Posts Tagged ‘IRB Notes’

Spring 2013 Institutional Review Board (IRB) analyst brown bags

April 25, 2013: The new and improved HIPAA research authorization process Led by Andrea Johnson 11:30 a.m. to 12:30 p.m. in UHS 8B60 New HIPAA regulations and guidance, which take effect on March 26, 2013, allow HIPAA authorizations for research studies to be built into the consent form in nearly all cases, even when the research has optional components. They also permit authorization for future research. This means fewer forms to submit and a more … 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

Guidance on Data Safety and Monitoring Plans Brown Bag, March 28

Thursday, March 28, 2013 OHSU Hospital, 8B60 Presenter: Trish Lindstrom The Institutional Review Board (IRB) is responsible for evaluating a study to determine, among other things, whether risks to subjects are minimized and risks to subjects are reasonable in relation to anticipated benefits. Part of that evaluation is to determine when data and safety monitoring is required and if so, what type and degree of monitoring provisions should be in place. We will cover: When … Read More

Repository Refresher brown bag, Feb. 28

Repository Refresher or “I got my repository approved…now what??” Andrea Johnson Thursday, February 28, 2013 at 11:30 a.m. in UHS 8B60 What happens with those stored data and specimens now that you’ve written the protocol, created the tracking spreadsheet, and drafted the submission and sharing agreements? This session will include: A brief refresher on the requirements of OHSU’s repository policy Guidance on how to manage and document the submission and sharing of repository materials Tips … 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

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