Katrina two years later: What have we actually learned?
Katrina two years later: What have we actually learned?
New Orleans IRBs hold lessons about disaster preparedness
Two years after Hurricane Katrina ravaged the Gulf Coast and caused a mass evacuation of New Orleans, research institutions in the city are still recovering.
They're coping with the long-term reverberations from the disaster — the flight out of the city of much of its population, including a number of university employees, and the loss of studies. And of course, they're preparing for the next potential hurricane, with disaster plans that have been honed and updated by their experiences with Katrina.
Kenneth Kratz, PhD, director of the Office of Research Services at Louisiana State University's Health Sciences Center in New Orleans, says the lessons in emergency preparedness that his IRB learned from Katrina are applicable elsewhere — not just along hurricane-prone coastal areas.
The problems uncovered in the wake of the disaster, including the loss of contact with many research subjects, have implications for any IRB threatened with a large-scale natural or man-made disaster.
"An institution could face all kinds of disasters, from tornadoes to hurricanes to floods," Kratz says. "I think all institutions with a human subjects protection program really have an obligation to have some kind of preparation for this. That's what I've been advising people when they contact me."
Many challenges
In the days and weeks after Katrina, Kratz and Mark James, PhD, chair of the biomedical IRB at Tulane University's Health Sciences Center in New Orleans, both faced similar challenges:
- finding and communicating with principal investigators, as well as trying to determine what had happened to thousands of subjects signed up for clinical trials;
- finding and communicating with their own IRB members and staff, many of whom had scattered across the country;
- gaining access to records and to their offices, often hampered by flood waters and law enforcement restrictions on accessing university buildings;
- reinstating a schedule of meetings and reviews to deal not only with existing studies, but with new proposals, many by faculty members wishing to study the effects of the hurricane.
Communications were sketchy — it was difficult to get phone service not just in New Orleans, but even as far away as Baton Rouge. E-mail access was debilitated as well — Kratz says that for the first few weeks, while LSU's servers were down, his staff communicated by text messaging.
LSU's IRB moved to the university's Baton Rouge campus and operated from there for about six months. Tulane's IRB director evacuated to North Carolina, and that IRB held its first few meetings after the hurricane via teleconference with members who were spread across the country.
One of the most critical challenges facing Kratz and James since the hurricane has been trying to re-establish contact with thousands of research subjects, including those on clinical trials being treated for serious diseases, such as cancer and diabetes.
Kratz says that at LSU's Cancer Center, investigators have been able to track down about 70 percent of subjects who were in their trials two years ago. The university used existing contact information, mail forwarding, newspaper ads and Social Security death information to get that far.
"There still remains a relatively large number of people that were in oncology trials and other trials we had open [who are still unaccounted for]," he says. "A significant number have not been relocated."
"The idea that we lost contact with those people really was disturbing for us, obviously," he says. "People were receiving treatments, particularly experimental kinds of drugs, which you shouldn't just terminate immediately because of potential consequences. Or people who moved to, say Houston, and went to see another physician because they had some sort of disorder — that physician would not know what their treatment regimen might have been. This created a situation for people where their continued treatment was compromised. "We've lost a lot of sleep over that."
James says his institution's investigators, too, were hampered in their attempts to locate all their subjects.
"There's a lot of PIs that are still frustrated that we have not completely contacted 100 percent of their participants," he says. "They're scratching their heads trying to figure out what can we do to contact these people."
Since Katrina, both LSU and Tulane have instituted new disaster preparedness plans that emphasize staying in contact with subjects.
LSU's plan instructs PIs to give every subject in existing trials, and those recruited for new trials, a letter informing them of a toll-free telephone number they could call in an emergency. Subjects could leave contact information with the call center in order to be put in touch with someone from their study team.
Both LSU and Tulane also have required investigators to issue new subjects wallet-sized cards they can carry with them at all times, with information about their trial and about emergency contacts.
