COVID-19 UPDATE: Pause to In-Person Interactions For Studies With Little/No Health Benefits
Please see the announcement below from the Vice President for Research and Innovation, Dr. Sriram Rao. Please continue to monitor the OVPRI COVID-19 Website and this blog for updates on COVID-19 impacts on human research. If you have questions about how this guidance affects your research, please contact the IRB Coordinator assigned to your study.
Following consultation with VCU’s research leadership and to ensure the continued safety of our human research participants, patients, and our community, VCU is further restricting access to its campuses.
All human research activity involving little or no potential health benefit to participants must pause all in-person interaction with participants immediately. This requirement applies regardless of the IRB of record approving the VCU human research activity.
Safety is our priority. This action is being taken to decrease potential exposure to COVID-19 by our staff, faculty and others. The following guidance has been prepared to assist research teams in acting on this decision:
You should determine if your study should be paused in accordance with this notice or can be modified to eliminate in-person study participant visits (e.g. telehealth or virtual visits):
- For studies that will be paused: Log-in to RAMS IRB and submit a public comment to document that you have paused in-person visits. The study team should notify all active study participants that study activity is paused. This notification may be done via telehealth, phone, or other personal means and may provide an opportunity to reassure participants that their safety is our priority.
- For studies that will continue by eliminating in-person visits: This action should be submitted as an amendment to the IRB of record prior to implementing the change. If prior amendment is not possible, the change must be reported to the IRB record in accordance with their policies. The VCU IRB process for submitting amendments in response to the COVID-19 pandemic can be found here.
If you determine that your study should continue with in-person study participant visits:
- Reduce risk by limiting in-person visits where possible (relying upon telehealth or virtual visits, including Zoom). This action should be submitted as an amendment to the IRB of record prior to implementing the change. If prior amendment is not possible, the change must be reported to the IRB of record in accordance with their policies. The VCU IRB process for submitting amendments in response to COVID-19 can be found here.
- Reminder: In person study participant visits must be in the best interest of the participant and should be evaluated daily, as the public health conditions evolve.
New human research studies with health benefits to research participants will be evaluated on a case by case basis. Priority will be given to studies with clear statements regarding therapeutic benefit and/or specific COVID-19 outcomes.
VCU’s research enterprise is a critical component of the University’s mission. We understand that this guidance will significantly impact your research. OVPRI will issue additional guidance as to how to manage research delays and sponsor requirements on the OVPRI COVID-19 website. Please visit the website daily for updates.
If you have questions regarding continuing your study, contact your VCU IRB Coordinator (assigned in RAMS-IRB). For other questions related to clinical research, you may find additional resources within your center, college or school and may also contact Lisa Ballance, Executive Director for Clinical Research and Compliance, firstname.lastname@example.org or 804-241-6223.
Please take care and stay safe.
P. Srirama Rao, Ph.D.
Vice President for Research and Innovation