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Judicial Council
Ethical Guidelines for
Organ Transplantation
Tt should be apparent that no stigma is attached
to the performance of human experiments per se;
- disgrace and infamy can arise only through its
misuse. The moral obligation of performing all
human experiments, with due regard to the sensi-
bility, welfare, and safety of the subject, must not
be violated. As phrased by Claude Bernard in
1856, "Christian morals forbid only one thing,
doing ill to one's neighbor." So, among experi-
ments that may be tried on man, those that can
only do harm are forbidden, those that are harm-
less are permissible, and those that may do good
are obligatory.
-S. S. Kety
he medical profession, in its never-ending search
for ways to save human life, relieve suffering,
and improve health, has always been motivated
and guided by the principles expressed in the above
quotation. To achieve these goals, it has recognized
that proper standards must be established and fol-
lowed in clinical investigation and experimentation
involving human beings.
In 1946, the American Medical Association suc-
cinctly listed three ethical guidelines to be followed
in human experimentation in order to have such
experimentation conform to medical ethics: (1)
voluntary consent must be obtained from the per-
son on whom the experiment is to be performed;
(2) the dangers of each experiment must have been
previously investigated by animal experimenta-
tion; and (3) the experiment must be performed
under proper medical protection and management.
In 1964, the World Medical Association adopted
the Declaration of Helsinki, which was later en-
dorsed by the American Medical Association. The
Declaration emphasizes "freely given consent" and
differentiates between clinical research combined
with professional care and nontherapeutic clinical
research.
In 1966, the American Medical Association
Reprint requests to AMA Judical Council, 535 N Dearborn St,
Chicago 60610.
Presented by E. G. Shelley, MD, chairman of the Judicial Coun-
cil, as Report B to Reference Committee E of the House of Dele-
gates, and approved by the House, June 1968.
JAMA, Aug 5, 1968 Vol 205, No 6
adopted a longer statement-'"'Ethical Guidelines
for Clinical Investigation." In part, these guide-
lines state:
In clinical investigation primarily for treatment,
A. The physician must recognize that the physician-
patient relationship exists and that he is expected
_ to exercise his professional judgment and skill in
the best interest of the patient.
B. Voluntary consent must be obtained from the pa-
tient, or from his legally authorized representa-
tive if the patient lacks the capacity to consent,
following: disclosure that the physician intends
to use an investigational drug or experimental
procedure; a reasonable explanation of the na-
ture of the drug or procedure to be used, risks to
be expected, and possible therapeutic benefits;
an offer to answer any inquiries concerning the
drug or procedure; and a disclosure of alterna-
tive drugs or procedures that may be available.
The Principles of Medical Ethics and these sev-.
eral statements have provided broad guidelines dur-
ing the period when transplants of major body
organs were first performed. In the opinion of the
Judicial Council these principles continue to be
3: Valid,
Now, theologians, lawyers, and other public-
spirited persons, as well as physiciens, are discuss-
ing with deep concern the many new questions
raised by the transplantation of vital organs. Man
participates in these procedures: he is the patient
in them; or he performs them. All mankind is the
ultimate beneficiary of them.
A man, in the final analysis, must make a deci-
sion whether to permit or to perform a transplanta-
tion procedure. The decision must be a reasoned,
intellectual decision, not an emotional decision. As
medical science advances, and as technological skill
increases, the ethical questions involved may be-
come increasingly complex and difficult.
The Judicial Council, therefore, commends dis-
cussions of the moral, ethical, legal, social, and
other aspects of clinical investigation, experimen-
tation, and organ transplantation in human beings.
It commends all efforts which encourage respect for
&9
_ 342
urs FOR ORGAN TRANSPLANTATION
the dignity of man, and which seek to sensitize
man's ethical conscience.
