9 No. 1
Who's Afraid of the IRB?
How the Institutional Review Board stepped into the research culture gap
Bolstering the Infrastructure
"If you look at the exponential growth in the amount of research dollars at Emory in 1990 as compared to 2005–06, it’s clear that we hadn’t invested in the overall infrastructure to keep pace with the volume of research and research dollars flowing through the institution."
"The granting organizations aren’t stupid. They’re going to go where they think can get a trial done fastest. If we’re slow, they’ll know about it and go somewhere else. When people approach me about doing clinical trials, they ask me how fast our IRB is. It’s one of their first questions."
New interest in an old standard
Keeping Cultural DNA Intact
The Italian Virtual Class Chiavi di lettura method
Ten years after the Emory Commission on Teaching
Suggestions from the Manuscript Development Program
Reading to help you write
Academic Exchange: How would you characterize your experience with the IRB?
Samuel Dudley: I’ve had pretty good experiences with the IRB in terms of the intellectual interactions related to getting a protocol approved and making sure people are safe. That’s never easy, so I’ve never had the expectation that the IRB would roll over and do whatever I ask them to do. I don’t want them to do that. If they’re doing their job correctly, they’re looking over my shoulder to make sure I haven’t made errors in judgment. A medical researcher is a potentially conflicted individual, because in all medical research you’re asking patients to try standard therapy or maybe something better, worse, or the same. Our careers are invested in the process—not necessarily in the outcome—though our intent is to help people. I don’t think any of us would do trials we didn’t believe had the potential for benefit. Many of us have been involved in trials that turned out to be wrong—either neutral or harmful—through nobody’s fault.
AE: What IRB–related issues have had an impact on your research?
SD: One is a control issue. For instance, someone from a drug or device company may approach me and tell me they have a nationwide, multicenter clinical study that is sponsored and already approved by the National Institutes of Health IRB, and Emory’s IRB still wanted changes. That creates a huge set of frustrations and time delays. This has happened to me before. Then I have to go back and forth from the companies to the nih and to Emory. It’s very slow and inefficient, and often the marginal benefit to patient safety is exceedingly small. Some universities, such as Ohio State, have solved this by contracting out multicenter, company-sponsored trials to a private IRB, which is fast and efficient and understands the politics of multicenter trials. I think we should contract out [IRB responsibilities] for the multicenter trials where we’re just one of twenty centers and quit using everyone’s time arguing about these things. Some of these trials are “take it or leave it.” Think how frustrating it is for me to be the twenty-first site on a trial and our irb says “no,” or it wants major changes, when twenty other irbs said it’s fine.
AE: What’s your broader view of Emory’s research support structure?
SD: Overall, Emory’s administrative structure is suboptimal. In part that’s because Emory grew quite fast and didn’t really have time to improve its support services in the way they should have, That’s good and bad; it makes it flexible but not as supportive as you might like. The IRB is one of those areas that has really not performed administratively up to par and has not been as efficient as it should be. Is it getting better? Yes. Is it where it needs to be? No. There have been huge staff turnovers and unhappiness among many of the faculty at how slowly things have moved, how inefficient notification is, and about the spotty feedback. If turnaround time is two, three, four months for a [proposal], you’re in trouble. The granting organizations aren’t stupid. They’re going to go where they think can get a trial done fastest. If we’re slow, they’ll know about it and go somewhere else. When people approach me about doing clinical trials, they ask me how fast our IRB is. It’s one of their first questions. It’s critically important that we are at least as competitive with other irbs around the country. Very few universities I can think of have as much potential as Emory does, and few I can think of have the gap between potential and achievement. I think overall Emory needs to take an extremely hard, razor-fine look at how it supports its faculty.
AE: What’s your perspective about the recent controversy over changes to the IRB?
SD: I think it’s disappointing that the university can’t seem to keep a solid, stable committee. You can’t just have committees come and go. What would happen if I’d submitted a protocol, that committee had looked at it, I’d responded, and that committee doesn’t exist anymore? You’re looking at a huge delay, and delays are money and delays are careers. I get pretty frustrated when I get some far-from-field comment from someone who doesn’t seem to understand what I’m doing. This can be fixed by having the greatest possible depth of expertise and stable committee structures.