Posts Tagged ‘eIRB’

March 22, PI Eligibility and Research Collaborations 11:30 a.m. to 12:30 p.m. MacDonald Auditorium Andrea Johnson and Kara Drolet, Ph.D. This session will address various issues that arise in developing collaborative research projects, both within and outside OHSU. Common questions to be discussed include: Who can be a Principal Investigator (PI)? Who needs to be listed as a co-investigator on my submission? When do I need an Individual Investigator Agreement (IIA)? How about an IRB … Read More

Question: I’m trying to add Jane Doe to our study. She finished her modules last week but her name does not populate in the dropdown in eIRB. Why? Answer: She hasn’t registered for the eIRB system. It sounds obvious but it’s true—we get this question more frequently than you’d expect. Here’s how you can get started in the Electronic IRB system. To register, go to the main eIRB login page and click on “register here” … Read More

The IRC class schedule for January to March 2012 is up! Please visit our website and register for IRB trainings. Our newest course, Introduction to IRB Review, was a big hit, and we are adding it to the rotation for the coming year. We are also offering the perennial favorites, eIRB 101 and eIRB 201.  Classroom space is limited so please register early. If you have any questions, please contact Ames Elliot at 4-7842.

Do you ever find yourself in the position of needing to look at patient data before those patients have consented to be in a study. Two examples: You’re thinking about writing a grant on adrenoleukodystrophy, but you need to know if we see enough patients at OHSU to be able to design a single site study or if you need to collaborate with colleagues at the Children’s Hospital in Washington, DC. Are you allowed to … Read More

Do you need to make a modificati0n in eIRB? The Research Integrity Office has updated two questions to help the IRB identify, at a glance, what has changed in your submission and why. This includes a change to questions 4 and 5 in the Modification Request Questionnaire (MRQ), along with the addition of questions 4.1 and 5.1. Complete and accurate responses to these new questions will help ensure that your modification is reviewed and approved … Read More

The OHSU Research Integrity Office is now holding monthly brown bag sessions led by the Institutional Review Board (IRB) analysts to address topics of interest to human subjects researchers. December’s brown bag session is jointly sponsored by the Knight Cancer Institute and the OHSU IRB.  Sarah Ward, Denise Mathes, and Susan Aust of the Knight Cancer Institute and Andrea Johnson of the IRB will cover the following topics: New IND/IDE management services for investigator initiated … Read More

The OHSU Research Integrity Office is now holding monthly brown bag sessions led by the IRB analysts to address topics of interest to human subjects researchers. The brown bag session for tomorrow will offer a description of the IRB review process and tips for getting your project reviewed and approved as quickly as possible. Analysts Wendy Doggett and Trish Lindstrom will cover the following topics: Types of IRB review (full board, expedited) Timelines of review … Read More

Congratulations! You got the grant. But you can’t actually get the grant until you determine  if you need Future Human Subjects or “Just-in-time” approval? Don’t panic—OHSU’s Research Integrity Office is here to help and can get you that “Just-in-time” approval quickly. “Just-in-time” approval The NIH (and other funding agencies) require full Institutional Review Board (IRB) approval for the research proposed in the grant. The IRB must review the IRB research protocol for that project under … Read More

Have you ever wondered what a Lay Language Summary is and why the Institutional Review Board (IRB) asks you to include one with your submission? The purpose of the Lay Language Summary is to provide a clear overview of the research in straightforward, non-technical language.  In other words, we want you to describe your project in layman’s terms. This summary is used by IRB staff for a quick rundown of the study when reviewing modifications … Read More

Don’t forget: Any advertising for the recruitment of study subjects requires Institutional Review Board (IRB) approval. The IRB needs to review the information contained in the advertisement and the method of communication, to determine that the procedure for recruiting subjects affords adequate protection. Advertisements used to recruit subjects are seen as an extension of the informed consent process. Based on FDA regulation and OHSU IRB policy, any advertisement used to recruit subjects should be limited … Read More