World Health Organization, Guiding Principles on Human Organ Transplantation - Geneva

World Health Organization, Guiding Principles on Human Organ Transplantation (Geneva: World Health Organization, 1991), reprinted in 42 International Digest of Health Legislation 389 (1991).

Preamble

1. As the Director-General's report to the seventy-ninth session of the Executive Board pointed out, human organ transplantation began with a series of experimental studies at the beginning of this century. That report drew attention to some of the major clinical and scientific advances in the field since Alexis Carrel was awarded the Nobel Prize in 1912 for his pioneering work. Surgical transplantation of human organs from deceased, as well as living donors to sick and dying patients began after the Second World War. Over the past 30 years, organ transplantation has become a worldwide practice and has saved many thousands of lives. It has also improved the quality of life of countless other persons. Continuous improvements in medical technology, particularly in relation to tissue 'rejection', have brought about expansion of the practice and an increase in the demand for organs. A feature of organ transplantation since its commencement has been the shortage of available organs. Supply has never satisfied demand, and this has led to the continuous development in many countries of procedures and systems to increase supply. Rational argument can be made to the effect that shortage has led to the rise of commercial traffic in human organs, particularly from living donors who are unrelated to recipients. There is clear evidence of such traffic in recent years, and fears have arisen of the possibility of related traffic in human beings. World Health Assembly resolutions WHA40.13 and WHA42.5 are an expression of international concern over these developments.

2. These Guiding Principles are intended to provide an orderly, ethical and acceptable framework for regulating the acquisition and transplantation of human organs for therapeutic purposes. The term 'human organ' is understood to include organs and tissues but does not extend to reproductive tissues, namely ova, sperm, ovaries, testicles or embryos, nor is it intended to deal with blood or blood constituents for transfusion purposes. The Guiding Principles prohibit giving and receiving money, as well as any other commercial dealing in this field, but do not affect payment of expenditures incurred in organ recovery, preservation and supply. Of particular concern to WHO is the protection of minors and other vulnerable persons from coercion and improper inducement to donate organs.

Organs and tissues (referred to in this text as 'organs') may be removed from the bodies of deceased and living persons for the purpose of transplantation only in accordance with the following Guiding Principles.
Commentary:

The purpose of this introductory proposition is to establish a comprehensive and exclusive system for the removal of organs from deceased and living donors for transplantation. As cadaver donation is best dealt with by national legislation, each jurisdiction will determine the definition of 'deceased person' and criteria of death, as well as the means of implementing the Guiding Principles.
Guiding principle 1

Organs may be removed from the bodies of deceased persons for the purpose of transplantation if:

a) any consents required by law are obtained: and

b) there is no reason to believe that the deceased person objected to such removal, in the absence of any formal consent given during the person's lifetime.
Commentary:

There are two systems dealing with the obtaining of organs from deceased persons. These are the 'opting in'/'contracting in' ('explicit consent') system of post mortem organ removal, in which deceased persons expressly state before death that they approve such removal, or an appropriate family member expresses approval when the deceased person left no statement or other evidence to the contrary, and the 'opting out'/'contracting in' ('presumed consent') system. This presumes that organs may be removed for transplantation from the bodies of deceased persons unless those persons when alive stated their objections, or perhaps others who were close to them stated at an appropriate time that the persons objected to their deceased bodies being so treated. In the case of both the opting in and opting out systems, any statements or other adequate indications of opposition by persons to posthumous organ removal from their bodies will prevent such removal.

When a deceased person leaves no evidence of opposition to removal, the opting in system normally requires consent of an appropriate family member for organ removal. In the opting out system, no consent is required, but family members may take initiatives to state the opposition of the deceased person or of themselves.
Guiding principle 2

Physicians determining that the death of a potential donor has occurred should not be directly involved in organ removal from the donor and subsequent transplantation procedures, or be responsible for the care of potential recipients of such organs.
Commentary:

This provision is designed to reduce the possibility of a conflict of interest that would arise if the physician or physicians determining the death of a potential donor were also involved in organ removal or implantation.
Guiding principle 3

Organs for transplantation should be removed preferably from the bodies of deceased persons. However, adult living persons may donate organs, but in general such donors should be genetically related to the recipients. Exceptions may be made in the case of transplantation of bone marrow and other acceptable regenerative tissues.

