Posts Tagged ‘research integrity’

It is important to report potential breaches of confidentiality to both the Institutional Review Board and the Office for Information Privacy and Security as soon as possible. For the IRB, a breach of confidentiality can be considered an Unanticipated Problem, a Protocol Deviation, or both. Submit an Unanticipated Problem (UP) report if: The incident was unanticipated and may place subjects or others at a greater risk of harm or discomfort. A confidentiality UP involves any … Read More

It’s that time of year again. The weather is warm and our student researchers are finishing up their school year. So here are some things for you to think about: If a student has been serving a major role on the project, plan for who is going to complete any analyses and assume administrative or regulatory duties (e.g., the next Continuing Review!) Update personnel as appropriate. Remove students if they are no longer going to … Read More

Due to a change in the HIPAA Privacy Rule, the Institutional Review Board has revised its consent and authorization templates so that all informed consent and authorization elements are combined into a single form that requires only one signature from the subject. Please follow the detailed instructions within the template to customize the form for your study. Additional consent and authorization form guidelines and instructions are available here. The new templates are available on the … Read More

May 23, 2013 Presented by: Melinda Allie and Kaija Maggard 11:30 a.m. to 12:30 p.m. UHS 8B60 Determining what is human subjects research and what is not can feel like a tricky process. Come discuss with the IRB Analysts why you must submit a request for determination to the IRB and gain a clearer understanding of how these regulatory-based decisions are made. Topics include: Quality Assessment and Improvement v. Research Human Subject v. Non-Human Subject … Read More

OHSU’s Institutional Animal Care and Use Committee (IACUC) is committed to the humane use and care of animals in biomedical research.  To uphold the highest standards in animal research, the IACUC has implemented an innovative new resource to satisfy animal care and use training requirements.  The American Association for Laboratory Animal Science (AALAS) Learning Library offers a wide variety of courses that are both general and species-specific.  These specialized modules can be used to help you gain … Read More

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