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:

What is reviewed during ICTR SRC?

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

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

  1. VA Merit Grant
  2. Internal research grant competitions (for example, WARF 2020, ICTR pilot project award)
  3. Federal funding agencies (NIH, DOD, NSF)
  4. Foundations with adequate peer review process

See Also: