unconsenting prisoners and detainees during the second world war. The Code, designed to protect the integrity of the research subject, set out conditions for the ethical conduct of research involving human subjects, emphasizing their voluntary consent to research.

The Universal Declaration of Human Rights was adopted by the General Assembly of the United Nations in 1948. To give the Declaration legal as well as moral force, the General Assembly adopted in 1966 the International Covenant on Civil and Political Rights. Article 7 of the Covenant states “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 free consent to medical or scientific experimentation”. It is through this statement that society expresses the fundamental human value that is held to govern all research involving human subjects—the protection of the rights and welfare of all human subjects of scientific experimentation.

The Declaration of Helsinki, issued by the World Medical Association in 1964, is the fundamental document in the field of ethics in biomedical research and has influenced the formulation of international, regional and national legislation and codes of conduct. The Declaration, amended several times, most recently in 2000…, is a comprehensive international statement of the ethics of research involving human subjects. It sets out ethical guidelines for physicians engaged in both clinical and nonclinical biomedical research.

Since the first publication of the CIOMS 1993 Guidelines, several international organizations have issued ethical guidance on clinical trials. This has included, from the World Health Organization, in 1995, Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products; and from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH),3 in 1996, Guideline on Good Clinical Practice, designed to ensure that data generated from clinical trials are mutually acceptable to regulatory authorities in the European Union, Japan and the United States of America.

In his 2005 article, John Williams, member of the Ethics Unit of the World Medical Association, laid out exactly on which points the documents essentially are in agreement (Williams, 2005):

Despite the different scope, length, and authorship of these documents, they agree to a very large extent on the basic requirements of research ethics, namely:

  • every proposal for medical research on human subjects must be reviewed and approved by an independent ethics committee before it can proceed;

  • a medical research project involving human subjects must be justifiable on scientific grounds;

3

For additional information, see ICH’s Web site, http://www.ich.org. Accessed on December 20, 2007.



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