New Law Could Eliminate Informed Consent for Human Experimentation With Vaccines and Drugs

Published March 30, 2017 | Best in Video

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.