Do informed consent forms impact whether parents allow kids to participate in research?

August 25, 2020

Research is key to improving children’s care. How much does the informed consent form factor into a parent allowing their child to participant in research studies?

Research is an important element to improving the care of children, but parents may be leery of enrolling their child into research studies. A report in JAMA Network Open looked at whether the timing of the decision to enroll a child into a weight management intervention study was linked with review of the informed consent form.1

Investigators sent an online survey to 88 parents who had either enrolled or declined to enroll their child in a weight management intervention study that was run between January 2018 and June 2019. The surveys were completed between February 2018 and July 2019. The survey had 31 items that covered a variety of topics including impressions of the study during the enrollment process, timing of enrollment decisions, and decision-making factors.

Of the 88 parents who completed the survey, 67 had enrolled their child in the study and 21 had declined. Nearly all of the parents responding to the survey were female and 75% of the participants were non-Hispanic White. Nearly three-quarters of the participants had a household income that was greater than or equal to $70,000. There were no significant differences found between the respondent characteristics of enrollee parents or decliner parents. Fifty-nine of the parents said that they made decision to enroll their child in the study before receiving the consent form. Just 25% of the parents who remembered getting the form say that it had given them new information.

The study did have limitations. One was the fact that the weight management study examined was an intensive one that required a lot of time, which could have factored into the decision to enroll in the study. The study was also passively recruited and required parents to contact the study’s investigators to begin enrolling their child. Additionally, the sample of declining parents could be biased because parents who had negative associations with the weight management study may have decided against providing their contact information to the investigators of this study.

The researchers concluded that any push to improve informed consent forms may not influence the decision making process because the choice to enroll was often made before the forms were received. The focus of improving parental decision making should be on early engagement with parents, such as during the recruitment period.

Reference

1. Kraft S, Porter K, Duenas D 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(7):e209296. doi:10.1001/jamanetworkopen.2020.9296