Scientific Review Requirement
Version: December 2019
Institutional policy requires that certain applications reviewed by the Health Sciences (HS) or Minimal Risk (MR) IRB undergo scientific review by the Institute for Clinical and Translational Research Scientific Review Committee (ICTR SRC). This guidance describes what types of applications require review by the ICTR SRC, provides a list of study procedures that may excuse an application from ICTR SRC review and outlines what is reviewed by ICTR SRC.
What types of applications may require ICTR SRC review?
Non-oncology-related applications for full initial IRB review require ICTR SRC unless they a) are otherwise reviewed and determined to be highly meritorious by an alternate internal or external scientific review process (see list of sponsors with adequate review below) or b) solely involve the procedures listed below. ICTR SCR review is not required for other application types (e.g., exempt, ceded, reading center, single or emergency use etc.).
All oncology-related IRB applications (including exemptions) are assessed by the University of Wisconsin Comprehensive Cancer Center Protocol Review and Monitoring Committee (PRMC) to determine whether PRMC scientific review is required.
What study procedures may excuse an application from ICTR SRC review?
Applications may be excused from ICTR SRC review if studies solely involve any or a combination of the following procedures:
- Collection of blood samples by finger stick, heel stick, ear stick or venipuncture, unless the purpose of the biospecimen collection is to perform large scale genetic analyses such as whole genome or whole exome sequencing
- Prospective collection of biological specimens for research purposes by noninvasive means unless the purpose of the biospecimen collection is to perform large scale genetic analyses such as whole genome or whole exome sequencing
- 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
- 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.
What is reviewed during ICTR SRC?
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
Do changes of protocol require ICTR SRC review?
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.
Examples of Sponsors with Alternative Scientific Review Processes
- VA Merit Grant
- Internal research grant competitions (for example, WARF 2020, ICTR pilot project award)
- Federal funding agencies (NIH, DOD, NSF)
- Foundations with adequate peer review process