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Who regulates the regulators?

  • Article
  • May 4, 2023
  • #Governance #Politics
Jason Crawford
@JasonCrawford
(Author)
rootsofprogress.org
Read on rootsofprogress.org
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Scott Alexander reviews a book about institutional review boards (IRBs), the panels that review the ethics of medical trials: From Oversight to Overkill, by Dr. Simon Whitney. From... Show More

Scott Alexander reviews a book about institutional review boards (IRBs), the panels that review the ethics of medical trials: From Oversight to Overkill, by Dr. Simon Whitney. From the title alone, you can see where this is going.

IRBs are supposed to (among other things) make sure patients are fully informed of the risks of a trial, so that they can give informed consent. They were created in the wake of some true ethical disasters, such as trials that injected patients with cancer cells (“to see what would happen”) or gave hepatitis to mentally defective children.

Around 1974, IRBs were instituted, and according to Whitney, for almost 25 years they worked well. The boards might be overprotective or annoying, but for the most part they were thoughtful and reasonable.

Then in 1998, during in an asthma study at Johns Hopkins, a patient died. Congress put pressure on the head of the Office for Protection from Research Risks, who overreacted and shut down every study at Johns Hopkins, along with studies at “a dozen or so other leading research centers, often for trivial infractions.” Some thousands of studies were ruined, costing millions of dollars:

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Alec Stapp @AlecStapp · May 6, 2023
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Highly recommend this whole piece from @jasoncrawford on what’s gone wrong with “review and approve” as a regulatory approach:
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