An organ may be removed from the body of a adult living donor for the purpose of transplantation if the donor gives free consent. The donor should be free of any undue influence and pressure and sufficiently informed to be able to understand and weigh the risks, benefits and consequences of consent.
Commentary:

The first paragraph of this principle is intended to emphasize the importance of developing cadaveric donation programmes in countries where this is culturally acceptable, and to discourage donations from living, genetically unrelated donors, except for transplantation of bone marrow and of other acceptable regenerative tissues.

The second paragraph seeks to protect potential donors from undue pressure and undue inducements from others. It emphasizes the necessity for complete and objective information to be given to the donor. It also takes into account issues relating to persons (other than minors) who are legally incompetent to fulfil the requirements for 'free consent' or the other conditions specified in this paragraph.
Guiding principle 4

No organ should be removed from the body of a living minor for the purpose of transplantation. Exceptions may be made under national law in the case of regenerative tissues.
Commentary:

This principle provides for absolute prohibition of the removal or organs for transplantation from legal minors. However, an exception concerning regenerative tissues may be allowed by national legislation. In such cases, the protection of minors could be assured by requiring, among other conditions, the minor's comprehending consent and the consent of the parent(s) or the legal guardian. The parent(s) or the legal guardian may have a conflict of interest, for example if they are responsible for the welfare of an intended recipient of the donated tissues. In such a case, prior permission of an independent body, such as a court or other appropriate authority of comparable independence or status, should be required. However, an objection by the minor should take effect and prevail over any other consent.
Guiding principle 5

The human body and its parts cannot be the subject of commercial transactions. Accordingly, giving or receiving payment (including any other compensation or reward) for organs should be prohibited.
Commentary:

This principle is designed to prohibit traffic in human organs for payment. The method of prohibition, including sanctions, will be determined independently by each jurisdiction. The principle does not prohibit payment of reasonable expenses incurred in donation, recovery, preservation and supply of organs for transplantation.
Guiding principle 6

Advertising the need for or availability of organs, with a view to offering or seeking payment, should be prohibited.
Commentary:

The intention of this principle is to prohibit advertisements that have a commercial (profit-making) purpose. Promotion and encouragement of altruistic donation of human organs and tissues by means of advertisement or public appeal are not affected by this principle.
Guiding principle 7

It should be prohibited for physicians and other health professionals to engage in organ transplantation procedures if they have reason to believe that the organs concerned have been the subject of commercial transactions.
Commentary:

This provision addresses medical professional and other involvement in removal, intermediate management and implantation of organs with knowledge, actual or constructive, that commercial transactions have occurred.
Guiding principle 8

It should be prohibited for any person or facility involved in organ transplantation procedures to receive any payment that exceeds a justifiable fee for the services rendered.
Commentary:

This provision reinforces guiding principle 7 by restricting entrepreneurial practice in organ recovery and implantation. A medical or other health practitioner uncertain whether a fee proposed to be charged is justifiable may seek the opinion of an appropriate licensing or disciplinary authority before the fee is proposed or levied.
Guiding principle 9

In the light of the principles of distributive justice and equity, donated organs should be made available to patients on the basis of medical need and not on the basis of financial or other considerations.
Commentary:

This provision is self-explanatory.

