The ethics police?: the struggle to make human research safe

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Abstract

Experiments on human beings have saved countless lives, but sometimes harmed participants. Critical questions thus emerge: how much government should regulate science, and how. Nazi experiments and the Tuskegee syphilis study led the US, in 1974, to establish Research Ethics Committees (or Institutional Review Boards -- IRBs) to oversee human research. But these committees have increasingly been criticized for blocking important studies, while ethical violations continue. Crucial dilemmas thus emerge: whether this system should be changed, and if so, how. In September 2015 President Obama's administration recommended several reforms. Yet we must first understand this system to know how to improve it. Unfortunately, these committees operate behind closed doors, and have received relatively little in-depth investigation. This talk, based on interviews with dozens of IRB leaders, explores how they make decisions, wrestling with conflicts and complexities assessing possible risks and benefits of studies, and deciding how much to trust researchers -- key questions that ultimately affect us all.

General Notes

Tuesday, January 12, 2016; noon to 1 p.m.; Room D1.602. "The Ethics Police? The Struggle to Make Human Research Safe". Robert L. Klitzman, M.D., Professor of Psychiatry Director, Masters of Bioethics Program, Columbia University.

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Subjects

Grand Rounds, Biomedical Research, Clinical Trials as Topic, Ethics Committees, Research, Human Experimentation, Informed Consent, Social Justice, Teaching Rounds

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