Winter 2013 IRB Analyst Brown Bag Sessions

January 24, 2013: Institutional Review Board (IRB) Myths and Misconceptions
Kelly Kidner and Stacie Fujisaki

11:30 a.m. to 12:30 p.m. UHS 8B60

Baffled by requests from the IRB (analyst, chairs or committee) or even by the eIRB system? Join us for this brown bag session to explore common myths and misconceptions that may delay IRB review and approval.

February 28, 2013: Repository Refresher or “I got my repository approved…now what??”
Andrea Johnson
11:30 a.m. to 12:30 p.m. UHS 8B60

What happens with those stored data and specimens now that you’ve written the protocol, created the tracking spreadsheet, and drafted the submission and sharing agreements? This session will include:

  • A brief refresher on the requirements of OHSU’s repository policy
  • Guidance on how to manage and document the submission and sharing of repository materials
  • Tips for submitting repository modifications and continuing reviews
  • Your FAQs! If you have questions you’d like to see answered in the session, please send them to Andrea.

March 28, 2013: Data and Safety Monitoring Plans
Trish Lindstrom

11:30 a.m. to 12:30 p.m. UHS 8B60

The IRB is responsible for evaluating a study to determine, among other things, whether risks to subjects are minimized and risks to subjects are reasonable in relation to anticipated benefits.  Part of that evaluation is to determine when data and safety monitoring is required and if so, what type and degree of monitoring provisions should be in place. We will cover:

  • When to Include Monitoring Provisions in your IRB Application
  • Required Monitoring Provisions
  • Determining the type of Monitoring Entity
  • Data Safety Monitoring Board (DSMB) / Data Monitoring Committee (DMC)
  • Submitting your Monitoring Provisions for Approval
  • IRB Review of the Monitoring Provisions

No registration is required for these sessions.  Please contact Ames Elliot if you have any questions.