Concerning article https://www.newsweek.com/fda-just-quietly-gutted-protections-human-subjects-research-opinion-1922464 "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." ETA link to legislation https://www.federalregister.gov/doc...of-informed-consent-for-minimal-risk-clinical
"At its core, the new FDA rule change allows any IRB to broadly assume the FDA's own exemption power, dubiously granted under the 21st 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." --- "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."" --- "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. 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." --- "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."
