The Parent’s Dilemma: Pediatric Assent in Research

Parents and their children rarely understand what it means “to consent” to participate in pediatric clinical research. This became clear during my 15 years as a patient advocate, when I facilitated hundreds of conversations about the implications of aggressive treatment of the very young and the existential crises faced by parents who made life-or death decisions for their children. In the United States, most children with cancer enter a clinical trial,¹  and although parents understand enough of the scientific information to deliberate on the pros and cons of research, it is harder to grasp the subtleties of “consenting for” experimental studies, “giving permission to” the investigators, or “gaining assent from” the child. This lack of clarity leaves parents confused about the ethical weight and propriety of their decisions or unaware of any ethical significance at all.

Prestudy discussions between investigators and children and their parents center on study risks, prospect for benefit, and the developmental stage or intellectual capacity of the subject.²  In the end, the ethical application of respect for persons, if that person is a child, defaults to whether pediatric assent is required, which is guided by federal regulation and stipulated by an institutional review board (IRB). Missing from regulations, IRB policies, and guidance documents is a meaningful definition of “assent” and the directive for investigators to make sure that both parties, parents and children, understand their roles in the decision-making process. When my young son was referred to clinical research for his brain cancer, I did not understand the context, power, and responsibility of giving permission for him to join this study. In the 25 years since, as he grew from a 5-year-old boy to a cognitively impaired adult, decision-making for his numerous health needs also evolved. As the weight of our decision voices changed, I realized that the importance of this balance had never been explained to us.

As the community member on national and local IRBs and the “patient and caregiver voice” in government workgroups, I see discussions about assent trend toward gradations of autonomy, agreement, and acquiescence. These committees land in different places on a spectrum between child signatures on assent documents and investigator attestations of the process, but there is consensus that children should have some kind of input, “a voice” is the phrase often used, when a decision is being made about their participation in research.^3,4  I argue that if the child does not understand what is asked of him, the nature of his agreement, or how these are weighed against parental wishes, there is no meaningful child voice. Likewise, the parent, the traditional “explainer of things” to the child, must understand these concepts so they can responsibly guide and interact with their child through prestudy discussions. Consent is considered a process, not a signature on a document. Likewise, assent is the organic, intimate interaction between parent and child that allows them their unique communication style and not the final decision, and it can only happen after they both understand what is expected of them.

Theory and practice are not the same. In addition to top-down formulaic guidance, the process should be framed from the ground-up: from the parent and child’s perspective of the immediate request. I suggest concise language that clearly delineates the distinctions between each scenario:

1. The parent decides and the child does not have input.

2. The parent decides, but the child has input.

3. The child can decide, but the parent must agree.

With the first option, if the young child is incapable of understanding the situation, a discussion would be needlessly alarming. Immediate procedures should be described, but there is no need to ask for input about trial participation. The second option involves an older child and a study that offers therapeutic benefit. The parent should solicit the child's input and respond to it, with both parties understanding that the parent will decide. The third instance refers to a minimal risk study, offering no therapeutic benefit or a case where the child is unusually mature or so near age of majority that there is added weight to their opinion. (I wish this could be identified as “the child decides,” but since parents can always overrule, it would not be a fair characterization.) The parent-child dyad must understand the ramifications of these settings, and with guidance from the investigator, align themselves with the one that applies to them.

Researchers, IRBs, parents, and children, the key stakeholders in pediatric research, have different roles in an ethical assent process. First, although investigators and IRBs might agree that assent improves relationships between researchers, parents, and participants and offers opportunities to share information and empower the child,⁴  this is an external view of the process. The real work is happening on the inside, between parent and child. IRBs must require, and researchers must create, tools for preconsent education about the basic tenets of clinical research and the parameters of parent and child decision-making. Print materials are a good start, but multimedia formats that address vocabulary and basic premises, and that can be viewed by families at home, would allow pauses for discussion or repeat viewing. Video vignettes by actors or in cartoon form would be a creative way to inspire conversation.

Secondly, parents should tap into the existing tradition of communication with their child and, assuming they are rational caregivers, decide on the level of information and interaction, and how weighty the “voice” of their child should be as their family unit moves toward a decision. At the same time, the child needs realistic expectations of their influence on the outcome, and permission, maybe even training, to express themselves. I have worked with families and patients, teaching basic self-advocacy skills that involve self-reflection, need identification, and assertive requests for help. Creative harnessing of the good will of experienced families creates resources for investigators to better inform and prepare potential subject families for research, and for peer mentors who act as a lifeline to those new to research and struggling to orient themselves.

Because I parent an adult survivor of childhood cancer, who is healthy but does not have the mental capacity to make health decisions, I have lived with the evolution of this balance of voices. At 5-years old, he had no say about the treatment of his brain tumor. At 15, we agreed on strabismus surgery for his vision problem, but I would have insisted. As a 30-year-old, he decided against a second cochlear implant because he “heard good enough with the first one and didn’t want another magnet in his head.” I would have preferred a second device, but his arguments were sound, so his preference was honored. As his legal guardian, I developed brief clarifying statements for when we face a medical or research issue: “I decide but we will talk first” or “you decide but I will give advice.” This clear understanding of our roles has developed trust and peace of mind for both of us, but we shouldn’t have had to come up with it by ourselves. Assent is a process, not an event, and ethical practice hinges on prestudy education, well-trained investigators, and the input of experienced families who understand the importance of honest communication.

IRB

institutional review board