Author Robert L. Klitzman, MD, interviewed some 45 IRB members for his new book, The Ethics Police?1 The following are some of the published comments by both IRB chairs and members on how they came to be on an IRB and their challenges in weighing the risks and benefits of human research.

  • “I was volunteered. My chairman said that the department needed to appoint someone to the IRB. I was now ‘it.’ But I was surprised — I had no training in ethics.”
  • “I was a statistician and started on the IRB because my interest was research. I saw this as a way to familiarize myself with a hospital on a research level.”
  • “We think it’s pretty important that the IRB chair be a practicing researcher, and we want lots of researchers on the IRB who have the respect of their colleagues and are pretty distinguished so that they can’t be intimidated by any department heads or vice presidents.”
  • “It’s very hard to weigh risks and benefits. Everybody has to make calculations on their own. We thought a drug might help a sick man, but a side effect was stroke. The likelihood was extremely small; but one patient turned it down because his mother had had a terrible stroke. He was a sick man, why would he turn down the possibility that this could help him for a 2% chance of stroke? He couldn’t take that risk. All the IRB can do is try to make things as clear as we can. We have ‘likely,’ ‘less likely’ and ‘rare but serious’ [risk categories]. I think likely is 20%, which in my mind is not likely. I would say likely is 50% to 60% — better than an even chance.”
  • “Some people just like to argue, nitpick, and be critical. You can’t have people like that. But you don’t want people who are just going to put in their time and leave and not read protocols carefully!”
  • “I worry — is the study truly safe? We do a lot of studies that are potentially high risk. We worry but have to trust the investigator. That’s why we look so carefully at the progress reports.”
  • “Being cautious is the IRB’s job, but they may be overly cautious. For most IRBs, nothing good can come from approving a protocol. Every time you approve a protocol, there is a risk for bad things happening — including bad press.”
  • “Members are so committed and hold themselves to standards in terms of doing the right thing, carefully reading and analyzing — taking it all seriously trying to protect subjects. It’s very inspiring and it makes me want to do a better job.”
  • “One of the challenging things about being a leader is mediating differences in opinion. Usually we come to a pretty easy consensus. But some cases elicit strong opinions on either side: not approving, or requiring something. That is always challenging — having the skill to further explore members’ thinking and reasoning.”

REFERENCE

  1. Klitzman, RL. (2015) The Ethics Police? The Struggle to Make Human Research Safe. New York: Oxford University Press.