When disaster strikes: In Katrina’s wake, IRBs struggle to regroup
Finding and protecting research subjects is institutions’ first priority
By now, everyone has seen footage of the horrible damage wrought by Hurricane Katrina on the Gulf Coast — more than 1,000 people dead, more than a million displaced, cities flooded and left in ruins.
But over the months since the hurricane blew ashore in late August, it has become apparent that Katrina also dealt a devastating blow to medical research in the New Orleans area, dispersing research subjects, destroying samples and wrecking facilities.
Now IRBs at Louisiana State and Tulane universities displaced by the storm are engaged in the huge task of locating subjects to ensure their safety and reconstructing IRB operations.
Most of LSU’s operations were moved to buildings on LSU’s Baton Rouge campus. The university set up an emergency web site, where IRB Chair Kenneth Kratz, PhD, posted notices directing investigators to get in touch, and to give the IRB a status report on all open studies.
Kratz says his staff is aggressively seeking out investigators and subjects, continuing to take on new trials, and continuing to oversee studies interrupted by the storm when possible, while dealing with a loss of resources, including staff laid off in the aftermath of the hurricane.
Tulane’s IRB operations and its Office for Grants and Contracts have moved even farther to the University of North Carolina-Chapel Hill, where Ina Friedman, MSN, NP-C, director of the school’s Office for Human Research Protection has set up shop at the invitation of former colleagues. There, the university gave her office space, a computer and laptop, fax and phone lines which gave her the capability to set up IRB meetings by conference call because members are scattered across the country.
"We are all over the place," Friedman says. "But the Internet is an amazing thing, and once you find everybody, you go to work."
She, too, is concentrating on locating subjects whose care has been interrupted by the hurricane, while taking the first steps toward helping the IRB regroup and move forward.
Tulane’s IRB already has met, albeit by conference call, and LSU’s board had planned a meeting in Baton Rouge in mid-November.
Both Kratz and Friedman expected to be back in their offices in New Orleans by November or December. Kratz says other research buildings on his campus may take much longer to reopen because of varying amounts of damage.
Communication disrupted
Friedman and Kratz say they had no idea what to expect when they left their offices and homes to escape the imminent arrival of Katrina, which made landfall in Louisiana Aug. 29.
Both admitted to leaving so quickly that they left their laptop computers behind.
"When somebody asks, If this happened again, what would you do?’ I’d say, Take your laptop because you’re crippled without it,’" Friedman says.
Kratz says the immediate aftermath of the hurricane left his IRB without any way for staff to communicate with each other.
"You could not make a telephone call to New Orleans, you could not make a telephone call to the Baton Rouge area or the surrounding metropolitan areas across the lake," he says. "It was impossible to get any number with those area codes for a long time."
He notes that the university’s servers were down, so e-mail communication was impossible as well.
"The only thing that was effective for a number of weeks was text messaging," Kratz says. "Through text messaging, I was able to find my staff, which had been dispersed all over, to Houston and Georgia and Boston. Once I was able to find them and we all had alternate e-mail addresses, we could then start communicating by e-mail."
Locating subjects is an uphill battle
The first priority has been finding subjects, many of whom have scattered to the winds and are on medications they can’t get elsewhere.
It’s an uphill battle, particularly among the indigent patients LSU saw at the public hospitals where it operated, Kratz says. He estimates that for some studies, the school has lost contact with all of the enrolled subjects.
"We hope that those people, if they had some sort of illness, would get themselves to a physician someplace," he says. "What’s problematic is that it may be difficult for them to relate to a physician in another town what the clinical trial was and how they were being treated. That has bothered me quite a bit."
He says the IRB has advertised locally, asking subjects to call in to be reunited with their physicians, but for the thousands who have left the area and even the state, that won’t do much good.
Tulane’s IRB has faced a similar challenge in locating investigators and subjects, Friedman says. She, too, is concerned about the health of subjects who were participating in clinical trials.
