IRB Notes: Changes to Initial Submissions in eIRB

From the Chair’s Desk: Update on Changes to Initial Submissions

Making the protocol approval process easier and more efficient is a major goal of the OHSU Institutional Review Board. There are a number of recent and upcoming changes to Initial Submissions that will help us achieve this goal, including redesigned collection of study information and reduced IRQ requirements. Here is a short summary of these changes:

1. Brief Project Description replaces Lay Summary

The Simplified Lay Language Protocol Summary has been eliminated and replaced with the Brief Project Description – an open-ended, non-technical overview of the study that is easier to complete and doesn’t result in duplicate (or discrepant!) information.

2. New Minimal Risk Protocol Template

For simple, minimal risk studies, the new Minimal Risk Protocol Template has the appropriate headers and instructions to help you include all the information the IRB needs to give you approval.

3. Simplified Initial Review Questionnaire (IRQ) – Coming Soon!

We’re on a mission to remove 250 IRB fields, 126 IRB questions and 9 pages of the IRQ. Watch for our lean and mean IRQ to rollout next month.

Where has that IRQ information gone?

  • Some of it the IRB doesn’t need – that just goes away…
  • Some is in your protocol – like description of recruitment, privacy measures. We only need it in one place – leave it there!
  • If it’s not in your protocol and we need it, it will go in the Local Context Supplement – a new document for multi-site studies to provide the OHSU-specific plan for recruitment and consent, payment and protection of privacy.

4. Fewer documents for IRB Review

Clinical Laboratory Improvement Amendments (CLIA) certificates are no longer required. Also gone or going – Clinical Research Billing Schedule (once you budget in eCRIS), Nursing Summary, and we’re working on a way to streamline PI Eligibility exceptions.

Questions? Contact the IRB office at (503) 494-7887, option 1.