Informed Consent on the chopping block as FDA attempts to"harmonize clinical research regulations"

apparently, when an institutional review board decides there's minimal risk, there's no need for informed consent

Please, please start reading past the headlines.

https://www.fda.gov/news-events/fda-voices/increasing-options-clinical-research-facilitate-medical-product-development

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)

You can read the Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations here.

From the document:

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.

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)).

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?

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.