pharynx" (42) just from a verbal description? Yet another danger is overwhelming potential subjects with excessively detailed information; indeed, this may be a subtle way of coercing consent. (43)

As pointed out by the U.S. Department of Health and Human Services, certain categories of potential research subjects "are likely to be vulnerable to coercion or undue influence, such as persons with acute or severe physical or mental illness, or persons who are economically or educationally disadvantaged." (44) This was certainly true in the case of the Tuskegee Syphilis Study (45): 

…during the Tuskegee Syphilis experiments various methods were used to stimulate

and sustain the interest of the subjects in continued participation. They were offered free burial assistance and insurance, free transportation, and a free stop in town on the return trip. They were also rewarded with free medicines and free hot meals on the days of the examination. The deprived socioeconomic condition of these subjects made them easily manipulable by those means. (46) 

It may not be so obvious that "ordinary patients in hospitals may also be subject to pressures that call in question the voluntariness of the consent that they give" (47): 

Patients are psychologically predisposed to act in ways that please physicians. Not only do physicians possess a social role that makes them figures of authority, but an ill person feels very dependent on those who may possess the power to make him well. Thus, he will be inclined to go along with any suggestion or recommendation

 

made by a physician. The ordinary patient, like the inmate in an institution, needs protection from the social and psychological pressures that are exerted by circumstances. Otherwise, the voluntariness of consent will be compromised… (48) 

It has also been pointed out that nursing homes and mental hospitals are total institutions within which "all aspects of a person's life are connected with the social structure." (49) In turn, there can be social forces operating to encourage and pressure a resident/patient to do what is expected of him/her. (50) 

In the past prisoners have been used in research projects. Whether individuals in a prison setting are truly capable of exercising freedom of choice, and thus, whether they should be considered as potential research subjects at all, has been a matter of considerable debate. (51) 

When an individual is incompetent to give consent to participation in a research project (e.g., a child, an individual who is mentally retarded, an incapacitated adult), this task must be assumed by a proxy decisionmaker. A distinction has been drawn by some ethicists between consenting for oneself and the role of consenting for another. Specifically, some ethicists hold that proxy decisionmakers cannot licitly give consent to experimentation that is nontherapeutic in character. (52) This restriction is based on the duty of a proxy to act in the best interests and for the welfare of the person he/she represents. (53) Other ethicists take a less restrictive position, allowing for proxy consent to experimentation which poses only minimal risk. (54) 

In general, the Ethical and Religious Directives for Catholic Health Care Services does not completely rule out proxy consent for participation in nontherapeutic research and experimentation, but takes a position in line with the minimal risk standard: 

No one should be the subject of medical or genetic experimentation, even if it is therapeutic, unless the person or surrogate first has given free and informed consent.  In instances of nontherapeutic experimentation, the surrogate can give this consent only if the experiment entails no significant risk to the person's well-being. 

(no. 31)   (55) 

However, a stipulation is added that "the greater the person's incompetency and vulnerability, the greater the reasons must be to perform any medical experimentation, especially nontherapeutic" (no. 31).  (56)  Moreover, there is one exception to this general policy, namely, that parents cannot legitimately consent to nontherapeutic experimentation on a living embryo or fetus. (57) 

Finally, it should be recognized that another dimension of informed consent is the right of the subject (or his/her proxy) to terminate participation in research and experimentation at any time (58), a point made explicit in the Nuremberg Code. (59) 

(5) Consent to participation in research and experimentation must be in accordance with the rights an individual has over his/her body. Thus, when there is reason to believe that experimental procedures will entail for the subject serious injury, impairment of health, destruction or mutilation of bodily parts or functions, grave dangers, death, or the destruction or considerable lessening of his/her freedom, consent cannot legitimately be given. 

In contrast to an unqualified concept of autonomy, the Catholic moral tradition works with a concept of stewardship. Life is considered a gift from God which we hold in trust, and thus we are not at liberty to do anything we may wish with our psychophysical life. 

That research and experimentation should not bring harm to subjects is emphasized in the Nuremberg Code

No experiment should be conducted where there is an a priori reason to believe that death or disabling injury ill occur...

 

Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

 

During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject. (60)

  

(6) Researchers who themselves participate in experiments as subjects are bound by the same principles and restrictions as other individuals. 

