Efforts to improve informed consent for research usually focus on consent forms, making them shorter, less complicated, and easier to understand. A recent study revealed most parents decide whether they want their children to participate in research before they ever see a consent form.1
“We conducted this survey to better understand when people make decisions about participating—or not—in research,” says Stephanie A. Kraft, JD, an assistant professor at the Treuman Katz Center for Pediatric Bioethics at Seattle Children’s Research Institute.
The findings upend the traditional assumption in research ethics — that the consent form plays a big role in decision-making. “Yet most efforts to improve informed consent haven’t increased participant understanding to the degree that we might have hoped they would,” Kraft says.
Kraft and colleagues wanted to learn more about the timing of when participation decisions are made. They surveyed 88 parents who enrolled or declined to enroll their children in a study on a weight management intervention. Sixty-seven percent made their decision before receiving the consent form. Of those who remembered receiving the consent form, only 25% said it taught them new information.
“Even though people viewed the consent document as a valuable part of the process, it played a fairly minimal role in decision-making,” Kraft says.
Instead, decisions were made early. Often, parents made the decision after the first conversation with a member of the study team, or after reviewing recruitment materials. “Our findings suggest that we should be paying attention to these early interactions as places to improve how we support potential participants in making decisions about research that are right for them and their families,” Kraft suggests.
Staff are the first ones to approach people about the study. “[Staff] need to be provided the tools they need to support potential participants,” Kraft adds.
- Kraft SA, Porter KM, Duenas DM, et al. Assessing parent decisions about child participation in a behavioral health intervention study and utility of informed consent forms. JAMA Netw Open 2020;3:e209296.