Who Needs IRB Review
The UTHSCSA IRBs review all of the research conducted by or at the five schools of the UTHSCSA and of six other institutions. All research involving human subjects conducted by someone affiliated with any of these institutions, or conducted by anyone at one of these institutions must be reviewed by the appropriate UTHSCSA IRB. The non-UTHSCSA institutions are: The South Texas Veterans Health Care System, University Health System-Bexar County, Texas, Cancer Therapy and Research Center, San Antonio State Hospital, Southwest Foundation for Biomedical Research and Southwest Research Institute. Other IRB Authorization Agreements are in place to cover some of the research conducted by or at Christus Santa Rosa Health Care facilities and by the University of Texas School of Pharmacy faculty who are located on the UTHSCSA campus.
FACULTY, STAFF, and STUDENTS
IRB review is required of faculty, staff, and students who are investigators in human subject research conducted on or off-campus. An investigator is an individual who assumes responsibility for part or all of the actual conduct of a research study and/or the preparation of results. When a faculty or staff member serves as a consultant on a project, that is, as expert advisor only, IRB review of the research is not required.
Students proposing to engage in human subject research must have a faculty member as an advisor under whose supervision the research will be conducted.
Please note that when an employee of any type (faculty or staff, full time or part time, permanent or temporary), or a student conducts research at an institution that has its own IRB, approval is necessary both from the IRB at the site of the study and from the appropriate UTHSCSA IRB. In addition, written documentation of the other IRB's approval (or appropriate alternative) is required. The requirement applies equally to research done outside of the United States, carried out by someone affiliated with an institution served by the UTHSCSA IRBs.
UTHSCSA CLINICAL FACULTY
Research conducted by clinical faculty (paid or unpaid) is subject to review by the appropriate UTHSCSA IRB if the research is within the course and scope of their university duties or is conducted in the facilities of any of the institutions that the UTHSCSA IRBs serve.
Private physicians who have clinical or adjunct faculty appointments, often perform important ancillary roles in research sponsored by the UTHSCSA, such as: recruitment and preliminary screening of patients, follow-up of patients, adjustment of medications, performance of tests, and collection of blood/urine samples. In cases where a UTHSCSA faculty member serves as the principal or a co- investigator in the conduct of the research, a UTHSCSA IRB will review the protocol in the standard manner.
Where primary responsibility is to be assumed by the clinical or adjunct faculty member for the conduct of a study in his or her private office or in an outlying hospital or other facility, the research may be reviewed by the appropriate UTHSCSA IRB if all of the following conditions are met:
- The department chair certifies that:
- the research is within the course and scope of university duties;
- the clinical faculty member is an active participant in the University's programs;
- the clinical faculty member has agreed to conform to all department and university policies governing research including review and approval by the IRB of the proposed research; and
- the standards of the private office or other facility where the research is to be conducted are sufficient to assure that adequate facilities and expert professional care are available for a subject in the event of difficulties;
- Approval of the IRB (or administration if there is no IRB) of the institution where the research is to be conducted is documented; and
- The investigator:
- understands his or her responsibilities relating to the conduct of human research and agrees in writing to abide by all requirements imposed by the UTHSCSA IRB;
- certifies that he or she has professional liability insurance which is applicable to the study being performed; and
- agrees to indemnify and hold harmless the University of Texas System, the System Board of Regents, employees, legal representatives, successors and assignees of the University and the System against all loss or liability, damage, cost or expense arising out of claims and/or suits seeking damages for injury, disease, and other bodily harm to persons, or damage to property, alleged to have been caused directly or indirectly as a result of the research.
Clinical and Adjunct faculty who are not full time and wish to serve as investigators for research, must submit an appropriate Clinical Investigator Agreement. [See sample of Investigator Agreements in Forms Table.]
NON-EMPLOYEES
Individuals who are not employees of the institutions regularly covered by the UTHSCSA IRBs, but who wish to conduct research involving patients, staff, students or facilities of any of the institutions regularly covered by the UTHSCSA IRBs, must have their proposed research reviewed by the appropriate UTHSCSA IRB, must obtain UTHSCSA IRB approval before beginning the study and must submit a “Non-affiliated Investigator’s Agreement together with a coyp of his/her Curriculum Vitae. [See sample of the Non-affiliated Investigator Agreement in Forms Table.]
Individuals who are not employees of the institutions regularly covered by the UTHSCSA IRBs but who wish to serve in the capacity of an investigator on a research study for which the principal investigator is affiliated, must submit a “Non-affiliated Investigator’s Agreement” together with a copy of his/her Curriculum Vitae. [See sample of the Non-affiliated Investigator Agreement in Forms Table.]