Although there are many similarities between Catholic moral teaching and major codes of research ethics, the Nuremberg Code departs from this particular principle. While maintaining that experimentation should not be conducted when there is "a priori reason to believe that death or disabling injury will occur," it allows as a possible exception "those experiments where the experimental physicians also serve as subjects." (61)

 

Other Principles Guiding Medical Research and Experimentation 

Given that there is no official Church document devoted specifically to the issue of medical research and experimentation, the principles found in ecclesiastical statements should probably not be taken as an exhaustive list of ethical principles to be followed. Even in the course of discussing these principles, several additional criteria have been suggested, viz., concerning a proportionality between the risks and benefits of a research project and concerning patient participation in experimental medical treatment when a standard, proven treatment is available. Yet other suggested criteria include the following principles: 

The knowledge sought through research and experimentation must be important and obtainable by no other means. (62) 

The research and experimentation must be carried on by appropriately qualified persons. (63) 

Subjects are selected equitably, that is, certain groups within society are not overutilized or exploited because of availability or convenience. (64)

 

This last principle is intended to protect against exploitation of e.g., the poor and the institutionalized as research subjects. 

Psychological Research and Experimentation 

The Ethical Principles of Psychologists and Code of Conduct from the American Psychological Association includes a section on research ethics. (65) In this document it is stated that "Psychologists design, conduct, and report research in accordance with recognized standards of scientific competence and ethical research" (66) and that "Psychologists take reasonable steps to implement appropriate protections for the rights and welfare of human participants, other persons affected by the research, and the welfare of animal subjects." (67) In other words, one can expect psychologists to take the same sort of precautions as are taken for other types of medical research and experimentation. 

The Ethical Principles of Psychologists and Code of Conduct explicitly includes the requirement of informed consent. (68) Prima facie, it might seem that a patient under psychological or psychiatric treatment, by the very nature of his/her illness, is not competent to give informed consent to participation in research and experimentation. This issue has been explored by Rem B. Edwards: 

Applying the principle of informed voluntary consent to psychiatric patients is complicated by the fact that, in these cases, the part of the person which controls knowing and willing is the diseased part. This generates the presumption in practice that the patient is not really competent to consent. Such a presumption has doubtless reinforced our resistance to applying this fundamental ethical principle to psychiatric patients themselves. We appeal instead to proxy consent by others on their behalf, a proxy consent often given in the clinical setting by the treating physician, or by family, friends, or guardians. Increasingly, however, we are realizing that to presume the incompetence of an individual is too much like a court's presumption that a defendant is guilty until proven innocent.

 

Although only an exceptionally alert and sensitive mental hospital staff can and will implement it, the ideal presumption should be that the patient is competent until and unless this presumption is defeated by his or her own behavior. Psychiatric illness is highly episodic, and it is always worthwhile to approach the patient afresh each new day with the presumption of competence. Legally, a formal competency hearing is required when specific areas of competency are at issue; but day to day judgments of the patient's ability to understand and manage must also be made by those who deal with the mentally ill. Most patients have periods of lucidity between psychotic episodes, are able to understand and cope in some areas of life even if they have blocks in others, and can best achieve responsible rational autonomy only if it is constantly being thrust upon them. (69)

 

When a patient is legally incapable of giving informed consent, the Ethical Principles of Psychologists and Code of Conduct stipulates that the psychologist should still provide an appropriate explanation of the proposed research, obtain the participant's "assent" (70), and obtain appropriate permission from a legally authorized person, if such substitute consent is permitted by law. (71) 

When considering informed consent, the aforementioned document also makes special note of the situation of students: 

When psychologists conduct research with individuals such as students or subordinates, psychologists take special care to protect the prospective participants from adverse consequences of declining or withdrawing from participation.

