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:

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:

Responsibilities of the IRB Chairperson (in addition to responsibilities of members)

Members

Sub-Committee Reviewers

IRB Staff

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

Document Number:

101-B05

Document Name:

IRB Autonomy and Functions

Approved by:

Executive Director, Research Compliance

Effective:

1 Aug 2008

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
6410 Fannin, Suite 1100
Houston, Texas 77030

Phone 713-500-7943
Fax     713-500-7951
Email cphs@uth.tmc.edu 

IRIS Support 713-500-7960

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