Understanding the world of institutional review boards.
Stanford University Press is proud to present a Q&A with Regulating Human Research» author Sarah Babb
What made you want to write about the history and the evolving role of IRBs?
I was the Graduate Director in the Boston College sociology department. Sometime around 2006, I began hearing from many students encountering problems “getting through IRB.” In an attempt to tackle this problem, I volunteered to serve on our IRB at Boston College. There I discovered that federal regulations were a great deal more flexible than our local Boston College IRB policies--for example, federal rules could allow most social research to be carried out without informed consent forms. As a faculty board member, I tried to get the BC IRB to adopt more flexible policies, but was unsuccessful.
I suppose you could say that this project was born out of my frustration with that experience. But once I started learning more about the IRB world, I began to see that there was something much bigger going on, and that this bigger thing was also happening in other areas of American regulation. So my book attempts to capture this.
What was the research process like?
As a qualitative researcher, I tried as much as I could to immerse myself in the IRB world. I became an avid reader of a trade journal for IRB administrators. This helped me understand the issues (which are surprisingly complex), and also gave me the names of contacts to start interviewing. It also allowed me to ask better, more targeted questions, and to connect more effectively with my informants (I ended up talking to about 50 of them). I also started attending the annual meeting of the IRB professionals’ association. This immersion made me sympathize with the dilemmas of these professionals, and I have tried to bring this out in the book.
As I carried out my research, I added my trade journal articles, interview transcripts, and other sources into a file in the qualitative data analysis program Atlas.ti, and coded them for themes. This process allowed me to be guided by what my data were telling me, and brought me to my final research question and arguments.
For scholars of regulation, I think the book speaks to the weirdness of the way we regulate in the United States. Instead of having strong federal bureaucracy, our system spins off thousands of locally financed compliance bureaucracies.
What do you find is the biggest misconception people have about IRBs?
That IRBs are faculty committees. Maybe they still are at some liberal arts colleges, but most of the research that gets reviewed happens either at research universities, or under the auspices of large biomedical research firms. When you send in a research proposal (or “protocol”) to one of these IRBs, decisions about that protocol (is it complete? does the consent form look good? can it be exempted?) are mostly being made by compliance administrators—full-time staff in charge of the daily work of making sure the IRB complies with federal regulations. A minority of protocols end up being reviewed by the full board, and faculty IRB members will weigh in then; but this only occurs after the protocol has been intensively vetted and revised in consultation with administrators. When you are fighting with your IRB office about the language on your consent form, chances are that it is the administration you are fighting with, not your faculty colleagues on the board.
The main reason that we think of IRBs as faculty committees is that this is what they were, once upon a time. If you want to know more about when and why IRBs evolved into what I call “compliance bureaucracies,” I hope you read the book!
What would you like people to take away from this book?
I think it’s different for different audiences. For scholars of regulation, I think the book speaks to the weirdness of the way we regulate in the United States. Instead of having strong federal bureaucracy, our system spins off thousands of locally financed compliance bureaucracies. This is a frequent pattern in the U.S., and IRBs are just one example.
For IRB professionals and faculty board members, I hope that the book provides a condensed, accessible, birds-eye view of what the IRB system is, how it got to be this way, and what forces are moving it. I think this can be hard to see when you are immersed in the system.
For researchers (and especially my fellow social researchers), I hope that the book helps foster greater understanding about an institution that we frequently encounter, and frequently misunderstand.
Finally, for concerned citizens, I think the book provides a unique perspective on the unintended consequences of our system for protecting human research subjects. One is the growing dominance of for-profit, independent IRBs—stand-alone firms that specialize in carrying out efficient, federally compliant ethics reviews. These have recently been bought up and consolidated by private equity firms. My book explains how this happened and what it may mean.
What’s the most surprising thing you learned?
I was surprised to find out how much work it is to comply with the IRB regulations. The federal rules are fragmented across different agencies, ambiguous, and hard for absent-minded professors like me to wrap our heads around. At the same time, they require enormous amounts of meticulous record-keeping. I discovered that to fully follow the rules, you really need to have full-time, specialized staff running the show.
What’s next?
Although I have another big project to move to the front burner, I still plan to keep following and writing about the IRB world, and compliance bureaucracy more generally. These issues aren’t going to go away any time soon!
Thank you for such a great post. It was interesting to read this piece of information.
Posted by: grademinrs | February 12, 2020 at 11:53 PM