IRBs as research censors

An anecdote illustrates the scariest aspect of the human subjects protection process.

A reader writes:

If you are still collecting stories of frustrating IRB silliness, perhaps I can contribute my own favorite.

Several years ago the new chief of general internal medicine at my hospital pointed out to me that every resident in internal medicine was a graduate of a foreign medical school, and that this had been the pattern for years. He was curious about whether our patient population was having any difficulty in communication with resident physicians who were almost all non-native speakers of English. We decided to conduct a small study of patients and physicians, and prepared a brief proposal for our hospital IRB (we are a teaching hospital associated with a major medical school).

I was very surprised when the hospital IRB rejected our proposal, with no real explanation. I contacted the chair of the IRB and was told simply that the IRB would not approve this project, and no further proposal to conduct the research would be considered.

When I reported this to our division chief, he clarified the issue. Every physician on the hospital’s IRB was a non-native speaker of English, and it was obvious that they were offended by the topic, and were possibly concerned that research would reveal communications problems.

At that point I went to the university IRB, which had no concerns at all, and didn’t even raise the point that we were not going through the hospital IRB. We conducted the little project over a month, and happily found no communications problems between foreign trained physicians and patients, in either direction. Ironically, this good outcome could have had the endorsement of the hospital IRB, had they not been such jerks.

I have regular frustrations with IRBs, but this case was certainly the most bizarre and silly that I have encountered.

That’s of course the most frightening aspect of the IRBs: that they can act as scientific Thought Police, not protecting human subjects from risk but “protecting” all of us from learning things the IRB members think we’d be better off not knowing.

Author: Mark Kleiman

Professor of Public Policy at the NYU Marron Institute for Urban Management and editor of the Journal of Drug Policy Analysis. Teaches about the methods of policy analysis about drug abuse control and crime control policy, working out the implications of two principles: that swift and certain sanctions don't have to be severe to be effective, and that well-designed threats usually don't have to be carried out. Books: Drugs and Drug Policy: What Everyone Needs to Know (with Jonathan Caulkins and Angela Hawken) When Brute Force Fails: How to Have Less Crime and Less Punishment (Princeton, 2009; named one of the "books of the year" by The Economist Against Excess: Drug Policy for Results (Basic, 1993) Marijuana: Costs of Abuse, Costs of Control (Greenwood, 1989) UCLA Homepage Curriculum Vitae Contact: Markarkleiman-at-gmail.com