New Op-ed: The FDA Just Quietly Gutted Protections for Human Subjects in Research | Opinion

Hi everyone,

I just published a new op-ed in Newsweek with Tom Nicholson that I think is worthwhile reading. Let me know your thoughts in the comments below!

— Jay

The FDA Just Quietly Gutted Protections for Human Subjects in Research | Opinion

By Tom Nicholson & Jay Bhattacharya

Late last year, the U.S. Food and Drug Administration (FDA) quietly introduced a regulation that may be one of the most important shifts in how non-profit and for-profit U.S. institutions, both at home and abroad, conduct future medical and public health research. It represents an erosion of personal medical choice and threatens to undermine the public's trust in scientific investigations in biomedicine.

A bedrock of ethical research design is the universal requirement of informed consent for any medical procedure, treatment, or intervention. Researchers must provide information to possible participants, without pressure or coercion, to decide whether the risks are worth the potential benefit of an intervention. The FDA's exceptions, until recently, are historically reserved for people who are incapacitated or for urgent, life-threatening emergencies.

These measures have generally been strengthened since the Nuremberg Trials, formally adopted across the U.S. government through the institutional review board (IRB) system. An IRB is a committee of specialists and administrators at each institution that oversees research design and assures the protection of research subjects.

At its core, the new FDA rule change allows any IRB to broadly assume the FDA's own exemption power, dubiously granted under the 21^st Century Cures Act of 2016, to grant exemptions to informed consent requirements based on "minimal risk." Based on vague guidelines, it effectively gives thousands of IRB committees the unilateral ability to determine that researchers need not obtain true informed consent from research participants.

This new power applies to the IRBs housed at clinical research organizations, universities large and small, pharma companies, and multi-billion dollar corporations that provide IRB services to research groups.

Critically, the threshold to employ this exemption is the vague definition of "minimal risk clinical investigation." As FDA describes, the primary requirement for this waiver is "if research can be practicably carried out without a waiver of informed consent, investigators cannot obtain a waiver under this rule."

So, the new rule is designed to make a different kind of scientific study or clinical trial easier to implement. Since nearly every clinical trial outside the military has secured informed consent since 1991, what sort of study does this waiver power apply to?

Logically, it applies either to studies where the number of patients is so large that researchers cannot practically survey them all for permission or studies where all the participants are not even necessarily known to the researchers.

Consider that prominent physicians have recommended greatly expanding the set of patients who receive statins, a cholesterol medication, to prevent heart disease. Some have even suggested adding statins to the water supply, though no clinical trial has studied the tactic. The new rule makes it more likely that a local university IRB, which considers statins "minimal risk"—which is the prevailing notion about them, might approve a study in which it would be impossible to gain the informed consent of water drinkers in the area.

Are Americans ready for such studies to be fast-tracked by their local ethics committee?

The relaxed standards could facilitate the quick approval of controversial research projects that straddle environmental and medical interventions. One example is the Gates Foundation-backed Oxitec program, which is currently releasing millions of genetically modified mosquitos in the Florida Keys. The FDA approved the program after a lengthy process. Despite years of debate and pushback from the local population, researchers will not be required to seek informed consent from locals.

If the FDA approved this, surely local IRBs across the country would have no problem approving many such projects without informed consent if millions of research dollars were on the line.

Another obvious application of the relaxed standards is to government-funded studies of online posts designed to identify "misinformation." Under the guise of conducting misinformation research projects, entities like the Stanford Internet Observatory have laundered government demands for censorship of speech—even true speech—in online settings like Facebook and X (formerly Twitter). The literal purpose of this research is to harm its research subjects by censoring their speech and labeling them as purveyors of misinformation.

In 2021, a conservative journalist sued Stanford University for slandering him via this research project, which never sought his informed consent to be a subject of their study. It was never clear why the Stanford IRB approved a study that harmed study participants without requiring informed consent. Under the new FDA rule, IRBs everywhere would feel no compunction to require it.

IRBs, the primary bodies delegated with the authority to protect research subjects from becoming the subject of unethical research, are only as rigorous and ethical as their members. Since IRBs are typically a part of the universities and research organizations they regulate, there is a structural conflict of interest; IRB priorities may extend beyond the protection of patients. They are ultimately neither elected, appointed by a public officer, nor accountable meaningfully to the public.

Under the new lax oversight standards, the FDA effectively authorizes IRBs nationwide to abdicate their oversight responsibility for risky research by granting dodgy exemptions to the ethical responsibility of seeking patients' informed consent.

The effect of this is predictable. At best, the public will become wary of scientists seeking taxpayer money, and the traditional bipartisan support for scientific research will evaporate. At worst, risky, unethical research approved under the new rule will harm the people researchers are supposed to help with their work.

The FDA should rescind this rule.

Tom Nicholson is a policy researcher, and leads Advance Access & Delivery, a non-profit global health organization. Jay Bhattacharya is a professor of health policy at Stanford Medical School. He is a co-founder of the Academy of Science and Freedom at Hillsdale College and Collateral Global, a UK charity devoted to documenting the collateral effects of covid-era public health policies.

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