Our concern regarding the ethics of these studies was of sufficient concern that we contacted the responsible organization within the (NIH) and requested that they review the studies. My own previous experience as a clinical research investigator and as the director of an NIH funded Pediatric Clinical Research Center led me to believe that a response from NIH would be forthcoming and that the concern about the ethical conduct of a NIH supported study in Africa would be taken seriously. We were disappointed. Our requests were largely ignored and one year later we were still attempting to get a copy of the research protocol. Requests for ethical review of the studies had been refused by the relevant IRB’s and ethics divisions of the National Institutes of Health, the universities that sponsored the studies, the NIH Office of Research Integrity, the Institute of Medicine, and the Presidential Commission for the Study of Bioethical Issues.
Needless to say this raised a question as to exactly how vulnerable research subjects in resource poor countries could be protected from research abuses and how seriously Federal rules and regulations governing research in humans were taken. We are about to give up when the news about the highly unethical 1946-1948 Guatemala research reported by Reverby was released. The report triggered a directive from President Obama to the Presidential Commission for the Study of Bioethical Issues to take on the task of thoroughly reviewing the Tuskegee experiments (1932) and the Guatemala research study (1946-1948) to determine precisely what ethical guidelines were violated and to also determine whether there were ongoing violations of international research guidelines in studies currently being conducted in resource poor countries and supported by the US government. A portion of the directive stated that the Commission should undertake , “…..a review of human subjects protection to determine if Federal regulations and international standards adequately guard the health and well-being of participants in scientific study supported by the Federal government…..In fulfilling this charge, the Commission should seek the insights and perspective of international experts, including from Guatemala; consult with its counterparts in the global community; and convene at least one meeting outside the United States. I expect the Commission to complete its work within 9 months and provide me with a report of its findings and recommendations.”