Informed Consent on the chopping block as FDA seeks to”harmonize clinical research regulations”
For the FDA, increasing options in clinical research requires the stripping away of informed consent.
In his latest newsletter, FDA Commissioner Robert Califf explains:
Today, I’d like to catch up with you about another critical component of FDA’s oversight of clinical studies: our work to harmonize clinical research regulations and to facilitate the development of medical products to benefit public health.
How does FDA commissioner Robert Califf propose we “harmonize clinical research regulations”?
In keeping with this harmonization, the FDA issued a final rule to help advance medical product development without compromising the rights, safety and welfare of people participating in clinical research.
The rule provides an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the people participating in the research, and the research includes appropriate safeguards to protect the rights, safety and welfare of participants. (emphasis mine)
This goes back to the 21st Century Cures Act.
On December 13, 2016, the Cures Act (Pub. L. 114–255) was signed into law. Section 3024 of the Cures Act amended sections 505(i)(4) and 520(g)(3) of the FD&C Act (21 U.S.C. 355(i)(4) and 360j(g)(3)) to provide FDA with the authority to permit an exception from informed consent requirements 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. This rule implements the statutory change by allowing an additional exception from the general requirements of informed consent for certain FDA-regulated clinical investigations.
You can read the Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations here.
Consider the difference between the current and proposed rule.
We started with this:
FDA’s current regulations governing the protection of human subjects (parts 50 and 56 (21 CFR parts 50 and 56)) require that a human subject, or the subject’s legally authorized representative (LAR), provide informed consent before the subject participates in a clinical investigation, and only allow exception from the general requirements of informed consent in certain life-threatening situations or by Presidential waiver for certain military operations when specific conditions are met (§ 50.23 (21 CFR 50.23)) or when the requirements for emergency research are met (§ 50.24 (21 CFR 50.24)).
The FDA now seeks this:
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act). This final rule allows an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The final rule permits an institutional review board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations. *emphasis mine
Why do we need to change this?
Apparently, informed consent is now an obstacle for clinical research. Why would that be? Are we facing a “clinical research hesitancy” crisis now, too? (After seeing what Maddie De Garay experienced as a result of participating in Pfizer’s pediatric clinical trial, it wouldn’t surprise me.)
I have questions. For example, how would an institutional review board determine that a clinical investigation poses minimal risk to participants BEFORE the clinical research takes place?
This public comment from an early incarnation of the rule pretty much sums it up:
I am commenting to voice my strong objection to the adoption of this proposed rule, “IRB Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations.” The terms of the rule and of the supporting documentation are impossibly vague: “minimal risk,” “reasonable risks in relation to anticipated benefits,” and similar expressions are meaningless if the individual who is taking on the risk is not the one doing the evaluating. Although IRBs have undergone some reform since the particularly egregious abuses of the 1990s, conflicts of interest still abound. I refer FDA to the work of Sidney Wolfe, Vera Sharav, and researchers at Harvard Medical School. (Some information is provided here: http://ahrp.org/hospital-irbs-are-on-the-take-tainted-by-conflicts-ofinterest_nejm/) To take power that international law and US law has long held belongs in the hands of the patient himself, and place that power in the hands of an IRB, goes against both the letter and the spirit of existing jurisprudence regarding the protection of human research subjects. Perhaps it is my BA in English from Harvard–or perhaps just my common sense–that moves me to point out that this rule allows the IRB to define the very meaning of such terms as “minimal” and “reasonable.” These terms are subjective, and the only appropriate person to render this subjective judgment is the human who is the research subject. More is not always better. Faster is not always better. When it comes to protecting human beings’ personal sovereignty, power can never be given to a third party whose interest is not primarily the safety of the patient.
Amen.
If you have questions, too, we’re provided with the following contact:
FOR FURTHER INFORMATION CONTACT: Lauren Milner, Office of Clinical Policy, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-5514, lauren.milner@fda.hhs.gov.
OR you can respond to the FDA’s Tweet here and Robert Califf’s Tweet here.