IRB Notes

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

IRB Notes: Enrollment questions in the Continuing Review Questionnaire

Continuing review is the ongoing monitoring mechanism by which Institutional Review Boards (IRBs) ensure the continuing protection of subjects who participate in research. The questions below, which are part of the Continuing Review Questionnaire, can be a confusing. Here are some helpful hints to determine who really is considered enrolled in your study. Question 5.5  Total subjects since study began In studies dealing with a warm body, this number includes all subjects who signed a consent … Read More

Five reminders for working in the eIRB

1. Have a system outside the eIRB for ensuring no one’s Conflict of Interest in Research (CoIR) compliance expires.  A whiteboard dedicated to this purpose, an excel spreadsheet, or a single-page table in your study binder is essential. In the eIRB, you can confirm requirements are met by choosing “Visual CoIR RCR” in the red “RCR/CoIR Compliance” box at the left of every study screen. 2. Check the current status of your project.  The main … Read More

IRB Notes: New NIH Regulations for Synthetic Nucleic Acid Molecules

Starting March 5, 2013, the NIH Guidelines will cover work with synthetic nucleic acid molecules in addition to current requirements for reviewing studies involving recombinant DNA molecules. With this change, the Institutional Biosafety Committee (IBC) will also review studies involving of the deliberate transfer into human research participants of synthetic nucleic acid molecules, or DNA or RNA derived from synthetic nucleic acid molecules, that meet any one of the following criteria: Contain more than 100 … Read More

Reminder: IRB Myths and Misconceptions Brown Bag, Jan. 24

Thursday January 24 OHSU Hospital, 8B60  Presenters: Kelly Kidner and Stacie Fujisaki Baffled by requests from the IRB (analyst, chairs or committee) or even by the eIRB system? Join us for this brown bag session to explore many common myths and misconceptions that may delay IRB review and approval. Please contact Ames Elliot if you have any questions

Welcome to the Research News Blog

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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