Health Sciences Clinical Research Guidance: COVID-19
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:
- 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.
- No new clinical trials other than those directly related to COVID-19 may be opened, and new enrollment into open trials will cease immediately.
- 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.
- 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.
- 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.
- 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