Islamic Center of Southern California

International Ethical Guidelines for Biomedical Research Involving Human Subjects

(An Islamic Perspective)

International Instruments and Guidelines

International Instruments and Guidelines

The first international instrument on the ethics of medical research, the Nuremberg Code, was promulgated in 1947 as a consequence of the trial of physicians who had conducted atrocious experiments on prisoners and detainees, without obtaining the subjects' consent, 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 United Nations General Assembly adopted the Universal Declaration of Human Rights in 1948. To give the Declaration greater 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 that "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 (Appendix 2), is a comprehensive statement of the ethics of research involving human subjects. It sets out ethical guidelines for physicians engaged in both clinical and non-clinical biomedical research.

Since the 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 Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), 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. The Joint United Nations Program on HIV/AIDS (UNAIDS) published in 2000 the UNAIDS Guidance Document Ethical Considerations in HIV Preventive Vaccine Research, issued by the United Nations International Development Agency.

In 2001 the Council of Ministers of the European Union adopted a Directive on clinical trials, which will be binding in law in the countries of the Union from 2004. The Council of Europe, with more than 44 member States, is developing a Protocol on Biomedical Research, which will be an additional protocol to the Council's 1997 Convention on Human Rights and Biomedicine.

Not specifically concerned with biomedical research involving human subjects but clearly pertinent, as noted above, are international human rights instruments. These are mainly the Universal Declaration of Human Rights, which, particularly in its science provisions, was highly influenced by the Nuremberg Code; the International Covenant on Civil and Political Rights; and the International Covenant on Economic, Social, and Cultural Rights. Since the Nuremberg experience, human rights law has expanded to include the protection of women (Convention on the Elimination of All Forms of Discrimination Against Women) and children (Convention on the Rights of the Child). In terms of human rights, all these instruments endorse the general ethical principles published by CIOMS. Islamic Center of Southern California