IRB Notes

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

Urgent notice: Door hinge replacement needed for certain Forma CO2 incubators

ThermoFisher Scientific has released an urgent field correction notice on certain Forma CO2 Incubators manufactured between April 2001 to September 2009. There is a possible problem involving the metal coated outer door hinge. If the hinge fails, the door may fall and could cause injury. The following incubator models are affected: Forma branded SteriCult models 3307, 3308, 3310, and 3311 Thermo Scientific NAPCO 8000 models 3584, 3585, 3598, and 3599 Thermo Scientific Series 8000 models … 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: 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

Brown Bag: Consent Forms, June 28

A well-written consent form significantly increases the efficiency of IRB review.  This brown bag session is designed to provide an overview of consent form writing. Handouts will be available to assist participants in the continuing pursuit of the well-written form. Topics include: Templates and boilerplate language Writing style Organization of procedures and risks Common corrections When: Thursday, June 28 from 11:30 a.m. to 12:30 p.m. Where: MacDonald Auditorium at Casey Eye Institute Bring your lunch … Read More

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.

Participation Guidelines

Remember: information you share here is public; it isn't medical advice. Need advice or treatment? Contact your healthcare provider directly. Read our Terms of Use and this disclaimer for details.