About Human Subjects Research
The Office of the Vice President for Research, headed by Juan Sanchez, Ph.D., is responsible for the administration of research ethics at The University of Texas at Austin. The Vice President for Research oversees the functioning of the Institutional Review Board (IRB) and the Office of Research Support (ORS). The ORS assists the IRB by providing administrative support and facilitating research reviews.
Representatives from diverse academic and scientific disciplines, as well as members from outside the academic community, compose the IRB. Their responsibility is to review the plethora of university research projects. The IRB reviews human subject research projects according to three principles: first, minimize the risk to human subjects (beneficence); second, ensure all subjects consent and are fully informed about the research and any risks (autonomy); third, promote equity in human subjects research (justice). All human subjects research (including but not limited to recruitment) must be approved by the IRB before commencing. The IRB typically approves projects for one year, thereafter conducting annual reviews. The IRB aims to assist investigators develop and implement practical strategies and solutions that uphold the protection of research subjects rights and welfare.
Our process for protecting human research subjects reflects federal regulations developed in response to such cases as the Public Health Service syphilis study and the U.S. government radiation experiments. The Department of Health & Human Services (HHS) Office for Human Research Protections (OHRP) oversees the operation of the IRB.
DESIGNATION OF THE INSTITUTIONAL REVIEW BOARDThe University of Texas at Austin has one IRB responsible for conducting initial and continuing reviews and providing oversight for all research activities involving the use of human subjects performed on the campus or at any location under the purview of The University of Texas at Austin. All review procedures will meet or exceed the requirements set forth in 45 CFR 46. For additional information about the review procedure see sections 6 and 7 in the Poicies and Procedures Manual.
COMPOSITION OF THE INSTITUTIONAL REVIEW BOARDThe University of Texas at Austin IRB is a faculty/staff committee appointed annually by the Vice President for Research, and composed of a sufficient number of members to assure complete and adequate review of activities commonly conducted at The University of Texas at Austin. The committee must be sufficiently qualified through the maturity, experience, and expertise of their members and diversity of membership to insure respect for their advice and counsel specific to safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific activities, the committee must be able to ascertain the acceptability of proposals in terms of organizational commitments, regulations, applicable law, standards of professional conduct and practice, and community attitudes. In addition to faculty members representing different disciplines, the IRB currently has two community members and one student representative; both community members are deemed to represent non-scientific areas; one is a prisoner representative. At times, the IRB may not have the necessary expertise to judge the scientific soundness of a research protocol and may be unable to make a fair and accurate determination of the risk-benefit ratio. For these protocols, the IRB may call upon ad hoc consultants for assistance in review for scientific merit. Member files are kept in the Office of Research Support. They include: 1) a letter of appointment, 2) a current curriculum vitae, and 3) documentation of education, which includes a) a statement that the member has read "Protecting Study Volunteers" and b) a certificate that shows the member has completed the NIH tutorial for IRB members. In addition, educational sessions are offered during each academic year to members of the IRB. Educational materials are generally distributed and discussed at each IRB meeting. Click here for list of current IRB Members.
CHAIRPERSONThe Vice President for Research appoints the IRB Chairperson. This appointment is made annually. The current IRB chairperson is Dr. James Wilson.
MEETINGSThe IRB holds one regularly scheduled meeting per month.The list of currently scheduled meeting dates is available on the dates and deadlines page.
CONFIDENTIALITY OF THE REVIEW PROCESS
During the process of initial or continuing review of an activity, material provided to the Institutional Review Board shall be considered privileged information and the Board shall assure the confidentiality of the data contained therein.
The Committee is charged with advising the IRB and Office of Research Support on pertinent and timely issues concerning human subjects researchers and how best to address these issues. This includes but is not limited to:
- Continuing education for faculty, staff and students engaged in human subjects research on regulations and guidelines.
- Educating faculty, staff and students regarding new requirements relating to human subjects research (e.g., disclosure of research-related financial interests).
- Implementing new resources and tools to help researchers in the administrative area of submitting protocols (e.g., on-line web-based electronic IRB submission and administration module).
- Continuing to strengthen the DRC review process to provide personal mentoring to researchers and students.
James Barufaldi, Ph.D., Department of Curriculum and Instruction
Sharon Brown, Ph.D., School of Nursing
Edward Emmer, Ph.D., Department of Educational Psychology
James Pennebaker, Ph.D., Department of Psychology
James Wilson, Ph.D., College of Pharmacy
Wayne Patterson, Ph.D., Office of Research Support
Lori Roalson, Ph.D., Office of Research Support