Declaration of Helsinki Laws

The Declaration of Helsinki is the formal code of ethics adopted by physicians in 1964 at the 18th World Medical Assembly meeting in Helsinki, Finland. This declaration is a worldwide standard for medical personnel who conduct human research trials. It has been revised by the World Medical Assembly in Tokyo, Japan, in 1975, in Venice, Italy, in 1983, in Hong Kong in 1989, and in South Africa in 1996. Physicians are not exempt from criminal, civil, and ethical responsibilities and penalties under the laws of their own countries, because the standards outlined in the code are considered only a guide to physicians worldwide.

The assembly recognized several basic principles regarding biomedical research involving human subjects. These principles are as follows. The purpose of such research must be to improve diagnostic, therapeutic, and prophylactic procedures and the understanding of the etiology and pathogenesis of disease. The research must conform to generally accepted scientific principles and be based on adequately performed laboratory and animal experimentation as well as on a thorough review and knowledge of the scientific literature. An experimental protocol detailing the design and performance of each experimental procedure is to be submitted for consideration, comment, guidance, and ultimately approval to a specially appointed independent committee that is in compliance with the laws and regulations of the country where the research will be performed. The research will only be conducted by scientifically qualified persons and under the supervision of clinically competent medical personnel. Responsibility for the human participant always rests with a medically qualified person and never on the participant regardless of the fact that he or she has given consent. Careful assessment of predictable risks compared to foreseeable benefits must precede every study involving human participants. Physicians should stop any investigation if hazards are found to outweigh potential benefits. The interests of the participant must always prevail over the interests of science and society. Physicians must protect a research participant's rights to privacy and minimize the study's impact on the integrity of his or her physical, mental, and/or personality status. When publishing research results, physicians are obligated to preserve the accuracy of these results. Results from experimentation not in accordance with this declaration's principles should not be accepted for [Page 133]publication. Potential participants must be adequately informed of the aims, methods, anticipated benefits, and potential hazards and discomforts associated with participation in the study. They can decline participation and withdraw consent at any time. Physicians must obtain participants' freely given, written informed consent. Physicians should not obtain informed consent from a potential participant with whom the physician has a dependent relationship. In cases of legal incompetence, the legal guardian can provide informed consent. For minor participants or those with physical or mental incapacity, permission for participation can be given by a responsible relative. Minor participants can give consent in conjunction with that of their legal guardian. The research protocol must contain a statement of the ethical considerations associated with the conduct of the research.

In addition to these basic principles, the declaration also provides for guidelines for the proper conduct of medical research combined with professional care (clinical research) and nontherapeutic biomedical research involving human subjects (nonclinical biomedical research).

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