Hurricane research proposals surge
Hurricane research proposals surge
Increase strains social-behavioral IRBs
One unexpected result from Hurricane Katrina has been a sharp increase in proposals for social-behavioral studies, as social scientists seek to find out how Katrina survivors and evacuees have responded to the disaster.
That has created challenges for IRBs at Louisiana State and Tulane universities, as they attempt to absorb the increased number of proposals, while protecting a potentially vulnerable evacuee population.
Robert Mathews, PhD, chair of the social-behavioral IRB at LSU’s Baton Rouge campus, says he expected to see an increase in study proposals in the wake of Katrina, but the sheer volume of applications has surprised him.
"I would say that the number of proposals we handle has quadrupled," Mathews says. "They began flowing in immediately and are still flowing in."
More frequent meetings
He says that while special funding has been made available for Katrina-related research, the deadlines allow for only a short turn-around time for proposals. And because Mathews considers evacuees to be a population that need special protection, he made the determination that all such proposals must be handled by the full IRB. That has meant a stepped-up schedule of IRB meetings.
"Our normal procedure for full board meetings is we only meet every other month, and we normally send out protocols two weeks prior to a meeting," he says. "Obviously that couldn’t happen here. So I had to schedule special meetings about every three weeks. We had to hand deliver the protocols to every member on the board five days before the meeting so they’d have time to review them."
Of Tulane’s three IRBs — two biomedical and one social-behavioral — only one biomedical board is operating, says Ina Friedman, MSN, NP-C, director of Tulane’s Office for Human Research Protection.
She, too, has seen a surge in Katrina-related research proposals and is expediting a number of them herself.
But Friedman also is worried about the vulnerability of the evacuee population, so any proposal involving more than minimal risk is going to the full board. "If the research is anything other than an anonymous questionnaire, I’m pretty much sending it to a full committee," she says.
Friedman says she does have input from a few of Tulane’s social-behavioral board members at the IRB board meetings, which she currently is conducting via conference calls. She also regularly consults with the social-behavioral IRB at the University of North Carolina-Chapel Hill (UNC), where Tulane’s IRB is housed temporarily.
Concern about PTSD
Mathews says his principle concern about evacuees is the possibility that they may suffer from post-traumatic stress disorder (PTSD), which could come to light during a study.
His IRB discussed the matter at length and now requires researchers to be ready to refer subjects for treatment, including free treatment if the subject is impoverished.
If children being studied show signs of PTSD, the IRB requires that the child be withdrawn from the study immediately and that the parents be notified.
"They have to put into the consent form for these kinds of studies with children that there is a risk of becoming emotionally upset, and if their child becomes upset, we will notify the parent," Mathews says. "And we felt it was important not only to tell parents that but in the assent form, to tell kids that if they get upset we’re going to tell their parents so they can get help."
Friedman says Tulane’s IRB also is requiring referrals for help for subjects who need it. "In cases where [researchers] are looking for significant depression or suicidal ideation, they also disclose that this has to be reported to the appropriate authorities," she says.
Mathews says that there was some discussion on his board as to whether subjects showing full-blown PTSD were even capable of giving consent to participate in research, but finally concluded that they should be allowed to participate, particularly in studies that might benefit them. "For example, there’s one study about helping people avoid substance abuse — it seems like they should be able to participate in those studies," he says. "But it’s an issue that’s very gray at this point."
Although most of the studies Mathews’ IRB is reviewing do not provide for compensation, some of the longer ones do. He says the board has taken care to ensure that the compensation is not so great that it could prove coercive, particularly to people who may have lost nearly everything they owned in the flooding.
He notes that some survivors of the Sept. 11, 2001, terrorist attacks were offered $100 for their participation in studies after that event. But Mathews says the economy of the New Orleans area is quite different from that of the Northeast.
"We felt like $100 would be excessive in this instance, so we were thinking more along the lines of $25 for an hour of participation would be more appropriate."
Mathews advises IRBs who have to cope with a similar disaster scenario to take advantage of the information on OHRP’s web site.
He also notes that he was fortunate to have a clinical psychologist serving on his IRB.
"We had a lot of information about what those [psychological] effects would be like and where to refer people," he says. "But if I didn’t have that asset, that would be a problem. So I would advise looking into that ahead of time — when people need help, where are you going to send them after an event?"
One unexpected result from Hurricane Katrina has been a sharp increase in proposals for social-behavioral studies, as social scientists seek to find out how Katrina survivors and evacuees have responded to the disaster.Subscribe Now for Access
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