Discussion

The COVID-19 pandemic has led to major disruptions in the clinical research enterprise. Our study demonstrated that during the early phase of the pandemic most investigators had to stop enrollment and study visits and modify study procedures for both their non-COVID-19-related interventional trials and observational studies at the time of the shutdown, consistent with other reports on clinical research from early in the pandemic. Most previous studies have reported on clinical trials only, finding that 20–87% of studies in various specialties at least temporarily halted enrollment [Reference Upadhaya, Yu, Oliva, Hooton, Hodge and Hubbard-Lucey4–Reference Grayson, McCormick, Thompson, Miller, Cho and Woodworth6]. Medidata Solutions, Inc. has been documenting the change in the activity of clinical trials, finding in April a 45% decrease in new patients entering study sites in the USA compared to the previous year [7]. While improved by August, new enrollments were still decreased by 22%. In April, two-thirds of investigators said they were halting or planning to halt patient recruitment in ongoing trials, half were delaying their new studies and over half were switching to virtual participant visits. These results were also somewhat improved by August [8].

Investigators responding to this survey were highly flexible in modifying trial procedures to continue clinical research despite the restrictions, some of which they intend to sustain. The most common modifications which many investigators plan to incorporate into future studies include conducting virtual study visits and using remote consenting. Fewer investigators introduced technologies that would allow remote clinical assessments, possibly due to lack of access to appropriate platforms or validated tools. Future work is needed to improve the ability to conduct study visits remotely including the development of tools to allow remote clinical assessments, creative trial designs to incorporate remote activities, and increased flexibility from IRBs and regulatory bodies to readily allow remote study activities.

The pandemic has also had a significant and far-reaching impact on the work–life balance of researchers and research teams, and their ability to continue their research activities. Some respondents did report positive impacts in terms of more time for activities such as writing. However, most faculty and many staff reported negative impacts including increased responsibilities at home. While we do not know the demographics of our respondents, the disproportionate challenges being faced by women [Reference Oleschuk9,Reference Staniscuaski, Reichert and Werneck10] and people of color in medicine [Reference Filut and Carnes11] and in academia during this pandemic have been highlighted, which could have repercussions for career advancement beyond the pandemic. A third of research faculty reported increased clinical workload, which could put them at risk for negative mental health consequences [Reference Preti, Di Mattei and Perego12], in addition to a decreased capacity to continue their research activities. Worries about personal COVID-19 infection risk were also common, which could influence both individual well-being and workplace performance. Finally, the large proportion of faculty and staff with technology-related barriers to working from home is notable, in addition to not having adequate workspace and access to needed materials/supplies. It is likely that those technological challenges were magnified for some as the prolonged school closures required multiple family members to have individual devices, simultaneous internet access, and adequate workspaces.

It is important for academic and research institutions to consider how workplace and occupational interventions [Reference Giorgi, Lecca and Alessio13] can best support investigators and their teams during this pandemic and beyond. Our findings highlight organizational factors that make COVID-19-related research adaptations easier for research teams. Examples include simplifying the IRB approval and other processes related to virtually obtaining informed consent, adapting data collection or interventions to digital platforms, and distributing study incentives electronically to participants. In addition, research groups or institutes should foster the sharing of ideas and resources across research teams since we found that over 90% of teams developed their own modifications for pandemic circumstances. Online repositories of revised protocols or procedures developed by teams and online seminars to support the exchange of ideas would likely reduce redundant efforts and possibly increase collaboration. Other innovative strategies to support connection, productivity, and well-being should be explored, as have shown success in some academic settings [Reference Kumar, Kodidela, Kumar, Gerth and Zhi14] such as regularly scheduled virtual sessions to support and empower colleagues.

In addition, strategies to reduce barriers to research participation for those historically underrepresented in research and, now, experiencing health disparities related to COVID-19 are urgently needed. Organizations can explore opportunities for funding or creating shared access to devices (such as tablets, hotspots) that study participants can use for remote research procedures. They can support and encourage researchers to partner with communities to meet their needs and promote health equity during this challenging time.

To support the overall professional development and work–life balance of faculty and staff, organizations need to reduce barriers and inequities in effectively working from home. Workplaces should consider their critical role in supporting child care and elder care for employees, including innovative strategies such as helping facilitate “pods” (small groups of students that gather regularly to learn in a shared space) for families to share care responsibilities. In academic settings, promotions committees should consider more lenient policies related to tenure and promotion clocks and offer extensions and grace periods, as has been recently done at the University of Washington, recognizing the effects of COVID-19 on faculty productivity may extend for several years. Trainees and early stage investigators may be disproportionately affected by social isolation or additionally burdened by the care of young children during the pandemic. Options such as bridge funding, small internal grant opportunities, and institutional support for new grant applications could be effective strategies. Finally, many institutions have instituted protocols to safely allow access to office and lab spaces for essential research procedures during the pandemic. Similarly, when faculty and staff can safely return to work, institutions will need to clearly communicate protocols and policies for the business resumption and address the concerns of faculty and staff.

Our study has several limitations that should be considered. The overall response rate was low and may have been answered primarily by investigators who were more affected by the pandemic restrictions. We did not collect demographic data due to concerns about protecting the privacy of respondents within the institutions. We are not able to separately examine the impact by factors such as gender, age, race, family composition, or academic rank. Our data are limited to two institutions, and therefore may not be generalizable to other settings. The data were collected relatively early in the pandemic and the effect of the restrictions may have lessened over time. For example, our institutions have subsequently offered equipment to support working from home. However, as the pandemic has not yet abated, similar work and research restrictions remain in place. Further follow-up may identify additional impacts over the course of the pandemic.

In conclusion, our findings build on recent data demonstrating the impact of COVID-19 restrictions on clinical research and add the perspective of faculty and staff on both the professional and personal impact of COVID-19 restrictions.