Current practices protect human research subjects, panel says

Advances in medicine occur because people agree to participate in clinical trials. Americans can be assured that current rules and regulations to protect them in federally sponsored trials are sufficient, according to a new report.

The Presidential Commission for the Study of Bioethical Issues released a report Thursday that addresses the question of whether people are protected from harm, fraud and unethical practices when they volunteer to enter clinical trials. The country, unfortunately, has a long history of abuse of research participants, including an incident that was uncovered only last year on unethical research sponsored by the U.S. Public Health Service that took place in Guatemala in the mid-1940s. President Obama requested the new report after that abuse was made public. The studies in Guatemala involved exposing thousands of people to sexually transmitted diseases without their knowledge or consent.

Over the last several decades, safeguards to protect human research subjects have been strengthened, said commission chairwoman Amy Gutmann. “What happened in Guatemala in the 1940s could not happen today.”

Nevertheless, people may still fear that their best interests are not taken into account when they enter clinical trials, the report says. The commission issued 14 changes to current practices designed to better protect participants. The changes include better record-keeping by federal agencies supporting research and more transparency to aid the public in accessing information about trials.

The commission also recommended improvements in compensating people who are injured during research. Since the research is designed to benefit society, people who are injured during that research should not have to bear the costs of treating their injuries, they wrote.

There is no way to protect all study participants from all manners of harm. But, Gutmann said, “our nation vigorously and rigorously protects people who volunteer for research studies.”

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