IRB Reminders Regarding Updated Public Health Guidelines
The VCU HRPP appreciates the work and dedication of the research community throughout the course of the COVID-19 pandemic. As VCU has recently announced an update to the University’s public health guidelines, the VCU HRPP would like to take this opportunity to remind investigators of continuing responsibilities related to human subjects research projects during this time of transition, including:
- All investigators and study teams remain responsible for following all current safety guidelines for VCU as well as for the location where research activities are conducted. More information on the remaining VCU COVID-19 health and safety requirements can be found on the Public Health Measures webpage.
- Research participants also must follow the safety guidelines for the location where research activities are conducted.
- Log a public comment to the IRB when the following events occur:
- Your study resumes research activities after being paused due to COVID-19
- Your study retires its IRB-approved COVID-19 Contingency Protocol and resumes the research procedures specified in the approved smartform/protocol
- As a reminder for VCU expedited and full board research, federal regulations require that modifications to research activities not be initiated without prior IRB review and approval, except when necessary to eliminate apparent immediate hazards to subjects (in which case the investigator must promptly submit a report to the IRB) (WPP VII-6). A request for modification to your study should be submitted via an Amendment submission in RAMS-IRB.
- Submit an amendment to the IRB in any of the following situations:
- Your study will continue following its IRB-approved COVID-19 Contingency Protocol, but the document requires updates. Add the changes to the existing COVID-19 Contingency Protocol (don’t fill out a new document or delete information). Submit the Word version of the Protocol so that IRB staff can compare versions and see your changes.
- Your study is retiring its COVID-19 Contingency Protocol, but you want to make some of the modified COVID procedures be permanent study procedures (e.g. you want to continue using electronic consent signatures). Make your changes directly in the relevant sections of the smartform/protocol.
- You have determined that changes to your IRB-approved smartform/protocol are needed in order to resume the research after being paused. Make your changes directly in the relevant sections of the smartform/protocol.
- You want to build more flexible procedures into your IRB-approved smartform/protocol (e.g. giving participants a choice of how to complete activities if they aren’t ready to return to in-person activities, expanding the time windows for study visits, making eligibility criteria more flexible, etc.). Make your changes directly in the relevant sections of the smartform/protocol.
Although a specific date has not yet been determined, the VCU HRPP is anticipating the institution-wide retirement of all COVID-19 Contingency Protocols in early Fall 2021. Further announcements about this will be made later in the summer.
Investigators are encouraged to consult with their assigned IRB Coordinator if they have any questions about what is expected for their study. Categories IRB Members, News and Updates