Research sites should update their disaster preparedness
Focus on communication, data security
As the past year's devastating tornadoes, unexpected flooding, and other disasters have shown, it is impossible to predict when and where a natural disaster might interrupt a city's business as usual.
Areas where research professionals have never experienced major flooding now can find their offices knee-high in water. Places where tornadoes left small, infrequent damage now can span a mile radius and wipe out entire towns within seconds. Hurricanes once meant broken windows; now they can incapacitate a major academic research complex for months.
Disaster planning has become more urgent and personal in the past decade, and research offices are responding with preparations that in an earlier time might have seemed excessive.
Some experts who have lived through one of the recent major natural disasters say it is especially important for clinical research institutions to fully prepare for an event that could wipe out usual communication, prevent access to offices and computers, and disrupt clinical trials for an extended period of time.
In June, 2001, the IRB office at the University of Texas Health Science Center (UTHSC) in Houston, TX, had concluded business as usual on a Friday evening, and by the next morning the basement research facilities had 23 feet of water, and the IRB offices on the ground floor were flooded to the second filing cabinet drawer, recalls Paula Knudson, UTHSC special advisor and former director of the committee for the protection of human subjects.
"Tropical storm Allison brought four days of severe rain," Knudson says. "The water rose up from underground springs, so we didn't know that was happening, and no one expected this disaster."
The research building lost all electricity and climate control. The research lab animals housed in the basement were killed by the floodwaters, and the resulting decay created an unbearable odor. No one could stand being in the IRB office for more than half an hour at a time when they were trying to retrieve files and anything else that wasn't destroyed by water, she recalls.
Knudson and other experts learned the hard way how ill-prepared they were for a major disaster. So they offered these suggestions for other research institutions:
• Set up a communication plan: From a clinical trials office perspective, communication with subjects is the first disaster planning procedure to consider, says Alicia Pouncey, MEd, managing director of Aureus Research Consultants of Metairie, LA.
When Katrina struck the New Orleans area in 2005 it took at least several days to re-establish some communication with staff through an Internet voice mail system. Finding patients is even more difficult, so research organizations need to plan for a major communication disruption, she suggests.
"One facility in New Orleans put together a database after Katrina where they sequestered parts of their emergency medical record system," she explains. "And several individuals, who were considered first responders, could access these data across all studies at the facility to identify study patients who might need a follow-up care and a re-supply of medication."
Others used the research institution's website as a communications hub.
"We put information in our health science center website asking subjects to contact the institution with their contact telephone numbers so we could try to get them in touch with the clinicians running clinical trials," says Kenneth E. Kratz, PhD, director of the office of research services at Louisiana State University Health Sciences Center (LSUHSC) in New Orleans, LA. Kratz witnessed the aftermath of Hurricane Katrina in August and September, 2005.
After flood waters prevented Kratz and other staff from returning to work in New Orleans, they found that employees, investigators, and research subjects were scattered far and wide. There was no access to landline phones, and cell phone use and Internet contacts were limited, so it was very difficult to re-establish communication.
"We put notices in newspapers in cities like Houston where many of the people had landed, and we hoped that might facilitate their being able to establish communication with investigators," he adds. "We also told our investigators that the IRB would not be able to meet for probably two months, so it couldn't process new studies of any sort."
The Internet provides an opportunity for fast and more easily accessible communication after a natural disaster.
"We moved our email to an offsite server," Pouncey says. "Prior to the storm we had our own server, and we still do, but part of our evacuation plan and disaster standard operating procedures is to switch over operations and go along with the email that's already offsite."
Since Katrina, the LSUHSC research office has educated staff and researchers on procedures to follow during a disaster, including visiting LSUHSC's website for emergency information and directions.
"Many people didn't know to do that six years ago when they left the city," Kratz says. "Now we make sure all of our investigators and employees are aware of it."
The website lists contact information for investigators and research coordinators. It has an emergency preparedness link for investigators. The link tells investigators to inform subjects when they enroll in a study that they if they should have to leave town for any reason they should call this toll-free number, he says.
"Investigators are asked to give subjects a wallet-sized card with the name of the institution, name of the trial, and contact information, including this toll-free number," Kratz adds.
"My staff monitors that number, and it has a voice mail system located in Shreveport (LA)," he says. "So there's no danger of there being a problem with the phone system."
Once subjects contact the research office through the toll-free number, they are given advice on how to proceed with their treatment, and they're asked to provide their out-of-town contact information," he says.
Communication problems also arose in Houston when Allison hit, Knudson says.
"It's tremendously important to remember that we are responsible for people in studies, so we need to be in touch with our principal investigators to see how they are managing the emergency with their study subjects," Knudson says.
So a good strategy is to start an emergency contact tree. Research offices should obtain all staff and investigators' telephone numbers, including cell phones and contact numbers of family members they would visit if they were to suddenly leave town.
"I have cell phone numbers for each of my staff members, and we make sure they can receive text information," Kratz says.
"One interesting thing after the storm was one day a text message came in from a coordinator," he recalls. "I didn't know how to do text messaging then, but that's how I communicated with her."
Sometimes cell phones might lose their ability to receive incoming phone calls, but they can still receive text messages, which transmit digitally and more quickly, Kratz notes.
Some research institutions plan to use text alert systems in which students and staff are sent a text message with instructions in anticipation of a hurricane or after a disaster.
• Design research data security measures in anticipation of a physical site disaster: After Hurricane Katrina, LSUHSC's research office lost much of its electronic information because the IRB building's servers were destroyed due to electrical and heat problems, Kratz says.
"The buildings had high humidity, and temperatures were up in the high 90s and 100 degrees," he explains. "Fortunately, almost all of the information on the servers were backed up at other places, and they were able to reconstruct everything, but that took our IT department a long time."
Since then, the institution has improved its data back-up system so information is stored at multiple sites, he adds.
"My understanding is it's much more secure now," Kratz says. "As a result of the tragedy in New Orleans, the information on servers would not be affected if there were another storm, but it was a significant problem back then."
Offsite data backup and data cloud services are good ways to provide protection against a local disaster, but they can pose other security problems that research sites should address, says Elizabeth A. Buchanan, PhD, endowed chair and director of the Center for Applied Ethics at the University of Wisconsin-Stout in Menomonie, WI.
"Seek out external storage sites – that's the future," she says. "Few of us can store our data on just one device anymore."
Cloud services are emerging as a popular option for research sites, but they're also raising some other data security issues.
"As we are putting more and more data in cloud services, saving things in places we're not necessarily in control of, it's creating an interesting contradiction for IRBs," Buchanan says
In recent years, many research institutions have moved to web-based systems for IRB and other work, and this creates flexibility in the event of a local disaster, Pouncey notes.
"At any given point they can sign on and access information, and this is a big change," she adds.
There remain data security issues, but things have improved considerably since Hurricane Katrina, Pouncey says.