Scope & Purpose of the IRB

The University of Texas Health Science Center at San Antonio (UTHSCSA) Institutional Review Boards (IRBs) review all human subject research conducted by faculty, staff, and students, regardless of the location of the research activity, or source of funding. All research must be submitted to the IRB office for appropriate review. Even research thought to be exempt under the Code of Federal Regulations for Protection of Human Subjects (45 CFR 46) must be submitted so that an official determination can be made whether it is exempt.

The University assures the Department of Health and Human Services (DHHS) that all human subject research will be reviewed by a properly constituted IRB and UTHSCSA has been issued a Federalwide Assurance (FWA00005928). The Federalwide Assurance covers the five schools of The University of Texas Health Science Center at San Antonio and UT Medicine (formerly University Physicians’ Group). The UTHSCSA has signed IRB Authorization Agreements with the University Health System - Bexar County, Texas, The South Texas Veterans Health Care System (Audie Murphy, Outpatient Clinics and Kerrville Divisions), The Southwest Foundation for Biomedical Research, Southwest Research Institute, The Cancer Therapy and Research Center, and San Antonio State Hospital, agreeing to serve as the IRBs of record for all research conducted by or at those institutions. In addition, IRB Authorization Agreements have been executed establishing provisions for the UTHSCSA IRB to review human research being conducted (1) at THE CHRISTUS SANTA ROSA HEALTH CARE CORPORATION facilities by UTHSCSA faculty and CSRHC Family Practice Residents; and (2) by faculty of THE UNIVERSITY OF TEXAS, AUSTIN, GRADUATE SCHOOL OF PHARMACY, who are located in and are operating out of the University of Texas Health Science Center at San Antonio.

The intent of the institutional policy to review all human subject research irrespective of location, source of funding, and exempt status, is to foster high ethical standards in the conduct of research and to assure that uniform criteria are applied to protect the human subjects who take part in research.

The IRBs review research in accordance with current Department of Health and Human Services (DHHS) and Food and Drug Administration (FDA) regulations, and with the Good Clinical Practice Guidelines. The main purpose of the IRBs is to protect the rights and welfare of human subjects who take part in research. More specifically, the IRBs seek to ensure that:

1. Risks to subjects will be minimized. For example, the IRBs evaluate whether procedures to be performed on subjects a) are consistent with sound research design and do not unnecessarily expose subjects to risk, and b) whether they are already being performed for diagnostic or treatment purposes.
2. Risks to subjects will be reasonable in relation to any benefits that might be expected from taking part in a research study and to the importance of the knowledge that may result.
3. Selection of subjects will be fair and equitable. For example, the IRB seeks to determine that no eligible individuals are denied the opportunity to take part in any study, particularly those from which they may benefit, based on an arbitrary criterion such as gender, age or because they do not speak English.
4. Planned recruitment and consent procedures will result in voluntary participation and that informed consent will be obtained from each prospective subject or where appropriate, from the subject's legally authorized representative.
5. The research plan provides for monitoring the data collected to ensure the safety of subjects.
6. There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

The IRBs also serve as privacy boards, acting upon requests for waivers or alterations of the Authorization requirement under the Privacy Rule for uses and disclosures of PHI for research studies, in compliance with the privacy rules defined in the Health Insurance Portability and Accountability Act.