In 1964, the 18th World Medical Assembly met in Helsinki, Finland, to outline basic ethical principles of research involving human subjects and human experimentation. The code was revised in 1975 at the 129th World Medical Assembly in Tokyo, Japan. The code includes 12 guiding normative principles:
- Biomedical research involving human subjects must conform to generally accepted scientific principles and should be based on adequately performed laboratory and animal experimentation, and on a thorough knowledge of the scientific literature;
- The design 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 always must 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 objective 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 always must prevail over the interests of science and society;
- The right of the research subject to safeguard his or her integrity always must be respected; every precaution should be taken to respect the privacy of the subject and to minimize the impact of the study on the subject’s physical and mental integrity, and on the personality of the subject;
- 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 her 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 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 always should contain a statement of the ethical consideration involved and should indicate compliance with the principles enunciated in the present declaration. [Source: Declaration of Helsinki, revised edition, World Medical Association, Inc.]
