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Obama requests review of U.S. research regulations

By the CNN Wire Staff
  • The president's request follows revelations of unethical research in the 1940s
  • In the 1940s, U.S. researchers infected Guatemalans with syphilis, other diseases
  • Obama sets a nine-month deadline for a report on the matter

Washington (CNN) -- President Barack Obama on Wednesday requested a review of regulations on federally funded scientific studies to ensure they "adequately guard the health and well-being of participants."

The memorandum followed the revelation last month that the U.S. Public Health Service intentionally infected Guatemalans with sexually transmitted diseases for research purposes in the late 1940s.

Obama's request called such research "clearly unethical" and said that he wanted assurance that "current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally."

The memorandum asked the head of the Presidential Commission for the Study of Bioethical Issues to form a panel in January to review existing regulations and thoroughly investigate the Guatemalan study.

Obama said he expected a report on the panel's findings within nine months.

"While I believe the research community has made tremendous progress in the area of human subjects protection, what took place in Guatemala is a sobering reminder of past abuses," Obama's memorandum said. "It is especially important for the Commission to use its vast expertise spanning the fields of science, policy, ethics, and religious values to carry out this mission. We owe it to the people of Guatemala and future generations of volunteers who participate in medical research."

On October 1, the U.S. government apologized to Guatemala for the 1946-1948 research study in which people there were intentionally infected with sexually transmitted diseases.

A statement then by Secretary of State Hillary Clinton and Secretary of Health and Human Services Secretary Kathleen Sebelius called the action "reprehensible," and Guatemalan President Alvaro Colom called the study 64 years earlier "a profound violation of human rights."

The scientific investigation, called the U.S. Public Health Service Sexually Transmitted Disease Inoculation Study of 1946-1948, aimed at determining the effectiveness of penicillin in treating or preventing syphilis after subjects were exposed to the disease. Gonorrhea was also studied. Penicillin was a relatively new drug at the time.

The tests were carried out on female commercial sex workers, prisoners in the national penitentiary, patients in the national mental hospital and soldiers. According to the study, more than 1,600 people were infected: 838 with syphilis and chancres, 772 with gonorrhea.

The study came to light recently when Wellesley College researcher Susan Reverby found the archived but unpublished notes from the project as she was researching a similar study that was conducted between 1932 and 1972 in Tuskegee, Alabama.

That study included nearly 400 poor African-American men with preexisting syphilis whose disease was allowed to progress without treatment. Researchers did not infect the subjects, but they did not tell them they had the disease either.

The Tuskegee study was done under the direction of Dr. John C. Cutler, a U.S. Public Health Service medical officer who died in 2003. Cutler also led the Guatemala research, Reverby said.

Dr. Francis Collins, director of the U.S. National Institutes for Health, said the Guatemala study represented "a dark chapter in the history of medicine."

Collins cited four primary ethical violations: 1) study subjects "were members of one or more vulnerable populations;" 2) there is no evidence they gave informed consent; 3) they were often deceived about what was being done to them; 4) they were intentionally infected with pathogens that could cause serious illness without their understanding or consent.

U.S. officials said last month that ethical safeguards would prevent such abuses from occurring today.

CNN's Tom Cohen contributed to this story.