Emedinews:Insights on Medicolegal issues:What are the WMA guidelines for medical doctors in biomedical research involving human subjects?

Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects. The purpose of biomedical research involving human subjects must be to improve diagnostic, therapeutic and prophylactic procedures and the understanding of the etiology and pathogenesis of disease.

• Any act or advice which could weaken physical or mental resistance/health of a human being may be used only in his interest.” 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. The World Medical Association has prepared the following recommendations as a guide to every doctor in biomedical research involving human subjects. 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 land applicable to them.

• Biomedical research involving human subjects must conform to accepted scientific principles and should be based on adequately performed laboratory and animal experimentation and on a thorough knowledge of the scientific literature.
• The designs and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol which should be transmitted to a specially appointed independent committee for consideration, comment and guidance.
• 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.
• Biomedical research involving human subjects cannot legitimately be carried out unless the importance of the objectives is in proportion to the inherent risk to the subject.
• 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 interest of science and society.

(Reference 18th World Medical Assembly, Helsinki, Finland, 1964 and revised by the 29th World Medical Assembly, Tokyo, Japan, 1975).

(Contributed by Dr Sudhir Gupta)