[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR640.61]

[Page 101]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 640_ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
--Table of Contents
 
                         Subpart G_Source Plasma
 
Sec. 640.61  Informed consent.

    The written consent of a prospective donor shall be obtained after a 
qualified licensed physician has explained the hazards of the procedure 
to the prospective donor. The explanation shall include the risks of a 
hemolytic transfusion reaction if he is given the cells of another 
donor, and the hazards involved if he is hyperimmunized. The explanation 
shall consist of such disclosure and be made in such a manner that 
intelligent and informed consent be given and that a clear opportunity 
to refuse is presented.