Prepare Contingency Plans for Transferring Oversight
OHRP/FDA guidance now finalized
By Melinda Young, Author
IRBs should create a contingency plan that would go into effect when a natural disaster or a major problem disrupts operations.
Animal protection committees have long had to create contingency plans, but the requirement for human research protection programs (HRPPs) is new, says Fanny K. Ennever, PhD, CIP, research compliance officer at Boston Medical Center.
IRBs might not have given contingency plans and disaster planning much thought before Hurricane Katrina caused major disruptions to New Orleans and the region in 2005.
Then, in 2009, an independent IRB had to close its doors after a federal sting operation revealed sloppy human protection oversight. Coast IRB of Colorado Springs, CO, had been targeted by the Government Accountability Office (GAO), which sent several independent IRBs a fake protocol from a fake medical device company. The investigators listed on the protocol had phony credentials, and the proposal was filled with red flags. Two of the IRBs rejected the fake study, but Coast IRB approved it, committing violations of HRPP laws and regulations. (For more information, see the story in the July 2008 issue of IRB Advisor at: http://bit.ly/2svL4hw.)
When the IRB abruptly closed, all of its existing protocols and studies were left in limbo until investigators could find an alternative IRB to conduct reviews. This was the type of disruption the new contingency guidance is designed to prevent, Ennever says.
The U.S. Department of Health and Human Services Office for Human Research Protections (OHRP) and the FDA issued their final joint guidance, titled “Institutional Review Board (IRB) Written Procedures,” in May 2018. (The guidance can be found at: http://bit.ly/2LNuJ0r.)
Item 51 in the written procedures checklist simply states, “Contingency plans for transferring oversight of one or more studies to another institution or IRB in the event the IRB is unable to continue oversight of the study (e.g., the IRB closes, suffers loss due to fire, natural disaster).” (See FDA Q&A on new guidance in this issue.)
OHRP and FDA provided no template or examples of how to create a contingency plan, Ennever notes.
“There were not many comments on the draft guidance,” she says. “We wrote a comment, asking for some guidance on the contingency plan.”
But the Boston Medical Center IRB didn’t wait for an answer. The organization created its own IRB guidelines, updated in May 2018, with three sections pertaining to a contingency plan.
When OHRP and FDA first issued the draft guidance, the IRB was preparing for accreditation. Ennever and the IRB brought the draft guidance to the institutional officials responsible for the Federalwide Assurances (FWAs) to see whether they should act on it.
“We said, ‘It’s draft guidance and not final guidance,’” Ennever recalls. “And they said, ‘Yeah, but it makes sense.’”
The institution went ahead with creating its own contingency plan (http://bit.ly/2xwAbS3), which includes these items:
• Disruptions and recovery: The first information in a contingency plan would identify the time frame of the disruption and who is responsible, Ennever says.
Many IRBs are located in areas where a natural disaster could cause a short-term disruption in service. And every IRB could be targeted by cybercriminals who disrupt operations.
When disruptions occur, the goal is to return to normal operations within a week, the Boston Medical Center IRB’s contingency plan states.
“The one-week goal is appropriate for most HRPP operations (IRB review, education, and compliance),” the plan says.
“An important question is, ‘Who makes the decision?’” Ennever says. “At our institution, it’s the IRB director who will make the decision about how serious the disruption is and what measures are needed.”
• Backup and recovery of the electronic system: A key component of the contingency plan is the availability of HRPP records, the Boston Medical Center IRB’s contingency plan states.
“For IRB functions, the electronic system is used as the system of record, and no records that are essential to IRB oversight are maintained only in paper or only in other forms such as email correspondence,” according to the plan.
Boston University’s server backs up IRB data daily, with a secondary backup made through a third-party vendor.
Before creating the contingency plan, the only backup was on servers within the institution — and these were located in the same floodplain, Ennever notes.
“So we found that Boston University has a professional backup where critical files are backed up, put on tape, and sent on a truck to the Philadelphia area,” she explains. “We found that we could just add our electronic system to that daily backup.”
Two things made this an affordable option. First, the IRB’s files did not add significantly to the data that the data recovery company already was handling. Secondly, the IRB decided that it could wait a week for its data recovery, she says.
“The quicker you need to restore an electronic system, the higher the cost,” Ennever says. “We said we didn’t need to get data back for a week, and the cost was so low the university didn’t even charge us for it.”
• Personnel disruptions: From the IRB’s perspective, this is the part of the contingency plan that could be the most challenging. In the event of a major disaster, such as flooding or a storm that causes evacuations and property damage, some of the IRB staff might not be able to return to work for days or weeks.
“There could be an electricity problem or a really bad flu season,” Ennever says.
Other causes could be multiple resignations, interruptions in internet service for work, and epidemic diseases, the contingency plan notes.
“In the specific instance where the disruption results from the inability of IRB staff and members to travel to the IRB office location, as long as electricity and internet access are available, they may use the electronic system from home and participate in convened meetings via teleconference,” the contingency plan states.
When the disruption is more severe or results in IRB closure, such as what happened with Coast IRB, then a contingency plan would be to have the IRB’s protocols transferred to an independent IRB.
In most cases, the independent IRB could provide staffing help during a limited disruption, Ennever says.
“We have relationships with independent IRBs and they can provide backup,” she explains. “They have said they could provide staff to review protocols according to our policies and procedures.”
The idea is to have the independent IRB serve as a staffing backup without transferring oversight.
“The independent IRB essentially would be a consultant, providing personnel who would act as our temporary employees,” Ennever says.
The IRB director would make the call of whether a disruption is temporary and short-term, or possibly long-term and necessitating a transfer of some studies, she adds.
“The IRB director would decide when the disruption is over whether to bring studies back or leave them where they’ve been transferred,” Ennever says.
IRBs should create a contingency plan that would go into effect when a natural disaster or a major problem disrupts operations.
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