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10.10 Human Research

The University of Texas at San Antonio complies with the Department of Health and Human Services (DHHS) regulations for the protection of human research subjects, 45 Code of Federal Regulations (CFR) Section 46, as amended to include provisions of the Federal Policy for the Protection of Human Subjects (56 Federal Register 28003), Subpart A.

1. Ethical Principle
   The University is guided by the ethical principles regarding all research involving humans as subjects, as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (entitled: Ethical Principles and Guidelines for the Protection of Human Subjects of Research [the "Belmont Report"]), regardless of whether the research is subject to Federal regulation or with whom conducted or source of support (i.e., sponsorship).

2. Institutional Policy
   1. All requirements of 45 CFR, Section 46 will be met for all applicable DHHS supported research, and all other human subject research regardless of sponsorship. Federal (all departments and agencies bound by the Federal policy) funds may not be expended for research involving human subjects unless the requirements of this policy have been satisfied.
   2. All research covered by this policy will be reviewed and approved by the University Standing Committee on Human Research except for those categories specifically exempted or waived by Federal Regulation as outlined in 45 CFR, Section 46.101 (b)(1-6) and Section 46.101 (i). The involvement of human subjects in research covered by this policy will not be permitted until the University Standing Committee on Human Research has reviewed and approved the research protocol and informed consent has been obtained from the subject or the subject's legal representative as required by Federal Regulations (45 CFR, Sections 46.111, 46.116 and 46.117).
   3. The University assures that before human subjects are involved in nonexempt research covered by this policy, the University Standing Committee on Human Research will give proper consideration to:
      1. the risks to the subjects,
      2. the anticipated benefits to the subjects and others,
      3. the importance of the knowledge that may reasonably be expected to result, and
      4. the informed consent process to be employed.
   4. Certification of the University Standing Committee on Human Research review and approval for all Federally-sponsored research involving human subjects will be submitted to the Office of Research Development for forwarding to the appropriate Federal department or agency. Compliance will occur within the time and in the manner prescribed for forwarding certifications of the University Standing Committee on Human Research review to DHHS or other Federal departments or agencies for which this policy applies. As required by 45 CFR, Section 46.119, in the event research is undertaken without the intention of involving human subjects but it is later proposed to involve human subjects in the research, the research shall just be reviewed by the University Standing Committee on Human Research. Human research involvement will not be permitted until certification of the University Standing Committee on Human Research's review and approval is received by the appropriate Federal department or agency.
      
3. Applicability
   1. This policy applies to all research involving human subjects, and all other activities which even in part involve such research, regardless of sponsorship, if one or more of the following apply:
      1. the research is sponsored by the University, or
      2. the research is conducted by or under the direction of any employee or agent of the University in connection with his or her institutional responsibilities, or
      3. the research is conducted using any property or facility of the University, or
      4. the research involves the use of the University's non-public information to identify or contact human research subjects or prospective subjects.
   2. All human subject research which is exempt under 45 CFR, Section 46.101 (b) (1-6) or 46.101 (i) will be conducted in accordance with:
      1. the Belmont Report,
      2. the University's administrative procedures to ensure valid claims of exemption; and
      3. orderly accounting for such activities.
   3. Procedures

      The University has adopted the necessary and appropriate procedures to implement the Federal Wide Assurance for compliance with DHHS Regulations, submitted to DHHS in 1992, including but not limited to designating the University Standing Committee on Human Research as the University's Internal Review Board (IRB) and designating The Office of Research Development as the University's Office of Research Administration (ORA).

      The Standing Committee on Human Research is charged with the sole responsibility of assuring that all human subjects participating in research as defined above are adequately and appropriately protected from research risks and fully advised of their rights as human subjects. The University Standing Committee on Human Research shall have complete and sole authority to review and authorize research involving human subjects. No University official shall be authorized to approve any research project which has not been approved by or which has been disapproved by the University Standing Committee on Human Research.

      A procedural outline form is available for your use. Forms for certification and approval must be submitted to comply with the requirements of this policy. These forms are available in the Office of Research Development.

Editorial Amendment Issued July 2005