At Astral Codex Ten Scott Alexander reviews From Oversight to Overkill by Simon N. Whitley, in light of his own experience with an Institutional Review Board’s demands:

Dr. Rob Knight studies how skin bacteria jump from person to person. In one 2009 study, meant to simulate human contact, he used a Q-tip to cotton swab first one subject’s mouth (or skin), then another’s, to see how many bacteria traveled over. On the consent forms, he said risks were near zero — it was the equivalent of kissing another person’s hand.

His IRB — ie Institutional Review Board, the committee charged with keeping experiments ethical — disagreed. They worried the study would give patients AIDS. Dr. Knight tried to explain that you can’t get AIDS from skin contact. The IRB refused to listen. Finally Dr. Knight found some kind of diversity coordinator person who offered to explain that claiming you can get AIDS from skin contact is offensive. The IRB backed down, and Dr. Knight completed his study successfully.

Just kidding! The IRB demanded that he give his patients consent forms warning that they could get smallpox. Dr. Knight tried to explain that smallpox had been extinct in the wild since the 1970s, the only remaining samples in US and Russian biosecurity labs. Here there was no diversity coordinator to swoop in and save him, although after months of delay and argument he did eventually get his study approved.

Most IRB experiences aren’t this bad, right? Mine was worse. When I worked in a psych ward, we used to use a short questionnaire to screen for bipolar disorder. I suspected the questionnaire didn’t work, and wanted to record how often the questionnaire’s opinion matched that of expert doctors. This didn’t require doing anything different — it just required keeping records of what we were already doing. “Of people who the questionnaire said had bipolar, 25%/50%/whatever later got full bipolar diagnoses” — that kind of thing. But because we were recording data, it qualified as a study; because it qualified as a study, we needed to go through the IRB. After about fifty hours of training, paperwork, and back and forth arguments — including one where the IRB demanded patients sign consent forms in pen (not pencil) but the psychiatric ward would only allow patients to have pencils (not pen) — what had originally been intended as a quick record-keeping had expanded into an additional part-time job for a team of ~4 doctors. We made a tiny bit of progress over a few months before the IRB decided to re-evaluate all projects including ours and told us to change twenty-seven things, including re-litigating the pen vs. pencil issue (they also told us that our project was unusually good; most got >27 demands). Our team of four doctors considered the hundreds of hours it would take to document compliance and agreed to give up. As far as I know that hospital is still using the same bipolar questionnaire. They still don’t know if it works.

Most IRB experiences can’t be that bad, right? Maybe not, but a lot of people have horror stories. A survey of how researchers feel about IRBs did include one person who said “I hope all those at OHRP [the bureaucracy in charge of IRBs] and the ethicists die of diseases that we could have made significant progress on if we had [the research materials IRBs are banning us from using]”.

Dr. Simon Whitney, author of From Oversight To Overkill, doesn’t wish death upon IRBs. He’s a former Stanford IRB member himself, with impeccable research-ethicist credentials — MD + JD, bioethics fellowship, served on the Stanford IRB for two years. He thought he was doing good work at Stanford; he did do good work. Still, his worldview gradually started to crack:

In 1999, I moved to Houston and joined the faculty at Baylor College of Medicine, where my new colleagues were scientists. I began going to medical conferences, where people in the hallways told stories about IRBs they considered arrogant that were abusing scientists who were powerless. As I listened, I knew the defenses the IRBs themselves would offer: Scientists cannot judge their own research objectively, and there is no better second opinion than a thoughtful committee of their peers. But these rationales began to feel flimsy as I gradually discovered how often IRB review hobbles low-risk research. I saw how IRBs inflate the hazards of research in bizarre ways, and how they insist on consent processes that appear designed to help the institution dodge liability or litigation. The committees’ admirable goals, in short, have become disconnected from their actual operations. A system that began as a noble defense of the vulnerable is now an ignoble defense of the powerful.

So Oversight is a mix of attacking and defending IRBs. It attacks them insofar as it admits they do a bad job; the stricter IRB system in place since the ‘90s probably only prevents a single-digit number of deaths per decade, but causes tens of thousands more by preventing life-saving studies. It defends them insofar as it argues this isn’t the fault of the board members themselves. They’re caught up in a network of lawyers, regulators, cynical Congressmen, sensationalist reporters, and hospital administrators gone out of control. Oversight is Whitney’s attempt to demystify this network, explain how we got here, and plan our escape.