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                                      WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects

                                      WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects

                                      • 分類:技術標準
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                                      • 發布時間:2017-06-30 10:35
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                                      【概要描述】Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 and amended by the:

                                      WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects

                                      【概要描述】Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 and amended by the:

                                      • 分類:技術標準
                                      • 作者:
                                      • 來源:
                                      • 發布時間:2017-06-30 10:35
                                      • 訪問量:
                                      詳情

                                        Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964

                                        and 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

                                        52nd WMA General Assembly, Edinburgh, Scotland, October 2000

                                        53rd WMA General Assembly, Washington DC, USA, October 2002 (Note of

                                        Clarification added)

                                        55th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added)

                                        59th WMA General Assembly, Seoul, Republic of Korea, October 2008

                                        64th WMA General Assembly, Fortaleza, Brazil, October 2013

                                        Preamble

                                        1. The World Medical Association (WMA) has developed the Declaration of Helsinkias a statement of ethical principles for medical research involving human subjects,including research on identifiable human material and data.The Declaration is intended to be read as a whole and each of its constituentparagraphs should be applied with consideration of all other relevant paragraphs.

                                        2. Consistent with the mandate of the WMA, the Declaration is addressedprimarily to physicians. The WMA encourages others who are involved in medicalresearch involving human subjects to adopt these principles.General Principles

                                        3. 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 ofWMA Declaration of Helsinki - EthicalPrinciples for Medical Research InvolvingHuman Subjects

                                        “The health of my patient will be my first consideration,” and the International Code ofMedical Ethics declares that, “A physician shall act in the patient's best interest whenproviding medical care.”

                                        4. It is the duty of the physician to promote and safeguard the health, well-beingand rights of patients, including those who are involved in medical research. Thephysician's knowledge and conscience are dedicated to the fulfilment of this duty.

                                        5. Medical progress is based on research that ultimately must include studiesinvolving human subjects.

                                        6. The primary purpose of medical research involving human subjects is tounderstand the causes, development and effects of diseases and improve preventive,diagnostic and therapeutic interventions (methods, procedures and treatments). Eventhe best proven interventions must be evaluated continually through research for theirsafety, effectiveness, efficiency, accessibility and quality.

                                        7. Medical research is subject to ethical standards that promote and ensurerespect for all human subjects and protect their health and rights.

                                        8. While the primary purpose of medical research is to generate new knowledge,this goal can never take precedence over the rights and interests of individualresearch subjects.

                                        9. It is the duty of physicians who are involved in medical research to protect thelife, health, dignity, integrity, right to self-determination, privacy, and confidentiality ofpersonal information of research subjects. The responsibility for the protection ofresearch subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.

                                        10. Physicians must consider the ethical, legal and regulatory norms andstandards 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 should reduce or eliminate any of the protections for research subjects set forth in this Declaration.

                                        11. Medical research should be conducted in a manner that minimises possible harm to the environment.

                                        12. Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and individuals with the appropriate ethics and scientific education, training and qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional.

                                        13. Groups that are underrepresented in medical research should be provided appropriate access to participation in research.

                                        14. Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.

                                        15. Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured. Risks, Burdens and Benefits

                                        16. In medical practice and in medical research, most interventions involve risks and burdens. Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.

                                        17. All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation. Measures to minimise the risks must be implemented. The risks must be continuously monitored, assessed and documented by the researcher.

                                        18. Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed. When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify or immediately stop the study. Vulnerable Groups and Individuals

                                        19. Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm. All vulnerable groups and individuals should receive specifically considered protection.

                                        20. Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research Scientific Requirements and Research Protocols

                                        21. 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 and, as appropriate, animal experimentation. The welfare of animals used for research must be respected.

                                        22. The design and performance of each research study involving human subjects must be clearly described and justified 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, potential conflicts of interest, incentives for subjects and information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study. In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions. Research Ethics Committees

                                        23. The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins. This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections 4/8 standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration. The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No amendment to the protocol may be made without consideration and approval by the committee. After the end of the study, the researchers must submit a final report to the committee containing a summary of the study’s findings and conclusions. Privacy and Confidentiality

                                        24. Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information. Informed Consent

                                        25. Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.

                                        26. In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information. After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed. All medical research subjects should be given the option of being informed about the general outcome and results of the study.

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