Impact of COVID-19 on the clinical research professional workspace: Perspectives across the CTSC

We are all witnessing the immense impact that the COVID-19 situation is having on research activities across our institutions.  The CTSC is particularly interested in how this pandemic is affecting clinical research professionals (CRPs) across the spectrum.  We surveyed our CTSC-affiliated CRPs seeking to gain feedback and insight from their first-hand experiences. The CRPs who shared their perspectives included staff from the IRBs, grants and contracts offices, clinical research management, and other areas of research administration representing Case Western Reserve University, the Cleveland Clinic, MetroHealth Medical Center, and University Hospitals Cleveland Medical Center.

The universal theme in the responses received from our CRPs was adaptability.  All areas of research administration reacted to the pandemic restrictions immediately to ensure staff safety while maintaining essentially uninterrupted service to the investigators and research teams in our community. While researchers were halting or modifying operations, our institutions were processing the changes and assisting investigators in navigating new options like electronic consent, shipping study drugs to participants, and starting in-home research visits.  Most staff and committee operations were successfully transitioned to remote conduct, observing some extra benefits associated with the shift.  We also collected perspectives on the most common challenges faced by investigators.

The table below contains a summary of the feedback from our CRPs.

Question Summarized Responses

What has changed operationally since the COVID-19 pandemic started? Are there any new or unique ways you’ve been able to offer assistance to investigators?

  • IRBs as well and grants and contracts offices have continued to provide services to the research community with no interruptions or shut downs.
  • CRPs have been working remotely and strategizing steps for staff to return to the office.
  • Web-based meetings and virtual office hours have been effective.
  • For Single IRB/reliant review, very little has needed to change in terms of processes.
  • For local IRB reviews, there has been a large volume of modifications to ongoing studies to change study procedures from in-person to remote methods. Institutions have supported investigators in shifting to risk-reducing alternatives like electronic consent, shipping study drugs directly to participants, and implementing in-home research visits.
  • IRBs have been prioritizing reviews of new studies related to COVID-19 and working rapidly to meet the urgent need for this research.
  • COVID-related studies have gone through pre-review committees to increase efficiency in processing and prevent overlap.  Institutions are facilitating collaboration across departments and providing investigators with the resources to quickly operationalize their projects.
  • Research education presentations have been provided via Zoom and there has been an increase in attendance (with some research studies paused, it provided more time for the research teams to attend). Specific coursework was designed around facilitating research during a time of uncertainty.
Are there policies/procedures/approaches that you have put in place that you think you’ll keep?
  • More studies designed with remote consenting, virtual visits and remote monitoring
  • New policies geared toward the virtual processes will help ensure compliance
  • Continuing the approach of acting with urgency and collaboratively
  • Keep offering educational presentations and office hours via Zoom which has proven to be better for the researchers' schedules and time management

What advantages have you observed with a mostly virtual work environment?

  • More work done with fewer interruptions
  • Safer at home that in office (less chance of COVID exposure)
  • Increased productivity by eliminating commute time
  • Work environment flexibility is paramount for productivity
  • Communication via Zoom has been crucial for conference calls and for short conversations
  • We have not lost a beat in staying in communication or completing work processes with our staff, colleagues and research community

What disadvantages have you observed with a mostly virtual work environment?

  • Not seeing faces (if not doing video calls) hinders building of relationships
  • Working longer hours
  • Feeling isolated
  • Cannot walk down the hall or over to the next building to talk to our colleagues

Have IRB meetings been any better or worse attended since moving them to web-based meetings?

  • IRBs have maintained solid meeting attendance with no decrease in quality of reviews.
  • Board members have verbalized that from a time management prospective, the web-based IRB meetings are easier to attend, since they do not have to travel to or across campus to attend.
  • When arranging an unscheduled emergency meeting, the process was significantly easier to do using a virtual meeting environment.

What are the most frequent questions or problems you’re hearing from investigators as a result of the pandemic?

  • Fear of losing NIH funding because research visits were stopped
  • Getting behind on projects
  • Questions about electronic consent
  • Feeling restless due to not being able to conduct in-person procedures
  • Seeking guidance about what research can remain open and how to conduct in-person visits safely and compliantly