HRPP Policy and Standard Operating Procedure Manual

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

Policies, Procedures, Guidance, and Related Documents

HRPP Policy and Standard Operating Procedure Manual
HRPP Investigator Manual
IRB Members and Chairs Manual
HRPP Supplemental Guidance Manual
IRB Submission Documents (Protocol Templates, Submission Forms, Consent Templates)
IRB Checklists and Worksheets
Forms & Templates
Protocol Builder

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