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Bioethics Director Explores the Power and Limits of IRBs

On Thursday in The Huffington Post, director of the M.S. program in Bioethics Dr. Robert Klitzman outlined some of the worst human subject experiments in history, and what these egregious examples can teach us about the need for more sophisticated medical ethics.

He wrote, “To help their soldiers on the front, Nazi physicians sawed off the limbs of concentration camp prisoners and then tried to reattach these body parts, but failed. Other prisoners were forced into the snow to measure how long it took for them to freeze to death. In response, the Nuremberg Tribunal developed the first moral guidelines on how to conduct experiments.”

He said, “In 1974, a journalist revealed the moral lapses of the Tuskegee syphilis study in which researchers, funded by the U.S. government, studied the course of this disease in African-American men in the South. When penicillin became available as a definitive treatment, the researchers decided not to mention or offer it to the men, since doing so would destroy the experiment.” This tragedy prompted Congress to pass the National Research Act, “which led to the creation of research ethics committees, known as institutional review boards, or IRBs, to oversee the ethics of research.”

Klitzman said that, while these are some of the most atrocious examples in medical history, there remain grey areas within human subject research that require further investigation by IRBs. Furthermore, these IRBs “frequently operate wholly behind closed doors; and have approved research that violated ethical guidelines, and delayed or blocked other, important studies.”

He wrote, “To improve the process of ethical oversight of research, we need to change our attitudes, and recognize far more fully that complicated moral issues, strains and vagaries are involved. We need to require ethical training for IRBs, and a broad open discussion about the underlying social and moral tensions involved.”

Klitzman wrote, “Such improvements can aid not only research subjects, but our health, science and moral lives - as individuals and as a country and world as a whole.”