Presidential Memorandum--Review of Human Subjects Protection
MEMORANDUM FOR DR. AMY GUTMANN Chair, Presidential Commission for the Study of Bioethical Issues
SUBJECT: Review of Human Subjects Protection
Recently, we discovered that the U.S. Public Health Service conducted research on sexually transmitted diseases in Guatemala from 1946 to 1948 involving the intentional infection of vulnerable human populations. The research was clearly unethical. In light of this revelation, I want to be assured that current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally.
I ask you, as the Chair of the Presidential Commission for the Study of Bioethical Issues, to convene a panel to conduct, beginning in January 2011, a thorough review of human subjects protection to determine if Federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the Federal Government. I also request that the Commission oversee a thorough fact-finding investigation into the specifics of the U.S. Public Health Service Sexually Transmitted Diseases Inoculation Study.
In fulfilling this charge, the Commission should seek the insights and perspective of international experts, including from Guatemala; consult with its counterparts in the global community; and convene at least one meeting outside the United States. I expect the Commission to complete its work within 9 months and provide me with a report of its findings and recommendations.
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. It is especially important for the Commission to use its vast expertise spanning the fields of science, policy, ethics, and religious values to carry out this mission. We owe it to the people of Guatemala and future generations of volunteers who participate in medical research.