IRB Notes

IRB Notes: Breaking down some frequently used IRB terms

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

IRB Notes: Using eCRIS and eIRB

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

IRB Notes: Upcoming IRB classroom training

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

IRB Notes: Upcoming IRB Analyst Brown Bag sessions

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

How to report breaches of confidentiality in eIRB

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

Are you a PI or a student leaving OHSU? What it means for your IRB protocol

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

IRB Notes: Consent and authorization forms now combined

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

IRB Notes: submitting continuing review questionnaires

Federal requirements dictate that studies and repository protocols be reviewed by the IRB annually. Continuing Review Questionnaires (CRQs) should be submitted at least 8 weeks prior to the expiration of your study/repository protocol, in order to ensure that there is adequate time to review and re-approve it. Please note that when a study lapses, all data collection, analysis and research activities must cease until it is reapproved. If you need assistance or have questions prior … Read More

IRB Notes: Interactions between eCoI and eIRB

The interactions between eCoI and eIRB The new conflict of interest reporting system housed in Big Brain, eCoI  has been up and running since late August. This system asks researchers to report Outside Activities and Conflicts of Interest (CoIRs) in one report; previously, this required two disclosures (one in the “old” CoIR disclosure system; the other in Big Brain). 1) CoIR Compliance in eIRB: Anytime a researcher has an eCoI submission “in the works” (awaiting … Read More

IRB Notes: quality improvement or research?

Quality improvement or research? How to make sure you’re in the clear In the era of quality improvement, questions about how to make QI into scholarship come up frequently. FAQs about Quality Improvement Projects and how they relate to research: Is all QI research?  No. Projects that are intended only for process improvement, and used in a local setting are quality improvement and do not require IRB approval.  An example of QI that is not … Read More

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Welcome to the Research News Blog

OHSU Research News is your portal to information about all things research at Oregon Health & Science University. Visit often for updates on events, discoveries, and important funding information.

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