Emedinews:Insights on MEdicolegal Issues:World Medical Association (WMA) guidelines for medical doctors in biomedical research involving human subjects

• Doctors should abstain from engaging in research projects involving human subjects unless they are satisfied that the hazards involved are believed to be predictable. Doctors should cease any investigation if the hazards are found to outweigh the potential benefits.
• In publication of the results of his or research, the doctor is obliged to preserve the accuracy of the results. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication.
• In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort, it may entail. He or she should be informed that he or she is at liberty to abstain from participation in the study and that he or she is free to withdraw his or her consent to participation at any time. The doctor should then obtain the subject’s freely given informed consent, preferably in writing.
• When obtaining informed consent for the research project the doctor should be particularly cautious if the subject is in a dependent relationship to him or her or may consent under duress. In that case the informed consent should be obtained by a doctor who is not engaged in the investigation and who is completely independent of this official relationship.
• In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject in accordance with national legislation.
• The research protocol should always contain a statement of the ethical consideration involved and should indicate that the principles enunciated in the present Declaration are complied with.

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