Health Sciences Clinical Research Guidance: COVID-19

Tuesday, March 17, 2020

March 17, 2020 - Social distancing, telecommuting, and technology-enabled meetings have been implemented in the University community. We are now providing the following recommendations, effective immediately, relevant to clinical research:

  1. No new clinical studies may be commenced unless they relate to the current COVID-19 pandemic, and then only with the approval of the Dean of your school and the Vice President of the Health Sciences Center or their designees.
  2. No new clinical trials other than those directly related to COVID-19 may be opened, and new enrollment into open trials will cease immediately.
  3. Only essential research functions should continue. Essential functions may include critical study medication dispensing and/or safety assessments. Only personnel who are needed to conduct the essential functions should remain on campus.
  4. Each clinical study principal investigator should identify critical services for their 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 sponsor and to the IRB.
  5. All investigators working remotely on data that potentially contain patient information must be aware that such data cannot be loaded on the computers that will leave WVU.
  6. Research should be assumed to continue on a ramped-down basis for at least the next 6-8 weeks. Because we are in a dynamic situation, the time period will be reviewed regularly.

If you have questions, please do not hesitate to contact Shelley Welch, Co-Director-Clinical Trials Center of Excellence, shelley.welch@hsc.wvu.edu or 304-293-7348