Chapter 3: Human Participants in Research
All research at The University of Texas at El Paso (University) that involves human participants must be submitted to the Human Research Oversight & Compliance 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.
3.1 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.
3.2 Role and Procedures of the Institutional Review Board
3.2.1 The IRB is established by the University to review research protocols involving human participants. The IRB will meet as needed, generally once a month.
3.2.2 The IRB will conduct initial, continuing, and closing review of each project involving human participants. The IRB will:
- Assess the benefits and risks to participants of proposed research projects.
- Review the adequacy of the informed consent process.
- Review policy and procedures in accordance with applicable federal regulations.
- Review reports concerning unanticipated problems.
- Investigate reports and allegations of non-compliance.
- Ensure prompt reporting of non-compliance to appropriate officials (as applicable).
3.2.3 The IRB will provide written notification of 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.
3.2.4 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.