Posts Tagged ‘IRB Notes’

Federal requirements dictate that studies and repository protocols be reviewed by the IRB annually. Continuing Review Questionnaires (CRQs) should be submitted at least 8 weeks prior to the expiration of your study/repository protocol, in order to ensure that there is adequate time to review and re-approve it. Please note that when a study lapses, all data collection, analysis and research activities must cease until it is reapproved. If you need assistance or have questions prior … Read More

Led by Andrea Johnson April 25, 2013, 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 integrated process. Come learn about: The changes to … Read More

The interactions between eCoI and eIRB The new conflict of interest reporting system housed in Big Brain, eCoI  has been up and running since late August. This system asks researchers to report Outside Activities and Conflicts of Interest (CoIRs) in one report; previously, this required two disclosures (one in the “old” CoIR disclosure system; the other in Big Brain). 1) CoIR Compliance in eIRB: Anytime a researcher has an eCoI submission “in the works” (awaiting … Read More

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

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

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 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

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

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

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