The Council for International Organizations of Medical Sciences (CIOMS) was established jointly by the World Health Organization (WHO) and the United Nations Educational, Scientific and Cultural Organization (UNESCO) in 1949 as an international, nongovernmental, nonprofit organization and now includes 45 international, national, and associate member organizations, representing many of the biomedical disciplines, national academies of sciences, and medical research councils. CIOMS recently released a new version of its International Ethical Guidelines for Health-Related Research Involving Humans.1 These guidelines were developed in collaboration with WHO and based on authoritative ethical guidance documents, such as the World Medical Association’s Declaration of Helsinki2 and UNESCO’s Universal Declaration on Bioethics and Human Rights.3 The aim of the guidelines is to provide internationally vetted ethical principles and detailed commentary on how these principles should be applied, with particular attention to conducting research in low- and middle-income countries (LMICs).
Reasons for Revisions
Several challenges and reasons prompted CIOMS to revise its ethical guidelines. A first challenge was to provide clearer guidance for ensuring that research addresses important questions for improving health using sound research methods. The ethical acceptability of research fundamentally depends on its social and scientific value,4 yet some of the research currently conducted is of questionable value.5
A second challenge was to further clarify what can be regarded as fair benefits of research in low-resource settings. Although the CIOMS guidelines have always addressed the interests of research participants and those in LMICs in particular, the previous version of the CIOMS guidelines (issued in 2002) was criticized for not providing sufficient guidance focused on this issue. That version required that externally sponsored research should be responsive to the health needs and priorities of the host country and that any proven products, such as drugs, should be made reasonably available to that population or community. However, the requirement was difficult to apply in practice, in particular because of its narrow focus on benefits that may, but not always will, result from a trial.