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Disaster management tips from the front lines
Technology, regulatory agencies can help during a disaster
While a devastating Category 5 hurricane may not be a realistic threat to your IRB's operations, there are still a number of disaster scenarios that could cause evacuations and region-wide disruptions in communications — everything from earthquakes and flooding to potential Sept. 11-style terrorist attacks.
Those who manned the front lines in Katrina say there are some smart steps every IRB can take to better prepare for such a catastrophe and rebound from it more quickly:
• Rely on technology, including the Internet — While land-line and cell phone communications may be disrupted for a large area around the disaster, technology can provide some useful work-arounds. IRBs at Tulane and Louisiana State universities used text-messaging, E-mail and teleconferencing to keep in touch and restart IRB operations in the days and months after Katrina hit.
Kenneth Kratz, PhD, director of the Office of Research Services at Louisiana State University's Health Sciences Center in New Orleans, says administration staff all have been issued Blackberry devices, which include wireless E-mail, in order to improve communications in case of emergency.
He points out that during Katrina, he evacuated his office without even remembering to take his laptop computer. "I'll definitely take it next time," Kratz says with a laugh.
Both offices also have Web-based IRB submission systems in place, with emergency data backups that are geographically located far from the New Orleans area.
"You want to be sure the servers you're using are secure — have them someplace remote, so you can get to your information and it's protected," Kratz says.
• Get useful emergency contact information from staffers — In many cases, the emergency telephone numbers on file were useless, since they were for New Orleans addresses which staffers already had fled. Kratz has asked that each LSU IRB staffer and board member provide a contact number outside the region — for example, a relative or close friend in another state who will know where the person is after he or she evacuates the city, and update the numbers regularly.
At Tulane, the IRB director provides an updated communication list at the beginning of each annual hurricane season, says Mark James, PhD, chair of the biomedical IRB at Tulane University's Health Sciences Center in New Orleans.
• Keep in close contact with regulatory agencies and study sponsors — Tulane's disaster plan authorizes the senior vice president for research to notify the FDA, the federal Office for Human Research Protections, external IRBs of record and study sponsors about Tulane's research situation in a disaster, James says.
"We received good feedback and good concessions, if you will, after the hurricane, in terms of interacting with the FDA, NIH, etc.," he says. "All the regulatory agencies were very responsive in terms of facilitating investigators and their research."
• Provide cross-training for staff — Kratz says the immediate loss of IRB staff at LSU after the storm was made easier by the fact that the remaining workers could cover each others' jobs.
"I'm a strong believer in cross-training of everyone, so any of my staff can pick up the processes and continue on with them," he says. "I don't know that anyone would expect that you'd lose that many people that quickly. To keep things up and running, it's important to have everyone cross-trained."
Research with victims
• Expect researchers to want to speak with victims of the disaster — Robert Mathews, PhD, chair of the social-behavioral IRB at LSU's Baton Rouge campus, says submissions to his board quadrupled in the months after Katrina hit.
While many of the proposals were innocuous, other researchers wanted to talk to victims about their potentially traumatic experiences in the hurricane. The IRB was very cautious with those requests, requiring that they be conducted by professionals with mental health experience. They also required that subjects be given contact numbers for psychological counseling, in case they needed it afterward.
"People who study hurricanes, people in engineering get involved," he says. "Suddenly, they're doing research with human subjects and they don't know what their responsibilities are."
Matthews himself attended campus-wide meetings set up to coordinate research, as well as informed faculty about their human subjects protection responsibilities.
Most, he said, showed little resistance to the idea of submitting proposals to the board. There was a little more grumbling about the required 1.5 hours of online human subjects training.
"Since I made a personal appearance there and talked about it, it kind of eased things," he says. "If it had just been a written notice, they might have been more resistant."
Matthews says IRBs should keep in mind that for those traumatized by a disaster, an initial vulnerability may not improve over time.
"When people start to realize they're not going back to their homes, and the government resources are not very good and they're living in these trailer parks, that's when things really start heating up," he says. "A lot of these people are still in trailer camps and will be for a long time."