The Office of the Vice Chancellor for Research has announced that all remaining human-subject research IRB protocols that were halted due to the COVID-19 pandemic now can apply to restart.
Investigators must first complete and submit a LResearch Safety Plan. The contact person identified in the form will receive an email confirming successful submission of the form.
Once received, the plan will be reviewed by an ad hoc committee assembled for this purpose and will be evaluated in the order they are received. The number received may impact how quickly the investigators receive a response. Investigators may be contacted for clarification, additional information, or to modify their plans.
When the committee has approved the plan, it will be passed onto the IRB for final review. The IRB will release consent pending any requirement for submitting an IRB protocol modification for review and approval through the RSS portal. The Research Safety Plan must be approved before the research will be allowed to proceed.
Key elements that will be requested in this Human Subjects Research Safety Plan include the following:
- Confirmation that the researchers have permission to restart by the funding sponsor, particularly if the sponsor paused the study.
- Confirmation that the researchers have permission to conduct the study in the location(s) proposed with the name of the person they spoke to obtain permission, as well as what mask, visitor, eyeglass protection, or other guidance or policies required by each site.
- What, if any, modifications have been made to enhance safety, such as distance techniques, where it is reasonable to do so, as well as the masking and cleaning protocol to be used.
- What COVID-19 screening questions will be asked of each research subject, and when they will be asked and by whom
- Acknowledgement that the study team is prepared to provide and have their own cleaning supplies and PPE for the study.
For answers to questions about the process or the form, please contact the IRB through the RSS portal.