II.03

Assignment of Research Studies to CPHS Reviewers and Consultants

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.

Applicable Regulations and Guidelines

21CFR 56, 45CFR 46, OHRP Human Subjects Regulations Decision Charts 1-9

Return to Policies and Procedures Home Page

Updated 10/2007, Report broken links