FDA Changes in Informed Consent Requirements for Experimental Treatment

John H. Boyles, Jr., MD
Article Type: 
March/April 1998
Volume Number: 
Issue Number: 

Dear Editor,

Congratulations on your Editor’s Corner article in the Fall 1997 issue of the Medical Sentinel. I am rapidly reaching the point of being afraid to criticize my government for fear that I will end up in jail.

We recently had an excellent meeting in Columbus, Ohio planned and executed by Nino Camardese, M.D. Leora Traynor, M.D., passed out the enclosed letter [i.e., “FDA and Dr. Shalala Strip Defenseless Patients of Protections of Informed Consent During Experimental Research” in which the FDA has amended informed consent regulations to permit experimental human research, in this case, “a blood derivative” to be given seriously injured patients with severe blood loss and shock in the emergency room of 35 hospitals nationwide]. It appears that the government hasn’t done enough by conducting experiments on humans. I don’t think the importance of Dr. Traynor’s short talk sunk into the participants of the conference. As I read this, the government will be able to conduct research for the maker of this blood derivative, so that it can be marketed worldwide. The obvious profit potential is enormous...

John H. Boyles, Jr., MD
Centerville, OH

Originally published in the Medical Sentinel 1998;3(2):38. Copyright © 1998 Association of American Physicians and Surgeons (AAPS).





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