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IV.01
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Research Requiring Review by the
Committee for the Protection of Human Subjects
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Objective
The University of Texas Health Science Center at
Houston (UTHSC-H) and the Department of Health
& Human Services (DHHS) have signed a Federal Wide Assurance Document (FWA
#00000667) that defines the obligation of the University to ensure the rights
and welfare of human subjects of research are protected. Under the FWA, the
UTHSC-H Committees for the Protection
of Human Subjects (CPHS) must review all proposed research involving
human subjects to determine if adequate measures are in place to protect
participants. This Policy and Procedure
identifies research that is covered by FWA #00000667 and must be reviewed,
approved, and monitored by UTHSC-H CPHS.
Policy/Procedure
I.
Human subjects research is defined as research involving human
subjects, human derived materials, or human derived data.
II. All human subjects research, funded and unfunded,
must be reviewed and approved by the UTHSC-H CPHS before it is initiated if it falls
in one of the following categories.
A.
Human subjects
research conducted by any UTHSC-H employee (faculty, staff, administrative and
professional), student, or resident in any facility/location (e.g. Memorial Hermann Healthcare System,
Harris County
Psychiatric Hospital, Thomas Street
Clinic, LBJ General
Hospital).
B. Human subjects research
conducted by non-UTHSC-H investigators that involves subjects/patients from any
UTHSC-facility (including Harris
County Psychiatric
Hospital). In such instances, a University
faculty member must be identified who will agree to assume co-responsibility for the conduct of the research.
C. Human subjects research conducted by
non-UTHSC-H investigators in Memorial Hermann Healthcare System facilities.
III. All human subjects research, except exempt research, receives ongoing
monitoring by the CPHS appropriate to the level of risk involved, but in every
instance at least annually.
IV. All modifications to
approved research protocols must be submitted to the CPHS for review and
approval prior to implementation.