Human Research Protection Program


HRPP Policies & Procedures

This section includes policies, procedures, guidance and checklists that aid members of the Yale human research community in fulfilling their obligations to ensure that research is designed, conducted, and approved consistently and in compliance with applicable laws, regulations and Yale’s commitment to the protection of its research participants.

Persons conducting, supporting or reviewing research subjects for Yale IRB approval should familiarize themselves with these policies, procedures and guidance. This section should be referenced regularly as policies, procedures and guidelines are revised to stay current with evolving issues and regulations related to human research.

Yale University Radioactive Drug Research Committee (Yale RDRC)

The Yale RDRC program operates under federal regulation 21 CFR 361.1, which permits review and monitoring of basic research using radioactive drugs in humans without an IND when the drug is administered under specific conditions. These specific conditions are outlined in detail on the FDA website. The new policies and procedures of the Yale RDRC will be posted shortly.


In this section:

HRPP General
100) IRB Review
200) Informed Consent in Research
300) Vulnerable Populations in Research
400) Special Issues in Research
500) Financial Interest in Research
600) IND/IDE/HUDs/Emergency Research
700) Post-Approval Issues
800) Education & Training
900) IRB Memberships, Agreements & Collaborations



Human Research Protection

University Policy 1360: Human Research Protection

100’s) IRB Review

Policy 100: Institutional Review Board (IRB) Review of Research Protocols Involving Human Participants


100 GD1:  Humanities Projects and IRB Review
100 GD2:
IRB Approval and Expiration Dates
100 GD4:  Scientific and Ethical Review of Protocols by the IRB

100 GD5:



Quality Improvement and Quality Assurance Projects and IRB Review

CH 9 Clinical Quality Improvement

CH 8 Clinical Research

SBE Quality Improvement Checklist

100 GD6:  Review of Institutional Review Board (IRB) Protocols by Consultants
100 GD7:  Select State and Federal Laws and Regulations Applicable to Human Research
100 GD9: 

Exemption from IRB Review

100 GD10: Role Based Security of e-IRB files: Documentation of IRB Submission, Review and Approval
100 GD12:  Preparation and Maintenance of Institutional Review Board (IRB) Minutes

  • Policy 110: Under Construction

200’s) Informed Consent in Research

300’s) Vulnerable Populations in Research

400’s) Special Issues in Research

500’s) Financial Interests in Research

501’s) Institutional Conflicts of Interest in Human Reseach

600’s) IND/IDE/HUDs/Emergency Research

700’s) Post-Approval Issues

800’s) Education & Training

900’s) IRB Memberships, Agreements & Collaborations


910 GD1:  Unaffiliated Investigator Instructions


920 CH1:  New Review Checklist



Last Revised January 16, 2015