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IV.05
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Assignment of Research Studies to CPHS Reviewers and
Consultants
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Objective
This Policy/Procedure describes the review process to
determine if the proposed research involves human subjects according to The University
of Texas Health Science Center at Houston (UTHSC-H) policies/procedures and
must be reviewed by the CPHS and, if so, the assignment of Reviewers.
Policy/Procedure
I.
The EVPR or his/her designee determines if proposed research qualifies as
research -See definitions of (1)Research, (2) Human
Subject, and (3) Clinical Investigations
in Definitions, and is subject to review by the CPHS.
II. If the research is subject
to CPHS review, the EVPR or his/her designee shall determine whether the
protocol qualifies as expeditable, or should undergo
full review at a convened meeting.
III. If the research qualifies
for expedited review, the EVPR or his/her designee shall assign the review to a
CPHS member designated to conduct expedited reviews.
IV. If the research requires a
full committee review, the EVPR or his/her designee shall assign the review to a subcommittee
within 7 working days of a scheduled meeting, unless there are extenuating
circumstances to warrant assignment to the next available meeting. The subcommittee shall be comprised of an
adequate number of CPHS Member(s) and possibly a consultant(s) (henceforth
Reviewer(s)) with consideration of the following.
A. The diversity of the
Reviewer(s) (e.g. race, gender, cultural background and sensitivity to such
issues as community attitudes)
B. If a vulnerable population
is involved, Reviewer(s) knowledge about or experience working with the
specific population
C. Expertise
to understand the background, aims, and methods of the research.
V. A Reviewer(s) must declare
any Conflict of Interest with the research assigned to him/her for review. If
there is a conflict, the EVPR or his/her designee shall reassign the research
to another Reviewer.
VI. Once the Reviewers are assigned , they will complete their evaluation and submit
their comments for final review by the IRB. Any one having a Conflict of
Interest should disclose it at that time.