WCG’s Flexible IRB Reporting Requirements for COVID-Related Changes

WIRB-Copernicus, WCG’s IRB, has posted recommendations for their sponsors and sites after receiving questions about making changes to clinical studies in the current COVID-19 pandemic.

WCG’s IRB advised that appropriate changes to clinical trial protocols can include:

  • Decreasing the number of required in person study visits
  • Utilizing home visits or telemedicine
  • Utilizing remote or commercial laboratories for required blood draws
  • Shipping investigational products directly to study participants

While recently published FDA guidelines allow sponsors or investigators to immediately implement changes that eliminate apparent and immediate hazards to participants, WIRB-Copernicus IRB is requesting that changes be reported to them within 5 days.

WCG also advised that notification may be any form of documentation (e.g. in a memo, letter) as long as it includes enough information for the IRB to assess the risks associated with the described changes. WCG’s IRB review process will remain the same.

To streamline submission of COVID-19 motivated changes, WCG has created a form for their sponsors and sites to use.

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