Review Ordered of Research Protections for Human Subjects

(USA.gov)

President Barack Obama yesterday (24 November) asked Amy Guttman, chair of the Presidential Commission for the Study of Bioethical Issues, to review protections afforded human subjects taking part in federally-funded research. The review stems from disclosures of U.S. Public Health Service (PHS) studies on sexually transmitted diseases in Guatemala from 1946 to 1948 involving the intentional infection of research participants.

In a memo released yesterday, the president requested that Guttman form a separate panel, starting in January 2011, to conduct “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.” The memo also requests Guttman’s committee oversee an investigation of the PHS’s Guatemala  studies in the 1940s.

In September, Wellesley College historian Susan Reverby released accounts of a PHS scientist in Guatemala who in 1946-48 tested the effects of various chemicals on sexually-transmitted diseases. Reverby’s research showed that the scientist infected Guatemalans at various national institutions: mental hospital, military barracks, and prison. Reverby could find no record that the scientist sought consent from the individual subjects.

Secretary of State Hillary Rodham Clinton and Secretary of Health and Human Services Kathleen Sebelius issued an apology soon after the accounts became public.

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