2018 Changes – Overview

We are rolling out a number of changes in the IRB submission and review process. Within the past year, both NIH and the Office for Human Research Protections (OHRP) have made significant changes, including issuing new federal regulations (known as the Common Rule). Most of the changes to our processes are a direct result of these new regulations, although we took this opportunity to improve some processes in other ways as well.

Unless otherwise noted, these changes are all effective January 19, 2018.

What’s changing at UWM?

Click on the links in the table below to learn details about each change. Or, you can download the pdf explaining all the changes.

Significant Changes (will affect most researchers)
Highlights
Clinical Trials Revised definition; additional training requirements; register on clinicaltrials.gov; post consent form & results
Post-approval monitoring IRB office staff / IRB members will perform in-person reviews of approved studies (originally scheduled to begin in 2017).
Informed Consent New template, broad consent for storage / banking
PI / Student PI Training CITI training now required for all PIs & Student PIs; renew every 3 years
Medium Changes (may affect you somewhat)
Highlights
Continuing Review No longer required for expedited studies submitted on or after 1/19/2018.
New Exempt categories Some research that was previously expedited can now be exempt; additional conditions on educational research
Minor Changes (may not affect you)
Highlights
SOPs (Standard Operating Procedures) Existing IRB guidelines are being updated and converted to a new SOP format (ongoing process).
Single IRB Single IRB review required for all multi-site, federally-funded research (effective 1/20/2020)
Definition of Research and Human Subjects Revised Determination Form for determining whether or not IRB review is required
IRBManager Updated numbering system