Guidance for Clinical Research Teams as COVID-19 Cases Rise
The following message was distributed via the ONE VCU Clinical Research email lists on December 28, 2020 (link: https://conta.cc/2KZ3dBh) and is also provided below:
Due to significant increases in COVID-19 cases at VCU Health and throughout our community, we are sharing additional guidance essential for the safe conduct of clinical research during unpresedented challenges to our healthcare infrastructure:
- Actively support the safety and wellbeing of your research participants given the rapidly evolving conditions of the pandemic. Evaluate the potential for added risks possible through either halting the research activity or associated with engaging in face-to-face visits.
- Consider also the safety and well-being of the team members, reducing exposure and risk as well as the availability of resources, including clinical services and staffing, should the situation continue to worsen.
(1) If your study already has flexibility in the form of a VCU IRB-approved COVID-19 Contingency Protocol, these changes can be implemented as needed, with notification provided to the VCU IRB by logging a public comment in the RAMS-IRB record.
(2) If your study does not yet have a VCU IRB-approved COVID-19 Contingency Protocol, it is strongly recommended that one be submitted in anticipation of rapidly evolving conditions.
- Important reminders:
(1) All IRBs, including external IRBs, require prior approval for any changes to an IRB-approved study protocol. However, there may be situations in which the principal investigator determines that a delay to implementing such changes would result in injury or risk. In these cases, the changes should be implemented and promptly reported to the IRB.
(2) Review the December 18 OVPRI/HRPP message pertaining to “Investigator Responsibilities Regarding COVID During the Winter Closure“.
(3) For specific FDA guidance, please review, “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”
(4) VCU Health is frequently updating guidance regarding patient flows within the health system, including visitor and valet changes. Research teams must continue to monitor the VCU Health Intranet for updates which may impact clinical research participants.
Research teams are urged to consider how the surge in COVID-19 cases in our health system, community, and among healthcare professionals could affect your clinical research participants and prepare to implement contingency plans.
As the situation at VCUHS and our region continues to evolve, please watch for additional notifications. If you have questions, please feel free to contact us.
F. Gerard Moeller, M.D.Associate Vice President for Clinical ResearchDirector, Wright Center for Clinical and Translational Research
Susan E. Robb, CRA, CHRCSenior Associate Vice President for Research ComplianceInterim Director, Human Research Protection Program(814) 571-3514 (cell)