The 21st Century Cure Act would demand that the Food and Drug Administration (FDA) add an exemption from informed Consent requirements for those clinical trials that pose no more than minimal risks and the appropriate safeguards protecting the right, safety and welfare of subjects.
The above can be found in section 3024 – Informed Consent Waiver or Alterations for Clinical Investigations.
So what they are saying now they don’t have to obtain informed consents to test vaccinations or drugs on humans beings if it has been determined that the proposed pose no more than minimal risks.
Let’s review the Exemption for Devices for Investigational Use
(g)(1) The purpose of this section to encourage to the extent consistent with the protection of public health and safety and ethical standards, the discovery and development of useful devices intended for human use and to that end to maintain optimum freedom for scientific investigators in their pursuit of that purpose.
In other words, you can get an exemption for certain conditions.
Question: if you don’t have informed consent in clinical trials experimentation on people, then how does anyone knows you are not part of an experiment?
If sponsors and clinical researchers not longer has to tell you that you are part of it or get your consent to informed you what they are doing? That may sound a little crazy.
Further source of research:
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