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IV.03 |
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Scientific
Pre-Review of CPHS Protocols |
Objective
The University of Texas Health Science Center at Houston (UTHSC-H) is committed to ensuring that research under the jurisdiction of the Committee for the Protection of Human Subjects (CPHS) is reviewed for scientific merit. This Policy/Procedure describes the process for ensuring the scientific merit.
Policy/Procedure
I. Scientific pre-review is available for CPHS protocols that have not undergone independent scientific peer-review by a granting agency with recognized standards for peer-review (as determined by the Office of Research), are not being conducted in the University Clinical Research Center (UCRC), or are not being conducted under an IND, IDE or HDE. Protocols undergoing scientific pre-review are not submitted to the CPHS until the pre-review has been completed, and the CPHS receives a copy of the outcome of the review.
II. The scientific pre-review panel includes a member of the Office of Research executive staff, the Department Head for the applicant, and a project-specific independent expert designated by the Office of Research. The latter individual will be someone with expertise in study design and methodology, the therapeutic area or some scientific aspect of the application. Reviewers use the UTHSC-H template for Scientific Pre-Reviews when conducting the review.
III. The outcome of the scientific pre-review is forwarded to the applicant and the CPHS indicating that the pre-review panel has determined the study meets appropriate scientific standards, with comments and recommendations in some cases, or that the study does not meet scientific standards.
IV. Principal investigators may submit protocols to the CPHS even if the outcome of the pre-review is negative. However, applicants are strongly encouraged to revise the study based on the scientific pre-review comments to avoid delays or disapprovals within CPHS review.
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Applicable Regulations
and Guidelines 21CFR 50 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr50_04.html)
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