Continuity plans keep IRBs going in hard times
Keep operations up during weather disasters
While monstrous hurricanes are not a frequent occurrence, it always pays to be prepared. Hurricane Sandy was something of an anomaly, but cities and hospitals in the Northeast braced for the monster hurricane, putting plans in place to evacuate patients when needed and ways to continue operations even if the worst happened.
IRB members, too, had to be quick on their feet and find a way to continue on, even in the face of flooding and destruction. Marjorie Speers, PhD, CEO of the Association for the Accreditation of Human Research Protection Programs (AAHRPP), stresses the importance of every IRB having a continuity plan in place for any unforeseen circumstance that could arise.
“In just over a decade, there have been a number of events that would interfere with an IRB’s operation,” Speers says, referencing 9/11, Hurricane Katrina, floods in Houston, and other major weather events. “To put Sandy in perspective, it’s not the first disaster IRBs have had to deal with.”
How to prepare
Speers offers tips for IRBs on forming a continuity plan and keeping things moving as smoothly as possible during an event:
• If the IRB must briefly close, formulate a plan to keep meetings going. “It’s much easier today with the information technology and software we have available,” Speers says.
When the offices at the Biomedical Research Alliance of New York (BRANY), located on Long Island, were closed in anticipation of the storm, members quickly identified other places to go: each other’s homes. After some IRB members lost power at home in the aftermath of the storm, they were able to go to nearby colleagues’ homes to charge phones and laptops and to access the electronic IRB databases and keep things going.
“We identified people willing to have a home office for other people in the area,” says Kimberly Irvine, CIP, CIM, executive vice president and chief operating officer of BRANY. “We could access the database, but it was good to have people willing to let others come to their home to work.”
In addition, BRANY institutes a “phone chain” to get information to colleagues. Members also update voice mail greetings to reflect the closing to anyone who might call, and send out email blasts to participants to keep them abreast.
In the days following the storm, the IRB at New York University Langone Medical Center in Manhattan held a virtual meeting for protocol review, giving priority to studies with greater than minimal risk, including therapeutic interventions and device studies. “That way, patients would continue receiving medications and follow-up calls,” says Elan Czeisler, IRB director at NYU Langone. There was no interruption in oversight, and IRB meetings resumed, with dozens being held over the phone.
• Ensure that database systems and protocol records are safe and secure. “Many IRBs are moving to electronic systems. That’s a real plus if the docs are stored electronically in the cloud,” Speers says. “The vulnerability we had even 10 years ago is much less today with electronic records.”
The NYU Langone IRB had staff members in place to assist in the evacuation of records of more than 100 research protocols from the hospital and other research affiliates. The records were moved to a secure location only accessible to investigators involved in the studies. “Those staff members were actually dedicated full time in support of that effort as they were familiar with the program itself,” Czeisler says.
Keeping operations running
• Inform the federal regulatory bodies of the situation. “It’s very important to inform OHRP [Office for Human Research Protections] and FDA [Food and Drug Administration] and let them know what is happening,” Speers says. “That’s important because one thing you’re vulnerable to is not being able to follow the regulations. If the regulatory bodies know you can’t conduct continuing review on time, they can work with the institution and the IRB to get things done under the circumstances.”
The NYU Langone IRB kept in contact with OHRP and apprised regulators of the backup plan. “We wanted to make sure we were conducting business within the framework,” Czeisler says. “They had some understanding of how to address the institutions after [Hurricane] Katrina.” Czeisler confirmed his IRB’s plan with OHRP’s senior leadership and also asked for input on specifics. With the organization’s input, the NYU Langone IRB kept operations and protocol review running by prioritizing the protocols with greater than minimal risk, and had more flexibility to delay minimal risk protocols.
• Plan for relocation of study staff and study participants. “We think about the IRB and its operations, but we also want to think about the subjects. If they’re on a protocol and need to receive the intervention and they might need to come in for dosing or for tests,” Speers says. “It’s important to have a system in place where the IRB and researchers can plan who will be affected by temporary closing and have to make arrangements.” Other arrangements include identifying nearby or affiliated facilities that are still operational and can accept investigators and clinical research subjects.
• Be prepared for the unexpected. Even the best continuity plan won’t prepare for everything, so be on the lookout for new solutions. For example, when BRANY staff found their offices had electricity but no Internet access, quick thinking and a cell phone got them back online. “One person in our office made her phone a hot spot, and we were able to use that — something else we now put in our disaster plan,” Irvine says.
When staff members with electricity in their homes opened their doors to colleagues who needed work space, BRANY identified that as a backup plan. “We were thinking of having hubs where we could say, ‘If you’re located in close proximity and have no power, there are people willing to let you come over to continue operations,’” Irvine says.
Since BRANY’s facilities were unscathed, Irvine’s team reached out to other IRBs in the area who may have needed a place to work. “We also did try to reach out to places that we knew were affected to see if people wanted to collaborate and needed an IRB to review something and we would try to work that out. No one took advantage, but we wanted to let them know we were available as a resource,” she says.
Staff members need support, too
Since many IRB staff members had homes damaged and lives shaken up by the storm, nerves were frazzled and focusing on work was often difficult. According to Irvine, going into the office was a stress reliever of sorts.
“People were feeling like it was a safe zone, in a way — people could come in and charge everything up,” Irvine says. “Some people had to bring their kids because schools were closed, so kids were in the office intermittently. Everyone was just open to thinking creatively and keeping the work moving.”
Czeisler notes the dedication of the IRB and staff members in the face of the storm. “One of the fascinating aspects of this entire ordeal was observing not just the camaraderie but the spirit exhibited by some of the IRB members, acting as if it was their own home affected by the storm and going out of their way to make sure investigators who evacuated would have access to their records,” Czeisler says. “The number of individuals that volunteered and helped remove samples and research records was amazing. It made quite a few people proud of the level of commitment to the program.”
While monstrous hurricanes are not a frequent occurrence, it always pays to be prepared. Hurricane Sandy was something of an anomaly, but cities and hospitals in the Northeast braced for the monster hurricane, putting plans in place to evacuate patients when needed and ways to continue operations even if the worst happened.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content