It’s been over eight months since the COVID-19 pandemic crisis struck, changing every facet of life as we knew it. The U.S. biomedical research enterprise was not spared, as lockdowns and severe restrictions on activities took hold across the country. At the time, we offered our perspectives on efforts we could take to cushion the shock. Since that time, much has happened. COVID-19 research has blossomed with impressive results including FDA approval of a therapeutic agent (remdesivir, which was found to have value in a large-scale NIH-funded trial), development of several candidate vaccines that have already made to pivotal Phase 3 trials, and the rapid development of a variety of diagnostic testing platforms.
However, research unrelated to COVID has seen a different picture. As early as April 2020, the Congressional Research Service posted a report on expected “Effects of COVID-19 on the Federal Research and Development Enterprise.” The report stated that implementation of social distancing guidelines was likely to lead to:
- Closure of many laboratories.
- Restricted or loss of access to facilities and equipment.
- Cancellation of scientific and technical conferences.
- Supply chain disruptions and problems acquiring new equipment.
- Delayed or uncertain graduation schedules and career prospects for trainees and early career scientists.
Over the last six months, nearly all these predictions have come to pass. Across the country laboratories were shut down (or nearly so), non-COVID clinical trial operations were halted or delayed, and U.S. faculty openings fell by 70%. An international survey study found that the pandemic had greater adverse effects on bench scientists, on women scientists, and on scientists with young children. Another study reported productivity declines among women scientists, many now shouldering both child care and educational responsibilities.
Last August the Council on Governmental Relations (COGR) issued a report, “Research Impact Under COVID-19: Financial Crisis and the ‘Pandemic Normal” that describes a framework to quantify the adverse effects of COVID-19 mitigation measures on the conduct of government-funded academic research. Research productivity declines were attributed to mandated remote status, reduced use of core facilities and shared resources, inefficient work patterns (e.g., shift work, more down time due to cleaning, greater need for PPE, reconfigured labs), need to reestablish cell lines and animal models – and many more. These stresses are likely to persist for many more months, or longer, meaning that we are now in what the report refers as a “pandemic normal.”
Given these known stresses, and likely more to come, how to proceed? In June, Gibson and colleagues published an interesting essay in which they noted that we should not respond by merely yearning to return back to normal, since the normal state was not that great. They wrote that the pandemic served to highlight longstanding problems in academic research, including a complicated system that “is catered towards senior-level researchers,” an observation supported by data from NIH and elsewhere. The authors argued that the pandemic offers an “unprecedented opportunity to reset,” with particular attention paid to early career researchers. They offer a number of recommendations: for funders they call for simplification of procedures, policies that decrease dependency on preliminary data, extension of early stage investigator status, and no-cost extensions for existing grants.
The NIH is already implementing a number of these recommendations, including:
- Plans for the Stephen I. Katz award, an R01 award for early stage investigators based on applications with no preliminary data allowed.
- Expedited processes for requesting extension of early stage investigator status.
- Revised application and review policies that allow for post-submission of preliminary data and instructions to reviewers to disregard situations directly related to the COVID-19 pandemic, such as temporary declines in productivity.
- Expedited processes for requesting on a case-by-case basis no-cost extensions for research, career, and training awards.
While these steps may be helpful, we recognize that productivity losses are extensive and present daunting challenges (financial and otherwise) for scientists attempting to restart their research programs. While each NIH institute and center will be considering its strategic objectives and scientific priorities, the agency as a whole will support the following three priorities:
- Early career scientists, including trainees, K-grant awardees, and early stage investigators.
- Meritorious established investigators at risk for losing all funding.
- Certain high-priority clinical trials in which completion of enrollment and follow-up are critical for project success.
We are not through this – which brings me to one final item. We previously announced two extramural surveys, one of institutional leaders and one of scientists and scientific staff. If you haven’t already, please fill out the survey if you received one. We need your input to make the best data-driven decisions. If you have already filled out the survey – thank you!
In the weeks to months ahead we will continue to keep in touch with you, in these pages and elsewhere, as we navigate the “pandemic normal,” which, hopefully before too long will transform to a “post-pandemic” state.