BAN ON MEDICAL EXPERIMENTS WITHOUT CONSENT
		IS RELAXED

		by Gina Kolata

		New York Times, 11/05/96

		For the first time in a half century, new Federal regulations
		allow investigators to enroll patients in some medical 
		research without their consent.

		The Food and Drug Administration regulations, which took
		effect on Friday, apply only in carefully circumscribed
	 	situations. The patients must have a life-threatening 
		condition, like a severe head injury, and must be unable to 
		say whether they want to be part of a study. They would be
		selected only if it was not feasibleto obtain consent from a
		relative.

		Furthermore, the community in which the research is done 
		must be notified about the study, and the research design
		must have been reviewed and approved by the Food and Drug
		Administration. 

		Even the most ardent supporters of the new regulations say
		they understand the seriousness of what they have done. They
		have repealed a principle that dates back to the Nuremberg
		trials of Nazi doctors after World War II, when American 
		judges were agonizing over rules that might prevent doctors
		from ever again using human subjects in horrendous experi-
		ments. The judges wrote a code of ethics, the Nuremberg Code,
		whose first principle was that no one should ever be forced
		to take part in a medical experiments.;"The voluntary consent
		of the human subject is essential", they wrote.

		"It's a tremendous philosophical change" ,said Dr. Norman 
		Fost, director of the Center for Clinical Ethics at the
		University of Wisconsin, who lobbied for the change.

		Bonnie Lee, a senior policy analyst at the drug agency who
		wrote the new regulations said, "This is not something we
		did lightly or easily."

		But supporters of the regulations say patients will benefit.
		The requirement for informed consent, they say, was hobbling
		research that could save lives. 

		Dr. Fost said the regulations would liberate researchers to
 		study treatments that were desperately needed. Until now, he
		said, "research was not moving forward". The harm would be
		greater if patients were kept out of such studies, he argued,
		than if they were entered without their explicit consent. 

		Others, however, are gravely concerned. "It's a fateful 
		step", Jay Katz, an ethicist and lawyer at Yale Unversity,
		said in a telephone interview from Germany, where he was at
		a conference marking the 50th anniversary of the Nuremberg
		doctors' trials. "The first sentence of the first principle
		of the Nuremberg Code", he said, stated that nothing should
		be done to human beings without their consent. "And now, he
		said, "here we are making exceptions."

		(The article goes on, but these are the essential points.
		Dr. Fost went on to state that "consent is a means to an
		end", and further stated that "the goal is to do what the
		patient would want."  My feeling is this is exactly how
		the Nazi doctors saw the world; ie., they were here to save
		the world, no matter what the cost. I am now to believe that
		doctors are more humanitarian than during the War? I am
		sorry, but up close I saw a couple of UCLA doctors abuse 
		their positions. I would rather err to the patient/human
		being having informed control over their outcome than a
		stranger/doctor making the decision without consulting the
		patient/the patient advocate/a relative before administering
		an experimental drug.)