Does the 21st Century Cures Act Allow the Government to Bypass Informed Consent for Experimental Vaccines?

Does the 21st Century Cures Act Allow the Government to Bypass Informed Consent for Experimental Vaccines

Many have noticed the rampant denialism within the US government concerning adverse events or potential deaths associated with the investigational COVID-19 vaccines. What hasn’t made sense is why the government is so adamant about denying such obvious data points. Why is there such hesitancy to acknowledge any events?  Government agencies are even changing the OSHA reporting rules in the cases of employer-mandated vaccines. The goal of vaccinating everyone so that society can collectively return to some semblance of normal after the COVID-19 pandemic is understandable. But TrialSite has delved deeper into what may be at least one driving rationale for such widespread and ubiquitous denial of any vaccine-associated adverse events, despite so many having been reported.  There is no question that the CDC VAERS self-reporting system is imperfect. Even when this is factored in, some level of serious or even severe adverse incidents (often unusually delayed) are clearly associated with the investigational vaccines. Could it be that there is some federal legal or statutory reason for asserting that there are absolutely no vaccine-associated deaths (for example)? Is there some reason for keeping the vaccines under the emergency use authorization (EUA) classification while studies on children continue full speed ahead? 

TrialSite is a pro-vaccine and drug development place, one where millions of people visit often to learn about medical and pharmaceutical breakthroughs at the level of the trial site, major academic research center, and R&D headquarters of biotech and pharmaceutical companies. With an eye on the importance of transparency and accessibility, our goal is that research can and will be embraced by ever more members of society as awareness and trust of the clinical research enterprise grows and thus engagement by the general public intensifies. 

The Clause

Back in 2016 when the 21st Century Cures Act was signed into law (December 13, 2016), the mission, among other things, was to accelerate medical product development to support the expedited commercialization of new innovative advancements to the bedside of patients. No one can oppose such an important goal, but patient safety is of course sacrosanct and infused into the underlying clinical research mission. 

When introduced by the 114th Congress, Section 3024 of the Act stated, “Clinical testing of investigational medical devices and drugs no longer requires the informed consent of the subjects if the testing poses no more than minimal risk to the subjects and includes safeguards.” 

The importance of informed consent and the Declaration of Helsinki cannot be overstated for anyone that knows the history of research. This particular clause ultimately couldn’t have remained in this version for the finalized legislation and indeed upon review of Section 3024 of the Act.

“ INFORMED CONSENT WAIVER OR ALTERATION FOR CLINICAL INVESTIGATIONS. 

(b) DRUGS.—Section 505(i)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)(4)) is amended by striking ‘‘except where it is not feasible or it is contrary to the best interests of such human beings’’ and inserting ‘‘except where it is not feasible, it is contrary to the best interests of such human beings, or the proposed clinical testing poses no more than minimal risk to such human beings and includes appropriate safeguards as prescribed.”

The Law and its Implications

The 21st Century Cures Act signed into law on December 13, 2016, was in part designed to help accelerate medical product development and bring new innovations and advancements to patients who need them faster and more efficiently.  

A Gift to Industry?

Modern biotech and pharmaceutical companies can contribute absolutely amazing advancements to society as can be witnessed in hospitals across the nation. Stories abound of what were once deadly cancers that are now treatable and even the first Alzheimer’s disease drug in decades in the United States was just approved. With brilliant, motivated personnel, substantial investment into communities creating all sorts of employment in many ways biotech and pharma are national treasure troves.

But rules such as informed consent have been around for decades for a reason. And despite tremendous progress with vaccines during the pandemic, a concerted effort to block low-cost, generic, repurposed treatments is but one example of industry becoming too influential.

When industry and government get too friendly, that raises additional problems. America’s long history of, from time to time, taking on and untying industry and government knots often is a call to a higher action as too much power concentrated in few hands is never healthy for the society, economy, and health of all. 

FDA’s Point of View on the Act’s Waiving Informed Consent

On July 2017, the U.S. Food and Drug Administration (FDA) issued guidelines for implementation of the rules, which seemingly waves key aspects of federal law for human research subject projection. 

For example, the FDA noted in accordance with 21 CFR 10.115(g)(3) that the agency didn’t bother to seek any prior comment from the public. According to the language, the Gold Standard agency determined that prior public participation is “not feasible or appropriate because this guidance presents a less burdensome policy that is consistent with the public health.” This was the justification for waiving key aspects of fundamental human research subject protection law and policy without so much as a public hearing.

To the FDA’s credit, they did acknowledge that the agency remained subject to public comment in accordance with 21 CFR 10.115. Were the modifications implemented a few years ago just “business as usual,” intended to establish more friendly conditions for expediting research and development? Or are they serious encroachments on a human subject’s expectations for true and transparent informed consent as has been defined in the Belmont Report and the Declaration of Helsinki, a cornerstone of subject safety arising ultimately out of the horrors of World War 2?

Responses

  1. To clarify…

    While the FDA rule might exempt the “investigator” from the burden of INFORMING the subject of every potential risk when “the proposed clinical testing poses no more than minimal risk to such human beings and includes appropriate safeguards as prescribed to protect the rights, safety, and welfare of such human beings” it does not exempt them from getting consent.

    Consent can’t be waived.

  2. I think there are at least 2 things to be considered on this. One is duty to inform, the other is getting consent (whether informed or not).

    And I note that “(1) The Secretary shall promulgate regulations for exempting from the operation of the foregoing subsections of this section drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs. …”
    https://www.law.cornell.edu/uscode/text/21/355

    It appears to me that this exemption only relates to the “investigational” stage. I think this current widespread mass-vaccination stage is well beyond that exploratory “investigational” stage.

    I do not believe consent, informed or not, can ever be waived without violating human rights.