Clinical trials are vital to developing new treatments and therapies for medical conditions affecting both people and animals. But veterinarian Dr. Caitlin Feiock wants to know if participants signing consent forms for these trials understand everything laid out in the form text—and she’s heading to the Minnesota State Fair to find answers.  

Feiock, an assistant professor at the College of Veterinary Medicine (CVM), will be conducting a study at the fair in the University of Minnesota’s Driven to Discover Research Facility that seeks to determine if the reading level of a consent form affects a participant’s comprehension of the trial and their willingness to participate as well as if demographics play a role in these factors. 

“To our knowledge, there has only been a single study assessing the readability of veterinary clinical trial consent forms,” Feiock says. “This study found that the average veterinary clinical trial consent form was written at a 13th-grade reading level, suggesting that most forms were written at a level that required a college education to read and understand.”

Studies indicate the average American reads at around an 8th-grade level, meaning the language used in many consent forms may present reading comprehension challenges for many potential participants.

The topic of consent forms is one Feiock encounters daily. She manages the Veterinary Clinical Investigation Center at CVM, which facilitates clinical trials targeting ailments such as cancer, osteoarthritis, and urinary stones in animals like dogs, cats, and horses. Pet owners signing their pets up for these trials complete a consent form as part of their paperwork. The principle that study participants—or in this case, pet owners—have and understand the information presented in these forms is called informed consent. 

“Informed consent is an essential component of conducting ethical clinical research, and the requirement of informed consent is contingent on the assumption that those individuals who are considering participating in clinical research have adequately understood the information provided to them,” Feiock says. “However, it has been reported that prospective participants in clinical research may understand only 30-81 percent of the information in standard consent forms. Presenting materials to clients that are readable and understandable is imperative to ensuring that we are approaching veterinary medicine and clinical trials in a way that is equitable and accessible.”

To collect study data, participating fairgoers will be presented with either a fictitious consent form written at a 6th-grade reading level or one written at an 11th-grade reading level. After reading the consent form, participants will then be asked an identical series of questions regarding the content of the consent form, and whether they would choose to participate/enroll their pet in this clinical trial and provide reasoning for why they would or not. 

Participant demographic information also will be collected, but participants will remain anonymous, and no identifying information will be collected. Feiock estimates this will take participants 10 to 20 minutes to complete.

If you’re interested in participating, the CIC team will be onsite at the fair from 9 a.m. to 2 p.m. on Wednesday, Aug. 28 and Friday, Aug. 30 in the Driven to Discover Building, located at 1367 Cosgrove Street. (Click here for a map)