"Even if they were on a placebo, if they’re not being monitored, we don’t know if they need a change in the therapy or some type of rescue therapy," she says. "The same thing goes for people who have implanted devices. They need follow up."
Friedman says investigators have been providing status reports on their subjects, and they and the IRB staff are working to try to find subjects.
Some investigators have set up their own toll-free numbers, and sent it out to physicians in the Gulf Coast area who specialize in the conditions being studied.
"For example, the people who see pediatric HIV patients have sent this number to all the pediatric infectious disease physicians in the Gulf Coast, asking them to be on the lookout for Tulane patients and to ask them to contact the 800 number if they identify them," she says.
Survivor web sites on the Internet, such as those operated by the Red Cross, have been very helpful in locating people. She says The Times-Picayune, New Orleans’ local newspaper, has recently set up a site where physicians and patients can reconnect, and her staff have been examining that site to try to find subjects.
Friedman is optimistic that Tulane will be able to locate subjects at the most risk.
"We feel like we’ve gotten good responses from the investigators who see patients where we’re really concerned that the interruption of the therapy makes a big difference," she says.
Both Kratz and Friedman say the problems they’ve encountered have led them to advocate creating centralized databases of research subjects at their institutions. The database would include primary and secondary contact information for subjects, so that the problems the IRBs currently are encountering could be avoided in the future.
Both noted that much of the contact information they had for subjects was useless, since people were no longer in their homes.
"If I were in a study, for example, I could give my sister’s name and phone number in New York," Friedman says. "Maybe our 504 area code doesn’t work, but if we have alternate phone numbers and people checked in with their family, we can find them."
Kratz says that when the idea had come up in the past, he was reluctant, citing concerns about privacy and other problems a separate database could pose.
"But in light of this, I think it’s important, because I’m concerned about some of these people," he says. "Some may be on medications that should not be terminated quickly. You wonder what’s happening in those situations, and unfortunately, we just don’t know."
Kratz says he’d like to ask investigators to give participants cards bearing as much information as possible about the trials and how to reach the investigators in an emergency.
Business as usual
In addition to locating subjects, the IRBs also are struggling to move forward, reapproving existing studies if the investigator and sponsor are willing, and even approving new studies when possible.
Both Friedman and Kratz have been in contact with the FDA and OHRP, which they say have posted guidelines on post-Katrina operations.
Kratz notes that in addition to the physical damage caused by Katrina, the destruction also has demolished revenue streams to the university, leading to furloughs and layoffs. He himself has had to lay off two IRB coordinators.
"In some respects, the reduced level of activity we’ve got is good, since we don’t have the magnitude of infrastructure to handle a lot of stuff right now," he says.
Friedman and Kratz offer this additional advice to IRBs rethinking their disaster plans:
• Make sure your information is stored somewhere off site. Friedman suggests some place that is geographically remote, since a disaster such as Katrina can affect a very large area.
Kratz says that luckily, his organization had recently switched to an IRB management software system in which information is stored on a server in New York.
"Even though my staff were spread out throughout the country, we had immediate access to our IRB information," he says. "It has made things a lot easier."
Friedman also suggests splitting physical samples such as blood and tissue, and keeping a set stored remotely as well. She says much of Tulane’s stored blood and tissue samples were lost because of weeks long power outages in the storage buildings.
• Defer to other IRBs, when possible. Friedman has deferred many studies, both existing studies and new requests, to other IRBs across the country with FWAs. "We are deferring as many of them as possible because logistically, you just can’t handle a load like you do when you’re set up in your own office."
• Remember that IRB staff are affected by disaster, too. "Many of our clinicians, our investigators, lost their houses," Kratz says. "They have personal problems they’re trying to cope with on top of work issues. Compound that with the financial situations of the institution — they’re worrying about their jobs, worrying about the people who work for them — it’s stressful for everybody."
By now, everyone has seen footage of the horrible damage wrought by Hurricane Katrina on the Gulf Coast more than 1,000 people dead, more than a million displaced, cities flooded and left in ruins.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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