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Keywords

child behavior, ethics, health services research, pediatrics

 

Authors

  1. Broome, Marion E.
  2. Richards, Deborah J.

Abstract

Background: Since the 1950s, children and adolescents have been defined as a vulnerable group for research participation. In 1998, federal mandates were issued to include children in clinical research.

 

Objectives: The purpose of this qualitative study was to describe children and adolescents' understanding of research and the sociocultural factors that influenced them to become involved and continue participation in clinical research. The specific objective of the study findings reported here was to describe how relationships with adults (e.g., parents and investigators) influenced children and adolescent involvement in clinical research.

 

Method: This study employed qualitative methods, using semistructured interviews and narrative analytic techniques. There were 34 children and adolescent participants, (8-22 years of age) who had a diagnosis of either diabetes or a hematological malignancy. Participants were interviewed to obtain an understanding of their experience with the assent/consent process for a research study. All interviews were transcribed verbatim from the audiotapes.

 

Results: Three themes discussed in this article were related to the child/adolescent's relationships with powerful adults: (a) faith in their parent(s), (b) relationships with members of the research/medical team, and (c) the child's perception of what happens when a child/adolescent and his/her parent disagree about research participation.

 

Discussion: Chronically ill children are willing to dialog about their involvement in research trials, and describe how relationships with their parents and clinician/investigators influence them. They can articulate their ability and right to make the decisions about involvement in research, along with their parent(s).

 

Children with acute and chronic illnesses are a vulnerable group for participation in clinical research (Broome, 1999;Committee on Bioethics, 1995;Elks, 1993;Grodin & Glantz, 1994). These children and their parents bring a unique set of experiences to the research setting. As a result of their life and illness experiences, these parents and their children may bring varied expectations about medical authority, research, and knowledge development that range from explicit trust in health professionals/researchers to skepticism and negativity about medical treatment and research (Engelking, 1991;McCarthy, 1994;Thorne & Robinson, 1989). Available research on child, adolescent, and parental understanding of the informed consent process and research participation has primarily been based on the assumption that the type and amount of information presented, influences an individual's participation in research. Yet, researchers and ethicists now acknowledge there are a number of other factors that influence a child's understanding of study participation (ACHRE, 1995;Nelson, 1998). Several studies have investigated other factors: (a) the context of the illness (Pletsch & Stevens, 2001;Scherer, 1991); (b) diagnosis and recommended treatment offered within a research study framework (Levi, Marsick, Drotar & Kodish, 2000;Liaschenko & Underwood, 2001); and (c) individual characteristics of the child and family (Geller, Tambor, Bernhardt; Fraser, & Wissow, in press) for their influence on research participation. Yet, the role and importance of relationships between the parent and child, the clinician/investigator and the family have received little attention.

 

Recent federal policy initiatives encourage investigators to include children in clinical research when there is sound scientific rationale (NIH, 1997). Yet, until recently, much of what is known about informed consent and assent has been gleaned from studying well children and adolescents, whose experiences are likely to be quite different from those with an acute or chronic illness. Additionally, most investigators have focused primarily on examining the beliefs and experiences of parents, not children, adolescents, or the family unit.

 

Potential influences on ill children who are involved in clinical research include their relationships with clinician/investigator and relationships with their parents. Scherer (1991) studied the effects of parental influence on treatment decisions of well children (9-10 years), adolescents (14-15), and young adults (21-25). All three groups responded similarly to vignettes of coercive parental influence by indicating deference to parental dictates. Subtle differences were related to the child's age, the nature and gravity of the decision, and the type of influence used by the parents. As decisions became more grave and complex, developmental differences became more salient, with younger children appearing more susceptible to parental influence.

 

Clinician/investigators exert some influence over children. A study comparing children's understanding of elements of consent and the research process with what investigators thought were important components to emphasize, revealed the majority of the children understood they had the freedom to ask questions, the benefits to self, and how long the study would last (Susman, Dorn, & Fletcher, 1992). However, less than half understood they had the freedom to withdraw, that there were alternative treatment options, and that potential benefits to others existed. Physician investigators ranked benefits to self, risks, and explanations of procedures as the most important issues to discuss during the informed consent/assent process. Alternative treatments, freedom to withdraw, and benefits to others were ranked as least important by the investigator, suggesting the beliefs and behaviors of the researcher about what is important during the informed consent process do influence children's perceptions and comprehension about research. In another study examining 18 5-18-year-olds' assent to medical research, half felt it was not acceptable to withdraw from a study, and 70% believed the investigator would respond negatively if they withdrew (Ondrusek, 1994). The results from these three studies indicate parents' and health professionals' opinions are valued by children and adolescents and have a direct influence on the perceptions they hold about participation in research and the child's decision about enrollment and continuing participation in research.

 

In a recent study, Levi, Marsick, Drotar & Kodish (2000) explored the informed consent process with parents whose children had cancer, where the parents reported having to make difficult decisions under adverse conditions, and experienced a high sense of stress and urgency following their child's diagnosis with a life-threatening illness. These parents reported that the relationship with the clinical investigator was extremely influential in their decision-making. With increasing demands for children and adolescents to be included in randomized trials of innovative treatments for a variety of chronic conditions, it is imperative to better understand both the child and parent's perspective.

 

The overall question addressed in this study was: How do children's and adolescents' perceptions of their relationships with adults, specifically parents and investigator/clinicians, influence their participation in a research study? Findings from interviews in which children/adolescents described relationships that influenced their decisions about and satisfaction with a research study are described.