Driven by concerns about a US-sponsored study ethics in the 1940s, bioethics advisers to President Barack Obama formed an international panel today will consider whether current rules adequately protect volunteers in global clinical trials.
A historian at Wellesley College last October shocked the nation with the revelation that, from 1946 to 1948, an American researcher Public Health Service deliberately exposed Guatemalan prisoners, soldiers, and other syphilis and gonorrhea. Experiments have drawn comparisons with Tuskegee study of 40 known in Alabama began in 1932 in which American researchers has hundreds of African American men with syphilis were not treated.
In response, President Obama asked his Presidential Commission for the Study of Bioethical Issues to consider whether "the current rules for research participants protect people against evil or otherwise processing ethics, nationally and internationally. "Obama also asked the Institute of medicine (IOM) to investigate the Guatemala study. But the investigative work also fell to the bioethics commission after IOM realized that five of its members were involved in the study. the committee is chaired by the University of Pennsylvania President Amy Gutmann and vice-chaired by Emory University President James Wagner.
today, Gutmann announced the members of a committee that will examine the "relevance" standard "in the field of international research today," she said. members include four experts of the Committee Bioethics and 10 others from 10 countries, from Belgium to Uganda to India. The panel will meet three times before reporting to the Committee in August the Gutmann panel will also receive notice of Guatemala's vice president, Jose Rafeal Espada, former cardiothoracic surgeon.
A team of 12 staff members of the commission and several academic consultants have already started digging into 477 boxes of documents on Guatemala studies. They want to respond to these "core issues" like who knew the study, when they knew it, and what they did about it, the commission said Executive Director Valerie Bonham. His staff plan to complete its report by the summer.
At today's meeting, the Commission heard from various experts on the landscape of international trials. clinical researcher Robert Califf Duke University described a surge in the number of tests in the last decade, companies seeking to reduce costs and avoid the inefficiencies of the US-based assays. He identified payments to patients that far exceed local standards as the most common ethical problem.
University of Washington researcher on HIV Lawrence Corey, head of the vaccine against HIV Trials Network US-funded, described the efforts of his team in partnership with local researchers so that the community benefits from the results, for example, on circumcision for reducing HIV transmission.
University of Wisconsin, Madison, historian Susan Lederer briefly reviewed the ethics of medical research in the early and mid 20th century. She said the control groups were a new idea when experiments like those of Guatemala and Tuskegee a team of US syphilogists expected, and researchers still do not use written protocols. The case of Guatemala "is unlikely that the only study of its kind out there lurking in the archives," said Lederer. (More studies contrary to ethics were revealed by the Associated Press yesterday.)
Yet ethicist Dan Brock of Harvard Medical School in Boston said it is "quite unlikely" that the study Guatemala could happen now. "Everybody now agrees" on what was wrong, he said, suggesting that "does not provide much new work of the commission." But Indiana University, Indianapolis, ethicist Eric Meslin in disagreement. "it could happen today" even the United States, he said, because the so-called common rule for the protection of US human subjects, not about research not funded by the government or submitted to the US Food and Drug Administration.
Guttmann said lots the commission to do so because of increased testing and because the general rule was not revised "for decades. "the Guatemala study are" a reminder of the historical injustices, "she said Science Insider." We have to ask ourselves, as a committee, are there practices against people seeking to return today as [being as] unethical practices that we plan to return to Guatemala? "
The presentation of the international jury is looking only research funded by the US government. But Gutmann said, "We are free to move beyond" for tests conducted by pharmaceutical companies Bioethics Committee will report to the President by the end of this year, says Gutmann
.. yesterday, the commission began discussing the ethics of genetic and neuroimaging, including the opportunity to say study volunteers about unexpected results that are not directly related to the research. the panel "refine the subject "before its next meeting in May, says Gutmann.
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