Jun 29, 2022·edited Jun 29, 2022

"[Being a subject] is not particularly hazardous...surveys both before and after the rise of the IRB system found few examples of serious risk3...people and institutions with incentives to discover and publicize risk locate little...studies repeatedly find that patients are not hurt and might be helped by being research subjects."

Taken in aggregate, yes, most IRB-reviewed biomedical studies don't pose significant risk to patients. However, RCTs of drugs--which the Cochrane Review does not actually include many of, despite their claim!--*especially* phase 1 trials, *especially* phase 1 trials where results from animal studies are concealed from trial enrollees, pose a significant risk both of harm and coercion of patients. Consider Jesse Gelsinger's death, or the excess deaths from the Vioxx clinical trials that were buried to permit the drug to precede to market. (Or consider every other drug that's gotten a black-box warning after "thorough" safety testing.)

However, since these all happened under the purview of IRBs, it's hard to say the system's working to prevent these harms. Nevertheless, it would be better to acknowledge they exist and we aren't preventing them, versus pretending--as trial funders do--that they don't.

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"More speculatively: if the UK COVID-19 human challenge trials (HCTs) that eventually took place in March 2021 had instead taken place in the summer of 2020, they might have meaningfully ACCELERATED vaccine approval, saving countless lives..."


Overall, after reading, thanks for making me love IRBs. The more sand in the gears of this beast, the better.

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