In lieu of an abstract, here is a brief excerpt of the content:

  • Pandemics and Protections:How to Keep It All Together in 2020
  • Gabrielle Rebillard

It is not unusual for even the most experienced, well-resourced IRBs and HRPPs to be in survival mode. The churn of requests for priority review, funding and academic deadlines and requests for help with applications never cease. The staff must juggle their own workloads and perfect their craft without sacrificing customer service. Meanwhile the QA/QI initiatives never seem to be finished and other areas of research operations need your assistance, too. The old adage "if want something done, ask a busy person" seems to be standard operating procedures for IRBs and HRPs.

The topic at hand is what happens when more chaos and challenges are thrown into the mix of an already difficult job. Collectively we may avoid even questioning whether 2020 could get much worse for fear of knowing the answer is "Yes." We are left to wonder if our IRBs and HRPPs will become victims or champions of circumstances. Maybe human research protections seem relatively insignificant when the world is so upside down? The truth is that we, members of the very entities responsible for protecting the safety and wellbeing of others, are ourselves human. This pandemic has changed the "where" and the "how" but not changed the essential nature of "what" we do. We are still the "go-to" compliance experts for researchers trying to keep old projects going and launching new ones. We remain key partners in the machine of research operations. Now we just meet our responsibilities and deadlines in makeshift home offices. We try to focus on difficult reviews while competing for internet connectivity, tuning out family activity, and caring for our own mental and physical health. COVID has created real and existential risks to our personal lives while all the same compliance standards remain in place.

While dealing with COVID-19 more than enough on its own, the fact is that it is just one of many serious challenges our institution has faced in the last year. Prior to the March lockdown, our university and its academic medical centers was already in turmoil. We were (and still are) dealing with the closure of one hospital system and establishment of new partnership for another while simultaneously also undergoing the process for our AAHRPP re-accreditation. Did I mention that we are also replacing our electronic research software system? So, adding chaos and challenges is not hypothetic. It is our "norm."

How are we getting our compliance work done? Let's start with the basics. The closure of our university was somewhat anti-climactic because of previous flood damage to the HRPP's building. (Yet another fun part of this year). Staff was already [End Page E13] moving towards remote work or finding temporary workspaces in the building. We were already running business operations online as much as possible. What stopped were the impromptu door-way conversations and the in-person training sessions for researchers and students. Without a commute, some staff started earlier, and some started later or work intermittently to accommodate a revised home-work life balance. The monthly meeting for our three IRB Committees went virtual.

On the whole the type and balance of the research we review has not shifted radically because of the pandemic. Instead a new focus emerged. Initially we began seeing clinicians scrambling to submit Emergency Use and Expanded Access applications. I got an early Saturday morning call from a Dean about a hot opportunity for collaboration which lead to a weekend's worth of conference calls, regulatory debates, and review work to meet a Monday morning deadline.

I have to confess that prior to March 2020, I did not expect to ever be in situation or see a project where I needed to dig into this part of the Revised Rule:

"(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends...

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