 

When research participation is a course requirement or opportunity for extra credit, the prospective participant is given the choice of equitable alternative activities. (72)

 

Catholic ethicists Benedict Ashley and Kevin O'Rourke recommend that psychological researchers work with rather than on subjects so that the experience becomes an opportunity for them to gain greater insight into themselves. (73) They further recommend that research projects avoid weakening or losing the trust of subjects by lying to or manipulating them. (74) As they point out, this is especially important "when dealing with mentally disturbed patients, since elements of distrust, withdrawal, and paranoia present in most forms of emotional disturbance can only be reinforced by deception from professionals who claim to be especially trustworthy and authoritative." (75) They also caution that psychological researchers should never take actions that permanently reduce the ability of subjects to remain free in managing their own lives. (76) This caution "applies to experiments that might make the subject unduly liable to hypnotic control or to compulsive patterns of behavior or that might create recurrent hallucinations." (77) 

 

Legal Considerations 

FEDERAL 

The National Research Act (1974) requires all recipients of research funds from the Department of Health and Human Services to establish an Institutional Review Board (IRB) to assess research protocols. The act also created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, whose duties include making recommendations about federal  rules on human research. (78) The Commission issued a series of reports (79) which resulted in the Department of Health and Human Services promulgating a revised set of regulations in 1981. (80) These regulations, the Policy for the Protection of Human Research Subjects, "provide the basic framework for oversight of research in the United States." (81)  

STATE OF IOWA 

At least in the context of civil liability claims for assault and battery or negligence on the part of a healthcare provider, the Iowa Supreme Court has attempted to spell out what is involved in informed consent. In Cowman v. Hornaday, 329 N.W. 2d 422 (Iowa 1983), the Iowa Supreme Court first selected the patient rule approach to informed consent over the professional rule approach. In discussing the evolution of the two different approaches, the Court explained: 

The first is the “professional rule”, which in essence requires the patient to prove the customary disclosure practices of physicians or what a reasonable physician would disclose under the same or similar circumstances... The second, or 'patient rule,' generally requires that the physician's communications to the patient be measured by the latter’s need, and that need is the information material to the decision... 

Once the court determined that material information must be supplied, the court went on to discuss which of two different tests for materiality, viz., subjective or objective, should be employed: 

In determining materiality in this context two different tests have been articulated. The first, which mainly exists only in theory, is a "subjective" test, focusing on whether the particular patient would have considered the nondisclosed information sufficiently significant so as to affect his or her decision... Most jurisdictions following the patient rule, however, apply an "objective" test. Thus the Wilkinson court wrote:  

 

(A) physician is bound to disclose all the known material risks peculiar to the proposed procedure. Materiality may be said to be the significance a reasonable person, in what the physician knows or should know is his patient's position, would attach to the disclosed risk or risks in deciding whether to submit or not to submit to surgery or treatment. 

In Doe v. Johnston, 476 N.W. 2d 28 (Iowa 1991), the Iowa Supreme Court expressly adopted the objective test for determining materiality under the patient rule.

1. Ronald Munson (ed.), Intervention and Reflection Basic Issues in Medical Ethics, 4th ed. (Belmont, CA: Wadsworth Publishing, 1992), p. 320.

 2. A.M. Capron, "Human Experimentation" in Robert M. Veatch (ed.), Medical Ethics  (Boston: Jones & Bartlett, 1989), pp. 137-8. 

3. Munson, Intervention and Reflection, p. 331. 

4. Capron, "Human Experimentation", pp. 138-9. 

5. For a description of these experiments and the ensuing controversy, see Munson, Intervention and Reflection, pp. 312-4, 367-75. 

6. Elinor Langer, "Human Experimentation: New York Verdict Affirms Patient's Rights" in Samuel Gorovitz et al., Moral Problems in Medicine  (Englewood Cliffs, NJ: Prentice-Hall, 1976), pp. 142-50. 

7. The text of this code is frequently reprinted in bioethics textbooks. See, for example, Tom L. Beauchamp and LeRoy Walters (eds.), Contemporary Issues in Bioethics, 5th ed. (Belmont. CA: Wadsworth, 1999), p. 433. 

8.  The Declaration of Helsinki was originally adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964, and subsequently amended by the 29th World Medical Assembly, Tokyo, Japan, 1975; the 35th World Medical Assembly, Venice, Italy, 1983; the 41st World Medical Assembly, Hong Kong, 1989; and the 48th General Assembly, Somerset West, Republic of South Africa, 1996. The text of this code is frequently reprinted in bioethics textbooks. See, for example, Beauchamp and Walters (eds.), Contemporary Issues in Bioethics, 5th ed., pp. 434-6. 

