Study: Schizophrenia researchers less likely to submit studies to IRBs
Study: Schizophrenia researchers less likely to submit studies to IRBs
More wary than depression researchers
In analyzing the potential obstacles to conducting schizophrenia research, it's tempting for some to see IRBs as the sticking point. But a recent study of mental health researchers suggests that the situation is more complex than that.
The study, published recently in the journal Schizophrenia Research, found that researchers who study schizophrenia were more reluctant to submit research protocols to IRBs than those studying depression.1
But when asked how their protocols were received by IRBs, the two groups of researchers reported no real differences between the turn-around times for protocol review, rates of approval or the number of IRBs required to review protocols.
Bernard A. Fischer, MD, assistant professor of psychiatry at the University of Maryland's Maryland Psychiatric Research Center in Catonsville, says he got interested in the issue of psychiatric research and IRBs after having difficulty getting approval for schizophrenia studies.
"It was difficult trying to explain to the IRB what we were trying to do," Fischer says.
He wanted to look at attitudes about mental health research from both sides of the protocol the researchers and the IRBs. His team hypothesized that both groups would be more leery of moving forward with schizophrenia research than depression research.
"Schizophrenia can be a more devastating illness people function at a lower level," Fischer says. "We thought people would have more caution in dealing with that population, in what the investigators submitted, in the time that the IRB would take. We thought IRBs would not approve at the same rates as for depression research."
Cautious investigators
He says the predictions about investigators' attitudes were borne out by the study, which surveyed 108 researchers 45 schizophrenia researchers and 63 depression researchers. Most schizophrenia researchers submitted about half as many protocols per year (1-2, compared to 3-4 for depression researchers).
When presented with ethically complex hypothetical protocols, schizophrenia researchers were less likely to say they would submit such a protocol to an IRB than depression researchers were:
- Asked if they would submit a protocol that involved studying prisoners, 57% of schizophrenia researchers said they wouldn't, 23% of them citing difficulty in getting such a study approved by the IRB. Only 22% of depression researchers said they wouldn't submit a prisoner study, with only 7% citing IRB issues.
- In considering a study comparing a standard treatment (such as an anti-psychotic in schizophrenia research or an anti-depressant in a depression study) to a placebo, 58% of schizophrenia researchers would decline to submit the study, the majority of them deeming it unethical. In contrast, 31% of depression researchers said they wouldn't attempt to submit the placebo protocol, in most cases for the same reason.
- In the case of an international protocol that would compare a low-cost treatment to the standard of care in a developing country (rather than the standard in a developed country), 64% of schizophrenia researchers would decline to submit the study, compared with only 27% of depression researchers. In both groups, the most common reasons given were concerns about ethics and the difficulty of implementing such a study rather than wariness about dealing with IRBs.
"It looked like for some researchers, concern about IRBs was the reason (for deciding not to submit), but they were also concerned about what was ethical, or concerned about just trying to get a study done," Fischer says.
The researchers' IRB experiences were far from ideal: None of those surveyed had had all of their protocols approved on initial submission, and about half reported that none of their protocols were approved unconditionally on the first try.
More than 90% of respondents had an average turn-around time (from initial submission to IRB review) of longer than three weeks.
But overall, schizophrenia researchers did not report longer turn-around times, or approval rates, results that Fischer says he found somewhat surprising.
Among both groups of researchers, most regarded IRB paperwork requirements as "burdensome but necessary," and more than half thought of IRB comments on protocols as either "always" or "mostly" helpful.
The majority thought IRBs should monitor conflicts of interest and enforce participant privacy, but should not evaluate research design.
Bridging communication gaps
Fischer says that in his own experience, problems between researchers and IRBs often come down to breakdowns in communication.
"Often, there's a set institutional way of doing things that an IRB has that it doesn't communicate to investigators," he says. "For example, there may be a set piece of language required that's not obvious to the investigators. So they submit something, and when they get it back, the IRB will say, 'You didn't address the privacy issues.' So they expand the privacy section, resubmit and it still wouldn't get through because it didn't hit (the IRB's) buzzwords."
Fischer says IRBs should communicate exactly what they need, particularly if the board is looking for specific language. "Tell them to cut and paste from the IRB Web site to the protocol, instead of making it a guessing game."
He says IRBs also may suffer from a lack of institutional memory, as members rotate off the board and others arrive who haven't been privy to previous discussions. He says this can cause roadblocks for researchers, even those who have previously had success getting protocols approved.
"There needs to be some sort of institutional memory, some ability to reference other IRB decisions," he says. "So an IRB can see that we've done this study before, even though the IRB may have a different makeup now. And that can weigh toward their decision."
He says it's important for IRBs to understand that most studies with people who have mental illness are not inherently more dangerous than other types of research, as long as reasonable protections are in place.
Fischer says he would like to see further study of IRB functions. Specifically, he's interested in the relationship between IRB turn-around times and measures of subject safety.
"It strikes me that nobody really knows whether taking more time with things is really helpful for safety or whether we are going through the motions without any benefit," he says.
Reference
- Fischer BA, George, P. The investigator and the IRB: A survey of depression and schizophrenia researchers. Schizophr Resi 2010; Jan 9:(Epub).
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