IRB ethic directives

Solution Preview

The Institutional Review Board

Prior to the twentieth century, research ethics were primarily governed by individual conscience and professional codes of conduct. Whether and how humans might be investigated, however, has always been subject to the laws and customs of the society and government at the time. For many reasons, in the second half of the twentieth century, an elaborate set of rules and regulations about research were established by the American government to protect individual and public interests. What follows is a discussion of why federal rules and regulations were established, including the Institutional Review Boards.

There are many examples of professional and governmental regulation of medical practice in ancient times. Hammurabi's Code (18th century b.c.) gave detailed and explicit penalties for what we would call malpractice, and to this day Western doctors swear an oath attributed to the 5th century b.c.physician Hippocrates which includes an affirmation, "to abstain from all intentional wrong-doing and harm, especially from abusing the bodies of man or woman, bound or free." There is also early evidence that ethical problems of research on humans were recognized, as in the case of the Roman physician Celsus (1st century a.d.) who wrote that using criminals as subjects for dangerous experiments was justified if it would benefit many other innocents.
Sometimes laws or customs which aimed at protecting human subjects have restricted new discoveries, as in medieval Europe where governments and the Catholic church outlawed autopsies. But there are also historical examples of reactions to researchers who unduly risked harm to human subjects. When attempts to use sheep's and calve's blood in the first human transfusions in the late 1660s produced questionable and some harmful results, the practice was banned in France for over 100 years.

NUREMBERG CODE

On December 9, 1946, an American military tribunal opened criminal proceedings against 23 leading German physicians and administrators for their willing participation in war crimes and crimes against humanity. During World War II, German physicians conducted medical experiments on thousands of concentration camp prisoners without their consent. They shot concentration camp prisoners to test blood clotting. They infected groups of inmates with viruses, then only treated part with the test vaccines, while they observed he course of the disease in the untreated inmates. They tested poison bullets to find more effective ways of killing; they tested prisoners to see how long they could remain alive under high altitude conditions of low air pressure and lack of oxygen.

Several German doctors had argued in their own defense that their experiments ...