9. The text of this code is frequently reprinted in bioethics textbooks. See, for example, Robert M. Veatch (ed.), Medical Ethics, 2nd ed. (Boston: Jones and Bartlett, 1997), pp. 177-84. 

10. Capron, "Human Experimentation", pp. 146-8. 

11. National Conference of Catholic Bishops, Ethical and Religious Directives for Catholic Health Care Services (Nov. 1994)  (Washington, DC: United States Catholic Conference, 1995), no. 4. 

12. Ibid., nos. 27, 31. 

13. Ibid., nos. 51, 66.  For discussion of these directives, see the entry RESEARCH AND EXPERIMENTATION INVOLVING EMBRYOS AND FETUSES. 

14. Pius XII, "The Intangibility of the Human Person", Allocution to the First International Congress of Histopathology, Sept. 13, 1952 in The Human Body: Papal Teachings (Boston: Daughters of St. Paul, 1960), p. 207. 

15. World Medical Association, Declaration of Helsinki, I.1; reprinted Beauchamp and Walters (eds.), Contemporary Issues in Bioethics, 5th ed., p. 434. 

16. Nuremberg Code, no. 3; reprinted in Beauchamp and Walters (eds.), Contemporary Issues in Bioethics, 5th ed., p. 433. 

17. Tom Regan, The Case for Animal Rights (Berkeley: University of California Press, 1983); Tom Regan, All That Dwell Therein: Animal Rights and Environmental Ethics  (Berkeley: University of California Press, 1982); Andrew Linzey & Tom Regan (ed.), Animals and Christianity: A Book of Readings (New York: Crossroads, 1988); Tom Regan (ed.), Animal Sacrifices: Religious Perspectives on the Use of Animals in Science (Philadelphia: Temple University Press, 1986); Robert M. Baird & Stuart E. Rosenbaum (eds.), Animal Experimentation: The Moral Issues (Buffalo, NY: Prometheus Books, 1991); Jeanne Williams (ed.), Animal Rights  (New York: H.W. Wilson, 1991); Janelle Rohr (ed.), Animal Rights: Opposing Viewpoints (San Diego, CA: Greenhaven Press, 1989); Bernard E. Rollin, Animal Rights and Human Morality  (Buffalo, NY: Prometheus Books, 1981). 

18. See, for example, Tom Regan, "Animal Rights and Experimentation" in Munson, Intervention and Reflection, pp. 381-87. 

19. John Paul XII, "Biological Research and Human Dignity", Address to participants in a week of study sponsored by the Pontifical Academy of Sciences, Oct. 23, 1982 in Origins 12/21 (Nov. 4, 1982): 342-3 at 432. 

20. Ibid., pp. 342-3. 

21. John Paul XII, "Church Offers Principles to Guide Medical Advances", Excerpt of address to the first international congress organized by the Pontifical Commission for the Apostolate of Health Care Workers, Oct. 24, 1986, Health Progress  (April 1987): 84, 93 at 84. 

22. See note 14 above. 

23. Willard Gaylin, "Harvesting the Dead," Harpers 249 (Sept. 1974): 23-6; R. Carson, J. Frias & R. Melker, "Case Study: Research with Brain-Dead Children", IRB 3/1 (1981): 5-6; S. Martyn, "Using the Brain Dead for Medical Research", Utah Law Review  (1986): 1-28. 

24. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Implementing Human Research Regulations (Washington, D.C.: Government Printing Office, 1983), p. 40. Cited in Capron, "Human Experimentation", pp. 158-9. 

25. The President's Commission has recommended that the use of Institutional Review Boards be expanded to all research on the deceased, including the brain dead (ibid., p. 41; cited in Capron, "Human Experimentation", p. 159). 

26. World Medical Association, Declaration of Helsinki I.5; reprinted in Beauchamp and Walters (eds.), Contemporary Isssues in Bioethics, 5th ed.. p. 435. 

27. Benedict M. Ashley, O.P. & Kevin D. O'Rourke, O.P., Healthcare Ethics A Theological Analysis, 3rd ed. (St. Louis: Catholic Health Association, 1989), p. 323. 

28. World Medical Association, Declaration of Helsinki I.4, 5, 7; reprinted in Beauchamp and Walters (eds.), Contemporary Issues in Bioethics, 5th ed., p. 435. 

