The classic admonition in pediatric medicine is “children are not little adults,” implying in part that you cannot just scale down adult care and treatment. Does this phrase resonate as well in human research trials involving children, particularly around issues of consent for the former and assent for the latter?
“Yes, I think that many of the practices that we have related to assent [in children] come from the adult model of consent, which is problematic for several reasons,” says Victoria A. Miller, PhD, director of research in the Division of Adolescent Medicine at the Children’s Hospital of Philadelphia (CHOP). “Kids are a moving target in terms of developmental changes — cognitively, but also emotionally and psychosocially. They have varying levels of experience with decision-making generally, and certainly in terms of whether they have participated in research or not, how familiar they are with the medical environment, and, specifically, health-related decision-making. They are learning how to make decisions.”
Miller is researching ways to empower children in this process, though ultimately, their parents must agree to participation in a clinical trial as part of relational decision process involving both parties.
“I think that the assent process is really an opportunity for them to practice” making decisions, she tells IRB Advisor. “And also, I would apply this to adults as well. Kids are not alone in a vacuum. They want parental input. They need parental input in decision-making. Other studies have shown that they do want the parents’ guidance. The focus on autonomy and competence can really detract from this idea that decision-making is really a relational process and there are multiple individuals involved. There are many ways the kids can and should be involved in the decision.”
Delving into this concept, Miller and colleagues conducted a study1 to analyze children’s involvement in decisions about research participation, including their perceptions of the decision-making process and “self-efficacy.” Children, ages 8 to 17 years, who were enrolled in research studies in the previous two months were asked to complete a questionnaire with their parents’ involvement that centered on three decision-making types:
- researcher engages child;
- researcher supports autonomy;
- child participates.
The study was approved by the CHOP IRB. After obtaining parental permission and child assent, research staff administered the questionnaires separately to parents and children by phone or in person if the family preferred.
Higher scores on the researcher-engages-child category were associated with greater self-efficacy in children, and higher scores on the researcher-supports-autonomy type were associated with greater perceived fairness by kids.
“These data underscore the potential importance of researcher–child interactions about research participation when assent is sought, including proactively involving children in the decision by asking for their opinions and communicating their central role in the decision, which are likely to be more meaningful to children than receiving information or signing a form,” the authors concluded.
IRB Advisor asked Miller to elaborate on some of the findings.
IRB Advisor: You found higher scores with one approach correlated with greater self-efficacy, while another was perceived with high fairness. Can you comment on the implications of these findings for IRBs and researchers, respectively? Should studies that seek assent through these approaches be encouraged?
Miller: Yes, absolutely. I think because of using the adult model of consent as the model for [child] assent there has been too much focus on the assent form and disclosing certain bits of information and covering all of these different details about the proposed research that may or may not be important for kids to know. I can’t make a blanket statement about what should or should not be included because I did not look at that specifically, but I think because of the focus on information disclosure we’ve neglected this idea of “how do we talk to kids?” So, yes, I think the findings support the idea that investigators and research staff should be encouraged to talk to children and ask their opinion: “What do you think? What are you concerned about?” The ultimate question is, “Do you want to do this or not?”
This is about really understanding where they are coming from and how they are thinking about the decision. I think it is important and beneficial to kids to have that kind of discussion and interchange, as opposed to, “Here are 10 bullet points on these different details about the study.” Yes, that’s important for parental permission, and it is important for adult informed consent, and it gets more important as the child gets older and more cognitively mature, and closer to the legal age of competence. But for many kids, most of that information is less important.
IRB Advisor: In a sense, could pursuit of these issues open a path to better assent or informed consent and ultimately improved protection and reduced risk to children participating in trials? Is there some perception or concern that children need these protections; i.e., that they and their parents may be assenting to inappropriate or higher-risk research than warranted?
Miller: No, not necessarily. That’s not the assumption of my research. The IRB is tasked first of all with judging whether the risks are reasonable in relation to the benefits. And then parents as well are tasked with that for their individual child when they are asked to provide permission for the research. So, I think the idea of risk is less relevant when it comes to kids, although certainly enhancing the assent process gives kids an opportunity to express their own concerns about the procedures involved. For example, whether they are comfortable or not. Or whether participation [in the research] could be emotionally stressing in some way. Whether or not those meet the level of risk as we think of it from an IRB perspective, I think that’s up for debate.
IRB Advisor: Can you elaborate on the meaning and impact of “self-efficacy” in concluding that, “when children perceived that researchers proactively engaged them by soliciting questions and asking for an opinion, children reported greater decision self-efficacy?”
Miller: Self-efficacy in general refers to competence in one’s ability to perform certain actions that are needed to produce a desired result. There is self-efficacy for many different things; there is self-efficacy for losing weight or for managing type 1 diabetes.
In this context, I measured self-efficacy related to health decision-making. This study assessed things like, “How confident are you that you can understand what your parents or doctors are telling you? How confident are you that you can ask questions without feeling dumb? How confident are you that you can talk to your doctor about what worries you?” Those sorts of things. I think that is really important when we think about involving kids not only in research decisions, but all sorts of medical decisions. By sending the message, “You’re opinion matters. We want to hear what you think. We’re listening to you,” that gives them confidence, hopefully, to play more of a role and be better able to make decisions in the future.
IRB Advisor: So you see ancillary benefits beyond just checking the box that assent was given?
Miller: There are certainly ethical and legal reasons to acquire assent for research participation, but I think the process of assent can benefit kids. It’s like being in a lab and practicing, making these sorts of decisions and hearing how people talk about decision-making. Hearing that their voice does matter and that they can play a role — and should play a role — in that decision in some way.
IRB Advisor: Your findings also underscore that, among children who enroll in research studies, explicit communication that addresses the child’s right to decline participation is associated with more favorable views of the decision-making process. While you note the conflict with parental permission, can you comment on why this “right to decline” is important in child research subjects?
Miller: I think in a medical environment, children aren’t accustomed to being able to say, “no.” Much of that happens because it has to happen; it is a clear benefit to their health. So, the right to decline is really unique here. I did find that it was associated with favorable views of decision-making, partly because kids are not used to hearing that. I think that they recognize and, hopefully, appreciate that they do have the choice about whether or not to participate. Obviously, you can’t have assent without also having the right to decline. When you are asking children whether or not they would like to do this, the right to decline has to go with that.
IRB Advisor: Children’s verbal participation in the assent discussion (e.g., expressing an opinion, asking questions) was not associated with perceptions of fairness or self-efficacy. That seems counterintuitive. Can you comment on what may have happened there?
Miller: I think there are a lot of potential reasons for that. As we mention in the paper, I’d say in both the research context and the clinical context children’s verbal participation is low in these types of encounters and discussions. There is clearly a power differential. They are used to parents deciding in these situations and being the prime communicator. Parents do intervene with kids’ verbal participation as well. There is research showing that the parents will jump in, interrupt, and answer questions that are directed to the child. Also, the kid may just lack the communication skills to speak up. There are adults, of course, that often don’t participate a lot in medical encounters.
Another potential explanation is just that the questionnaire didn’t really capture the children’s verbal participation adequately. Although I have found [something similar] in another analysis that I am doing right now. Ultimately, it just might be that whether the child is actually speaking up or not, it’s again those messages and behaviors from the adults that really drive children’s perceptions of the process.
- Miller VA, Feudtner C, Jawad AF. Children’s Decision-Making Involvement About Research Participation: Associations With Perceived Fairness and Self-Efficacy. J Empir Res Hum Res Ethics. 2017 Apr;12(2):87-96.