From monitoring to superpower

Dr. Rob Knight studies how bacteria in the skin pass from person to person. In a 2009 study, intended to simulate human contact, he used a cotton swab to dab first one subject's mouth (or skin), then another, to see how many bacteria are propagated. On the consent forms, he said the risks were close to zero - it was like kissing another person's hand.

His IRB — that is, the Institutional Review Board, the committee responsible for maintaining the ethics of the experiments — disagreed. They feared that 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 sort of diversity coordinator who offered to explain that claiming you can get AIDS through skin contact is offensive. The IRB backed down and Dr. Knight successfully completed his study.

Just kidding! The IRB demanded that he give his patients consent forms warning them that they could catch smallpox. Dr Knight tried to explain that smallpox had been extinct in the wild since the 1970s, with the only samples remaining in US and Russian biosafety labs. Here, there was no diversity coordinator to step in and save him, although after months of delays and arguments, he finally got his study approved.

Most IRB experiences aren't that bad, are they? Mine was worse. When I worked in a psychiatric ward, we used to use a short questionnaire to screen for bipolar disorder. I suspected that the questionnaire was not working and wanted to record how often the opinion of the questionnaire matched that of the medical experts. It didn't require anything different - it just needed to keep track of what we were already doing. “Of the people who were surveyed as bipolar, 25%/50%/whatever later got a full bipolar diagnosis” – that sort of thing. But because we were recording data, it constituted a study; because it was a study, we had to go through the IRB. After about 50 hours of training, paperwork and back-and-forth arguments - including one where the IRB asked patients to sign consent forms in pen (not pencil) but the psychiatric ward didn't allowed patients only pencils (no pens) - what was originally intended as quick record keeping turned into extra part-time work for a team of about 4 doctors. We made a tiny bit of progress in a few months before the IRB decided to re-evaluate all projects, including ours, and told us to change twenty-seven things, including re-opening the pen versus pencil issue. (they also told us that our project was exceptionally good; most received more than 27 requests). 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, this hospital still uses the same bipolar questionnaire. They still don't know if it works.

Most IRB experiences can't be so bad, can they? Maybe not, but a lot of people have horror stories. A survey of what researchers think of IRBs included one person who said, "I hope everyone in OHRP [the bureaucracy in charge of IRBs] and ethicists is dying from diseases that we could have made significant progress if we had [the research material IRBs forbid us to use].

Dr. Simon Whitney, author of From Oversight To Overkill, does not wish death on the IRBs. He himself is a former member of the Stanford IRB, with impeccable research ethicist credentials - MD+JD, Bioethics Fellowship, served on the Stanford IRB for two years. He thought he was doing a good job at Stanford; he did a good job. Yet his worldview gradually began to crack:

In 1999, I moved to Houston and joined the faculty of Baylor College of Medicine, where my new colleagues were scientists. I started going to medical conferences, where people in the hallways told stories about IRBs they saw as arrogant and abusing helpless scientists. As I listened, I knew the defenses IRBs would offer themselves: scientists cannot objectively judge their own research, and there's no better second opinion than a thoughtful committee of their peers. But these...