HRPP Policy and Standard Operating Procedure Manual

HRPP Policy and Standard Operating Procedure Manual
Revision Date: July 24, 2023

This document serves as the Yale HRPP Policy and Standard Operating Procedure Manual which serves as a guide for all components of the Human Research Protection Program, including the Institutional Review Board, Investigators and their Research Teams, and other members of the Research Community. This document includes links to the following HRPP Standalone Policies, Procedures, and Guidelines cited in Part II of the Manual:

• Yale University Policy 1360, Human Research Protection
  Revision Date: March 22, 2022
• HRPP Policy 501, Institutional Conflicts of Interest In Human Research
  Revision Date: April 1, 2013
• Policy 1000, Clinical Trial Registration and Reporting Requirements
  Revision Date: April 18, 2017
• HRPP Policy 1200 Oversight of Yale Sponsor-Investigator held Investigational New Drug (IND) Applications, Investigational Device Exemptions (IDE) or Emergency Use or Emergency Use Authorizations(EUA)
  Revision Date: September 17, 2021
• Guidance 410, Research Recruitment at Yale and Yale New Haven Hospital
  Revision Date: December 2, 2022
• Guidance 940, Guidance on Committee Reviews Required for Human Subjects Research Protocols Using Radiation
  Revision Date: March 22, 2022
• Guideline, Reference Guidance - Quality Improvement Projects
  Revision Date: April 1, 2024
• Yale Human Research Protection Program Business Continuity Plan
  Revision Date: January 30, 2023