1. I need to add or remove a staff member on my eIRB study. What’s the best way to do this? You should submit staff changes independent of other changes to your study. Normally, staff-only modifications can be turned around within 24 hours, allowing your change to take effect quickly. If you pair this change with other items, the staff has to wait for the approval of the entire modification. 2. I am trying to … Read More
eIRB Upgrade Coming summer 2015! The new eIRB will help us support the rapidly growing research community at OHSU and maintain our high standards of compliance as a world-class research institution. We expect this new version will provide a much simpler, understandable and streamlined approach for submitting your studies for IRB Review. The eIRB Upgrade project has been divided into two phases: Phase 1 – Design & Phase 2 – Development and … Read More
We have recently received a few questions about the billing for industry sponsored studies. Below is a reminder of the types of modifications that are “billable” and “not billable” on these studies. As a reminder, including “no charge” or similar language in the title of your modification does not serve as a trigger for whether items are billed. If you have questions or concerns about IRB billing, please email Dave Holmgren, IRB Manager.
The new Electronic IACUC is set to go live in the fall of 2014 and we need your help! We are looking for participants to test the system for bugs or errors and to look over the questions and give suggestions to improve ease of use. We want this system to work for you and here is how you can help: Click here and log in with the ID (1) & Password (2) from any OHSU … Read More
You’ve received good news that your grant to support existing research has been funded. Congratulations! Before you get started, you will need to link this new grant to the research that is currently approved by the OHSU Institutional Review Board. The IRB will help you make sure that your previously approved protocol still meets all criteria for approval as you incorporate activities of the new grant. To add your new funding to a currently approved … Read More
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
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