COVID-19 HRPP Toolkit Supplemental Documents Release

Huron understands the difficult and challenging nature of today’s research enterprise and how it is rapidly evolving during the COVID-19 pandemic.

After carefully reviewing existing regulatory approval pathways, as well as newly issued guidance from the Office for Human Research Protections (OHRP) and the U.S. Food and Drug Administration (FDA), our team of experts has created the resources listed below to help you navigate research during the pandemic.

• HRPP-Related Federal Guidance on COVID-19: Year in Review
• HRPP-Related Federal Guidance on COVID-19
• Existing Regulatory Pathways and Processes Relevant to COVID-19
• Ensuring Human Subject Protection and Compliance — Pandemic-Ready Toolkit

This series of Human Research Protection Program (HRPP) toolkit supplement documents is being released to provide HRPPs with additional resources and tools to manage their research during the COVID-19 pandemic. While these materials are developed to align with Huron’s HRPP toolkit, they can also be used as a standalone set of resources for HRPPs that are not toolkit users.

The materials are aimed primarily at investigators/study teams. They are intended to provide guidance for determining whether study-specific COVID-19 risk mitigation plans are needed for certain studies and, if yes, to provide considerations for the kinds of modifications that may be needed and how the mitigation plans should be documented and communicated to the institutional review board (IRB) and others.

• Flowchart: Study-Specific COVID-19 Risk Mitigation Planning
• SOP: COVID-19 Risk Mitigation Planning
• COVID-19 Considerations for Investigators Conducting Human Research (can be used as “Appendix 12” to the HRPP Toolkit–Investigator Manual or repurposed as a separate set of investigator guidance)
• Worksheet: Research-Specific COVID-19 Risk Mitigation Plan
• Form: COVID-19 Modification

Please note some caveats with these documents for your consideration:

• We recognize that we are all operating in a highly fluid environment right now, and recommended guidance is likely to continue to evolve rapidly. The attached materials were developed to be consistent with the FDA's Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Pandemic released last week. We will continue to monitor the regulatory and research environment and will continue to refine and provide updates as needed in the coming weeks.
• We know that many organizations have already implemented COVID-19 pandemic-related policies and requirements. We do not intend these supplemental toolkit materials to replace or contradict your local institutional policies. Your institutional policies will continue to take precedence, and to the extent that you need to make revisions to these materials to align with your local policy requirements, please do so.
• We are releasing these materials as “working drafts” in the interest of providing tools and resources as quickly as possible. As such, we recognize that further refinements will be needed. In the spirit of collaboration, we ask that you please provide us with feedback on these materials. We will make adjustments and provide updates as needed.