What Happens After an Application Is Submitted to the Health Sciences or Minimal Risk IRB: Scientific Review

Version Date: April 1, 2012

What happens after an application is submitted to the Health Sciences or Minimal Risk IRB: Scientific Review

After an IRB application is submitted by the study team in ARROW, the application may undergo scientific review before the IRB review process begins. Understanding what happens to an IRB application after it is submitted can help study teams better navigate the review process. This FAQ describes the different paths an application may take before the IRB review process begins. Please also see What Happens After a New Application Is Submitted to the Health Sciences or Minimal Risk IRB: IRB Administrative Review and IRB Pre-Review for information on what happens to an application after scientific review is complete or if no scientific review is required.

What types of review may happen before the IRB review process begins?

Some initial review applications as well as some full changes of protocol may undergo one or more review processes before the application is received by the HS-IRBs Office. These review processes are:

  • UW Comprehensive Cancer Center Protocol Review and Monitoring Committee (UWCCC PRMC): Any initial review application (regardless of application type) that involves cancer-related research, enrollment of cancer patients, or review or use of specimens/data/images/records must be reviewed by the PRMC.
  • Institute for Clinical and Translational Research Scientific Review Committee (ICTR SRC): Some types of initial review applications require review by the ICTR SRC. For information on what types of studies require this review, see Scientific Review Requirement  guidance.
  • Clinical Research Unit Protocol Implementation Review (CRU or CTRC PIR): Any study that will use the Clinical Research Unit must be reviewed by the CRU PIR.For additional information on submitting applications using the CRU (formerly CTRC), see Submitting the CRU Application in ARROW .

How do I know if my study requires scientific review?

Based on answers provided by the study team in the IRB application, ARROW will typically automatically assign applications that require scientific review to the appropriate committee. The HS-IRBs Office also can assign applications to any of these committees as needed. For additional information about what studies require scientific review, see Scientific Review Requirement guidance .

Does the HS-IRBs Office manage the scientific review committees?

No. The review committees described above are managed by offices separate from the HS-IRBs Office. Study teams who have questions about the scientific review process should contact the review committees directly.

Does IRB review occur concurrently with scientific review?

No. If required, scientific review must be completed before the IRB review process can begin.

See Also:

Keywords:scientific review, CTRC, CRU, PRMC, ICTR SRC,   Doc ID:23806
Owner:Carol P.Group:Health Sciences IRBs
Created:2012-04-16 12:43 CDTUpdated:2016-03-31 15:37 CDT
Sites:Health Sciences IRBs
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