29. Nuremberg Code, no. 6; reprinted in Beauchamp and Walters (eds.), Contemporary Issues in Bioethics, 5th ed., p. 433. 

30. U.S. Department of Health and Human Services, Policy for the Protection of Human Research Subjects, 46.111 (2); reprinted in Veatch (ed.), Medical Ethics, 2nd ed., p. 181. 

31. For this distinction, see e.g., Ashley & O'Rourke, Healthcare Ethics, p. 236. 

32. John Paul XII, "A Patient is a Person," Address to Two Congresses of Physicians and Surgeons, Oct. 27, 1980 in The Pope Speaks  26/1 (Spring 1981): 1-5 at 4. 

33. See, e.g., Orville N. Griese, Catholic Identity in Healthcare: Principles and Practice (Braintree, MA: Pope John Center, 1987), p. 486:  "There is the presumption, of course, that established or standard modes of treatment have been tried unsuccessfully, or that the particular status of the individual has ruled out a priori the accepted procedures." Griese fails to take into account, however, the situation in which a proven treatment is available but research and experimentation is desired on a new type of treatment which may prove better in certain respects. 

34. Munson, Intervention and Reflection, pp. 325-6; Capron, "Human Experimentation," pp. 154-5. Capron adds a qualification: "...when a study is being done with patients, it is usually ethically required to assign the control group to the best available form of treatment rather than to a placebo, although there are factors that can outweigh this presumption (such as when the failure to use any treatment would create at worst a small or transient risk to subjects and when the existing treatment differs too much from the intervention being tested to allow a blind or double-blind study)." Ibid., p. 155. 

35. Nuremberg Code, no. l; reprinted in Beauchamp and Walters (eds.), Contemporary Issues in Bioethics, 5th ed., p. 433. 

36. World Medical Association, Declaration of Helsinki I.9, 11; see also I.10. Reprinted in Beauchamp and Walters (eds.), Contemporary Issues in Bioethics, 5th ed., p. 435. 

37. U.S. Department of Health and Human Services, Policy for the Protection of Human Research Subjects, 46.111 (4); reprinted in Veatch (ed.), Medical Ethics, 2nd ed., p. 181. 

38. Ibid., 46.116 (a)-(b): "(a) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information shall be provided to each subject: (1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental; (2) A description of any reasonably foreseeable risks or discomforts to be subject; (3) A description of any benefits to the subject or to others which may reasonably be expected from the research; (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; (7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. (b) Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable; (2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent; (3) Any additional costs to the subject that may result from participation in the research; (4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject; (5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and (6) The approximate number of subjects involved in the study." Reprinted in Veatch (ed.), Medical Ethics, 2nd ed., pp. 182-3. 

39. National Conference of Catholic Bishops, Ethical and Religious Directives for Catholic Health Care Services (Nov. 1994) (Washington, DC: United States Catholic Conference, 1995). 

40. Louis Lasagna, "Some Ethical Problems in Clinical Investigation" in Munson, Intervention and Reflection, p. 341. 

41. Ibid

42. F.J. Ingelfinger, "Informed (But Uneducated) Consent" in Munson, Intervention and Reflection, p. 356. 

43. Ibid., "Extensive detail, moreover, usually enhances the subject's confusion. Epstein and Lasagna showed that comprehension of medical information given to untutored subjects is inversely correlated with the elaborateness of the material presented. The inconsiderate investigator, indeed, conceivably could exploit his authority and knowledge and extract 'informed consent' by overwhelming the candidate-subject with information." 

44. United States Department of Health and Human Services, Policy for the Protection of Human Research Subjects, 46.111 (7b); reprinted in Veatch (ed.), Medical Ethics, 2nd ed., p. 182. 

45. See above "Past Abuses with Research and Experimentation on Human Subjects." 

46. Tom L. Beauchamp, "Informed Consent" in Veatch (ed.), Medical Ethics, p. 190. 

47. Munson, Intervention and Reflection, p. 324. 

48. Ibid

49. Ibid

50. Ibid

51. Ibid., pp. 329-30; Beauchamp, "Informed Consent" in Veatch (ed.), Medical Ethics, p. 187. 

52. This position is taken e.g., by Ashley & O'Rourke, Healthcare Ethics, p. 240. For a critical discussion of this position, see Munson, Intervention and Reflection, pp. 328-9. 

