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HUMAN RESEARCH PROTECTION MANUAL

1. Introduction
2. IRB Structure and Function
3. IRB: General Policies and Procedures
4. COI: General Policies and Procedures
5. Recruitment and Participation
6. Initial IRB Application Procedure
7. Continuing IRB Review
8. Modifications and Amendments
9. Unanticipated Problems
10. Protocol Deviations and Non-Compliance
11. Suspensions and Deactivations
12. Vulnerable Populations
13. Non-Traditional Research
14. Research with Investigational Devices
15. Traditional Research

CHAPTER 1

 

1.0 INTRODUCTION

The University of Texas at El Paso (UTEP) is committed to conducting research involving human participants in a manner that upholds the highest ethical standards and complies with all applicable federal, state, and institutional requirements. As a Carnegie R1 research institution and a member of The University of Texas System, UTEP recognizes its responsibility to protect the rights, welfare, and well-being of individuals who participate in research conducted under its auspices.

Human subjects research at UTEP is guided by the ethical principles outlined in the Belmont Report—Respect for Persons, Beneficence, and Justice—and is conducted in accordance with Title 45 of the Code of Federal Regulations Part 46 (45 CFR 46), commonly referred to as the Common Rule, as well as other applicable regulations, sponsor requirements, and institutional policies.

1.1 Purpose and Scope of the Manual

This manual outlines the policies and procedures of UTEP Human Research Protection Program (HRPP). It provides comprehensive information regarding the organization, structure, and operation of the HRPP for members of the UTEP research community and affiliated institutions. The manual serves as a central reference by integrating UTEP’s human subject protection program, Institutional Review Board (IRB) operating procedures, and applicable institution-wide policies.

The manual is organized in accordance with the standards of the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and describes UTEP’s compliance with applicable federal regulations, including the Common Rule (45 CFR 46, pre-2018 and 2018) and U.S. Food and Drug Administration regulations governing human subjects research (21 CFR 50 and 21 CFR 56).

All UTEP personnel engaged in research involving human subjects are required to be knowledgeable of and comply with the HRPP. Information governing the review and conduct of human subjects research under the authority of the UTEP HRPP is available through the UTEP Research website.

UTEP has established the HRPP to safeguard the rights and welfare of individuals participating in biomedical and behavioral research through an integrated system of education, oversight, compliance, and IRB review. The HRPP promotes ethical research practices while supporting investigators, study staff, and sponsors in the responsible conduct of research.

1.2 Institutional Commitment

UTEP is committed to protecting the rights, welfare, and well-being of individuals who participate in research conducted under its auspices. UTEP upholds the highest ethical standards in human subjects research and ensures compliance with all applicable federal, state, and institutional requirements. Research involving human participants at UTEP is guided by the ethical principles of the Belmont Report and conducted in accordance with the Common Rule (45 CFR 46) and other applicable regulations and policies.