The COVID vaccine arrival as well as Biden’s choice for his nomination of California Attorney General Xavier Becerra to lead the Health and Human Services Department makes it imperative that we give the Cures Act a review. There have been administrative tweaks to the bill but section 3023 remains.
The Cures Act was passed in the tail end of 2016. Today I focus on Section 3023, 3024 regarding Informed Consent and why you should care. No longer is the Gold Standard of “Informed Consent” required if there are “no more of minimal risks to participants.” And who decides this?
Earlier I posted Trump hogties the EPA, will he stop their illegal human medical experiments? This is why you should care. But let me not get ahead of myself. I include a video.
A year and a half after the original bill left the House of Representatives, the much-discussed and highly anticipated 21st Century Cures Act became law on December 13, 2016. The legislation went through more than a few changes in those seventeen months; it expanded from four sections to twenty-five and from 362 pages to 966. Informed Consent Waiver or Alteration for Clinical Investigations
The Cures Act introduces the possibility of waiving or altering informed consent for some FDA-governed research. This decision could mark a major step in the required harmonization of regulations; the rules around waivers of informed consent are some of the significant differences between FDA and Common Rule requirements.
The law sets two requirements for waiving or altering informed consent:
- The research must pose no more than minimal risk to participants; and
- Other measures to protect study volunteers must be in place.
The bill does not specify who will confirm decisions about minimal risk or appropriate safeguards, but the requirements seem consistent with determinations that IRBs already make.
From Science Blogs:
Title:The 21st Century Cures Act passes, potentially turning the FDA into a puppet of the pharmaceutical industry. (Well worth the full read.)
Worse, the bill undermines informed consent, as I discussed before. The provision is still there that would add another category of research for which it is acceptable to forego informed consent. Normally, it is only acceptable to skip informed consent when it is not feasible or it is contrary to the best interests of the subject.
Add to that now that it would be acceptable to forego informed consent when “the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject.”
As Merrill Goozner put it and I agreed, even if the risk is minimal, why would the authors of this legislation waive a central tenet of international agreements designed to protect the rights of human subjects in clinical trials? I didn’t understand either (and still don’t), particularly since the act doesn’t define “minimal risk” or specify who determines whether a study is minimal risk.
Well worth a good look. Our lives may depend on it. An excellent review of the bill and the ramifications.
This is a B-ville repost done in March of 2017:
I am not sure I for one want the Biden administration in charge of:
Human research subject protections
The 21st Century Cures Act calls on the Secretary of Health and Human Services to harmonize differences between the HHS Human Subject Regulations and FDA Human Subject Regulations. In so doing, the Secretary may change rules applying to vulnerable populations in order “to reduce regulatory duplication and unnecessary delays” and “modernize such provisions in the context of multisite and cooperative research projects.” – Wikipedia,
Unfortunately the Quorum links are no longer available.
Other than this all is well in the swamp.