How resilient is your IRB?

Extreme situations like Hurricane Sandy pose obvious threats to business continuity. It’s important to recognize that routine occurrences also have significant disruptive potential, particularly if organizations don’t anticipate them and develop backup plans in advance.

Emergency plans are explicitly required in the animal research realm, and have been for many years. Even though the concept of “minimizing risk” logically includes planning ahead for possible disruptions in human research activities, this is by no means obvious to everyone in the research enterprise. IRBs in various settings are beginning to recognize the need for emergency plans, especially for protocols that involve medical interventions. It is the policy of the Virginia Commonwealth University IRB is that investigators conducting such protocols are responsible for developing a plan to provide continuity of care and ensuring that all members of the research team understand what to do in an emergency situation. Investigators also need to think about the protection of research data, and in the case of federally funded research, responsible stewardship of the public investment in those studies.

IRBs need emergency plans, too. The regulations do not make any allowances for the continuation of research without IRB approval, except to the extent necessary to prevent harm to participants. IRBs need to build resilience into their operations to minimize the potential for approvals to lapse because a committee is unable to meet as scheduled, or the staff cannot access the electronic recordkeeping system. The Human Subjects Protection Program at the Louisiana State University Health Sciences Center in New Orleans has developed a comprehensive emergency readiness plan that addresses how communication will be maintained among IRB and study staff.

There is no such thing as a perfect system. It is possible to create resilient systems that reduce the potential for disruption and shorten the time to recovery when things do go wrong. A few suggestions:

  • Recognize that systems or individual system components can fail.

Develop a realistic list of potential failures and work through them. For each scenario, ask, how likely is it that something like this could happen? How disruptive would it be? To what lengths should the office or department go to avoid it? The answers to these questions can inform the development of appropriate prevention and mitigation strategies.

  • Coach staff to document their work in real time.

All of us have heard the mantra: if it’s not documented, it didn’t happen. The ALCOA standard (attributable, legible, contemporaneous, original and accurate) goes even farther by specifying that things should be documented when they happen. It is far easier to pick up where someone else left off if they have made a habit of keeping good records.

  • Cross train.

Over-reliance on a single individual to manage a critical process or system is all too common, especially in small offices where resources are tight. What happens if that key person suddenly becomes unavailable? Knowledge hoarding is another situation that is unfortunately very common. It may not be recognized for what it is until the person leaves the organization.

  • Back up the data.

Organizations using electronic record keeping systems should have systematic backup and recovery procedures in place to protect against the loss of critical data. IRBs that are primarily paper based can still benefit from the use of a backup system (which could be paper or electronic) to track basic information about the protocols they review.

  • Back up the process.

It’s a mistake to assume that any electronic system will be available and working as intended, 100% of the time. In addition to software applications and databases, which must be installed and configured properly to work as intended, these systems depend on properly functioning hardware, internet connectivity and electricity. Any of these things can fail without warning. Backup considerations might be as simple as bringing printed copies of reviewer comments to a meeting, or as complex as temporarily reverting to a paper process.

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