Overview of Recent Changes

We are rolling out a number of changes in the IRB submission and review process. The NIH and the Office for Human Research Protections (OHRP) have recently 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.

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
Effective Date
Clinical Trials Revised definition; additional training requirements; register on clinicaltrials.gov; post consent form & results

January 2018 for NIH-funded studies

January 21, 2019 for all other federally funded studies

Post-approval reviews IRB office staff / IRB members will perform in-person reviews of approved studies (originally scheduled to begin in 2017). January 2018
Informed Consent New template, broad consent for storage / banking

 

January 2018

PI / Student PI Training CITI training now required for all PIs & Student PIs; renew every 3 years January 2018
Medium Changes (may affect you somewhat)
Highlights
 

Effective Date
Continuing Review No longer required for expedited studies approved after 1/19/2018. January 21, 2019
New Exempt categories Some research that was previously expedited can now be exempt; additional conditions on educational research January 21, 2019
Minor Changes (may not affect you)
Highlights
 

Effective Date
SOPs (Standard Operating Procedures) Existing IRB guidelines are being updated and converted to a new SOP format (ongoing process). ongoing
Single IRB Single IRB review required for all multi-site, federally-funded research (effective 1/20/2020) January 20, 2020
Definition of Research and Human Subjects Revised Determination Form for determining whether or not IRB review is required January 2018
I-Manager Updated numbering system January 2019