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
Greetings from Integrity! The OHSU Code of Conduct establishes our individual and organizational commitment to the principles of integrity in all of our activities, every day. It is distributed to every new member of the OHSU community and provides a reference point for ethical behaviors throughout the year. This spring, we are updating the Code of Conduct in order to align with the revised Vision 2020 and the new Core Competencies. We are seeking reviewers from … Read More
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
Q&A: Minimal risk research Got questions about minimal risk research? We’ve got answers! Join all of the IRB Analysts for a question and answer session this Thursday, November 14, from 10-11a.m. in OHSU Hospital 8B60 Questions: Email the Research Integrity Office.
Q&A: Unanticipated problems Got questions about unanticipated problems? We’ve got answers! Join all of the IRB Analysts for a question and answer session this Thursday, October 24, from 11:30 a.m. to 12:30 p.m. in OHSU Hospital 8B60. Questions? Email the Research Integrity Office (ORIO).
From the Chair’s Desk Under HIPAA, using or disclosing Protected Health Information (PHI) for research purposes generally requires a signed authorization from the subject. There are, however, a number of exceptions to this rule. When you will not be obtaining signed authorization from subjects for a research project that is eligible for an exception, you need to complete the appropriate form or agreement to document that you have met the HIPAA requirements for the exception. … Read More
Analyst Notes Institutional Review Board (IRB) terminology can often be confusing to new and seasoned researchers alike. Here is a brief refresher on the most commonly used terms. Fully identifiable: Data or samples which include personal identifiers — information which would allow the person who provided the materials to be identified. If a study involves interaction with subjects the data or samples would be considered fully identifiable, at least when collected. Personal identifiers include, but … Read More
eIRB Helpdesk eCRIS, OHSU’s electronic Clinical Research Information System, increases the efficiency, effectiveness, accuracy, and compliance of clinical research at OHSU. The eCRIS system ‘speaks’ directly to other systems at OHSU, like eIRB, so much of the information you enter into eCRIS will export automatically into the eIRB thus streamlining your submission process. Studies involving prospectively consented human subjects will eventually be required to track their subjects in eCRIS, though other types of studies are … Read More