UTDPP1035
Committee on Research Involving Human Subjects (Institutional Review Board)

Policy Statement

The IRB operates under Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) regulations for the protection of Human Research Subjects (45 CFR 46 and 21 CFR 56).

1. Applicability - The responsibilities of the IRB are applicable to all activities which, in whole or in part involve research with human subjects if:
   1. the research is sponsored by this institution, or
   2. the research is conducted by or under the direction of any employee or agent of this institution in connection with his or her institutional responsibilities, or
   3. the research is conducted by or under the direction of any employee or agent of this institution using any property or facility of this institution, or
   4. the research involves the use of this institution's nonpublic information to identify or contact human research subjects or prospective subjects.
2. Scope of Responsibility
   1. This institution acknowledges and accepts its responsibilities for protecting the rights and welfare of human subjects of research covered by this policy.
   2. This institution acknowledges that it bears full responsibility for the performance of all research involving human subjects, covered by this policy.
   3. This institution bears full responsibility for complying with federal, state or local laws as they may relate to research covered by this policy.
   4. This institution has established and will maintain one IRB in accordance with 45 CFR 46 and 21 CFR 56. The IRB has the responsibility and authority to review, approve, disapprove or require changes in applicable research activities so that the rights and welfare of human subjects will be protected.
   5. This institution has provided and will continue to provide both meeting space for the IRB and sufficient staff to support the IRB's review and recordkeeping duties as well as other the requirements of the IRB set forth in federal regulations.
   6. This institution encourages and promotes constructive communication among the research administrators, department heads, research investigators, clinical care staff, IRB, other institutional officials and human subjects as a means of maintaining a high level of awareness regarding the safeguarding of the rights and welfare of the subjects.
   7. It is the policy of this institution that, except for those categories specifically exempted by 45 CFR 46.104, all research covered by this policy will be reviewed and approved by the University's Institutional Review Board which has been established under a policy of compliance negotiated with HHS. The involvement of human subjects in research covered by this policy will not be permitted until the IRB has reviewed and approved the research protocol and informed consent has been obtained in accord with and to the extent required by 45 CFR 46.116 et. seq.. Certification of the IRB's review and approval for all HHS funded research involving human subjects will be submitted to HHS no later than sixty days following the submission of an application or proposal for funding. Further, the IRB's review of research on a continuing basis will be conducted at appropriate intervals as determined by the IRB.
   8. It is the policy of this institution that unless informed consent has been specifically waived by the IRB in accordance with federal regulations, no research investigator shall involve any human being as a subject in research unless the research investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative as required by 45 CFR 46.117.
   9. This institution will maintain documentation of IRB activities as prescribed by 45 CFR 46.115.
   10. This institution will exercise appropriate administrative overview carried out at least annually to insure that its practices and procedures designed for the protection of the rights and welfare of human subjects are being effectively applied and are in compliance with federal regulations and this policy.
   11. This institution will comply with the policies set forth in 45 CFR 46 Subpart B, which provide additional protections to research, development, and related activities involving fetuses, pregnant women, and in vitro fertilization of human ova.
   12. This institution will comply with the policies set forth in 45 CFR 46 Subpart C, which provide additional protections for prisoners involved in research.
   13. This institution, in addition to complying with the requirements of 45 CFR 46, will consider additional safeguards in research when that research involves children, individuals institutionalized as mentally disabled and other potentially vulnerable groups.
   14. This institution will comply with the requirements set forth in 45 CFR 46.114 regarding cooperative research projects. When research covered by this policy is conducted at or in cooperation with another entity, all provisions of this policy remain in effect for that research. This institution may accept, for the purpose of meeting the IRB review requirements, the review of an IRB established under another policy of compliance with HHS. Such acceptance must be in writing, approved and signed by this institution's Office of the Vice President for Research and Innovation, approved and signed by correlative officials of each of the other cooperating institutions.
   15. Copies of the general policy will be available to all faculty through the Office of the Vice President for Research and Innovation, the offices of the Deans and the Department Heads, and the Chair of the IRB. This institution will also provide each individual at the institution conducting or reviewing human subject research a summary of the rules and regulations including any future modifications and an outline of the procedures to be followed in any research involving human subjects as covered by this policy.
3. Institutional Official
   1. The Vice President for Research and Innovation has been appointed by the President as the University’s Institutional Official (IO) for the IRB.
   2. All information concerning Committee activities, reports, and other related documents and approvals shall be housed in the Office of the Vice President for Research and Innovation.
   3. The Vice President for Research and Innovation shall be responsible for the submission of annual reports to appropriate government agencies.
4. Institutional Establishment of the IRB
   1. Membership and terms:
      1. The University of Texas at Dallas IRB is formally appointed by the IO with input and membership nominations from University leadership, IRB members, UTD's Office of Human Subjects Protections, and by self-nomination.
      2. Committee shall be composed of membership as required by 46 CFR 46.107 and shall include members of the general faculty with appropriate natural science, social and behavioral science, and engineering and technology backgrounds.
      3. It shall include one graduate student member nominated by the Dean of Graduate Education.
      4. At least one member shall not be affiliated with the University apart from their membership on the Committee and shall not be part of the immediate family of a person affiliated with the University.
      5. The Committee shall have professional staff, appointed by the IO. At least one member whose primary concerns are in nonscientific areas must be appointed. Professional staff may serve this role.
      6. The term of office of the Committee members shall be for two years, effective September 1 to August 31, and members may be reappointed by the IO for additional terms. If for any reason a Committee member resigns, the IO shall appoint another individual to serve the remainder of the unexpired term.
      7. To ensure continuity, initial appointments of Committee members will be for staggered terms so that one-half of the appointments expire August 31 of each academic year. The Chair and Vice Chair shall be appointed from among the faculty members of the IRB. The term of office shall be two years, renewable.
      8. Committee Chair and Vice Chair are selected as highly respected individuals from within the institution, fully capable of managing matters brought before the IRB with fairness and impartiality.
   2. IRB Membership Requirements:
      1. Members shall have varying professions and backgrounds to promote complete and adequate review of research activities covered by this policy. Members shall be sufficiently qualified through experience, expertise, and diversity to include diversity in race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. When research is reviewed involving a category of vulnerable subjects (e.g., prisoners, children, individuals institutionalized as mentally disabled), the IRB shall include in its reviewing body one or more individuals who have as a primary concern the welfare of these subjects.
      2. Individuals with potential competing business interests cannot serve on the IRB or be involved in the day-to-day operations of the review process. For example, the Director of Sponsored Projects, the Vice President for Research and Innovation or others who are responsible for raising funds or garnering support for research cannot not serve as voting members on the IRB or be involved in the daily operations of the review process.
5. Full Board Quorum Rule:
   1. For actions that require a vote of the full board, a quorum shall be one-half of the total membership plus one.