The Judicial Council of the AMA offers the fol-
lowing statement for guidance of physicians as they
seek to maintain the highest level of ethical conduct
in their practices.
de
90
In all professional relationships between a physician and
his patient, the physician's primary concern must be
the health of his patient. He owes the patient his primary
allegiance. This concern and allegiance must be pre-
served in all medical procedures, including those which
involve the transplantation of an organ from one person
to another where both donor and recipient are patients.
Care must, therefore, be taken to protect the rights of
both the donor and the recipient, and no physician may
assume a responsibility in organ transplantation unless
the rights of both donor and recipient are equally pro-
tected.
. A prospective organ transplant offers no justification for
relaxation of the usuai standards of medical care. The
physician should provide his patient, who may be a pros-
pective organ donor, with that care usually given others
being treated for a similar injury or disease.
.When a vital, single organ is to be transplanted, the
death of the donor shall have been determined by at
least one physician other than the recipient's physician.
Death shall be determined by the clinical judgment of the
physician. In making this determination, the ethical phy-
sician will use all available, currently accepted scientific
tests.
. Full discussion of the proposed procedure with the donor
and the recipient or their responsible relatives or repre-
sentatives is mandatory. The physician should be objec-
tive in discussing the procedure, in disclosing known
risks and possible hazards, and in advising of the alterna-
tive procedures available. The physicians should not en-
courage expectations beyond those which the circum-
stances justify. The physician's interest in advancing
scientific knowledge must always be secondary to his
primary concern for the patient.
5. Transplant procedures of body organs should be under-
taken (a) only by physicians who possess special medical
knowledge and technical competence developed through
special training, study, and laboratory experience and
- practice, and (b) in medical institutions with facilities
adequate to protect the health and well-being of the par-
ties to the procedure.
6. Transplantation of body organs should be undertaken
only after careful evaluation of the availability and effec-
tiveness of other possible therapy.
7. Medicine recognizes that organ transplants are news-
worthy and that the public is entitled to be correctly in-
formed about them. Normally, a scientific report of the
procedures should first be made to the medical profes-
sion for review and evaluation. When dramatic aspects
of medical advances prevent adherence to accepted pro-
cedures, objective, factual, and discreet public reports to
the communications media may be made by a properly
authorized physician, but should be followed as soon as
possible by full scientific reports to the profession.
In organ transplantation procedures, the right
of privacy of the parties to the procedures must
be respected. Without their authorization to dis-
close their identity the physician is limited to an
impersonal discussion of the procedure.
Reporting of medical and surgical procedures
should always be objective and factual. Such re-
porting will also preserve and enhance the stature
of the medical profession and its service to mankind. _
EL THICS/ETIQUETTE.-For the average physician, medical ethics (of which
'4 there is no satisfactory exposition) means only medical etiquette, and actually
there is usually as great a penalty attached to a transgression of one as to the other.
Medical etiquette is concerned with the conduct of physicians toward each other,
"and embodies the tenets of professional courtesy. Medical ethics should be con-
cerned with the ultimate consequences of the conduct of physicians toward their
individual patients and toward society as a whole, and it should include a considera-
tion of the will and motive behind this conduct... .
It is interesting that writers on medical ethics have seldom availed themselves
of the philosophical analyses of the principles of ethical theory made by recognized
ethical scholars. The two chief ethical positions are idealism which stresses the in-
terests of humanity as a whole, and hedonism which emphasizes the interests of
individual selves. Hedonism is usually concerned with personal pleasure; ideal-
ism, with the furtherance of the welfare of society.
The ethical basis for the professional system of etiquette is primarily hedonistic,
since it is designed to promote the dignity and pecuniary advancement of the
individual physician and of the profession as a whole. On the other hand, the
ethical basis for the professed attitude of medicine toward the sick and toward the
public is idealistic, since it presumes that every professional act of the physician
is motivated by rational and sincere concern for the ultimate welfare of society.
These two ethical positions are difficult to compromise.-Leake, C.D. (ed.): "In-
troductory Essay," in Percival's Medical Ethics, Baltimore: Williams & Wilkins,
1927, p23.
JAMA, Aug 5, 1968 Vol 205, No 6