Planning an Agile Response.

Abstract

Planning an Agile Response John D Tupin Our IRB reviewed just over 200 COVID-related studies with an additional 170 individual actions in relation to those studies. [End Page 80] Social behavioral ranged from studies addressing PTSD among front line workers to transitions to telemedicine care; many of our studies focused on underserved and racially diverse communities. Biomedical and clinical studies addressed early efforts to evaluate the efficacy of remdesivir, convalescent plasma, and vaccines. Imaging studies included detection of ancillary effects on organ systems and inflammation. The university also created and validated high throughput, up to 56,000 tests a week, saliva-based testing. One of the challenges we faced was emergency use. Our first encounter with COVID-19 occurred in early 2020. The subject was in critical condition, incapacitated and on a ventilator. The patient had no definitive COVID diagnosis as the test was withheld by the responsible public health agency owing to irregularities in symptoms. However, due to the nature of the virus we made the decision to move forward with the manufacturer to treat the patient in the belief that the formal diagnosis would be made and coincide with administration. The IRB made the decision to verbally remote consent the legally authorized representative (LAR), with a waiver of documentation until the immediate hazard could be eliminated and document the process concurrently with written consent at a later time. Our early experience in obtaining treatment medication was rocky. The original study was funded by NIH and as such was beholden to a single reviewing IRB. At that time I believe that the potential scope and impact was less understood. As such, the reviewing IRB had not considered "out of network" providers and researchers and had to delay until institutional approval could be obtained. The problematic issue here was the unavailability of the institutional decision maker and no process for emergency delegation. I can't blame them, as this was new territory. It was apparent to the IRB and the potential PI that it was necessary to add a second IRB of record. The sponsoring agency was contacted and apprised of the issues; shortly thereafter a second IRB was activated. The additional IRB was structured for multisite studies and had a great deal of experience in pharmaceutical studies. Further, the second IRB employed Smart IRB, allowing for a streamlined reliance process and quick activation. Moving forward, we have developed a robust delegation chain and will advocate strongly for an expedited waiver of the single IRB requirement. The university has been an active and leading center for telemedicine, however, COVID 19 produced some interesting issues. First, there were many commercial services that provided peer to peer programs that are easy to use and accessible to the majority in the community. That meant that providers and researchers were no longer tied to proprietary, homegrown systems that required specialized hardware, software and user accounts generated by in-house IT. However, it presented a new host of issues. Security concerns including data transmission, encryption, storage and ownership became a very important issue. Best case scenario data was being transmitted only and never backed up or duplicated. But what if it was? And where were the duplicates residing: dedicated domestic servers, in the cloud? Were the systems HIPAA or part 11 compliant? Additionally, what about rural patients, the homeless and impoverished, or my 86 year-old father who uses his laptop as a paperweight? We quickly were able to identify systems and vendors that we had used in patient care as secure and validated a handful of others that could be used during the public health crisis. What remains to be done is a clearer way for new vendors or those who did not intend for their systems to be used in medical treatment to validate their products in a way that is acceptable to the end user and the vendor. As to the underserved communities, how to make the technology available in a safe secure way that addresses all of the above issues and public safety needs to be studied and addressed. Another challenge we faced, and one of the now-obvious issues that we didn't consider, is the budget crunch that...