ANNEXE 2
DECLARATION OF HELSINKI (WORLD MEDICAL ASSOCIATION)
Recommendations guiding physicians in biomedical research involving human subjects

Adopted by the 18th World Medical Assembly Helsinki, 1964 as amended by the 29th World Medical assembly Tokyo, 1975; the 35th World Medical Assembly Venice, 1983 and the 41st World Medical Assembly Hong Kong, 1989
Introduction

It is the mission of the physician to safeguard the health of the people. His or her knowledge and conscience are dedicated to the fulfilment of this mission. The Declaration of Geneva of the World Medical Association binds the physician with the words, 'The health of my patient will be my first consideration', and the International Code of Medical Ethics declares that, 'A physician shall act only in the patient's interest when providing medical care which might have the effect of weakening the physical and mental pathogenesis of disease'. In current medical practice most diagnostic, therapeutic or prophylactic procedures involve hazards. This applies especially to biomedical research. Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects.

In the field of biomedical research a fundamental distinction must be recognised between medical research in which the aim is essentially diagnostic or therapeutic for a patient, and medical research, the essential object of which is purely scientific and without implying direct diagnostic or therapeutic value to the person subjected to the research. Special caution must be exercised in the conduct of research which may affect the environment, and the welfare of animals used for research must be respected.

Because it is essential that the results of laboratory experiments be applied to human beings to further scientific knowledge and to help suffering humanity, the World Medical Association has prepared the following recommendations as a guide to every physician in biomedical research involving human subjects. They should be kept under review in the future. It must be stressed that the standards as drafted are only a guide to physicians all over the world. Physicians are not relieved from criminal, civil and ethical responsibilities under the law of their own countries.
I Basic principles

1 Biomedical research involving human subjects must conform to generally accepted scientific principles and should be based on adequately performed laboratory and animal experimentation and on a thorough knowledge of the scientific literature.

2 The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol which should be transmitted for consideration, comment and guidance to a specially appointed committee independent of the investigator and the sponsor provided that this independent committee is in conformity with the laws and regulations of the country in which the research experiment is performed.

3 Biomedical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given his or her consent.

4 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.

5 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. Concern for the interests of the subject must always prevail over the interests of science and society.

6 The right of the research subject to safeguard his or her integrity must always be respected. Every precaution should be taken to respect the privacy of the subject and to minimize the impact of the study on the subject's physical and mental integrity and on the personality of the subject.

7 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.

8 In publication of the results of his or her research, the physician is obliged to preserve the accuracy of the results. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication.

9 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.

10 When obtaining informed consent for the research project the physician should be particularly cautious if the subject is in a dependent relationship to him or her or may consent under duress. In that case the informed consent should be obtained by a physician who is not engaged in the investigation and who is completely independent of this official relationship.

11 In 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.

Whenever the minor child is in fact able to give consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian.

12 The research protocol should always contain a statement of the ethical considerations involved and should indicate that the principles enunciated in the present Declaration are complied with.
II Medical research combined with professional care (clinical research)

1 In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure, if in his or her judgement it offers hope of saving life, re-establishing health or alleviating suffering.

2 The potential benefits, hazards and discomfort of a new method should be weighed against the advantages of the best current diagnostic and therapeutic methods.

3 In any medical study, every patient - including those of a control group, if any - should be assured of the best proven diagnostic and therapeutic method.

4 The refusal of the patient to participate in a study must never interfere with the physician-patient relationship.

5 If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal should be stated in the experimental protocol for transmission to the independent committee. (I,2)

6 The physician can combine medical research with professional care, the objective being the acquisition of new medical knowledge, only to the extent that medical research is justified by its potential diagnostic or therapeutic value for the patient.
III Non-therapeutic biomedical research involving human subjects
(non-clinical biomedical research)

1 In the purely scientific application of medical research carried out on a human being, it is the duty of the physician to remain the protector of the life and health of that person on whom biomedical research is being carried out.

2 The subjects should be volunteers - either healthy persons or patients for whom the experimental design is not related to the patient's illness.

3 The investigator of the investigating team should discontinue the research if in his/her or their judgement it may, if continued, be harmful to the individual.

4 In research on man, the interest of science and society should never take precedence over considerations related to the wellbeing of the subject.