OBAMA'S "LEGACY" SILENTLY PUT INTO EFFECT
DECEMBER 2016, ATTACKS INFORMED CONSENT
NEW LAW COULD ELIMINATE INFORMED CONSENT FOR HUMAN EXPERIMENTATION WITH VACCINES & DRUGS
DECEMBER 2016, ATTACKS INFORMED CONSENT
NEW LAW COULD ELIMINATE INFORMED CONSENT FOR HUMAN EXPERIMENTATION WITH VACCINES & DRUGS
republished below in full unedited for informational, educational, and research purposes:
They’re talking about a bill here, they’re talking about Section 3024 of
this bill and they’re talking about informed consent, and I will play
for you what they had to say having to do with vaccines and the 21st
Century Cures Act. This speaks to informed consent waiver or
alteration for clinical investigations. There, I have to say, are still a
lot of discussions going on whether this really will apply to two
vaccines for the following reason, this the 21st Century Cures would
amend the Food and Drug Act to add an exception from informed consent
requirements for those clinical trials that pose no more than minimal
risk and there are appropriate safeguards protecting the rights, safety,
and welfare of the exam place. Now, for vaccine trials we always have
taken the position that these trials do involve more than minimal risks,
so this may not be applicable but, again, we have our lawyers,
everybody, engaged to really help guide this along.
