A report released this month by the Presidential Commission for the Study of Bioethical Issues concluded that current rules and regulations adequately protect human research subjects from avoidable harm or unethical treatment, but improvements can and should be made.

The Commission recommended improved accountability for federally funded research involving human subjects, including making information about the research grants publically available online. Currently, there is no central source for information about the overall size, scope, and cost of such research.

The report found that the government should also pursue a national system of compensation or treatment for research-related injuries. Most other developed nations have policies in place that require researchers or sponsors to treat or compensate for treatment for injuries suffered by research subjects.

Improvements should also be made to the Common Rule, which regulates basic protections for human subjects in federally funded research. The Commission recommends addressing the responsibilities of investigators in the rule.

The report was ordered by President Obama, who requested an assessment of human subject research standards following the revelation that the U.S. Public Health Service supported research in Guatemala in the 1940s that intentionally exposed thousands of people to sexually transmitted diseases without their consent.

“The Commission is confident that what happened in Guatemala in the 1940s could not happen today,” said Commission Chair Dr. Amy Gutmann. “However, it is also clear that improvements can be made to protect human subjects going forward. With the Commission’s recommendations, society will continue to benefit from advances in quality of life made possible by human subjects research and ensure respect for the inherent dignity of individual research volunteers.”

Read the report, “Moral Science: Protecting Participants in Human Subjects Research,” at http://bioethics.gov/cms/node/559.


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