Islamic Center of Southern California

International Ethical Guidelines for Biomedical Research Involving Human Subjects

(An Islamic Perspective)

Background Of The International Ethical Guidelines for Biomedical Research Involving Human Subjects ( CIOMS )

Background Of The International Ethical Guidelines for Biomedical Research Involving Human Subjects ( CIOMS )

The Council for International Organizations of Medical Sciences (CIOMS) is an international non-governmental organization in official relations with the World Health Organization (WHO). It was founded under the auspices of WHO and the United Nations Educational, Scientific and Cultural and Organization (UNESCO) in 1949. Among the mandates of CIOMS is maintaining collaborative relations with the United Nations and its specialized agencies, particularly with UNESCO and WHO.

CIOMS, in association with WHO, undertook its work on professional ethics in relation to biomedical research in the late 1970s. At that time, newly independent WHO Member States were setting up health-care systems. WHO was not then in a position to promote ethics as an aspect of health care or research. Therefore, CIOMS has set out, in cooperation with WHO, to prepare guidelines to determine "how the ethical principles that should guide the conduct of biomedical research involving human subjects, as set forth in the Declaration of Helsinki, could be effectively applied, particularly in developing countries, given their socioeconomic circumstances, laws and regulations, and executive and administrative arrangements." The World Medical Association had issued the original Declaration of Helsinki in 1964 and an amended version in 1975. The outcome of the CIOMS/WHO undertaking was, in 1982, Proposed International Ethical Guidelines for Biomedical Research Involving Human Subjects.

The period that followed saw the outbreak of the HIV/AIDS epidemic and proposals to undertake large-scale experiments with vaccine and treatment drugs for the condition. These raised new ethical issues that had not been considered in the preparation of the proposed guidelines. There were other factors also: rapid advances in medicine and biotechnology, changing research practices such as multinational field trials, experimentation involving vulnerable population groups, and a changing view, in rich and poor countries, that research involving human subjects was largely beneficial and not threatening. The Declaration of Helsinki was revised twice in the 1980s: in 1983 and 1989. It was timely to revise and update the 1982 guidelines, and CIOMS, with the cooperation of WHO and its Global Programme on AIDS, undertook the task. The outcome was the issuing of two sets of guidelines: in 1991, International Guidelines for Ethical Review of Epidemiological Studies; and, in 1993, International Ethical Guidelines for Biomedical Research Involving Human Subjects.

After 1993, ethical issues arose for which the CIOMS Guidelines had no specific provision. They related mainly to controlled clinical trials, with external sponsors and investigators, carried out in countries with moderate resources, and to the use of comparators other than the established effective intervention techniques. The issue in question was the perceived need in those countries for low-cost, technologically appropriate, public-health solutions, and in particular, for HIV/AIDS treatment drugs or vaccines that poorer countries could afford. Some may advocate, for low-resource countries, trials of interventions that, while they might be less effective than the treatment available in better-off countries, would be less expensive. Others may believe that all research efforts for public solutions appropriate to developing countries should not be rejected as unethical. The research context should be considered, and local decision-making should be the norm. Paternalism on the part of the richer countries towards poorer countries should be avoided. The challenge was to encourage research for local solutions to the burden of disease in much of the world, while providing clear guidance on protecting against exploitation of vulnerable communities and individuals.

Another group argued that such trials constituted, or risked constituting, exploitation of poor countries by rich countries and were inherently unethical. Economic factors should not influence ethical considerations, they said. It was within the capacity of rich countries or the pharmaceutical industry to make established effective treatment available for comparator purposes. Certain low-resource countries had already made available from their own resources established effective treatment for their HIV/AIDS patients.

This conflict between the two sides complicated the revision and updating of the 1993 Guidelines. Ultimately, it became clear that the conflicting views could not be reconciled, though the proponents of the former view claimed that the new guidelines had built in effective safeguards against exploitation. The commentary on the Guideline concerned (Guideline 11) recognizes the unresolved, or irresolvable, conflict.

The revision/updating of the 1993 Guidelines began in December 1998, and a first draft prepared by the CIOMS consultant for the project was reviewed by the project Steering Committee, which met in May 1999. The committee proposed amendments and listed topics which the new or revised guidelines addressed. It recommended papers to be commissioned on those topics and invited authors and commentators for presentation and discussion of these papers at a CIOMS interim consultation office. It was considered that an interim consultation meeting, of members of the Steering Committee, together with the authors of commissioned papers and designated commentators, followed by further redrafting and electronic distribution and feedback, would better serve the purpose of the project than the process originally envisaged, which had been to complete the revision in one further step. The consultation was accordingly organized for March 2000, in Geneva.

At the consultation meeting, progress on the revision was reported and contentious matters reviewed. Eight commissioned papers previously distributed were presented, commented upon, and discussed. The consultation continued with ad hoc electronic working groups over the following several weeks, and the outcome was made available for the preparation of the third draft. The material commissioned for the consultation was made the subject of a CIOMS publication: Biomedical Research Ethics: Updating International Guidelines. A Consultation (December 2000).

An informal redrafting group of eight - from Africa, Asia, Latin America, the United States and the CIOMS secretariat - met in New York City in January 2001, and subsequently, its members interacted electronically with one another and with the CIOMS secretariat. A revised draft was posted on the CIOMS website in June 2001 and otherwise widely distributed. Many organizations and individuals commented, some extensively, some critically. Views on certain positions, notably on placebo-controlled trials, were contradictory. For the subsequent revision two members were added to the redrafting group, from Europe and Latin America. The new draft was posted on the website in January 2002 in preparation for the CIOMS Conference in February/March 2002.

The CIOMS Conference was convened to discuss and, as far as possible, endorse a final draft to be submitted to the CIOMS Executive Committee for final approval. Besides representation of member organizations of CIOMS, participants included experts in ethics and research from all continents. They reviewed the draft guidelines seriatim and suggested modifications. Guideline 11, Choice of Control in Clinical Trials, was redrafted at the conference in an effort to reduce disagreement. The redrafted text of that guideline was intensively discussed and generally well received. Some participants, however, continued to question the ethical acceptability of the exception to the general rule limiting the use of placebo medicines, given to patients, to the conditions set out in the guideline; they argued that research subjects should not be exposed to risk of serious or irreversible harm when an established effective intervention could prevent such harm, and that such exposure could constitute exploitation. Ultimately, the commentary of Guideline 11 reflects the opposing positions on the use of a comparator other than an established effective intervention for control purposes.

The new text, the 2002 text, which supersedes that of 1993, consists of a statement of general ethical principles, a preamble, and twenty one guidelines, with an introduction and a brief account of earlier declarations and guidelines. Like the 1982 and 1993 Guidelines, the present publication is designed to be of use, particularly to low-resource countries, in defining national policies on the ethics of biomedical research, applying ethical standards in local circumstances, and establishing or redefining adequate mechanisms for the ethical review of research involving human subjects

Comments on the Guidelines are welcome and should be addressed to the Secretary-General, Council for International Organizations of Medical Sciences, c/o World Health Organization, CH-1211 Geneva 27, Switzerland; or by e-mail to cioms@who.int Islamic Center of Southern California