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I.06
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Development, Approval and Maintenance
of Policies and Procedures
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Objective
The University of Texas
Health Science Center at Houston (UTHSC-H) Committee for the Protection of Human
Subjects (CPHS) maintains written policies and
procedures in compliance with federal regulations, State/local laws, UTHSC-H
policies and procedures, and standards of regulatory, accrediting, and funding
agencies that apply to research conducted under its jurisdiction. This
policy/procedure describes the processes for developing, approving, and
maintaining them.
Policy/Procedure
I.
The UTHSC-H
CPHS policies and procedures are developed and maintained by the Director of
the Office of Research Support Committees (ORSC) under the direction of the
CPHS Executive Committee Chairman.
II.
CPHS polices
and procedures are to be reviewed every 2 years and when changes in
regulations, laws, and institutional policies necessitate revision.
III.
The CPHS is
charged with the implementation and enforcement of its policies and procedures.
IV.
It is the
responsibility of the Principal Investigator (PI) to routinely view the CPHS
website for new or revised CPHS policies and procedures. In addition, new
information can be disseminated via iRIS,
during study coordinator meetings, and by regular updates to the electronic
Investigator Handbook.
V.
Updates to the
Investigator Handbook will be made every two years, alternating with the
scheduled updates to the policies and procedures.
VI.
The Director of
the Office of Research Support Committees (ORSC) will discuss with the CPHS
Executive Committee and Office of Research Support Committees staff any
necessary revisions of policies and procedures.
VII.
The CPHS and
the Office of Legal Affairs and Institutional Compliance will maintain a joint
relationship to discuss changes and assist with interpretation of Federal,
State and local regulations affecting CPHS polices and procedures.
VIII.
The Director of
the ORSC will provide educational sessions to the CPHS members and staff
regarding CPHS policies and procedures, as well as updates or revisions in a
timely manner.
IX.
The ORSC staff
will use the CPHS policies and procedures when processing research activities and
responding to PI queries.
X.
If the ORSC
staff notices that a policy or procedure is inaccurate or out of date, the
staff member should bring it to the attention of the Director of the ORSC who
will verify the issue and bring it to the attention of the CPHS Executive
Committee Chairman. It is all ORSC staff’s responsibility to keep the
CPHS policies and procedures current and applicable to the daily processes.