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1、 WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI - Ethical Principles for Medical Research Involving Human Subjects窗体顶端窗体底端Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by the:29th WMA General Assembly, Tokyo, Japan, October 197535th WMA General Assembly, Veni
2、ce, Italy, October 198341st WMA General Assembly, Hong Kong, September 198948th WMA General Assembly, Somerset West, Republic of South Africa, October 199652nd WMA General Assembly, Edinburgh, Scotland, October 2000 53rd WMA General Assembly, Washington 2002 (Note of Clarification on paragraph 29 ad
3、ded)55th WMA General Assembly, Tokyo 2004 (Note of Clarification on Paragraph 30 added)59th WMA General Assembly, Seoul, October 2008A. INTRODUCTION 1. The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving hu
4、man subjects, including research on identifiable human material and data. The Declaration is intended to be read as a whole and each of its constituent paragraphs should not be applied without consideration of all other relevant paragraphs. 2. Although the Declaration is addressed primarily to physi
5、cians, the WMA encourages other participants in medical research involving human subjects to adopt these principles. 3. It is the duty of the physician to promote and safeguard the health of patients, including those who are involved in medical research. The physicians knowledge and conscience are d
6、edicated to the fulfilment of this duty. 4. The Declaration of Geneva of the WMA 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 in the patients best interest when providing
7、 medical care. 5. Medical progress is based on research that ultimately must include studies involving human subjects. Populations that are underrepresented in medical research should be provided appropriate access to participation in research. 6. In medical research involving human subjects, the we
8、ll-being of the individual research subject must take precedence over all other interests. 7. The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, p
9、rocedures and treatments). Even the best current interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality. 8. In medical practice and in medical research, most interventions involve risks and burdens. 9. Medical research is s
10、ubject to ethical standards that promote respect for all human subjects and protect their health and rights. Some research populations are particularly vulnerable and need special protection. These include those who cannot give or refuse consent for themselves and those who may be vulnerable to coer
11、cion or undue influence. 10. Physicians should consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement sh
12、ould reduce or eliminate any of the protections for research subjects set forth in this Declaration. B. BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH 11. It is the duty of physicians who participate in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy
13、, and confidentiality of personal information of research subjects. 12. Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory an
14、d, as appropriate, animal experimentation. The welfare of animals used for research must be respected. 13. Appropriate caution must be exercised in the conduct of medical research that may harm the environment. 14. The design and performance of each research study involving human subjects must be cl
15、early described in a research protocol. The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding funding, sponsors, institutional affiliations, othe
16、r potential conflicts of interest, incentives for subjects and provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study. The protocol should describe arrangements for post-study access by study subjects to interventions identified as beneficial in the study or access to other appropriate care or benefits. 15. The research protocol must be submitted for co
