Issues of concern directed to the Commission members.

 Conflict of Interest Concerns and Representation Issues

 Conflicts of interest may arise when the institutions represented by Commission members or members themselves receive direct or indirect benefit from clinical research studies.  It is our understanding that the U.S. Government requires individuals participating in U.S. Government committees to reveal actual or potential conflicts of interest, whether individuals come from academic or industry backgrounds. Universities, clinical research groups, individual investigators and others who participate in clinical research, whether in the U.S. or in resource-poor countries, often receive significant income from government agencies such as NIH as well as from pharmaceutical organizations. The financial and career benefits in conducting  international research creates a potential, if not actual, conflict of interest for some Commission members charged with investigating current ethical practices.

As pointed out by several of the commission members, there is a definite shift of clinical research to the more easily accessible and greater numbers of research subjects in resource-poor countries, both by industry and importantly also by academic clinical researchers.  A commission member pointed out that this creates a situation of potential conflict of interest and the necessity of achieving a balanced and independent review of the ethical standards for the conduct of clinical research.  The mere size of these studies, involving thousands of research subjects and millions of dollars, naturally make it difficult for invested researchers to make objective and unbiased decisions as to whether studies conform to all international ethical standards, as well a whether a study should be stopped because it has become unethical to continue.

Given the clear potential for conflict of interest, each Commission member should make available for the public record a complete CV and a potential conflict or non conflict of interest declaration, as well as a list of potentially conflicting activities.  These disclosures should include financial disclosures. The declaration should also state whether the Commission member has him/herself ever been subject to ethical review for studies performed. (One committee member has participated in a vaccine trial that was later questioned by HIV advocates as to scientific and ethical integrity. Another committee member is also a member of the Institute of Medicine, which recused itself from review of the Guatemala study.)