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DECLARATION OF HELSINKI

World Medical Association

l964  and 1975 

 

The first document reproduced below, which offers recommendations for conducting experiments using human subjects, was adopted in 1962 and revised by the 18th World Medical Assembly at Helsinki, Finland, in 1964. The second document is the Declaration of Helsinki as revised by the 29th World Medical Assembly in Tokyo in 1975. Revisions in the second document are noted in italics.

 

1. The Helsinki Declaration of 1964

Introduction 

It is the mission of the doctor to safeguard the health of the people. His knowledge and conscience are dedicated to the fulfillment of this mission.

 

The Declaration of Geneva of The World Medical Association binds the doctor with the words: "The health of my patient will be my first consideration" and the International Code of Medical Ethics which declares that "Any act or advice which could weaken physical or mental resistance of a human being may be used only in his interest."

 

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 each doctor in clinical research. It must be stressed that the standards as drafted are only a guide to physicians all over the world. Doctors are not relieved from criminal, civil and ethical responsibilities under the laws of their own countries.

 

In the field of clinical research a fundamental distinction must be recognized between clinical research in which the aim is essentially therapeutic for a patient, and the clinical research, the essential object of which is purely scientific and without therapeutic value to the person subjected to the research.

 

I. Basic Principles

 

1. Clinical research must conform to the moral and scientific principles that justify medical research and should be based on laboratory and animal experiments or other scientifically established facts.

 

2. Clinical research should be conducted only by scientifically qualified persons and under the supervision of a qualified medical man.

 

3. Clinical research cannot legitimately be carried out unless the importance of the objective is in proportion to the inherent risk to the subject.

 

4. Every clinical research project should be preceded by careful assessment of inherent risks in comparison to foreseeable benefits to the subject or to others.

 

5. Special caution should be exercised by the doctor in performing clinical research in which the personality of the subject is liable to be altered by drugs or experimental procedure.

 

II. Clinical Research Combined with Professional Care

 

1. In the treatment of the sick person, the doctor must be free to use a new therapeutic measure, if in his judgment it offers hope of saving life, reestablishing health, or alleviating suffering.

 

If at all possible, consistent with patient psychology, the doctor should obtain the patient's freely given consent after the patient has been given a full explanation. In case of legal incapacity, consent should also be procured from the legal guardian; in case of physical incapacity the permission of the legal guardian replaces that of the patient.

 

2. The doctor can combine clinical research with professional care, the objective being the acquisition of new medical knowledge, only to the extent that clinical research is justified by its therapeutic value for the patient.

 

III. Non-Therapeutic Clinical Research

 

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

 

2. The nature, the purpose and the risk of clinical research must be explained to the subject by the doctor.

 

3a. Clinical research on a human being cannot be undertaken without his free consent after he has been informed; if he is legally incompetent, the consent of the legal guardian should be procured.

 

3b. The subject of clinical research should be in such a mental, physical and legal state as to be able to exercise fully his power of choice.

 

3c. Consent should, as a rule, be obtained in writing. However, the responsibility for clinical research always remains with the research worker; it never falls on the subject even after consent is obtained.

 

4a. The investigator must respect the right of each individual to safeguard his personal integrity, especially if the subject is in a dependent relationship to the investigator.

 

4b. At any time during the course of clinical research the subject or his guardian should be free to withdraw permission for research to be continued.

 

The investigator or the investigating team should discontinue the research if in his or their judgment, it may, if continued, be harmful to the individual.

 

2. The Helsinki Declaration of 1975

 

Introduction 

 

It is the mission of the medical doctor to safeguard the health of the people. His or her  knowledge and conscience are dedicated to the fulfillment of this mission.

 

The Declaration of Geneva of The World Medical Association binds the doctor with the words "The health of my patient will be my first consideration," and the International Code of Medical Ethics declares that "Any act or advice which could weaken physical or mental resistance of a human being may be used only in his interest."

 

The purpose of biomedical research involving human subjects must be to improve diagnostic, therapeutic and prophylactic procedures and the understanding of the aetiology and pathogenesis of disease.

 

In current medical practice most diagnostic, therapeutic or prophylactic procedures involve hazards. This applies a fortiori 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 recognized 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 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 doctor 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. Doctors are not relieved from criminal, civil and ethical responsibilities under the laws 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 he clearly formulated in an experimental protocol which should he transmitted to a specially appointed independent committee for consideration, comment and guidance.

 

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. Doctors should abstain from engaging in research projects involving human subjects unless they are satisfied that the hazards involved are believed to be predictable. Doctors 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 doctor 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 doctor should then obtain the subject's freely given informed consent, preferably in writing.

 

10. When obtaining informed consent for the research project the doctor should he 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 he obtained by a doctor who is not engaged in the investigation and who is completely independent of this official relationship.

 

11. 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.

 

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 doctor must be free to use a new diagnostic or therapeutic measure, if in his or her judgment it offers hope of saving life, reestablishing 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 doctor-patient relationship.

 

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

 

6. The doctor 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 doctor to remain the protector of the life and health of that person on whom biomedical research is being carried out.

 

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

 

3. The investigator or the investigating team should discontinue the research if in his, her or their judgment 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 well-being of the subject.

 

[Reprinted with the permission of The World Medical Journal.