Scientific Review Requirement

Version Date: July 10, 2017

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 University of Wisconsin-Madison.

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 an assessment by the UWCCC PRMC regarding whether PRMC review is required. If the PRMC determines a project does not fall under its purview, the study may instead require review by an ICTR SRC. 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

The categories of new submissions that do not require scientific review are listed below. 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 of protocol applications.

Types of IRB submission that do not require review by an ICTR SRC:

  • Project under UWCCC PRMC purview
  • Protocols for which the UW has agreed to defer IRB review to an independent IRB, such as Western IRB (WIRB)
  • Projects that have undergone peer-review, such as most federally funded research (e.g., R01) and some foundation-supported projects
    • NOTE: Study teams may be asked to provide the criteria the funding agency used to evaluate the project so that the level of peer-review can be assessed

  • Research studies funded by VA Merit Grants
  • 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, images, or specimens) that have been collected, or will be collected solely for non-research 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
    • Wearable devices, such as accelerometers and fitbits, or tests that use external sensors that do not otherwise result in physical stimulation (e.g. EEGs)
    • Walking tests
    • Imaging (MRIs, ultrasounds) with FDA-approved devices (hardware and software) when the imaging is performed within the FDA indications and evaluation of the device is not the focus of the research
      • NOTE: PET-MRI does not fall under this category.

  • 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 to be exempt from IRB review

For more information about the ICTR SRC, please see their website.

See Also:

Keywords:peer review, scientific review, SRC, ICTR, PRMC   Doc ID:18844
Owner:Faye L.Group:Health Sciences IRBs
Created:2011-06-14 19:00 CDTUpdated:2017-07-10 16:02 CDT
Sites:Health Sciences IRBs
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