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), T he Belmont Report
(1978), and  Institutional Review Boards
(1978); see Capron, “Human Experimentation”, pp. 146, 162.

80.
Capron, “Human Experimentation”, p. 146.

81.
Ibid.