Posts Tagged ‘eIRB’

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

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

The Office for Civil Rights (OCR) released new guidance on November 26, 2012, that elaborates on HIPAA’s data de-identification standards. Under the HIPAA Privacy Rule, there are two ways that health information can be de-identified and therefore no longer considered Protected Health Information (PHI): Remove all 18 listed identifiers (the “safe harbor” method); or Obtain confirmation from a qualified statistician that the risk of identification is very small (the “expert determination” method). Most researchers are … Read More

January 24, 2013: Institutional Review Board (IRB) Myths and Misconceptions Kelly Kidner and Stacie Fujisaki 11:30 a.m. to 12:30 p.m. UHS 8B60 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 common myths and misconceptions that may delay IRB review and approval. February 28, 2013: Repository Refresher or “I got my repository approved…now what??” Andrea Johnson 11:30 a.m. to … Read More

Below, you’ll find information from the eIRB Helpdesk on how to prepare a Summary of Changes document. But before we get to that ‘How-To’, it’s important to talk about why the Institutional Review Board (IRB) needs a Summary of Changes document. There are several reasons for this, related to the following requirements placed on the IRB: Determine level of review.  Specifically, the IRB analyst must determine if the changes represent a ‘minor change in approved research’.  … 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

Thursday, September 27, 2012 Confidentiality and Privacy: Consent, Authorization and Beyond Presented by Andrea Johnson 11:30 a.m. to 12:30 p.m. in UHS 8B60 This brown bag session will provide guidance on the Institutional Review Board’s requirements for protecting human subjects’ confidentiality and privacy during and after research studies. Discussion points will include: describing confidentiality risks and protections in the consent form; using authorizations, waivers of authorization, and other HIPAA mechanisms appropriately; obtaining a Certificate of … 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!

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