IRB Member Duties and Responsibilities
POLICY
The primary duty of CPHS 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, CPHS members are expected to be familiar with CPHS Policies and Procedures.
Authority of the Committee for the Protection of Human Subjects
UTHealth grants the Committee for Protection of Human Subjects the authority to research involving human subjects research conducted by UTHealth faculty and staff and in UTHealth premises. UTHealth grants CPHS the following authority:
- CPHS shall have the authority to approve research proposals, request modifications to secure approval, and disapprove all research activities overseen and conducted by UTHealth.
- CPHS shall have the authority to suspend or terminate approval of research that is not conducted in accordance with the CPHS’s requirements or that has been associated with unexpected serious harm to research subjects.
- CPHS shall have the authority to observe or have a third party observe the conduct of the research including the consent process.
Independence of the Committee for Protection of Human Subjects
Research that has not been approved or has been disapproved by the CPHS may not be conducted in UTHealth or by UTHealth staff. Individuals may not try to influence the deliberations and decisions of the CPHS. IRB chairs, vice chairs, members and staff may report any attempt to influence CPHS deliberations or decisions to the Executive Vice President for Academic and Research Affairs or Vice President of Human Research Protection Program. The Executive Vice President for Academic and Research Affairs or Vice President of Human Research Protection Program shall investigate and resolve any concerns of undue influence.
Leadership of Human Subjects Protection Program
Leadership for UTHealth’s research enterprise is provided by the Executive Vice President for Academic and Research Affairs (EVPARA), George Stancel, PhD. The EVPARA has administrative and budgetary responsibility for the HRPP. The EVPARA is also responsible for keeping the President and executive leadership informed about the Program’s status, priorities, and needs. The EVPARA is responsible for the human research protection program including the Institutional Review Boards, conflict of interest program and clinical research education.
The Vice President for Human Research Protection Program is the signatory on UTHealth’s Federalwide Assurance. The VP for HRPP is also the Chair of the CPHS Executive Committee and has the following responsibilities:
- Chair the CPHS Executive Committee Meetings;
- Sett the ‘tone’ for an institutional culture of conscience by communicating the importance of human research protections to the UTHealth research community;
- Communicate and advise EVPARA and other senior UTHealth officials on human subjects protection issues.
- Ensure that the number of boards 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 EVPARA.
- Ensure that the IRB Panels have adequate resources to perform their duties.
Responsibilities of the IRB Chairperson (in addition to responsibilities of members)
- Chair IRB Panel Meetings;
- Adhere to and administer Board decisions;
- Maintain the independence of the Board;
- Be knowledgeable and up to date about relevant regulations and policy;
- Participate in the resolution of controversial substantive or procedural matters;
- Suspend the conduct of a study if he/she determines that an Investigator is not following CPHS’s requirements;
- The Chairperson may delegate any of his/her responsibilities as appropriate to other qualified individual(s).
- Report any undue influence to the Executive Committee or Executive Chairperson. The Executive Chairperson may report undue influence to the EVPARA.
Members
- Attend regularly scheduled CPHS meetings either in person or via teleconference;
- Review all research proposals/materials received prior to the meetings;
- Actively participate in discussions at Board 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 Board discussions and all materials included in the meeting;
- Keep abreast of regulations and policies pertaining to human research; and
- Report any undue influence to the Chairperson.
Sub-Committee Reviewers
- In addition to the responsibilities of members, each member will be expected to act as a sub-committee reviewer for assigned studies at convened meetings.
- 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 CPHS.
- The Sub-Committee Chairperson will lead CPHS discussion of the study.
- The Sub-Committee may be required to review additional material requested by the CPHS for the purpose of study approval.
IRB Staff
- Ensure that submitted research protocols are reviewed efficiently and consistent with the regulations, guidelines and policies.
- Screen and process all applications and correspondence received by the review board.
- Serve as a resource for Investigators and researchers regarding implementation of CPHS policies, procedures and forms.
- Ensure that Review Board’s meetings are properly conducted, including meeting agendas, ensuring quorum, documenting minutes and follow up action including correspondence to Investigators / Sponsors.
- Report any undue influence to the IRB Director or to the Executive Chairperson
PROCEDURE
The IRB Chairperson should notify all the members of their responsibilities. When a new member joins CPHS, the IRB Chairperson should discuss with them the terms of reference of CPHS and their individual responsibilities.
The IRB Chairperson should ensure that members are carrying out their expected functions and that there is adequate staff support to ensure that members are able to function as documented.
If the IRB Chairperson feels that staff support is not adequate, he / she is responsible for bringing this issue up to the Executive Committee.
Training – New members are invited to attend the new member orientation. The new members are assigned to sub-committees with experienced IRB Members for mentoring. New members also attend a comprehensive in-service within a few months of joining the IRB.
Members and Staff are encouraged to attend local conferences and seminars and several members and staff receive sponsorship for attending annual national conferences.
IRB Chairs update members on changes to regulations and guidance documents. IRB Staff circulate relevant articles of interest to all members with monthly agenda.
APPLICABLE REGULATIONS
1. 45 CFR 46
2. 21 CFR 56
REFERENCES TO OTHER POLICIES
1. None
ATTACHMENTS
1. None
If you find errors in this document, contact clinicaltrials@uth.tmc.edu
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Document Number: |
101-B05 |
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Document Name: |
IRB Autonomy and Functions |
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Approved by: |
Executive Director, Research Compliance |
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Effective: |
1 Aug 2008 |
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Revision History: |
1 Aug 2011, 1 Jun 2016 |
CPHS HELPLINE 713-500-7943
iRIS HELPLINE 713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)
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Committee for the Protection of Human Subjects IRIS Support 713-500-7960 |
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CLINICAL TRIALS RESOURCE CENTER OFFICE OF RESEARCH ENVIRONMENTAL HEALTH & SAFETY |
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