Chapter 3: Human Participants in Research
3.1 Purpose
All research at The University of Texas at El Paso (University) that involves human participants must be submitted to the Human Subjects Research Office for review and determination. This policy is established to assist researchers in the protection of human research participants and compliance with requirements set by the federal government in the Code of Federal Regulations: 45 CFR Part 46 and 21 CFR Parts 50 and 56.
3.2 Institutional Policy Statement
All research sponsored or sanctioned by the University involving human participants, whether funded or non-funded, conducted by faculty, students or staff, using any property or facility owned or controlled by the University, or involving the use of non-public information maintained by the University to identify or contact human research participants will be conducted in compliance with federal regulations. Research involving human participants may not be performed unless the requirements of federal and institutional policy have been satisfied, and written certification of the University’s Institutional Review Board (IRB) is obtained.
3.3 Role and Procedures of the Institutional Review Board
3.3.1 The IRB is established by the University to review research protocols involving human participants. The IRB reports directly to the Institutional Official (IO) who is the Vice President for Research & Innovation. The IRB will meet as needed, generally once a month.
3.3.2 The IRB will:
- Review and approve all human subjects research protocols, including as part of their review, the adequacy of the informed consent process and the benefits and risks to participants.
- Review and approve proposed changes to approved protocols.
- Formulate and implement policies and procedures in accordance with applicable federal regulations to safeguard the welfare and safety of human subjects involved in research.
- Educate investigators, staff, students, and affiliated researchers on research with human subjects and promote best practices for the ethical conduct of such activities.
- Review reports from principal investigators concerning unanticipated problems (e.g., unexpected events that may pose risks to participants).
- Investigate reports and allegations of non-compliance, including suspension or termination of human subjects research found to be associated with serious non-compliance or serious harm to human subjects.
- Ensure prompt reporting of non-compliance to appropriate officials (as applicable).
3.3.3 The IRB will provide written notification of all its determination actions to the Principal Investigator(s). Common notifications are approval/disapproval, modification, exemption, or determination that the project is not human subjects research.
3.3.4 For collaborative projects with one or more non-University organizations, the IRB may identify and designate another IRB to be the reviewing IRB for the research.
3.4 References
3.5 Dates Approved or Updated
December 18, 2025
November 9, 2021