POLICY
The primary duty of the UTHealth Houston Institutional Review Board (IRB) is the protection of the rights, safety and welfare of human research subjects in accordance with the principles outlined in the Belmont Report. In order to fulfill this duty, IRB members are expected to be familiar with IRB Policies and Procedures.
Authority of the Institutional Review Board
UTHealth Houston grants the IRB the authority to approve research involving human subjects conducted by UTHealth Houston, faculty, staff, and students and in UTHealth Houston premises. UTHealth Houston grants the IRB the following authority:
- The IRB shall have the authority to approve research proposals, request modifications to secure approval, and disapprove all research activities overseen and conducted by UTHealth Houston.
- The IRB shall have the authority to suspend or terminate approval of research that is not conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to research subjects.
- The IRB shall have the authority to observe or have a third party observe the conduct of the research including the consent process.
Independence of the IRB
Research that has not been approved or has been disapproved by the IRB may not be conducted in UTHealth Houston or by UTHealth Houston staff. Individuals may not try to influence the deliberations and decisions of the IRB. IRB chairs, vice chairs, members and staff may report any attempt to influence the IRB deliberations or decisions to the Executive Vice President and Chief Academic Officer or Vice President of Human Research Protection Program. The EVP &CAO and the VP HRPP will be responsible for investigation and resolution any concerns of undue influence.
Leadership of Human Subjects Protection Program
Leadership for UTHealth Houston’s research enterprise is provided by the SVP Academic and Faculty Affairs. The SVP Academic and Faculty Affairs has administrative and budgetary responsibility for the HRPP. The SVP Academic and Faculty Affairs is also responsible for keeping the President and executive leadership informed about the Program’s status, priorities, and needs. The office of the SVP Academic and Faculty Affairs is responsible for the human research protection program including the Institutional Review Boards, conflict of interest program and clinical research education.
Responsibilities of the Institutional Official:
The VP HRPP is the signatory on UTHealth Houston’s Federalwide Assurance. The VP HRPP has the following responsibilities:
- Chair the IRB Executive Committee Meetings;
- Set the ‘tone’ for an institutional culture of conscience by communicating the importance of human research protections to the UTHealth Houston research community;
- Communicate and advise SVP Academic and Faculty Affairs and other senior UTHealth Houston officials on human subjects protection issues.
- Ensure that the number of panels is appropriate to the volume and types of human research reviewed so that reviews are accomplished in a thorough and timely manner.
- Ensure that the composition of the IRB panels meets regulatory requirements. Appoint IRB chairs and members in collaboration with the EVP&CAO
- Ensure that the IRB Panels have adequate resources to perform their duties.
Responsibilities of the IRB Chair (in addition to responsibilities of members)
- Chair IRB panel meetings;
- Administer IRB decisions;
- Maintain the independence of the IRB;
- Be knowledgeable and up to date about relevant regulations and human subjects research policies;
- Participate in the resolution of controversial substantive or procedural matters;
- Has authority to suspend or terminate IRB approval for research according to non-compliance policy;
- Delegate IRB chair responsibilities as appropriate to other qualified individual(s).
- Report any undue influence to the VP HRPP.
IRB Members
- Attend regularly scheduled IRB meetings;
- Review agenda items prior to the meetings;
- Actively participate in discussions at IRB convened meetings;
- Nonaffiliated members are expected to provide input regarding their knowledge about the local community and be willing to discuss issues and research from that perspective;
- Nonscientific members are expected to provide input on areas germane to their knowledge, expertise and experience, professional and otherwise;
- Scientific members are expected to contribute to the evaluation of a study on its scientific and statistical merits and standards of practice;
- Vote to approve, disapprove, abstain, or request for modifications based on the regulatory requirements (unless a conflict of interest exists);
- Maintain confidentiality of IRB discussions, decisions and all materials included in the meeting;
- Keep abreast of regulations and policies pertaining to human research; and
- Report any undue influence to the IRB chair or VP HRPP.
Sub-Committee Reviewers
- In addition to the responsibilities of members, members is may be assigned as sub-committee reviewers.
- The sub-committee must perform an in-depth review of assigned material and present an assessment of the scientific merits and safety of the research proposal and recommend specific actions to the IRB.
- The sub-committee chair will lead discussion of the research at the meeting.
IRB Staff
- Screen and process all applications and correspondence received by the review board.
- Serve as a resource for researchers and research staff regarding IRB policies, procedures and forms.
- Ensure that IRB meetings are properly conducted, including meeting agendas, ensuring quorum, documenting minutes and follow up action including correspondence to researchers.
- Report any undue influence to the IRB Director or to the VP HRPP
PROCEDURE
New members are invited to attend the new member orientation. New members may be assigned to sub-committees with experienced IRB members for guidance.
Members and Staff are encouraged to attend local conferences and seminars and several members and staff receive sponsorship for attending annual national conferences.
IRB staff update members on changes to regulations and guidance documents. IRB staff circulate relevant articles of interest to all members with meeting agenda.
REFERENCES
If you find errors in this document, contact [email protected]
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Document Number: |
101-B05 |
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Document Name: |
IRB Autonomy and Functions |
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Reviewed by: |
Associate Vice President, Research Compliance |
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Effective: |
1 Aug 2008 |
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Revision History: |
1 Aug 2011, 1 Jun 2016, 21 Jan 2019, 1 Jun 2021, 1 Jun 2026 |
Please contact the IRB office for answers to questions, express concerns, and convey suggestions regarding human subjects protections.
IRB Office House: Thursdays, 1–4pm via Teams Room
Email: [email protected]
IRB Helpline: 713-500-7943 (please leave a message and we will get back to you as soon as possible)
iRIS Helpline: 713-500-7960
IRB Review Feedback: IRB Survey
Houston, Texas 77030
Phone: 713-500-7943
Email: [email protected]
Committee for the Protection of Human Subjects
IRIS Support: 713-500-7960
