FALL 2019

RSPO Satisfaction Survey Results Are In

Thank you to everyone that took the time to fill out the recent satisfaction survey. Your feedback and comments help us to know what’s working and where we can still improve, unlike your DMV comment card, which is still gathering dust in the drawer of someone named Karen, or Herb. We are continuously updating the website with new and revised guidance materials so please continue to check out the forms and templates section of the website and the library in IRBNet. We want to take this opportunity to express our appreciation for everyone’s efforts during the IRBNet rollout. With equal parts patience and persistence, the research community here at CHR has been really fantastic to work with during this transition. So, the survey is closed, but don’t let that keep you from reaching out to let us know how we can help.


Express Exemption Pilot Says Farewell

After a whirlwind 6-month courtship, RSPO and Express Exemptions have decided to call it quits. Sources close to the two (that did not wish to be named) have suggested that the honeymoon is over, and the pair will be “consciously uncoupling” in the upcoming weeks. Moving forward, study teams should employ the usual submission process in IRBNet, and can still schedule a meeting with the RSPO to review study design and regulatory requirements. Mark McNamara, IRB Coordinator, released a statement over the weekend to assuage any concerns. “The RSPO’s focus continues to be on the investigators and their work. We want to reassure the investigators that this is not their fault and RSPO loves them very much. Sometimes the RSPO and processes just drift apart.”


IRBNet Automated Reports

Now that we’re up and running in IRBNet, KFRI has begun auditing IRBNet to make sure that all the data is feeding into reports appropriately. We may be reaching out to you if we get an error report that affects a study you are working with the IRB on. So far most of these have been typos or transposed fields. So, in summary, no action is required on your part now, but don’t be surprised if we ask you to edit a form that has been in the system for a while.

IRB Tips and New Information

Yellow is the new Red – As you may have noticed, the IRBNet displays an expiration date next to your list of projects when in ‘Project Status View.’ You may have also noticed that depending on how close to the expiration date your study is, the date will change color. Dates turn yellow 30 days prior to expiration and red once they are expired. Essentially, if you see a yellow date next to your project and have not already submitted your continuing review package, you’re already past the due date and it’s time to get cracking. If you see a red date, the team will have to stop all study related activities. As a reminder, continuing review packages are due four weeks prior to expiration for minimal risk studies, and greater than minimal risk (full board) studies are due the first working day of the month prior to expiration (example: if the study expires on 10/3, the CR would be due on the first business day of September).

Mark Mac’s Media Corner

History in Healthcare - This summer I was fortunate to take part in a tour of Portland with my Kaiser department. The focus was to highlight the inequities experienced by disenfranchised communities over the course of Portland’s history. One of the more striking moments was learning that the Portland Expo Center was once used to imprison American citizens of Japanese heritage during World War II. The podcast “Sawbones” focuses on the history of medicine (including some of its missteps), and in this episode talks about how interned Americans of Japanese heritage ended up taking on the role of health care providers in the camps. It’s an amazing (and at times emotional) episode.

Medical Device Approval - John Oliver looks at the different regulatory pathways through which Medical Devices are marketed and introduces us to a geriatric hip-hop dance troupe. Please note, this clip contains adult language.