August 29. 2011
Washington, D.C. – Presidential Commission for the Study of Bioethical Issues Chair Amy Gutmann, Ph.D., today announced that the Commission has concluded its investigation into the U.S. Public Health Service (U.S. PHS) studies done in Guatemala in the 1940s. The U.S. PHS research involved intentionally exposing and infecting vulnerable populations to sexually transmitted diseases without the subjects’ consent. The Commission discussed several of its findings at its public quarterly meeting in Washington today as it worked to refine its conclusions. The report will be provided to President Obama in early September.
“It is important that we accurately document this clearly unethical historical injustice. We do this to honor the victims,” Gutmann said. “In addition, we must look to and learn from the past so that we can assure the public that scientific and medical research today is conducted in an ethical manner. Research with human subjects is a sacred trust. Without public confidence, participation will decline and critical research will be stopped. It is imperative that we get this right.”
Following the revelation last fall that the U.S. PHS supported research on sexually transmitted diseases in Guatemala from 1946 to 1948, President Obama tasked the Bioethics Commission with two assignments: 1. oversee a thorough fact-finding investigation into the specifics of the research in Guatemala (due in September); and 2. assure him that current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally (due in December).
The Government of Guatemala has undertaken its own research into the 1940s studies and that effort is led by Dr. Espada. To date, Guatemala has not yet released its investigation report. Espada had been scheduled to brief the Commission this morning, but was forced to cancel. Espada also cancelled a briefing at the Commission’s last public meeting in May in New York.
Commission staff carefully reviewed over 125,000 original documents collected from public and private archives around the country and completed a fact finding trip to Guatemala. The Commission staff worked cooperatively with the Guatemalan government, including meeting with their own internal investigation committee.
Today the Commission discussed key findings from the investigation including how research in Guatemala compared to similar research that also involved intentionally exposing prison inmates to gonorrhea in Terre Haute, Ind. in 1943. The Commission learned that many of the same researchers involved in Terre Haute later went to Guatemala to conduct the STD research. The key difference between the two research projects was that in Terre Haute the prisoners were fully briefed, volunteered and gave informed consent. A few years later, the subjects of the same researchers in Guatemala gave no consent.
“This finding goes a long way to helping the Commission answer the question about whether ethics rules of the time were violated,” Gutmann said. She added that the Commission will now quickly finish writing its conclusions about the ethics of the case and will send its full investigation report to the President in September.
With the historical investigation concluded, the Commission will turn its attention tomorrow to its ongoing work in reviewing contemporary standards that protect human research participants.
“Guatemala is the catalyst for this important work that the Commission will complete at end of this year,” Gutmann said.
In particular, the Commission looks forward to receiving the proceedings and recommendations from the International Research Panel that it assembled to advise it on the effectiveness of current federal rules and international standards for research involving human subjects.
The Panel, a subcommittee of the Commission, met three times. The International Research Panel’s findings and recommendations will be printed in the Federal Register and the Commission will also take public comment on the Panel’s recommendations. The Commission will use both the Panel’s recommendations and the public comments to inform its final report to President Obama. That final report is due to the President in December.
“Assuring the President that the current rules for research participants protect people from harm or unethical treatment, domestically, as well as internationally, is at the heart of the Commission’s charge on human subjects protection,” Gutmann said.