Posts Tagged ‘IRB Notes’

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

New HIPAA guidance on de-identification and the mysterious “expert determination” method

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

Winter 2013 IRB Analyst Brown Bag Sessions

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

From the IRB Chair’s Desk: Summary of Changes Documents

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

Reminder: Recruitment and Consent Discussions Brown Bag Session, Dec. 13

Thursday December 13 11:00 a.m. to 12:00 p.m. *please note early start time* OHSU Hospital, 8B60 Presenters: Triana Nagel and Trish Lindstrom The Office for Human Research Protections considers recruitment part of the consent process. Join us for a discussion and tips on how best to proceed wit: developing an effective recruitment plan and what is approvable by the IRB; new FDA guidance on advertisements; and the informed consent process – is your subject truly … Read More

IRB Notes: eIRB Helpdesk

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

IRB Notes: Analyst notes on consent forms

Did you know that obtaining a signature on a consent form does not complete the consent process? Maintaining informed consent requires that subjects be provided with any new information that arises during the course of a study (such as changes to the research plan, change in risk/benefit profile, the results of related research, etc.) that may affect a subject’s decision whether or not to continue participation in the study. When such information arises, the investigator … Read More

IRB Notes: From the Chair’s Desk

Why are things sitting in Chair Screening so long? Unfortunately, due to staff changes, IRB Chair functions are operating at 25% capacity. The good news is that we have welcomed Dr. Betsy Haney, from the Division of General Internal Medicine, and Dr. Lynn Marshall, an epidemiologist in the Department of Orthopedics, as Vice Chairs on the IRB leadership team. Drs. Haney and Marshall have completed their training and are now diving into approving studies, modifications … Read More

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