NEWSLETTER

SPRING 2020

Single IRB or sIRB! – By Kaija Maggard

You’ve heard the words tossed about over the past year and half and might still be wondering, what does this mean? sIRB is the term du jour for what we all know as a “reliance” or “cede” arrangement. However, while sIRB is not really any different than a cede/reliance scenario, there are some new pieces of information that we, and sites who act as an IRB of record for us, need to make sure are accurately documented. We’re talking local context, institutional nuances at participating sites, etcetera. The RSPO has been hard at work over the last 6 weeks updating our website with new information and finalizing the documentation we require in sIRB scenarios. To make sure you are on the cutting edge, please go to our website and take a look at the Reliance page. Give us a call or shoot us an email, too, if you have questions about navigating the process.

Website Updates – By Mark McNamara

In addition to the new reliance guidance documents and forms that are now posted, the RSPO wants to highlight a couple of new additions to the website.

With more than 50 years of combined experience working in regulatory compliance, the RSPO team has compiled our ‘Top 10 Best Practices for Efficient IRB Review.’ We’ll be referring to this document often so please give it a look over and let us know if you have questions. To say this document is “recommended reading” would be an understatement.

The ‘RSPO Service Level Expectations’ document outlines what you can expect with regard to submission deadlines, turnaround times, and office workflow for both the IRB and for data transfer requests. It’s basically a ‘What to expect when you’re expecting’ for IRB submissions.


Data Commitments FAQs – By Melinda Bodayla

Q: Why are there so many studies on the “my data commitments” page?

A: The “my data commitments” page is for the data commitment coordinators (DCCs). You must use the “search” function to find your project. The ProBud number is the best way to search. If you do not have the ProBud number, you can use the project title or the PI name.

Q: What should I do if can’t find my project? 

A: If you can’t find your study, it may not have migrated from the SPA database yet. If it’s a new project, try again in a week. If you are a DCC, which is usually the data analyst, you must be assigned to a project to have access. If you are a PM, contact CHR_ComplianceApprovals@kpchr.org and we will troubleshoot.

Q: I don’t see the Data Transfer Request (DTR) button?

A: A “share with” commitment must be created prior to a DTR. Please work with the DCC to get commitments entered for the project.

Q: I have more than one project with the same title. Which one should I use to enter my commitments?

A: Any time there is new funding for a project, a new ProBud number will be generated and a new project will populate in Data Commitments. New funding could include an additional funding source, additional grant funding, year-to-year funding, etc. These projects can be linked by a Data Commitment Administrator. Once projects are linked you can access the data commitments, and DTRs from any of the ProBud numbers/projects. This means you can also enter new commitments, and DTRs from any of the linked projects. If you would like projects/ProBud numbers linked please contact CHR_ComplianceApprovals@kpchr.org.

Q: I already have a Data Use Agreement (DUA), Data Transfer Agreement (DTA), or other agreement, why do I also need a DTR?

A: The agreements DUAs, DTAs, etc. are agreements with outside agencies. The DTR is an intra-CHR agreement and allows Research Compliance and IT to confirm that the data and/or samples being sent, received, or stored are in alignment with CHR policy, procedure, and with the project’s IRB-approved protocol.

Q: My study is unfunded, so there is no ProBud number. How do I track commitments and submit a DTR?

A: We have a ProBud number set up specifically for unfunded projects. Please contact CHR_ComplianceApprovals@kpchr.org and we will give you the ProBud number and instructions on how to enter the information.

For more information on sharing data, including the Data Commitments Tracking Overview and the Data Commitments Tracking User Guide, please see the Research Compliance website. If after reviewing both documents you still have questions, please contact CHR_ComplianceApprovals@kpchr.org.


IRB Tips and New Information

Welcome to our new IRB Chair Sam Wasmann, MD

Sam Wasmann, MD, a KP internist practicing in Beaverton, has served on the Institutional Review Board as one of our trusted medical reviewers for six years now, and we are excited that he has agreed to assume chair responsibilities. A true Northwest native, Sam has lived, studied, and practiced medicine in Oregon and Idaho his whole life. When not caring for members or debating ethical dilemmas, he enjoys hiking, mountain biking and cooking. As previous board chair Ryan Radecki, MD begins his adventures in the down-under, Sam is well poised to lead the IRB here in the up-over. Please join us in congratulating Sam on his appointment to the chair position.

Mark Mac’s Media Corner

“Sawbones Podcast Episode 327: The Black Panthers and Public Health – This was a great podcast to educate me about the Black Panther movement and how they made a very intentional push to try to improve their community through advocating for adequate health care. Great listen! Find it here or wherever you download podcasts.