December 6, 2022

Panel gives US govt funded clinical research clean bill of health

Current rules and regulations provide adequate safeguards to mitigate risk in clinical trial, says the Presidential Commission for the Study of Bioethical Issues. After a survey of federally-sponsored research involving human volunteers after a scandal over highly unethical treatment of Guatemalan patients in the late 1940s by doctors in the Public Health Service, Commission basically gave American research a clean bill of health.

Current rules and regulations provide adequate safeguards to mitigate risk in clinical trial, says the Presidential Commission for the Study of Bioethical Issues. After a survey of federally-sponsored research involving human volunteers after a scandal over highly unethical treatment of Guatemalan patients in the late 1940s by doctors in the Public Health Service, Commission basically gave American research a clean bill of health.

The report, Moral Science: Protecting Participants in Human Subjects Research, recommends 14 changes to current practices to better protect research subjects, and calls on the federal government to improve its tracking of research programs.

“The Commission is confident that what happened in Guatemala in the 1940s could not happen today,” Commission Chair, Amy Gutmann. said.  “However, it is also clear that improvements can be made to protect human subjects going forward.”

“Many of the most important advances today are driven by research that involves human participants,” Commission Vice Chair, James W. Wagner, said. “We must ensure that the way we conduct research involving human subjects protects, encourages, and makes fruitful the selfless practice of allowing oneself to become the subject of a medical or social study intended for the benefit of another.”

While there is no way to eradicate all risk of harm, particularly in some types of medical and translational research, Gutmann noted that “our nation vigorously and rigorously protects people who volunteer for research studies.  However, the Guatemala experiments remind us never to take ethics for granted. We must never confuse ethical principles with burdensome obstacles to be overcome or evaded. Good science requires good ethics, and vice versa.” 

Michael Cook
clinical trials
Guatemala
US