IRB Notes

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

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

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