Back in December, we told you about the NIH’s revised regulations regarding conflict of interest in research. These regulations were enacted to manage the growing complexity of conflicts of interest for investigators receiving grants from the Public Health Service through objectivity, transparency and accountability. OHSU’s Integrity Office has developed a new Conflict of Interest (CoI) System named eCoI. This new system replaces two separate systems (CoIR Management System and the Big Brain CoI module) with … Read More
Posts Tagged ‘IRB Notes’
A well-written consent form significantly increases the efficiency of IRB review. This brown bag session is designed to provide an overview of consent form writing. Handouts will be available to assist participants in the continuing pursuit of the well-written form. Topics include: Templates and boilerplate language Writing style Organization of procedures and risks Common corrections When: Thursday, June 28 from 11:30 a.m. to 12:30 p.m. Where: MacDonald Auditorium at Casey Eye Institute Bring your lunch … Read More
Until now, researchers conducting research that engages both OHSU and the VA in human subjects research had to obtain separate IRB approvals from OHSU and the VA. Because of the difference between the boards and the two different management systems (electronic vs. paper-based) the approval process was burdensome. OHSU and the VA have entered into an agreement to allow single IRB review for studies that required dual review in the past. Beginning in June, joint … Read More
Help us help you IRB updates for Principal Investigators When: Wednesday, May 2, 2012, 11am to noon Where: UHS 8B60 Speaker: Susan Bankowski, MS, JD. IRB Chair By attending the town hall meetings you are automatically entered to win a gift basket! Visit our website for more information or contact us if you have any questions. We can’t wait to see you there!
April 26, Updates from the IRB 11:30 a.m. to 12:30 p.m. MacDonald Auditorium Kelly Kidner This session will bring you all the latest information from the IRB including: Document updates — consent templates Recent changes to the eIRB — PI change, funding Please contact Ames Elliot if you have any questions.
The Office of Research Integrity is adding a part time co-chair position to the Institutional Review Board (IRB) and invites members of our research community to review the job announcement posted on the OHSU iRecruitment site. Please consider either applying for this important and interesting position, or sharing the opportunity with your colleagues. To view a full description of the position, log into your iRecruitment account and search for IRC35971.
The electronic IRB (eIRB) system has a scheduled downtime on Friday, March 23rd, from noon to 6:00 p.m. It has been so long since we’ve had a downtime you have probably forgotten all about them! We wanted to be sure that everyone is aware that the system will be unavailable during that time so if you have anything you need to access (i.e., consent forms) please print them out ahead of time. This downtime will … 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.