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
Introduction to IRB Come learn a little about the history of institutional review boards (IRB) and the role they play in research. You will also get basic information about the review process for IRB approval at OHSU. We can help get you started. Getting started in the eIRB This class is a basic introduction to the OHSU eIRB interface, basic navigation and search functions. It will also include an overview IRB requirements and an introduction to the IRB … Read More
STudents As ResearcherS: STARS in the IRB Sky Penny Hogarth and Lynn Marshall Thursday September 26, 2013 Noon to 1 p.m. (note later start time) UHS 8B60 IRB analysts and vice chairs will lead a space walk through the basics of submitting your research to the Institutional Review Board (IRB) for review. We will cover our online submission system, the documents you need to prepare, what elements should be in the documents, and how to … Read More
It is important to report potential breaches of confidentiality to both the Institutional Review Board and the Office for Information Privacy and Security as soon as possible. For the IRB, a breach of confidentiality can be considered an Unanticipated Problem, a Protocol Deviation, or both. Submit an Unanticipated Problem (UP) report if: The incident was unanticipated and may place subjects or others at a greater risk of harm or discomfort. A confidentiality UP involves any … Read More
It’s that time of year again. The weather is warm and our student researchers are finishing up their school year. So here are some things for you to think about: 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
Due to a change in the HIPAA Privacy Rule, the Institutional Review Board has revised its consent and authorization templates so that all informed consent and authorization elements are combined into a single form that requires only one signature from the subject. Please follow the detailed instructions within the template to customize the form for your study. Additional consent and authorization form guidelines and instructions are available here. The new templates are available on the … Read More