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What are the first steps for study teams to get approval to restart face-to-face visits for an IRB-approved study?

Last updated: 6.8.2020

It's important for researchers to recognize that there may be IRB implications when restarting face-to-face research visits with human subjects. However, given the campus’s phased in approach to restarting, there are multiple steps that need to occur prior to working with the IRB on restart requirements.

The campus has determined that IRB-approved face-to-face human subjects interactions for studies that provide the potential for direct and meaningful benefits to individual participants may resume on or about June 1, 2020, at the earliest, while restarting remaining necessary face-to-face study interactions will resume no earlier than July 1, 2020. These dates are tentative and subject to change.

Department chairs, center directors, and deans are responsible for making decisions about which studies in their department, center, or school can restart face-to-face visits. In order to receive approval from the necessary department chair, center director, and/or dean, researchers must submit an application to request return to on-campus research through the OVCRGE portal. In addition to the OVCRGE approval form, SMPH studies also require the completion of the SMPH approval form; more information on SMPH reboot requirements are provided here. The study will then be reviewed by the appropriate individual(s) or committee to determine if face-to-face activities can resume, based on specific guidance and processes determined by the researcher’s school/college/center and research site.

Much of this review process will focus on requirements outside the IRB’s purview, including social distancing practices, PPE availability, study staffing needs, study location requirements, and more. These requirements should be addressed as part of the departmental chair, center director, or dean approval process and prior to submitting any changes of protocol to the IRB. Please visit the following sites for guidance on these campus related requirements:

Practical information about on-campus restart: Returning to Campus Safely

If you need PPE not supplied by your school/department: request PPE

Keywords:COVID, coronavirus   Doc ID:102570
Owner:Monica E.Group:Health Sciences IRBs
Created:2020-05-28 06:24 CDTUpdated:2020-06-08 16:26 CDT
Sites:Health Sciences IRBs
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