Message from Institutional Review Board – Heath Sciences and Behavioral Sciences:
The UMOR Human Research Reengagement process has been in place for about a month. The process is designed to evaluate the benefits of the research to individual participants against the incremental risks of COVID-19 exposure to participants, research staff, and the community. The Human Research Activation Committees have begun reviewing Human Research Activation Checklists for studies that may be classified as Tier 2 (PDF). Given the fluidity of the COVID-19 situation, investigators should continue to conduct research activities remotely whenever possible and also have a study plan if a ramp down is required.
Important Information for Investigators
Activation Committee Approval
Investigators must provide a copy of their Activation Committee approval notice to the IRB via an attachment to a Posted Correspondence in the main study workspace (aka the parent application). Be sure to click “IRBHSBS” as the recipient of the correspondence to notify the staff owner that the approval has been submitted.
Amendments
Amendments are not required to describe COVID-19 mitigation procedures (e.g., face coverings, physical distancing, disinfecting, etc.). Only changes to the IRB-approved protocol or documentation needed to reactivate the research must be reviewed and approved by the IRB. Include “REACTIVATE” in the title of the amendment to help the IRB staff prioritize the submission. Amendments can be submitted to the IRB concurrent with the submission to the Activation Committee. Reactivation of the research cannot begin until you have approval from both the Activation Committee and the IRB.
New Studies
Checklists for new studies must also be submitted to the Human Research Activation Committee for approval before face-to-face research activities can begin. The Committee will only consider projects that already have received IRB approval.
International Research
Investigators with research outside of the U.S. must check in with the IRB before submitting a Checklist to the Human Research Activation Committee. You must obtain documentation from the in-country IRB, collaborating institution, or governmental entity such as Ministry of Health that supports the reactivation of the study in light of the COVID-19 conditions in that location. For projects that do not involve in-country collaborators or IRB review, investigators are required to understand and describe to the Activation Committee the COVID-19 situation at the research location and mitigation procedures that will be implemented.
Multi-site Studies
For projects where IRB-HSBS is serving as the IRB-of-Record, check in with the IRB to discuss the plan to re-activate face-to-face research interactions at the external site or by external investigators. The IRB will ask that you obtain documentation from the external institution’s IRB or COVID activation committee that permits re-engagement in face-to-face research at that site or by their researchers.
For More Information
Key Guidance
Contact Information
Questions about the Research Reactivation Process should be sent to [email protected]
Questions about an IRB-HSBS project or application should be sent to the IRB staff owner or to [email protected]..