Monthly Archives: May, 2011
In clinical trials, questions around community rights
At the final session today of the Presidential Commission for the Study of Bioethical Issues, one issue that rose repeatedly was the importance of involving the community in discussions around ethical issues in clinical trials. “A lot of people talked about individual rights and community rights, but how do we take that into consideration and [...]
Could another Guatemala case happen?
The question was simple, the answers not. At the Presidential Commission for the Study of Bioethical Issues today, Commission Chair Dr. Amy Gutmann, president of the University of Pennsylvania, asked a panel of international experts on bioethics whether the so-called Guatemala incident could happen again. In Guatemala, from 1946 to 1948, a U.S.-funded research experiment [...]
At meeting, one very interested onlooker
She sat up front at the Presidential Commission for the Study of Bioethical Issues meeting in New York City, listening closely and feeling extremely curious as to how the Commission would proceed in its in-depth look at human subjects research in clinical trials. But Susan M. Reverby, a professor of women’s studies at Wellesley College [...]
Professor: IRB, IRS, what’s the difference?
One of the themes in the discussion today at the Presidential Commission for the Study of Bioethical Issues: Why did proper concerns for protecting human subjects in trials lead to the creation of a regulatory structure that makes so many researchers cringe? Researchers equate dealing with Institutional Review Boards (IRBs) as like “going before a [...]
Not too hot, not too cold …
Sometimes fairy tales help explain the most complex problems. Dr. Amy Gutmann, president of the University of Pennsylvania and chair of the President’s Commission for the Study of Bioethical Issues, today reached back to Goldilocks and the Three Bears to frame an issue before the Commission. The Commission is listening to experts today talk about [...]
Frustration grows over long list of rules for trials
Researchers and federal officials today gave an overview of a confusing array of the numbers of federal controls and regulations of human subject trials before the Presidential Commission for the Study of Bioethical Issues. Commission member Dr. Christine Grady, deputy chief of the Department of Bioethics at the National Institutes of Health Clinical Center, said [...]
US investigation finds efforts to ‘deceive’
Sometime this summer, the staff of the Presidential Commission for the Study of Bioethical Issues will release its report on the US-funded research study from 1946 to 1948 in Guatemala in which investigators deliberately infected people with sexually transmitted diseases. Valerie H. Bonham, the Commission’s executive director, gave a sneak preview this morning of the [...]
Live from New York: Commission’s meeting on human subjects trials
Welcome to the live blog for the fifth public meeting of the Presidential Commission for the Study of Bioethical Issues . The two-day hearing, held in midtown Manhattan, will focus in part on the investigation into the revelations last October about the U.S. Public Health Service’s support for sexually transmitted disease research conducted in Guatemala [...]
