IRB Notes

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

The Research Integrity Office has recently received a few questions regarding Clinical Laboratory Improvement Amendments, particularly in reference to the Washington state exemption. Here is a quick overview and refresher. The Clinical Laboratory Improvement Amendments (CLIA) were enacted by congress in 1988 as a result of a troubling number of inaccurate results from Pap smears intended to detect cervical cancer. The program is run by the federal Centers for Medicare and Medicaid Services (CMS). CMS … 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 U.S. Food and Drug Administration (FDA) has amended the regulatory requirements for obtaining informed consent for FDA-regulated products. The changes require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials must include a specific statement that clinical trial information will be entered into the ClinicalTrials databank. This databank is the clinical trial registry databank maintained by the National Library of Medicine.

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. Join us this month for a Q&A session with all your favorite analysts! If you’ve talked or emailed your analyst but never met them, now is the perfect time to greet them face to face. They will be available to answer general questions or walk you through a particular … 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.

During Integrity Week last May, we told you about the new Conflict of Interest (CoI) Disclosure System which will streamline all CoI disclosures into one form to be completed annually, housed in Big Brain.  We were ready to roll the new system out this summer when the NIH revised their regulations regarding conflict of interest in research. These changes mean we have to update our system to accommodate the revised requirements. The planned release date … Read More

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