If you perform clinical research and have a student on your Institutional Review Board (IRB) protocol, here are some things for you to keep in mind as summer approaches: If a student has been serving a major role on the project, plan for who is going to complete any analyses and assume administrative or regulatory duties (e.g. the next Continuing Review). Update personnel as appropriate – remove students if they are no longer going to … Read More
Posts Tagged ‘IRB Notes’
What happens if your lap top is stolen? What if you leave your thumb drive somewhere? Join John Rasmussen, chief information security officer, for a presentation and Q&A on knowing where you data is and best practices on how to protect it. IRB brown bag: Lost and stolen devices Thursday, May 22, 11:30 a.m. to 12:30 p.m. OHSU Hospital room 8B60 Questions? Contact Kimberly Lee.
If you are submitting a memo with your Institutional Review Board submission, it should be written to give the IRB staff and reviewers a brief overview of the initial, modification, continuing review or reportable event. Memos are not required with submissions but are helpful if the changes are extensive, complicated, or potentially confusing. If you are submitting a modification or continuing review that includes changes to the protocol and/or Investigator’s Brochure, it is important that … Read More
Improvements in eCoI: In the Electronic Conflict of Interest system, researchers describe outside activities, significant financial interests and related research projects. The portion of the eCoI disclosure where these related projects are chosen and described has been updated: a) The “master project list” that the researcher reviews to find his/her “related” projects is now sortable by a number of parameters (e.g., title, sponsor, PI, IRB #, PPQ#) and b) The questions posed about each related … Read More
Understand the review process and cover your bases up front Learn the Institutional Review Board (IRB) review process (outlined at About IRB Review) and ensure your project submission includes all relevant information/documents before submitting. If your study involves non-OHSU researchers, arrange and clarify collaborations in advance. Don’t Neglect CoIR The eIRB will not allow projects to be submitted or approved unless all researchers involved in a study have completed Conflict of Interest in Research (CoIR) … Read More
You may have heard over the past couple of months that the OHSU Institutional Review Board has been working to streamline the electronic Initial Review Questionnaire (IRQ). We are removing pages and questions that are unnecessary or duplicative. A short IRQ means less work for you, but it also means that it’s important to make sure your study documents contain all of the information the IRB needs to review your study. Your study protocol should … Read More
Thursday, March 27, 2014 UHS 8B60 11:30 a.m. to 12:30 p.m. The newly streamlined Initial Review Questionnaire, or IRQ, is rolling out in early March. This session, lead by OHSU Institutional Review Board analysts, will give you an in-depth tour of the changes and provide guidance on how they affect the rest of your IRB submission. Bring your questions! Learn about other 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 … Read More
Analyst Notes The OHSU Institutional Review Board website has new resources for investigators regarding the retirement of the Lay Summary and a new Minimal Risk Protocol Template. Brief Project Description Replaces Lay Summary As part of ongoing efforts to streamline submission and review processes, the IRB is replacing the six-question Lay Language Protocol Summary with a simplified Brief Project Description document. The new document contains the following instructions: Provide a brief (one page maximum) description, … Read More
IRB Update Hear details of recent and upcoming changes at the OHSU Institutional Review Board (IRB). See the new Local Context document and learn when and how to use it! Get a tour of the new Protocol Template, designed for investigator-initiated minimal risk studies – it will help you give the IRB all the information needed for your approval. Hear about other updates and get a peak of what’s coming next on Thursday, January 23, 2014 from … Read More