Declaration Of Helsinki
- 1. Declaration of Helsinki World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964; amended by the 29th WMA General Assembly, Tokyo, Japan, October 1975; 35th WMA General Assembly, Venice, Italy, October 1983; 41st WMA General Assembly, Hong Kong, September 1989; 48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996, and the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000 A. Introduction subjects in their own countries as well as applicable international requirements. No national ethical, legal or 1. The World Medical Association has developed the regulatory requirement should be allowed to reduce or Declaration of Helsinki as a statement of ethical principles to eliminate any of the protections for human subjects set forth provide guidance to physicians and other participants in in this Declaration. medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data. B. Basic principles for all medical 2. It is the duty of the physician to promote and safeguard the health of the people. The physician’s knowledge and research conscience are dedicated to the fulfillment of this duty. 10. It is the duty of the physician in medical research to protect the life, health, privacy, and dignity of the human 3. The Declaration of Geneva of the World Medical subject. Association binds the physician with the words, ‘‘The health of my patient will be my first consideration,’’ and the 11. Medical research involving human subjects must International Code of Medical Ethics declares that, ‘‘A conform to generally accepted scientific principles, be based physician shall act only in the patient’s interest when on a thorough knowledge of the scientific literature, other providing medical care which might have the effect of relevant sources of information, and on adequate laboratory weakening the physical and mental condition of the patient.’’ and, where appropriate, animal experimentation. 4. Medical progress is based on research which ultimately 12. Appropriate caution must be exercised in the conduct must rest in part on experimentation involving human of research which may affect the environment, and the subjects. welfare of animals used for research must be respected. 5. In medical research on human subjects, considerations 13. The design and performance of each experimental related to the well-being of the human subject should take procedure involving human subjects should be clearly precedence over the interests of science and society. formulated in an experimental protocol. This protocol should be submitted for consideration, comment, guidance, 6. The primary purpose of medical research involving and where appropriate, approval to a specially appointed human subjects is to improve prophylactic, diagnostic and ethical review committee, which must be independent of the therapeutic procedures and the understanding of the investigator, the sponsor or any other kind of undue aetiology and pathogenesis of disease. Even the best proven influence. This independent committee should be in prophylactic, diagnostic, and therapeutic methods must conformity with the laws and regulations of the country in continuously be challenged through research for their which the research experiment is performed. The committee effectiveness, efficiency, accessibility and quality. has the right to monitor ongoing trials. The researcher has 7. In current medical practice and in medical research, the obligation to provide monitoring information to the most prophylactic, diagnostic and therapeutic procedures committee, especially any serious adverse events. The involve risks and burdens. researcher should also submit to the committee, for review, information regarding funding, sponsors, institutional 8. Medical research is subject to ethical standards that affiliations, other potential conflicts of interest and incen- promote respect for all human beings and protect their tives for subjects. health and rights. Some research populations are vulnerable and need special protection. The particular needs of the 14. The research protocol should always contain a economically and medically disadvantaged must be recog- statement of the ethical considerations involved and should nized. Special attention is also required for those who cannot indicate that there is compliance with the principles give or refuse consent for themselves, for those who may be enunciated in this Declaration. subject to giving consent under duress, for those who will 15. Medical research involving human subjects should be not benefit personally from the research and for those for conducted only by scientifically qualified persons and under whom the research is combined with care. the supervision of a clinically competent medical person. 9. Research Investigators should be aware of the ethical, The responsibility for the human subject must always rest legal and regulatory requirements for research on human with a medically qualified person and never rest on the Bulletin of the World Health Organization, 2001, 79 (4) # World Health Organization 2001 373
