§ 640.61 - Informed consent.  


Latest version.
  • Link to an amendment published at 80 FR 29905, May 22, 2015.

    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.

    Effective Date Note:

    At 80 FR 29905, May 22, 2015, § 640.61 was removed, effective May 23, 2016.