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
FDA
Expanded Access: Sample Information Sheet
Implementing a New Electronic IRB Management System
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
COVID-19 Resource Links
AAHRPP Guidance on HRPP Response to COVID-19
CITI Program Coronavirus (COVID-19) Resources
PRIM&R COVID-19 and Coronavirus: Updates for the Oversight Community
Office of Civil Rights: HIPAA, Civil Rights, and COVID-19
COVID-19 – related protocols on ClinicalTrials.Gov
COVID-19 Information From the FDA
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding
CDC Interim Biosafety Guidelines for COVID-19 Specimens
FDA CDER (Drugs) – COVID-19 Information
FDA CDRH (Medical Devices) – COVID-19 Information
FDA CBER (Biologics) – COVID-19 Information
FDA Emergency Use Authorizations (EUA) Page
FDA Recommendations for Investigational COVID-19 Plasma
Countermeasures Injury Compensation Program (CICP)
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Exception Process for Revised Common Rule Single IRB Requirement
HRP recently sought clarification from NIH and OHRP regarding the process for organizations to request exceptions from the revised Common Rule requirement for single IRB for cooperative research. While NIH was previously able to grant exceptions from its own single...
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