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II.03
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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, whether expedited, subcommittee, or
consultant, 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.
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Applicable Regulations and Guidelines
21CFR 56, 45CFR 46, OHRP Human Subjects Regulations Decision Charts
1-9
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Updated
10/2007, Report broken links
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