NEWSLETTER

WINTER 2020

Research Compliance Has Moved!

The Research Compliance team has moved from WIN to 3800. Our new home is the “Compliance Cave” — the offices in the hallway across from Lucy Savitz’s office. We miss our dear friends at WIN (and the natural light), but we look forward to connecting with more of you at 3800! Please feel free to swing by any time to say hello, check out our new digs, and try to stump us with your most vexing compliance questions.


What Happens When Research Participants Call the Compliance Manager?

Every single informed consent document used in KPNW research contains the direct phone number for the Research Compliance Manager. This helps ensure that individuals can easily express concerns or ask questions about their rights as research participants. 

So … what happens when people call that number, or does anyone ever call it? 

Yes, participants do call, although not very often: The Research Compliance Manager receives around 10-15 calls per year. Calls are documented and tracked in a spreadsheet. 

Will I find out if a participant calls about my study? 

Most participant calls center on questions that need to be answered by the study team, and they are provided with assistance in reaching the right person. You won’t be notified if participants want to address a concern with the Research Compliance Manager. When a participant calls with a concern, the Research Compliance Manager follows our policy – NWRC.HRP.115, Response to Questions, Concerns, and Complaints – to resolve the issue. The Principal Investigator and research team are involved in the resolution as appropriate, depending on the situation. 

I’m burning with curiosity and want to know if people are calling about my study.  Will you tell me? 

Sure! Contact Andrea.M.Seykora@kpchr.org if you have any questions about this process.


I may see dead people, but now that I’m an IRB Coordinator, I don’t oversee the use of their data in research.

By Haley Joel Osmond’s character in “The Sixth Sense”

First, let’s just get one thing out of the way: I have a name. So why do I reference HJO instead of telling you my name? Because all anyone remembers from that movie is his adorably terrified face and his name. Oh, and that Bruce Willis had finally just embraced baldness and damn if he didn’t look spectacular (even for a dead guy — oops, spoiler alert!).  

With that out of the way, I want to talk about my new passion: regulatory compliance. That’s right — I got out of the scared kid game and super into the common rule.

Now that I’m an IRB Coordinator, I don’t worry about the deceased quite as much. Do I still see their tortured faces on my commute, at the gym, and in the bagel shop? Of course I do, and I wouldn’t have it any other way. What’s different is that I no longer have to worry about their data being used in research. You see, IRBs don’t have oversight of data belonging to the deceased (or a “decedent”) since they do not meet the definition of a “human subject.” So now, when Abraham Lincoln’s ghost approaches me about the flagrant intellectual property violations in the 2012 sleeper hit “Abraham Lincoln: Vampire Hunter,” I can tell him, “Abe, you know I’d love to help you out, but that’s outside my jurisdiction.” Seriously, though, that guy’s the best.

If you do want to use decedent data for your research, the best thing to do is to fill out a decedents form and email it to CHR_complianceapprovals@kpchr.org.


Policy Updates

To stamp or not to stamp, that is the question. Authorizations don’t get stamped or “published” — the IRB “acknowledges” rather than “approves” them. Only participant-facing physical consent process documents (information sheets, consent forms, combined consent/authorization forms) receive an IRB stamp. Consent phone scripts, web information sheets, and the like are not published in board documents with a stamp.

IRB Tips and New Information

Reliance Inquiries Point of Contact – In order for our office to streamline and organize the increasing volume of reliance (cede) requests, all new inquiries should go to Kaija Maggard first.

New Modification Quick Guide – The new Modification Quick Guide is now available on the Research Compliance website. It’s an annotated crash course in prepping and submitting mods in IRBNet. If you’re submitting for the first time, or are an infrequent user, this is a useful tool to have handy.

Mark Mac’s Media Corner

“The Inventor: Out for Blood in Silicon Valley” (HBO) – A portrait of the cult of personality combined with venture capitalism run amok. Brainchild of Stanford drop out Elizabeth Holmes, her company Theranos was supposed to democratize the health care industry, envisioning a Keurig-sized machine in every house where you could run your own tests on micro-droplets of blood. As it becomes clearer to investors and her own colleagues that the underlying technology doesn’t work, it’s hard to know who Elizabeth Holmes deceived more: those around her or herself. As an aside, there’s a TV mini-series in the works with Kate McKinnon (“SNL,” “Ghostbusters”) signed on to play Elizabeth Holmes!

“How the Placebo Effect Works” (Stuff You Should Know podcast) – Everything you wanted to know about placebos but were afraid to ask. For example, the word placebo originated from the Latin word which means “I will please.” It became associated with mourners who were paid to attend a funeral in order to make the bereaved feel better. The first recorded medical use of placebos was in the late 1700s, and the word was generally used to describe many commonplace medical practices and medicines. Listen or download here.