All IRBs should prepare for possible disaster interruptions

Flooding, storms on the rise

IRB directors who think their areas are safe from natural disasters should think again. Some U.S. IRBs learned the hard way that even in non-coastal cities and areas they can find their IRB offices underwater. Or they could experience earthquakes, tornadoes, hurricanes, and fires. And any research institution and IRB is at risk of an epidemic that leaves them short-staffed.

As demonstrated by the recent East Coast earthquake, which could be felt from New York to South Carolina, by the hurricane that caused major flooding in Pennsylvania and other Northeastern states, and by mile-wide tornadoes that destroyed whole towns in Missouri and Alabama, natural disasters are on the rise.

In a series published in February, 2011, Scientific American catalogued 960 natural disasters worldwide with record-breaking financial costs. Extreme floods have tripled globally in the past three decades, according to reinsurer Munich Re.

One reason for flooding damage is heavier rainstorms, which are more likely to lead to flooding. Climate change has resulted in more moisture being captured and stored in the warmer atmosphere. This leads to increased droughts and heavier rainfall once it's released, scientists say.

The result is a world in which IRBs and research institutions need to prepare for the unpredictable.

"We felt safe before tropical storm Allison hit in 2001," says Paula Knudson, special advisor at the University of Texas Health Science Center (UTHSC) in Houston (TX). Knudson had been the IRB director when the storm struck.

"We thought the worst would be a hurricane that blew out a window upstairs," Knudson says. "Instead, we had a flood coming up from the basement."

The storm and flooding resulted in the ground floor IRB office filling with nearly a foot of water, reaching the second drawers of filing cabinets. The office lost its electricity and telephone service, and about one-third of the IRB files were destroyed. Also, the IRB office was uninhabitable for more than a month, she recalls.

To recover the damaged IRB files, the institution had to send them to NASA for document recovery. But even collecting them was a slow, tedious process that created potential health risks for staff. They were able to enter the office after a couple of days, but because there was no air filtering or air conditioning each person could only tolerate 30 minutes in the building, Knudson says.

"You could be overcome by the heat or smell," she notes.

The smell was unbearable because it included the odor of dead animals since the building's basement had housed research animals, which all had been killed in the flood, she explains.

"The IRB chair and I went in together, holding flashlights under our chins," Knudson recalls. "We went in every day for several days, trying to salvage what we could and stacking things in boxes."

Louisiana State University Health Sciences Center (LSUHSC) in New Orleans, LA, felt the full impact of Hurricane Katrina's devastating flooding in August and September, 2005. One of the main problems after the disaster involved communication between IRB staff, investigators, and research participants, says Kenneth E. Kratz, PhD, director of the office of research services at LSUHSC. Kratz also is the IRB chair.

"Some coordinators left for Mississippi and Boston," he says. "Initially finding those people was difficult because of problems with the phone service, and then that put the process of oversight on hold for a couple of weeks."

Retrieving paper files was less of a problem for the IRB office because of a fortunate decision the office had made months earlier: "Six months prior to the storm we started using a new, commercially-available database and management software system for the IRB review process," Kratz says. "Those are housed in a server in New York, and we had access to that over the Internet."

There was some delay in retrieving the information and continuing the IRB's work because of the fact that some IRB staff did not have access to computers and the Internet right after the hurricane, he notes.

"One person was living in a camping trailer in a state park," Kratz says.

Also, the IRB office had to move to temporary facilities in Baton Rouge, where it stayed for more than half a year, he adds.

"We were able to re-establish our office at a sister campus in Baton Rouge, and begin paperwork and oversight," Kratz says. "We slowly re-established contact with our investigators and began holding a meeting of the IRB at the end of October, beginning of November."

Kratz and Knudson share these lessons learned for future disaster planning efforts:

• Establish a back-up communication plan: When a major natural disaster strikes, a research institution likely will lose electricity and telephone service for an indefinite period of time. Even cell phone service might be blocked or limited. So IRB offices need to plan ways to reach staff, IRB members, and investigators when this occurs.

After Hurricane Katrina, LSUHSC staff had no landlines or cell phones that worked, Kratz recalls.

"So communications were difficult to say the least," he says.

The university put important emergency contact information and directions on its website, but not everyone thought of checking there. So now staff is trained to go to the website's emergency information page both prior to an anticipated disaster and after it happens, he adds.

"Everyone is made aware of what is going on through the institution's emergency preparedness system," Kratz says. "First thing you do is go to the website and look at the emergency notification section."

Also, the IRB now keeps a complete list of contact information for all IRB staff, member, investigators, and research coordinators, he adds.

"We have an emergency contact tree developed with information about each of our employees, and I keep this on my own computer," Kratz says.

UTHSC also found IRB communication limited to a single phone number in the university president's office after the 2001 floods. But should a similar disaster happen again, the IRB office is better prepared, Knudson says.

The IRB keeps a continually updated list of all possible contact numbers for IRB staff and others, she adds.

• Establish safe back-up storage for data: Knudson learned the hard way that even when the IRB system relies on hard copies, these should be stored electronically in a safe place.

After the Houston flooding, the UTHSC IRB office discovered that all of its back-up disks were floating in water, she says.

IRB offices should make sure that all files are backed up on a safe server or on disks that are stored in a secure off-site location.

The IRB office at LSUHSC had just made the transition to a new software management system prior to Hurricane Katrina. It stored data in a server in New York, so it wasn't impacted by the disaster, Kratz notes.

But all folders specific to individual protocols were still stored as hard copies in the IRB office, and these were difficult to access after the disaster, he says.

"I could go back in the office on an intermittent basis to get things and pull them out to take to Baton Rouge, but that was pretty difficult," Kratz explains. "Fortunately, all of the basic information about the trials was in the new management system, and having access to that information was the only way we could get started as quickly as we did."

Now, the IRB has expanded its use of electronic software management, putting as many documents as possible into the system, Kratz says.

Initial IRB submissions still come as hard copies, but they're now making a transition to a fully electronic system, he adds.

"The other thing we have done is give each coordinator a laptop and wireless internet cards so they have access with their laptops to the Internet and can get to this management system wherever they are," he says. "That's a significant change because [when Katrina struck] six years ago many coordinators did not have access to computers."