- 2. Declaration of Helsinki subject of the research, even though the subject has given 25. When a subject deemed legally incompetent, such as a consent. minor child, is able to give assent to decisions about participation in research, the investigator must obtain that 16. Every medical research project involving human assent in addition to the consent of the legally authorized subjects should be preceded by careful assessment of representative. predictable risks and burdens in comparison with foresee- able benefits to the subject or to others. This does not 26. Research on individuals from whom it is not possible to preclude the participation of healthy volunteers in medical obtain consent, including proxy or advance consent, should research. The design of all studies should be publicly be done only if the physical/mental condition that prevents available. obtaining informed consent is a necessary characteristic of the research population. The specific reasons for involving 17. Physicians should abstain from engaging in research research subjects with a condition that renders them unable projects involving human subjects unless they are confident to give informed consent should be stated in the experi- that the risks involved have been adequately assessed and can mental protocol for consideration and approval of the review be satisfactorily managed. Physicians should cease any committee. The protocol should state that consent to remain investigation if the risks are found to outweigh the potential in the research should be obtained as soon as possible from benefits or if there is conclusive proof of positive and the individual or a legally authorized surrogate. beneficial results. 27. Both authors and publishers have ethical obligations. In 18. Medical research involving human subjects should only publication of the results of research, the investigators are be conducted if the importance of the objective outweighs obliged to preserve the accuracy of the results. Negative as the inherent risks and burdens to the subject. This is well as positive results should be published or otherwise especially important when the human subjects are healthy publicly available. Sources of funding, institutional affilia- volunteers. tions and any possible conflicts of interest should be declared 19. Medical research is only justified if there is a reasonable in the publication. Reports of experimentation not in likelihood that the populations in which the research is accordance with the principles laid down in this Declaration carried out stand to benefit from the results of the research. should not be accepted for publication. 20. The subjects must be volunteers and informed participants in the research project. C. Additional principles for medical 21. The right of research subjects to safeguard their research combined with medical care integrity must always be respected. Every precaution should 28. The physician may combine medical research with be taken to respect the privacy of the subject, the medical care, only to the extent that the research is justified confidentiality of the patient’s information and to minimize by its potential prophylactic, diagnostic or therapeutic value. the impact of the study on the subject’s physical and mental When medical research is combined with medical care, integrity and on the personality of the subject. additional standards apply to protect the patients who are 22. In any research on human beings, each potential subject research subjects. must be adequately informed of the aims, methods, sources 29. The benefits, risks, burdens and effectiveness of a new of funding, any possible conflicts of interest, institutional method should be tested against those of the best current affiliations of the researcher, the anticipated benefits and prophylactic, diagnostic, and therapeutic methods. This does potential risks of the study and the discomfort it may entail. not exclude the use of placebo, or no treatment, in studies The subject should be informed of the right to abstain from where no proven prophylactic, diagnostic or therapeutic participation in the study or to withdraw consent to method exists. participate at any time without reprisal. After ensuring that the subject has understood the information, the physician 30. At the conclusion of the study, every patient entered should then obtain the subject’s freely-given informed into the study should be assured of access to the best proven consent, preferably in writing. If the consent cannot be prophylactic, diagnostic and therapeutic methods identified obtained in writing, the non-written consent must be by the study. formally documented and witnessed. 31. The physician should fully inform the patient which 23. When obtaining informed consent for the research aspects of the care are related to the research. The refusal of a project the physician should be particularly cautious if the patient to participate in a study must never interfere with the subject is in a dependent relationship with the physician or patient–physician relationship. may consent under duress. In that case the informed consent should be obtained by a well-informed physician who is not 32. In the treatment of a patient, where proven prophy- engaged in the investigation and who is completely lactic, diagnostic and therapeutic methods do not exist or independent of this relationship. have been ineffective, the physician, with informed consent from the patient, must be free to use unproven or new 24. For a research subject who is legally incompetent, prophylactic, diagnostic and therapeutic measures, if in the physically or mentally incapable of giving consent or is a physician’s judgement it offers hope of saving life, re- legally incompetent minor, the investigator must obtain establishing health or alleviating suffering. Where possible, informed consent from the legally authorized representative these measures should be made the object of research, in accordance with applicable law. These groups should not designed to evaluate their safety and efficacy. In all cases, be included in research unless the research is necessary to new information should be recorded and, where appropriate, promote the health of the population represented and this published. The other relevant guidelines of this Declaration research cannot instead be performed on legally competent should be followed. n persons. 374 Bulletin of the World Health Organization, 2001, 79 (4)