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Undergraduate courses will move online through Sept. 25. The Return to Campus website has updates about WVU's fall plans. Visit coronavirus.wvu.edu and CDC.gov for health resources related to the global pandemic.

Clinical Trial/Research Reopening at the Health Sciences Center

In March, the SARS CoV-2 pandemic necessitated recommendations for WVU Health Sciences Center clinical research investigators to ensure research personnel and participant safety by minimizing on-site visits. The March recommendations included pausing enrollment of open clinical studies as well as not opening new studies to enrollment unless related to COVID-19 or with a waiver granted by the COE.

In order to continue protection of research participants and research staff during the COVID-19 pandemic, the following tiers and timelines for reinstating enrollment of study participants on the WVU Health Science Campus are recommended. Noteworthy, however, is that in-person visits should take place only at the PI’s discretion. Where possible, continued remote visits should be considered unless in-person visits are necessary to monitor subject safety, is part of a treatment plan, or coincides with a patient care visit. When needed, investigational product can continue to be shipped to participants using appropriate measures.

Tier 1: May 7, 2020

Tier 2: May 17, 2020

Tier 3: June 1, 2020

Principal Investigators (PIs) and their study personnel should continue to screen participants for COVID-19 symptoms prior to the participant coming to the study site for a visit and institute measures to prevent exposure to study staff and other subjects. Subjects should be instructed to wear a mask to the visit and must be provided with a mask if they come to the visit without a mask. COVID-19 testing of participants and research personnel must be performed prior to any study procedures involving increased risk of aerosol production or increased risk of transmission by prolonged close contact where use of personal protective equipment (PPE) is not possible.

Human subject research studies should not be restarted if there is a lack of resources to safely conduct all activities. It is expected adequate PPE, supplies and staffing will be available to ensure safety of research personnel or participants, continuity of therapeutic intervention, and monitoring of participants. The PI must be available to provide appropriate oversight for all active studies. If an investigator needs to make a change to research plans in order to eliminate apparent immediate hazards to research participants, these changes can be made and then reported promptly to the IRB and to the sponsor if applicable.

Federal, State and local public health and hospital policies must be followed for all interactions with human subjects. Training should be performed to ensure research personnel understand personal PPE requirements and procedures for effective use. Any PPE used by research personnel must be provided by the University or affiliated hospital system.

For additional resources for healthcare providers, researchers, faculty and staff of WVU visit coronavirus.wvu.edu.

Additional Resources

For clinical trials, external monitors from Sponsors or Clinical Research Organizations (CRO) can return to performing on-site visits only when restrictions to hospital visitors and telework requirements for the University personnel are lifted. Monitors must be presented with and follow precautionary measures in place to prevent the spread of COVID-19. Remote monitoring visits, with the exception of site initiation visits, are recommended to continue when possible.

The very real possibility remains that a new phase of the pandemic may create a renewed need for more restrictive clinical research procedures that will be disseminated.

Contacts

If you have questions, please do not hesitate to contact Shelley Welch or Tanya Moran, Co-Directors-Clinical Trials Center of Excellence, shelley.welch@hsc.wvu.edu or (304) 293-7348 and tanya.moran@hsc.wvu.edu or (304) 293-0216.