Presidential subcommittee urges compensation for victims in research studies

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An international bioethics panel urged the U.S. recently to offer a compensation program for those who are injured or affected during the course of research studies.

One of the most famous U.S. research studies to put humans at risk was conducted in the 1940s and exposed Guatemalan prostitutes, prisoners and soldiers to sexually transmitted diseases. The research was conducted by U.S. public health employees and was intended to discover what would happen if syphilis was left untreated and put male prisoners in Guatemala at risk for two years.

Dr. John C. Cutler, who led the experiment, intentionally infected six prostitutes from Guatemala with syphilis and then let them have sex with male prisoners. Those who participated in the research did so without knowing about it or giving consent.

The President's Commission for the Study of Bioethical Issues had a subcommittee look into the possibility of compensating similar victims after the practices of the study in the 1940s were revealed. The subcommittee said The National Vaccine Injury Compensation Program is a good model on which to base any kind of future compensation program for those hurt during the course of research.

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The subcommittee President Obama asked to look into the possibility of compensation turned to bioethics experts from 10 different countries around the world to determine whether or not current U.S. policies are sufficient to protect those who have been or might become hurt during the course of research.

"Over the past five decades, the U.S. has made significant progress in developing rules, standards, and practices for protecting human subjects in research," the panel wrote in a 48-page report. Overall, the panel was satisfied with current policy, with the most notable exception being the recommendation to create "a system to compensate research subjects for research-related injuries."

The panel also said that other countries are currently ahead of the U.S. in the area of compensation for research participants. In fact, researchers in some European countries are asked to carry indemnity insurance for similar situations.

The panel made several other recommendations, including asking the U.S. to keep an open dialogue with other countries regarding bioethics issues and suggesting they refrain from insisting that foreign research trials abide by U.S. rules for research when alternative rules are acceptable as well. In addition, the panel recommended enforcing the current rules more aggressively before creating new ones.

The subcommittee will make an announcement next month regarding its findings on the Guatemala study and the full commission will release its final report in December after taking the subcommittee’s findings under advisement.

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