The Council for International Organizations of Medical Sciences (CIOMS) was established in 1949. It was formed with the support of the World Health Organization (WHO) and the United Nations Educational, Scientific and Cultural Organization (UNESCO). This year (2009) marks the 60th anniversary of its formation.
Goals and Objectives of CIOMS
In the beginning, the goals and objectives of CIOMS were simple:
- To collaborate with the United Nations, WHO, and UNESCO.
- To promote international cooperation in biomedical sciences.
- To serve the “scientific interests of the international biomedical community.”
CIOMS began focusing on bioethical issues during the late 1970s, when concerns arose over how the principles set forth in the Declaration of Helsinki (1964) could be applied to biomedical research involving human subjects — especially in developing countries, where protective regulations were not well established.
After years of deliberations, CIOMS published its Proposed International Ethical Guidelines for Biomedical Research Involving Human Subjects in 1982. At first, the Guidelines seemed adequate. Most clinical research was conducted in single countries throughout the developed world and under controlled conditions.
And then the unexpected happened.
AIDS Leads to New Guidelines
During the 1980s, HIV/AIDS emerged as a global epidemic. As a result, the worldwide demand for new treatment options and effective vaccines prompted clinical trials to become international in scope. Thus, the expansion of biomedical research created new ethical problems that had not been addressed by the 1982 Guidelines.
For example, the ‘standard of care’ controversy raised in the Tuskegee Study of Untreated Syphilis erupted again in developing countries. AIDS patients who were participating in international clinical trials often were denied effective medical treatment (or given placebos) simply because the standard of care in their area was 'no treatment at all.'
The 1982 Guidelines were first updated in 1993. In 2002, the Guidelines were revised again when CIOMS published International Ethical Guidelines for Biomedical Research Involving Human Subjects. The Guidelines, however, do not address all possible ethical conflicts. To date, issues such as human genetics and fetal tissue research have been excluded from discussion.
The 2002 CIOMS Revision Contains 21 Guidelines
The 2002 CIOMS revision consists of a statement of general ethical principles (i.e., respect for persons, beneficence, and justice) as well as 21 specific Guidelines. The first nine Guidelines deal with human experimentation:
- Guidelines 1-3 specify that the clinical research study must be scientifically sound. The study must not only be approved by the Institutional Review Board (IRB) in the country of origin, but also by the host country as well.
- Guidelines 4-7 deal with informed consent.
- Guidelines 8-9 discuss the risks and benefits of any proposed medical procedure.
- Guidelines 10-21 deal with patient selection in poorer countries, as well as protection for women and children.
CIOMS and Informed Consent
Recognizing the importance of informed consent in biomedical research, CIOMS explored the issue across several overlapping sections. Unfortunately, CIOMS' Guidelines did not seem to strengthen the concept of informed concept, but introduced circumstances where consent could be weakened by research investigators.
For example, Guideline 4 explicitly allows for “some or all of the elements of informed consent” to be waived by an IRB. The conditions under which consent could be ignored were when the research risks were minimal, or the consent process would make “the conduct of the research impractical.”
Guideline 5 lists 26 separate pieces of information that an investigator must provide to a potential research subject before informed consent can be requested. Among the requirements are instructions concerning the voluntary participation of the subject, the right of the subject to withdraw from the research at any time, the purpose of the research, the risks and benefits of the study, the amount of compensation for participation in the study, and the role of the investigator in the research.
Guideline 6 incorporates concerns from the Belmont Report over the difference between justifiable persuasion and undue influence, in the context of recruiting research subjects. At the same time, Guideline 6 also discussed circumstances under which withholding information and outright deception of a research subject would be permissible — so long as approval was given by an Independent Ethics Committee (IEC) or an IRB.
CIOMS and Ethical Violations
Perhaps the most shocking revision involved enforcement. How would CIOMS deal with investigators who committed ethical violations? The usual method of fines was not recommended, as IECs and IRBs do not have the power to impose sanctions.
But, even if sanctions were eligible for violators, CIOMS opposed such strict regulation. Instead, the Council preferred to rely on voluntary compliance: “Preferred methods of control include cultivation of an atmosphere of mutual trust, and education and support to promote in researchers and in sponsors the capacity for ethical conduct of research.”
If Henry K. Beecher proved anything from his 1966 article on clinical research ethics, it was that voluntary compliance never induced biomedical researchers to act ethically. Once again, the dominant attitude adopted by CIOMS was that physicians were 'gentlemen' who did not need regulation.
References
Council for International Organizations of Medical Sciences (CIOMS). 2002. International Ethical Guidelines for Biomedical Research Involving Human Studies. Geneva: CIOMS.
CIOMS. 2009. What is CIOMS? Geneva: CIOMS.
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