I.07

 

 

Human Research Protection Program Quality Assurance and Quality Improvement

 

 

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Objective

The University of Texas Health Science Center at Houston (UTHSC-H) monitors and promotes the effectiveness, quality, and compliance of its Human Research Protection Program through quality assurance and improvement programs described in this policy and procedure.

 

Policy/Procedure

I.        Roles and Responsibilities

A.     The Executive Vice President for Research (EVPR) is responsible for implementing quality assurance and quality improvement programs to promote the effectiveness, quality, and compliance of the UTHSC-H Human Research Protection Program.

 

B.     The Executive Committee for the Committee for the Protection of Human Subjects (CPHS) is responsible for working with the EVPR to monitor/promote the effectiveness, quality, and compliance of the Human Research Protection Program (CPHS Executive Committee Guidelines).

 

C.     The Quality Improvement/Quality Assurance Advisory Committee is appointed by the EVPR, and is responsible for advising him/her about the quality of the UTHSC-H Human Research Protection Program and strategies to improve it.

 

D.     The CPHS advises the EVPR about strategies to improve the effectiveness, quality, or compliance of the Human Research Program through venues such as bi-annual retreats and informal meetings.

 

E.      The UTHSC-H Institutional Compliance Committee is responsible for monitoring and ensuring compliance of the Human Research Protection Program through the Human Research Protection Compliance Plan.

 

II.     Research protocols approved by the CPHS are monitored/audited (HRP PP III.01 Compliance Oversight) as part of the quality assurance program. 

 

III.   The Quality Improvement/Quality Assurance Advisory Committee meets at least quarterly with the EVPR to review/discuss quality indicators for the Human Research Protection Program and to advise him/her about potential problems and/or opportunities for improvements (Quality Improvement/Quality Assurance Advisory Committee Guidelines).

 

IV.  Education/training support quality assurance/improvement of the Human Research Protection Program and include training of investigators, CPHS members, and staff (HRP PP VI.01 CPHS Member Education, VII.02 Investigator Education) and participation in national meetings.

 

 

Applicable Regulations and Guidelines

 

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Updated 7/24/2007, Report broken links