Washington, D.C. –Today the Presidential Commission for the Study of Bioethical Issues publicly released the results of its investigation into the U.S. Public Health Service (PHS) studies conducted in Guatemala in the 1940s, after fully briefing and delivering its report to the White House. The PHS research involved intentionally exposing and infecting vulnerable populations to sexually transmitted diseases without the subjects’ consent.
“In the Commission’s view, the Guatemala experiments involved unconscionable basic violations of ethics, even as judged against the researchers’ own recognition of the requirements of the medical ethics of the day,” Commission Chair Amy Gutmann, Ph.D., said. “The individuals who approved, conducted, facilitated and funded these experiments are morally culpable to various degrees for these wrongs.”
Following the revelation last fall that the PHS supported research on sexually transmitted diseases in Guatemala from 1946 to 1948, President Obama asked the Bioethics Commission to oversee a thorough fact-finding investigation into the studies.
The full report, "Ethically Impossible" STD Research in Guatemala from 1946 to 1948, also includes the Commission’s ethical analysis of the case. The report has been posted on the Commission’s website, www.bioethics.gov.
“The best thing we can do when faced with a dark chapter is to bring it to light. The Commission worked to provide an unvarnished ethical analysis to both honor the victims and to make sure it never happens again,” Gutmann said. “Our commitment to identifying the full facts in this case will help to ensure, going forward, that current rules for research participants protect people from harm or unethical treatment wherever research occurs.”
Commission staff carefully reviewed more than 125,000 original pages of documents and approximately 550 secondary sources collected from public and private archives around the country. Commission staff also completed a fact finding trip to Guatemala and met with Guatemala’s own internal investigation committee.
The Commission concluded that researchers conducted diagnostic tests including blood draws and spinal taps on as many as 5,500 Guatemalan prison inmates, psychiatric patients, soldiers, commercial sex workers, orphans and school children. Of those, researchers deliberately exposed about 1,300 inmates, psychiatric patients, soldiers and commercial sex workers to sexually transmitted diseases syphilis, gonorrhea or chancroid.
“A civilization can be judged by the way that it treats it most vulnerable individuals,” Gutmann said. “It is our moral responsibility to care for those who cannot protect themselves and clearly in this dark chapter of our medical history we grievously failed to keep that covenant. The research team in Guatemala and their immediate supervisors had considerable latitude in the design and conduct of individual experiments. Substantial evidence reflects efforts by the researchers to limit knowledge of the Guatemala activities as much as possible outside of those conducting or directly supervising it,” Gutmann said.
Careful examination of thousands of pages of treatment and follow up records indicates that at least 83 subjects died, although the exact relationship between the experimental procedures and the subject deaths remains unclear.
One key to informing the Commission’s conclusions about moral culpability was discovering that several of the same researchers had conducted similar experiments that involved intentionally exposing prison inmates to gonorrhea in Terre Haute, Ind., in 1943. In the Terre Haute experiments, the researchers went to some lengths to obtain consent of their subjects: they fully briefed the prisoners who, in turn, volunteered and gave informed consent. A few years later, the same researchers in Guatemala did not seek their subjects’ consent.
“Why is Terre Haute important? We know the researchers sought consent from their subjects in the U.S. and disregarded this fundamental ethical standard in Guatemala. The double standard is shocking,” Gutmann said.
“The researchers in Guatemala treated the rules of the day as obstacles to be overcome. We must ensure that today’s researchers do not view the ethical rules and regulations that we have in place as hindrances to research, but understand them to be the bedrock that protects us all,” Gutmann said.
With the historical investigation concluded, the Commission now turns its attention to its ongoing work in reviewing contemporary standards that protect human research participants.
That report is due to the President in December.