Scientific Review Committee (SRC)

• Oncology studies: All oncology-related IRB applications (including exemptions) are assessed by theUW Carbone Cancer Center Protocol Review and Monitoring Committee (PRMC) to determine whether PRMC scientific review is required.
• Multi-site Industry sponsored studies
• Studies that have received a highly meritorious peer review (funding approved or pending). Examples of adequate peer review organizations:
  • NIH, DOD, NSF and other PHS funding agencies
  • UW Internal granting mechanisms, including OVCRGE competitions, ICTR pilot studies, UWCCC core grant sub-award projects
  • VA merit grant
  • Foundations with adequate peer review (for example American Heart Association, American Kidney Foundation, Wisconsin Partnership Program, etc.)
• Extended/Emergency use applications, Humanitarian Use Device Applications, or training/umbrella grant applications.
• Studies that solely include 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.

The SRC reviews the formal study protocol uploaded into the ARROW application for the following:

• Adequate rationale and justification for the study based on a literature review or other data
• Adequate study objectives and clearly defined primary and secondary outcomes
• Valid, reliable and rational proposed measures
• When applicable, planned treatments commensurate with standard of care or a reasonable experimental alternative
• Subject population that is appropriate to answer the scientific question, including whether inclusion/exclusion criteria will allow the study team to enroll the intended population
• Adequate statistical considerations (e.g., sample size/justification, estimated accrual and duration) to meet study objectives
• Data monitoring procedures to ensure the collection of high-quality data

The Scientific Review: Other page appears in ARROW for HSIRB initial review applications that do not have federal funding.

• If your study has received non-federal peer review (see examples above), please select “funding proposal has already undergone peer review”.
• If your study only involves the minimal risk procedures listed above, select “protocol solely involves any or a combination of the minimal risk procedures outlined in the SRC guidance document”.

If a study underwent ICTR SRC review during the initial review process, subsequent changes of protocol may require ICTR SRC review if the study changes affect the study design or methodology.