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 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’s research enterprise is provided by the Executive Vice President and Chief Academic Officer. The EVP&CAO has administrative and budgetary responsibility for the HRPP.  The EVP&CAO 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 VP HRPP is the signatory on UTHealth’s Federalwide Assurance. The VP 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 EVP&CAO 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 Chair (in addition to responsibilities of members)

• Chair IRB Panel Meetings;
• 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;
• 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 EVP&CAO or VP HRPP.

Members

• Attend regularly scheduled CPHS meetings either in person or via teleconference;
• Review agenda items 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 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 CPHS.
• 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 CPHS 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 are assigned to sub-committees with experienced IRB members for mentoring.

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.

APPLICABLE REGULATIONS

1. 45 CFR 46 Protection of Human Subjects
2. 21 CFR 56 Institutional Review Board

REFERENCES TO OTHER POLICIES

1. None

ATTACHMENTS

1. None

If you find errors in this document, contact cphs@uth.tmc.edu

CPHS HELPLINE   713-500-7943
iRIS HELPLINE    713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)

IRB OFFICE HOURS Thursdays from 1 to 4pm, via the Teams Room at this link

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