HS IRBs News July 2020

Health Sciences and Minimal Risk IRBs, IRB News/Volume 12, Number 5, July 2020

Phase 2 Research Reboot Update

With the rollout of phase 2 of research reboot on campus, the IRB offices are receiving many questions from study teams about how to restart their studies as well as what needs to be reported to the IRB regarding things like Covid-19 screening procedures. This newsletter focuses on addressing the key questions study teams have as well as providing links to important resources as study teams plan how to move forward with their studies.

The pandemic has created a complicated and ever-evolving landscape for human subjects researchers. We strongly encourage study teams to review our Covid page FAQs and then contact us with any questions they may have (608.263.2362 or asktheirb@hsirb.wisc.edu). We are here to help.

What NOT to Report to the IRB

Nearly all information regarding institutionally required Covid-19 precautionary measures and approvals does NOT require IRB review and approval. This includes, but is not limited to:

  • Institutional approvals to restart a study
  • Copies of documents that describe Covid-19 precautionary measures, such as EHS’s guidance on precautionary measures for study visits occurring outside UWHC facilities
  • Information sheets for subjects describing the precautionary measures that will be in place for their face-to-face visits (see template information sheet on the bottom of this page)
  • Covid-19 screening scripts or tools that will be used with study subjects or staff (see template screening script on the bottom of this page)
  • Information about any Covid-19 testing subjects may be required to undergo

What Should be Reported to the IRB

Useful Links for Study Teams

In addition to those provided above, the following links may be useful:

Keywords:research reboot, reboot, phase 2, reporting, covid, coronavirus, covid-19   Doc ID:103752
Owner:Monica E.Group:Health Sciences IRBs
Created:2020-07-08 10:59 CSTUpdated:2020-07-08 11:00 CST
Sites:Health Sciences IRBs
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