Monday, November 3, 2014

New Rules for Human-Subject Research Are Delayed and Debated

The Chronicle of Higher Education
November 3rd, 2014

When I. Glenn Cohen, a professor at Harvard Law School and director of a bioethics center there, helped to organize a conference in 2012 about the future of research on human subjects, he says he worried about being "late to the party."
In 2011, the Department of Health and Human Services had floated some ideas for changes in the rules governing such research. The aim was both to better protect the subjects and to reduce the much-resented bureaucratic burden on professors and university staff members.
Mr. Cohen needn’t have worried about tardiness. Today, more than two years after the conference, the regulations remain just where they were in 2011: still under development.
Human-subjects rules are designed to prevent such horrors as the Nazis’ medical experiments as well as homegrown examples of abuse, such as the Tuskegee studies, in which black men with syphilis were falsely told they were receiving treatment. The revelation, in 1972, of that research, in particular, led to a requirement that grants from the U.S. Public Health Service for research on human subjects receive close scrutiny.

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