NewslettersSummer 2021

NEWSLETTER- SUMMER 2021

Staffing Changes at the CHR RSPO

As you may have already heard, the RSPO is undergoing some staffing changes after the departure of Andrea Seykora from her role as Research Compliance Manager at CHR. Kaija Maggard and Melinda (Myndi) Bodayla will be stepping up to jointly take on Andrea’s responsibilities as well as continue to act in their existing roles. Kaija now oversees all things related to the IRB/Human Research Protection Program (HRPP) and Myndi is responsible for all things related to Research Compliance. Not sure which one to talk to? Email them both! Mark will remain in the role of IRB Trainer and Coordinator. We are currently looking to hire another IRB Coordinator; that position has been approved by the region and HR and we hope to begin the process of identifying candidates in the next few weeks. If you know of someone in the research space that has an interest in human research protection, regulatory compliance and/or research ethics, please notify them that the job will be posted shortly.

We appreciate all your patience and diligence while we navigate this transition.

Updated Waiver of Consent/Authorization Form and Accompanying Guidance

After receiving feedback from the research community, we worked with a group of project managers to revise the Waiver of Consent and Authorization Form. Big thanks to Celeste Machen, Sara Gille, Stefan Massimo, Jan Van Marter, Judy Donald, and Nadia Yosuf for all their help developing the new form.

The updated waiver form allows for more detailed documentation of waivers requested for different aims of the study. There are additional fields to enable study teams to provide more than one justification for the waiver. We’ve also removed the option for “data only” studies from the form; these requests are now done in the data only protocol template since they tend to be relatively simple to document.

We have also developed a new companion guide to the waiver request form, our Annotated Waiver Form. The annotated form contains point by point guidance explaining many of the more nuanced aspects of the waiver request process. We hope these two items will make the waiver request process easier to understand and document. Both the updated waiver form and the annotated form can be found on the Form and Templates section of our website, under the 'Protocol and Supplemental IRB Forms' section.

Compensation for KP employees for research

Gather round denizens of CHR, and listen to a tale; a tale as old as time. Truly compensation for KP employees as research participants is turning into one for the ages. Once upon a time, KP employees were paid for their participation in CHR research, and the research clinic did overflow with vanilla Ensure and honey. Then a wise oracle from the Ministry of Financiers warned of mysterious forces known as The Auditors, who it is said abhor conflicts of interest and will rain compliance headaches upon any institution known to be harboring such anathemas. A declaration went out throughout the land, or at least CHR, stating that no such payment may be given to a KP employee for their participation in any CHR research.

Well, the good people of CHR rose up and cried out, “This is wrong! Who will save us?” Then a figure rose from the crowd, unwavering and defiant, and removing the hood of her Slayer sweatshirt said, “I, Kaija Maggard, will not stand for this.” She cast a powerful spell with these words, “This policy is based on an overly conservative interpretation of the regulations...patronus!” With that a cheer went out throughout the land. KP employees would now be able to receive compensation for their participation in research as long as their inclusion is not related to their job role, or done on work time.

In reality it took a village of mighty forces and minds to work through the complexities of this issue and we want to acknowledge that Andrea Seykora, Kayline Allison, Chris Webber, the Research Compliance Committee, CHR Leadership, Mica Werner, Deralyn Almaguer, Britta Torgrimson-Ojerio and many others all put in hours of work to bring this new policy to fruition.

TLDR (too long didn’t read): Researchers can now pay KP employees for their participation in research if the study is unrelated to their status as KPNW employees and participation is on non-work time.

Policy Updates

There are no updates to report this quarter.

IRB Tips and New Information

Tables in IRBNet Smart Forms – Turns out, IRBNet hates tables. When entering information in the free text fields of the smart forms in IRBNet, using tables will break the resulting PDF file. Please attach any tables you need to reference to the package as Word or Excel documents. Big thanks to Jeff Fellows for his perseverance in troubleshooting this problem with me. v

Mark Mac’s Media Corner

How should we think about requiring a COVID vaccine in research?

For all the challenges of the last year, the pandemic has forced us to think about healthcare and research in new and innovative ways. Similarly, the field of research ethics has also been forced to grapple with some new and novel dilemmas. Last month we had a wonderful discussion at the IRB meeting after reading the article ‘Can we require COVID-19 vaccination for research participation? Should we? A group discussion from the SBER Network.’ Is the IRB within its purview to allow (or even require) researchers to enact this precaution? The answer may shock you! Just kidding; the answer is ‘it depends.’ It’s always ‘it depends.’ For those interested, here is that discussion, in two parts:

Part 1

Part 2