Panel proposes injury compensation for research participants

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A panel of international research experts recommends that the United States adopt a model to compensate people who have been injured during the course of research.

The recommendation comes as part of a full report to assess the adequacy of existing safeguards for U.S. research participants compiled by the Presidential Commission for the Study of Bioethical Issues.

President Obama formed the Commission last year, after historians discovered Guatemalan prostitutes, prisoners and soldiers were unknowingly exposed to sexually transmitted diseases in the 1940s as part of U.S. experiments.

From 1946 to 1948, well-known public health figure John C. Cutler, MD, and colleagues intentionally infected female sex workers with syphilis and paired them with male prisoners. The researchers also inoculated inmates, patients at mental hospitals and soldiers with the pathogens responsible for syphilis, gonorrhea and chancroid, without their knowledge or consent.

After issuing a public apology, the President requested the Commission investigate the Guatemala experiment, as well as current U.S. research policy, and make recommendations to prevent future research-related abuses.

"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 the 48-page report.

However, despite the praise, the Commission pointed out several areas for improvement during a public meeting in Washington earlier this week.

In addition to adopting a research participant compensation model similar to the National Vaccine Injury Compensation Program already in existence, the Commission recommended creating a single national patient database. “We know about ClinicalTrials.gov, but it is not at all comprehensive,” said Commission chair Amy Gutmann, MD, president of the University of Pennsylvania.

Ezekiel J. Emanual, MD, PhD, former chief of the Clinical Center Department of Bioethics at the National Institutes of Health agreed: “I've been saying for the last 15 years it is a scandal that neither the head of the FDA or NIH can report how many people are on clinical trials, or how many people have had an adverse event, or had died” in connection to a trial.

The Commission is currently compiling information from 18 federal agencies involved in conducting scientific research to determine the feasibility of developing a national database.

Other Committee recommendations for improvements include: regular dialogue with international organizations about research ethics; sponsor-funded ethics training for clinical investigators and institutional review board members; more transparency and monitoring of ongoing research; and better enforcement and refinement of existing rules.

The Commission is expected to report full findings on the Guatemala experiments next month.

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