Study participants retained more relevant information from a consent form based on revised U.S. Common Rule requirements than they did from other designs, according to the authors of a recent study.1

“People participating in a clinical trial require a lot of information,” notes Michael Yu, PhD, the study’s lead author. However, not all of that is important at the point when someone is deciding whether to enroll.

Obviously, contact information and detailed study schedules become important after someone decides to participate. “But it can distract and obfuscate more critical information during the enrollment decision,” says Yu, a postdoctoral fellow in the biomedical ethics unit at McGill University in Montreal.

To satisfy the needs of people with different values, consent forms usually include information that is irrelevant for individual decision-makers. “To this end, we wanted to explore ways to reformat informed consent documents that improve enrollment decisions, without removing information that could be important at later stages,” Yu explains.

Participants with an asthma diagnosis were randomized to one of five different informed consent documents: An original full-length document, a concise version, an interactive version, a re-ordered version, and a “highlights” version that followed the suggested Common Rule structure. Participants who saw the “highlights” version, which put important information at the top, were more likely to answer questions correctly.

“Our findings suggest that the Common Rule’s guidelines can improve recall of enrollment-relevant information without hurting recall of other material in the consent document,” Yu reports.

The “interactive” consent form allows participants to navigate to different sections of the consent form as they wished. “This version performed among the lowest of the formats investigated,” Yu says.

This suggests that people struggle to predict which categories of information are important to their enrollment decisions. “Efforts to personalize informed consent should recognize that people can benefit from guidance in what may be a complex and unfamiliar process,” Yu suggests.

Different types of information serve different purposes. “Highlighting the information about the clinical trial that is specifically important for the enrollment decision can empower people to make better decisions for themselves,” Yu says.

Those responsible for enrolling people into clinical trials should help potential participants navigate this information. According to Yu, informed consent documents “need to not only provide information, but also help people to use that information to make better enrollment decisions.”

REFERENCE

  1. Yu M, Fischhoff B, Krishnamurti T. Implementing a new Common Rule requirement for informed consent: A randomized trial on adult asthma patients. MDM Policy Pract 2019;4:2381468319839315.