Scientific Review Requirement

Version Date: February 21, 2014

Initial review and full change applications submitted for review by the Health Sciences IRBs are required to undergo scientific review prior to IRB review. This requirement is expected to enhance the quality of health sciences protocols conducted at the UW.

Currently, three scientific review committees exist to review research - the University of Wisconsin Comprehensive Cancer Center Protocol Review Monitoring and Review Committee (UWCCC PRMC) and two Institute for Clinical and Translational Research Scientific Review Committees (ICTR SRCs). All oncology-related protocols require scientific review and fall under the purview of the UWCCC PRMC. Non-oncology protocols that require scientific review will be handled by the ICTR SRCs. In conjunction with the requirement for scientific review, the IRBs require most interventional studies to develop a formal protocol that includes the information about study objectives or the primary study questions, the significance of the study, and the research design and methods and how these will allow the research team to meet the study objectives or answer the study questions.

Below describes the categories of new submissions that do not require scientific review. Submission types not listed in the table likely will need approval by a scientific review committee before IRB review can commence for initial and change applications.

Types of IRB submission that do not require review by an Institute of Clinical & Translational Scientific Review Committee:

  • Project under UWCCC PRMC purview
  • Protocols for which the UW has agreed to defer IRB review to Western IRB (WIRB)
  • Federally funded projects that have received peer-review (e.g., R01)
  • Research studies funded by VA Merit Grants
  • Foundation-supported projects that have received peer-review
  • Protocol Development Activities (PDA) applications
  • Protocols limited to the creation of a recruitment database, research database, databank, or tissue bank
  • Protocols that solely involve any of the following procedures:
    • Collection of blood samples by finger stick, heel stick, ear stick or venipuncture
    • Prospective collection of biological specimens for research purposes by noninvasive means
    • Use of materials (data, documents, records or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis)
    • Collection of data from voice, video, digital, or image recordings made for research purposes
    • Surveys
    • Interviews, including focus groups
  • Humanitarian Use Device protocols that do not involve research
  • One-time, emergency use protocols
  • Treatment IND or compassionate use device protocols
  • Protocols that are limited to the approval of a grant (e.g., training grant or core grant)
  • Protocols where the UW's role is limited to analysis of data, images, or samples on behalf of a multi-site study (e.g., Statistical Data Analysis Center (SDAC), Fundus Photograph Reading Center protocols, image or sample analysis center)
  • Retrospective medical records research studies
  • Human subjects research determined by the IRB to be exempt from IRB review

See Also:

Keywords:SRC, ICTR, PRMC   Doc ID:18844
Owner:Stella K.Group:Health Sciences IRBs
Created:2011-06-14 19:00 CDTUpdated:2016-03-31 15:45 CDT
Sites:Health Sciences IRBs
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