Factors That Influence Parental Decisions to Participate in Clinical Research

Abstract

Objective To determine factors associated with parental consent for their child’s participation in a randomized, placebo-controlled trial. Design Cross-sectional survey. Setting 7 Children’s Hospitals participating in a randomized trial evaluating management of children with vesicoureteral reflux; July 2008 to May 2011. Participants Parents asked to provide consent for their child’s participation in the trial were invited to complete an anonymous online survey about factors influencing their decision. 120 (44%) of the 271 invited, completed the survey: 58 of 125 (46%) had provided and 62 of 144 (43%) had declined consent. Outcome Measures 60-question survey examining: child, parent, and study characteristics; parental perception of the study; understanding of design; external influences; and decision-making process. Results Having graduated from college and private health insurance were associated with lower likelihood of providing consent. Parents who perceived the trial as having low degree of risk, resulting in greater benefit to their child and other children, causing little interference with standard care or exhibiting potential for enhanced care or who perceived the researcher as professional were significantly more likely to consent to participate. Higher levels of understanding of randomization process, blinding, and right to withdraw were significantly associated with consent to participate. Conclusions Parents who declined consent had a relatively higher socioeconomic status, had more anxiety about their decision and found it harder to make their decision compared with consenting parents, who had higher levels of trust and altruism, perceived the potential for enhanced care, reflected better understanding of randomization, and exhibited low decisional uncertainty.

Health benefit for the child and promotion of the common good were the two most important reasons for participation in the FinIP vaccine trial

“…Promotion of the common good and public health was the second most important reason to participate. It can be interpreted as a form of altruism, which in previous studies has been discovered to be an important reason to participate in clinical trials [9,[11][12][13].…”

Asking For Parents' Permission to Enroll Their Child Into a Clinical Trial: Best Practices

“…12,15 Establishing the research team's credibility with the clinical team in front of the parents may also increase the likelihood of obtaining parental permission because parents who have a positive perception of the research team are more likely to provide permission. 10,11,17 Investing the time to build a professional relationship between the research team and the family also promotes both recruitment and study retention. 10 Specific team members present during the consent discussion may affect parents' understanding.…”

“…Parents who do not feel pressured and believe that the study is important, will benefit their child, has a low level of risk, and will not interfere with standard care are more likely to provide permission. 16,17,23 Tailoring the amount of information provided to the needs of the parents is also an effective strategy. 21 Use of additional tools such as a video or study brochure may also increase understanding, and is highly encouraged.…”

“…These include learning more about their child's illness, altruism in contributing to medical knowledge, belief that there would be a direct benefit to their child, and perception that there would be no negative outcomes. 17,23,24 Families who did not provide permission report that they felt they were given too little information, the consent discussion was rushed, or that the clinical trial would affect their child's care or place more burden on the child. 13,16,19,23 Other factors resulting in unwillingness to provide permission included parental anxiety around making the decision, parental difficulty making the decision, parents with a higher educational level, and parents of children with a chronic disease.…”

“…13,16,19,23 Other factors resulting in unwillingness to provide permission included parental anxiety around making the decision, parental difficulty making the decision, parents with a higher educational level, and parents of children with a chronic disease. 11,13,17 This discussion highlights the many complex and interrelated components of the consent process when attempting to obtain parental permission for a child to participate in a clinical trial. Interestingly, most research team members learn how to obtain parental permission "on the job" through informal training and observation of a mentor.…”