President Asks for Review of Human Subjects Protection Regulations
In light of recent revelations that the U.S. Public Health Service conducted research from 1946 to 1948 on sexually transmitted diseases in Guatemala that involved the intentional infection of humans, President Obama is seeking a review of federal regulations and international standards to determine if they adequately protect participants in research studies, both domestically and internationally.
In a memo dated November 24, 2010, the President asked the Chair of the Presidential Commission for the Study of Bioethical Issues to convene a panel that would conduct a “thorough” review. The panel will begin its work in January 2011, seek input from international experts, and complete its review within nine months.
The President requested a report of the panel’s findings and recommendations. The comprehensive review will include a fact-finding investigation of the study in Guatemala.
“While I believe the research community has made tremendous progress in the area of human subjects protection, what took place in Guatemala is a sobering reminder of past abuses…. We owe it to the people of Guatemala and future generations of volunteers who participate in medical research.”