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Human Subjects Division (HSD)

Quick Tips from HSD

Exempt Status Changes

Aug 8, 2013 at 12:00am

 

"I can't seem to get my subjects to answer the survey questions honestly." The research scientist sighed as she sipped her rapidly cooling latte. "Three of them are clearly trying to give me the answers they think I want to hear, and one is thoroughly combative." She traced her finger around a coffee stain on the table.

"How about changing the survey questions?" Her colleague was always giving unwanted advice.

"No…" She sighed again. "I've been through these questions backwards and forwards; this is just a classic example of demand characteristics. I need to use deception so they don't know what I'm trying to evaluate, but the study is otherwise Exempt. I didn't want to do anything that was going to mean going through the full-fledged IRB review process." The research scientist rested her elbows on the table and placed her chin in her hands, thinking of all the paperwork, and of the lost funding for the coordinators who used to handle all the details.

"Psst..." she hears a breathy whisper from behind. At first, she thinks it's the milk steamer at the espresso counter.

"Hey, ahem!" A louder cough and a nudge finally force her out of her paperwork fog.

"Yes?" she turns around.

"Haven't you read the latest HSD eNews?" A slightly accusatory voice pipes up from behind an enormous laptop.

"Well, I was going to…"

"If you had, then you'd know that HSD just changed its policy regarding the automatic exclusion of studies that use deception from the Exempt Status." The unseen speaker continued: "Now studies using deception or concealment may qualify for Exempt Status when all applicable Exempt criteria are met and when the deception or incomplete disclosure is necessary to ensure valid results."

"What?" The research scientist's colleague exclaimed. "Is that true? Or are you deceiving us right now?"

"No!" squeaked the voice from behind the laptop. "As long as the deception isn't being used to get subjects to do something that they wouldn't do if the information was fully disclosed to them and as long as the deception creates no more than minimal risk of physical or emotional distress."

The research scientist smiled."Where did you get all this wonderful information?"

"Just read that new Standard Operating Procedure about Exempt Determination!" The unseen speaker quickly slammed the laptop shut and hurried out the back door.

"Who was that elusive person, anyway?" The research scientist turned back to her colleague and sipped the last foamy bits of her coffee. Now the smiley face the barista made in the crema seemed appropriate.

"It sounds like you should definitely be reading that eNews!" Her colleague exclaimed.

Sigh. More unwanted advice.