The first International Statement on the ethics of medical research using human subjects namely, the Nuremberg Code was formulated in 1947(Post World War II Nuremberg Trials 1946-1947).German physicians conducted pseudoscientific medical experiments on thousands of concentration camp prisoners without their consent.Most prisoners died or were permanently crippled as a result.
In 1948, Universal Declaration of Human Rights (adopted by the General Assembly of the United Nations) expressed concern about rights of human beings being subjected to involuntary maltreatment.
In 1966, the International Covenant on Civil and Political Rights specifically stated, ‘No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his consent to medical or scientific treatment.’
In 1964 at Helsinki, the World Medical Association formulated general principles and specific guidelines on use of human subjects in medical research, known as the Helsinki Declaration, which was revised from time to time.
1979- Belmont Report (issued by U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research)
- Principle of Respect: Recognized autonomy of humans and requires clear informed consent.
- Principles of Beneficence: Research mush be shown to be beneficial and reflect the Hippocratic idea of do no harm.
- Principle of Justice: The benefits to some must be balanced against the risks of subjects.
In February 1980, the Indian Council of Medical Research released a ‘Policy Statement on Ethical Considerations involved in Research on Human Subjects’ for the benefit of all those involved in clinical research in India
In 1991,CIOMS brought out the ‘International Guidelines for Ethical Review in Epidemiological studies’