53. Ashley & O'Rourke, Healthcare Ethics, pp. 240-1; Munson, Intervention and Reflection, p. 328. 

54. See Ashley & O'Rourke, Healthcare Ethics, p. 240. 'Minimal risk' is a technical term. In the Policy for the Protection of Human Research Subjects from the U.S. Department of Health and Human Services, it is defined as meaning "that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." (46.102 (g); reprinted in Veatch (ed.), Medical Ethics, 2nd ed., p. 179. 

55. National Conference of Catholic Bishops, Ethical and Religious Directives for Catholic Health Care Services (Nov. 1994)  (Washington, DC: United States Catholic Conference, 1995). 

56. Ibid

57. Ibid

58. Robert J. Levine and Karen Lebacqz, "Ethical Considerations in Clinical Trial" in Rem B. Edwards & Glenn C. Graber (eds.), Bioethics (New York: Harcourt Brace Jovanovich, 1988), p. 220; Ashley & O'Rourke, Healthcare Ethics, p. 241; Griese, Catholic Identity in Health Care: Principles and Practice,  p. 322. 

59. Nuremberg Code, no. 9; reprinted in Beauchamp and Walters (ed.), Contemporary Issues in Bioethics, 5th ed. , p. 433. 

60. Ibid., nos. 5, 7, 10; reprinted in Beauchamp and Walters (ed.), Contemporary Issues in Bioethics, 5th ed., p. 433. 

61. Ibid., no. 5; reprinted in  Beauchamp and Walters (ed.), Contemporary Issues in Bioethics, 5th ed., p. 433. 

62. See Ashley and O'Rourke, Healthcare Ethics, p. 236; Nuremberg Code, no. 2, reprinted in Beauchamp and Walters (eds.), Contemporary Issues in Bioethics, 5th ed., p. 433. 

63. See Ashley & O'Rourke, Healthcare Ethics, p. 236; Griese, Catholic Identity in Health Care: Principles and Practice, p. 323; Nuremberg Code, no. 8, reprinted in Beauchamp and Walters (eds.), Contemporary Issues in Bioethics, 5th ed., p. 433; World Medical Association, Declaration of Helsinki  I.3, reprinted in Beauchamp and Walters (eds.), Contemporary Issues in Bioethics, 5th ed., p. 434. 

64. See Levine & Lebacqz, "Ethical Considerations in Clinical Trials," p. 221-2; Ashley & O'Rourke, Healthcare Ethics, p. 238; U.S. Department of Health and Human Services, Policy for the Protection of Human Research Subjects 46.111 (3), reprinted in Veatch (ed.), Medical Ethics, 2nd ed., p. 181. 

65. American Psychological Association, Ethical Principles of Psychologists and Code of Conduct 6.06 - 6.20, in American Psychologist  47/12 (Dec. 1992): 1597-1611 at 1608-9. 

66. Ibid., 6.06(a). 

67. Ibid., 6.06(d). 

68. Ibid., 6.11. 

69. Rem B. Edwards, Psychiatry and Ethics (Buffalo, NY: Prometheus Books, 1982), p. 190. 

70. 'Assent' refers to a patient's compliance with or submission to a procedure. See Beauchamp, "Informed Consent", p. 183. 

71. American Psychological Association, Ethical Principles of Psychologists and Code of Conduct 6.11 (e). 

72. Ibid., 6.11 (c)-(d). 

73. Ashley & O'Rourke, Healthcare Ethics, p. 242.

74. Ibid., "This rule against lying, however, does not prohibit experiments in which previous warning is given that the experiment may involve games with ambiguous clues and the subject's possible embarrassment and defeat" (ibid., p. 243). The issue of deception in research is dealt with in the American Psychological Association's Ethical Principles of Psychologists and Code of Conduct  6.15. 

75. Ashley & O'Rourke, Healthcare Ethics, p. 242. 

76. Ibid., p. 243. 

77. Ibid., p. 243.

78. Capron, "Human Experimentation", p. 146.

 79. These reports include Research on the Fetus (1975), Research Involving Children (1977), The Belmont Report (1978), and Institutional Review Boards (1978); see Capron, "Human Experimentation", pp. 146, 162. 

80. Capron, "Human Experimentation", p. 146. 

81. Ibid. 


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