While an International Research Panel will soon start its review of ongoing scientific trials using human subjects, a separate review already is well under way: A focus on what happened in the Guatemala trials in which U.S.-sponsored research deliberately injected hundreds of people with a sexually transmitted disease from 1946 to 1948.
Valerie H. Bonham, Executive Director of the Presidential Commission for the Study of Bioethical Issues, told the Commission today that many members of her staff have been holed up in the National Archives over the last several weeks, pouring through old records.
Bonham said a staff of 12 people, plus senior medical advisors, have so far gone through 477 boxes of materials, including hundreds of thousands of pages of documents. She said the group also has examined documents from the Centers for Disease Control and Prevention, the Pan American Health Organization, the University of Pittsburgh, the University of Virginia, the National Library of Medicine, and the National Academies.
Guatemalan officials also are conducting a separate investigation. The two groups will be communicating and sharing their findings, Bonham said. She said she hoped to bring the staff report to the Commission by early this summer.
Bonham said the review is guided by four questions: what happened in Guatemala between 1946 to 1948 and was it part of a series of studies at the time; to what extent was the U.S. government and the medical establishment at the time aware of the protocol of the study; what was the historical context of scientific research; and did the Guatemala study diverge with what were the relevant medical standards for the time.
Commission member Dr. Anita L. Allen, the Henry R. Silverman Professor of Law and Professor of Philosophy at the University of Pennsylvania Law School, questioned Bonham further about the purpose of the review.
“President Obama clearly indicated in his view that the experiments were unethical,” Allen said. “I want to confirm that the point of this review is not to excuse or justify the experiments, but to understand them and to understand them in context.”
Bonham replied: “Absolutely. The report is to provide little in the way of judgment but to get the facts out. “
Dr. John D. Arras, Porterfield Professor of Biomedical Ethics and Professor of Philosophy at the University of Virginia, asked for a preview of the findings. “When we go back in time, you often find differing opinions. What are you seeing in the historical record? Are you seeing voices at the time opposing this research?”
Bonham said her researchers had found dissent, but said it was too early to give a report to the Commission.