For someone weighing whether to participate in a clinical trial, receiving a 20-page consent form can act as a deterrent. “IRBs should be thinking about the consequences of information overload,” says Susan E. Morgan, PhD, vice dean for research and creative activity at the University of Miami (FL).
The current format of informed consent hinders adequate accrual to clinical trials. “It’s so much easier just to dismiss the opportunity, just so they don’t have to endure the hell of being ‘informed’ about an optional clinical trial,” Morgan says.
The challenge is for patients to truly understand what is involved with clinical trial participation without information overload. “IRBs should investigate ways to inform patients about risks and benefits, just as importantly, in a way that is friendlier,” Morgan offers. “Patient care has become more patient-centric, so why hasn’t the informed consent process?”
Few people fully comprehend everything in informed consent forms. The ethical concern is people are asked to sign something they do not really understand. “Patients also have trouble figuring out whether clinical trial participation is going to be a good fit for their circumstances,” Morgan adds.
Morgan and colleagues created an interactive information aid to provide tailored information to patients, based on their own values and personal circumstances. (The beta version of the tool is available here.)
“The information aid is completely unique, because it’s tailored to the information needs of people based on their circumstances — but also because of the multimedia format,” Morgan says. The tool includes animations instead of traditional text-based approaches. “It improves meaningful informed consent, or informed refusal, and that’s something that IRBs should find very attractive,” Morgan offers.
Morgan and colleagues surveyed 302 cancer patients and survivors about factors that would be barriers to or help facilitate their participation, and then asked them to evaluate the information aid.1 Participants reported the information aid significantly alleviated their fears and boosted their knowledge. “It has real potential to help cancer patients understand the complicated concepts associated with clinical trial participation. It makes the whole process much less intimidating,” Morgan says.
The reality is potential participants are not always making an entirely informed decision to participate in research, says Andria Bianchi, PhD, a bioethicist at the University Health Network in Toronto. Sometimes, the problem is the terminology used in the forms.
For instance, many people receive a long form referring to an investigational drug as “treatment” without any discussion of what that really means. Many people who sign the form assume they’re agreeing to receive a proposed, proven treatment. “This would not be an example of informed consent to research participation,” Bianchi says.
Ultimately, the onus is on the research team to offer information about the study in a way that enables informed decision-making. Depending on the study population, that might mean verbal explanations, written text, pictures, diagrams, or large fonts.
“Getting a signature on a form does not necessarily mean that a person has made an informed decision,” Bianchi asserts.
REFERENCE
1. Morgan SE, Peng W, Occa A, et al. Tailored messages about research participation: Using an interactive information aid to improve study recruitment. J Cancer Educ 2022;37:16-22.
For someone weighing whether to participate in a clinical trial, receiving a 20-page consent form can act as a deterrent. IRBs should be thinking about the consequences of information overload.
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