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December 14, 2011

US Report Finds Human Research Subjects Enjoy Adequate Protection

by Jessica Berman

A report commissioned by the Obama administration concludes that despite some egregious past abuses, people taking part today in medical tests and clinical trials enjoy adequate legal protections. The report follows the disclosure last year that the U.S. Public Health Service in the 1940s supported unethical research involving inmates at a Guatemalan prison.  

Between 1946 and 1948, U.S. public health officials, hoping to test the effectiveness of the antibiotic penicillin against syphilis, reportedly exposed 1,300 Guatemalan prisoners to the potentially fatal venereal disease. Prostitutes known to be infected with syphilis were sent into jails to have sex with the inmates. Men who did not become sick from these contacts were purposely infected with syphilis, through cuts researchers made on the prisoners' genitals. Eighty-three people died in the experiments.

This little-known research project was brought to light in 2010 by a medical historian at Wellesley College, and reported widely by the news media, including the New York Times. In response to the public furor that ensued, the Obama Administration issued an apology to the Guatamalans affected by the research, and called for a study to determine if current rules and regulations adequately protect human research subjects from similar abuse.

Amy Gutmann, president of the University of Pennsylvania, heads the Presidential Commission for the Study of Bioethical Issues, which issued its final report on the matter Wednesday.

“The commission is confident that what happened in Guatemala in the 1940s could not happen today," said Gutmann. "We also are confident that there is room for improvement in protecting human subjects from harm, avoidable harm, and unethical treatment.”

In its survey of 18 U.S. government agencies, including the Pentagon, the commission found that few could easily access information on the more than 55,000 human test subjects worldwide currently involved in some kind of medical research.

As a result, the ethics panel recommends more than a dozen changes to current practices to ensure the well-being of those taking part in clinical trials. A key recommendation is that all federal agencies supporting human research abroad must maintain accurate and accessible electronic records of all experiments, including the nature and purpose of the research, the names of the researchers, and the names and locations of all test subjects.

Ross McKinney, director of the Trent Center for Bioethics at Duke University in North Carolina, has lectured on the Guatemala experiments. McKinney, who describes the 1940s syphilis research as “barbaric,” believes it’s highly unlikely that something like that could happen again.

“There are many levels of oversight now that didn’t exist at that point in time," he said. "The entire structure of institutional review boards, IRBs, which independently review research, didn’t exist [in the 1940s]. And now, most countries, most medical centers, require things to have IRB approval, essentially approval by a neutral body that judges the ethics. I don’t think they would let slip something as grotesque as the Guatemalan experiment.”

The bioethics panel also recommends that the U.S. government consider a way to compensate any of the affected Guatemalan prisoners who might still be alive, more than 60 years after the experiments.