"That makes it a little easier for subjects," Kratz says. "They don't have to find a letter someplace and remember it. They just have to stick this in their wallet or purse and have it with them."
The LSU and Tulane disaster plans also call for increased contact information about IRB staff and PIs, including alternate contact numbers in the event of another evacuation.
James says Tulane's IRB director develops a disaster communication list at the beginning of each hurricane season (the annual Atlantic hurricane season runs from June 1 to Nov. 30), with updated contact information for IRB members. Elsewhere in the university, units establish their own communication trees.
He says the IRB also expects investigators to include emergency plans with any applications for greater-than-minimal risk studies, and to include information about evacuation procedures in informed consent for such studies.
Smaller staffs, changing studies
Even while coping with the challenges of communications and running offices in a disaster mode, both universities suffered an immediate loss of human subjects protection staff.
"Right after the hurricane I lost three of my [five] coordinators," Kratz says. "Two of them evacuated and decided not to return to Louisiana. Another one quit and took a job in New Mexico, leaving me with two full-time staff." Kratz also lost the help of three student workers, and the assistant director of his office was reassigned to another post at LSU.
"That left us pretty lean for quite awhile," he says. "In the last six months or so, I've been able to hire back another coordinator, so I'm up to three full-time coordinators, and I finally got the three student workers back."
At Tulane, the IRB director herself, who also chaired the IRB, decided not to return. The Tulane human subjects protection office was restructured, separating the two jobs, and James was appointed chair of the IRB.
The Office for Human Research Protection worked under an interim director until April 2006, when a permanent director was chosen.
James says in the months after the disaster, the office lost two staffers because of financial considerations.
"Basically, we did have an adjustment period where we had to rearrange staff," he says. "We're just now beginning to get to the point where we're working with an intact, complete office."
According to US Census estimates, the population of New Orleans is less than half what it was before Katrina. In addition, many of the city's major public and private hospitals were closed, and not all have reopened. As a result, the number of new studies being opened in the city has dropped substantially.
Kratz says that before the storm, LSU's office was managing more than 1,200 studies, about half of them greater than minimal risk. Now, he says, that number is down to about 650, about 220 of which are greater than minimal risk.
In addition, a number of faculty members left, some because they moved to other institutions and some because the university reduced faculty after the storm. Those factors led to the deactivation of one board and a reduction in members on the other.
"We reduced the size of the board from 18 permanent members to 11, which was OK because we still maintained the expertise that we needed on that one board," Kratz says. "And we were reviewing fewer studies, of course."
Tulane, which previously was operating with two review teams, is down to one, and has reduced the number of meetings from two monthly to one, as well, James says.
James says that the Tulane IRB's workload has changed, with more of an emphasis on the university's existing international public health research program.
One IRB a little farther afield saw a sudden and dramatic increase in the number of studies submitted in the days and months after Katrina. The social-behavioral IRB at LSU's Baton Rouge campus was inundated by researchers wanting to conduct surveys of the evacuating New Orleans residents, many of whom initially decamped to Baton Rouge.
At first, says Robert Mathews, PhD, chair of the social-behavioral IRB, he demanded full board studies of all such proposals, in effect, treating all of the evacuees as a vulnerable population.
"I really was over-conservative — I had no experience with this sort of thing," Mathews says. "Everything, initially, in the first month or so, was going to the full IRB, so we had to have lots of meetings."
After the first few weeks when he realized most of the proposals were fairly low risk, he began to handle some of them through expedited, and then exempt, reviews.
"Some of the stuff was really mild — asking about businesses, asking people where they want to relocate," Mathews says. "And as we started to realize we weren't getting any complaints, I felt like we could handle a lot of it through expedited reviews. And I even started exempting some routine types of surveys again."
Access Tulane University IRB's emergency plan at http://www.irb.tulane.edu/emergency_plan.htm
Two years after Hurricane Katrina ravaged the Gulf Coast and caused a mass evacuation of New Orleans, research institutions in the city are still recovering.Subscribe Now for Access
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