Monday, October 15, 2007

No Substantive Due Process Right

From an Institutional Review Board (IRB) Tutorial for Human Subjects Research:

THE ABILITY TO CONDUCT HUMAN RESEARCH IS A PRIVILEGE; IT IS NOT A RIGHT

"There is no substantive due process right to conduct human subject research" Federal District Court, Fourth Division, 1996

The formal codification of ethical guidelines for the conduct of research involving humans began in the late 1940's.

In 1946, 23 Nazi physicians went on trial at Nuremberg because of research atrocities performed on prisoners of war.

Subsequently, in 1947, the Nazi War Crimes Tribunal issued the Nuremberg Code, which was the first internationally recognized code of research ethics.

While the Nuremberg Code and subsequent ethical guidelines represented the most enlightened thinking of the time, many well- intentioned researchers did not know about them or did not apply this guidance to their research activities.

A series of abuses of research subjects came to public attention in the U.S. between 1953 and 1972, including the infamous Tuskegee Study, on the natural history of syphilis, conducted by Public Health Service employees.

These cases led some people to conclude that researchers should not be trusted to conduct studies involving humans.

Until the middle of this century, concerns about the ethics of the practice of medicine centered around therapeutic medicine, not research medicine.

National and international efforts to protect the rights and welfare of human subjects in research have occurred often in response to ethical violations -- situations in which researchers were found to have ignored the fundamental rights of human subjects


Infamous Cases: Ethical Violations in Research Involving Humans (Click on a case to view a case or click continue to continue the course):


Nazi War Crimes of a Medical Nature

The Tuskegee Syphilis Study

The Jewish Chronic Disease Hospital Study

The Willowbrook Studies

Radiation Tests on Mentally impaired Boys

This is what you call "seriously bad shit done in the name of science."

It is depressing. All I want to do is review human resources literature on family and medical leave and conduct surveys of managers to assess how they comply with the FMLA, to assess (with the idea of explaining) both over-and-under compliance.

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