HRP Helpful Information
HRP Consulting Group provides the following sample documents and other resources to help the research community navigate various requirements and challenges. Please contact us (see sidebar) if there are any other topics you could use help with yourself or that you think would be helpful to the community at large.
General
Conducting Virtual IRB Meetings
Implementing a New Electronic IRB Management System
FDA
Expanded Access: Sample Information Sheet
COVID-19
Management of Ongoing Human Subjects Research During COVID-19
COVID-19 Update: Guidance for Institutions and Researchers
Implementing a COVID-19 Research Triage Process
Reportable Events During COVID
Research with COVID-19 Data and Biospecimens
Impact of COVID-19 on IRB Staffing and Membership
Comparison of OHRP COVID-19 Guidance to FDA’s
Considerations for the Safe Resumption of Research Activities
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OHRP Issues Single IRB Draft Guidance
On July 1, 2022, OHRP posted a draft guidance document for public comment entitled “Use of a Single Institutional Review Board for Cooperative Research.” The draft guidance will be open for public comment until August 30, 2022. The recently posted draft guidance...
IND Safety Reports and IRBs
HRP recently engaged in extensive correspondence with the FDA regarding the following statements that appeared in one of the later iteration’s of the FDA’s guidance document “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”:...