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.

These changes were originally scheduled to go into effect January 19, 2018. Due to a delay in the new Common Rule, the implementation date has changed for some. See the table below for specifics.

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

Effective Jan 2018 for NIH-funded studies

Delayed until January 21, 2019 for all other federally funded studies

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

New template in use as of Jan 2018

Broad consent delayed until January 21, 2019.

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

Effective Date
Continuing Review No longer required for expedited studies submitted on or after 1/19/2018. Delayed until January 21, 2019
New Exempt categories Some research that was previously expedited can now be exempt; additional conditions on educational research Delayed until 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). Jan 2018 – 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 Jan 2018
IRBManager Updated numbering system Delayed until January 21, 2019