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Group to study protection of humans
Panel probes human subject protection
President Barack Obama has called for an investigation of U.S. human subjects research protections in response to last fall's disclosure that in the 1940s U.S. public health researchers deliberately infected Guatemalan research subjects with syphilis while testing penicillin.
Obama personally apologized to the Guatemalan people and government in October 2010, after Susan Reverby, MA, PhD, a professor of women's studies at Wellesley College in Massachusetts, made the discovery while researching the infamous Tuskegee study of the 1940s through the 1960s. In that study, black men with syphilis were left untreated for years, despite the availability of antibiotics.
The Guatemalan study followed prison inmates, women, and mental patients. Investigators appeared to have deliberately exposed inmates to syphilis for the purpose of then treating them with an experimental antibiotic.
Obama established the Presidential Commission for the Study of Bioethical Issues on Nov. 24, 2009, for the stated purpose of advising the president on bioethical issues that could emerge as a consequence of biomedicine and technological advances, according to Executive Order 13521, dated Nov. 30, 2009.
In March 2011, the president's bioethics commission named an international research panel to report on the effectiveness of current international standards and U.S. rules for the protection of human subjects in studies funded by federal grants. "Last October's revelations about STD research studies in Guatemala were particularly disturbing because they involved vulnerable populations," says Valerie Bonham, JD, executive director of the Presidential Commission for the Study of Bioethical Issues of Washington, DC.
"It is another reminder of historic injustices in medical research programs and the need to make it right," Bonham says.
A society has an ethical responsibility to protect people who are participants in scientific research, which has driven many of the important advances in medicine, she adds.
"There is nothing more ethically important than protecting people who are participants in scientific research. Many of the most important advances in medicine were driven by research that involved human participants," Bonham says. "If we can't assure people that they will be safe and treated ethically, they won't volunteer for studies, and without volunteers, critically important research suffers and society suffers."
The international research panel includes medical ethics experts, researchers, and others from the United States and nations around the world, including Argentina, Brazil, China, Egypt, Guatemala, India, Russia, Uganda, and Belgium. The panel includes ethicists, scientists, physicians, and researchers.
"Their diverse backgrounds and commitment to the highest ethical standards will help inform the bioethics commission's report to the president which is due at the end of the year," Bonham says.
Bonham explains that the international research panel is expected to meet to discuss existing research subject protections worldwide, as well as any conflicts that might exist between U.S. norms and international standards.
"The commission works with the goal of identifying and promoting policies and practices that ensure scientific research, healthcare delivery, and technological innovation are conducted in an ethically responsible manner," she adds.