Victoria A. Miller

The Concept of Voluntary Consent

Our primary focus is on analysis of the concept of voluntariness, with a secondary focus on the implications of our analysis for the concept and the requirements of voluntary informed consent. We propose that two necessary and jointly sufficient conditions must be satisfied for an action to be voluntary: intentionality, and substantial freedom from controlling influences. We reject authenticity as a necessary condition of voluntary action, and we note that constraining situations may or may not undermine voluntariness, depending on the circumstances and the psychological capacities of agents. We compare and evaluate several accounts of voluntariness and argue that our view, unlike other treatments in bioethics, is not a value-laden theory. We also discuss the empirical assessment of individuals’ perceptions of the degrees of noncontrol and self-control. We propose use of a particular Decision Making Control Instrument. Empirical research using this instrument can provide data that will help establish appropriate policies and procedures for obtaining voluntary consent to research.

Parent-child collaborative decision making for the management of chronic illness: a qualitative analysis.

Parent-child collaborative decision making (CDM) is a potentially important precursor to full decision-making independence and may be particularly significant for the management of childhood chronic illnesses. The primary aim of this qualitative study was to explore the concept of CDM from the perspective of children and parents. Children (ages 8-19 years) with asthma, type 1 diabetes, or cystic fibrosis and parents of children with these illnesses participated in focus groups and individual interviews. Participants described various ways they collaborate with one another (e.g., asking for the others opinion; providing information). Participants viewed collaboration as beneficial, regardless of who ultimately makes the decision. Several factors emerged as potential predictors of CDM, including parent/family factors (e.g., parental time; parent-child conflict), child factors (e.g., maturity; emotional/behavioral functioning), and decision/situation factors (e.g., seriousness of the decision; extent to which the child is experiencing symptoms). These data suggest ways to enhance collaborative decision-making interactions between children with a chronic illness and their parents, as well as several areas for future quantitative research.

Stakeholders’ Opinions on the Implementation of Pediatric Whole Exome Sequencing: Implications for Informed Consent

Advances in whole genome and whole exome sequencing (WGS/WES) technologies have led to increased availability in clinical settings. Currently, there are few guidelines relating to the process and content of informed consent for WGS/WES, nor to which results should be returned to families. To address this gap, we conducted focus groups to assess the views of professionals, parents, and adolescents for the future implementation of WES. The discussions assessed understanding of the risks and benefits of WES, preferences for the informed consent discussion, process for return of results, and the decision-making role of the pediatric patient. Professional focus group participants included bioethicists, physicians, laboratory directors, and genetic counselors. Parent focus groups included individuals with children who could be offered sequencing due to a potential genetic cause of the child’s condition. On-line discussion groups were conducted with adolescents aged 13–17 who had a possible genetic disorder. We identified discrepancies between professionals and patient groups regarding the process and content of informed consent, preference for return of results, and the role of the child in decision-making. Professional groups were concerned with the uncertainty regarding professional obligations, changing interpretation in genomic medicine, and practical concerns of returning results over time. Parent and adolescent groups focused on patient choice and personal utility of sequencing results. Each group expressed different views on the role of the child in decision-making and return of results. These discrepancies represent potential barriers to informed consent and a challenge for genetic counselors regarding the involvement of pediatric patients in decision-making and return of results discussions.

Regoaling: a conceptual model of how parents of children with serious illness change medical care goals

BackgroundParents of seriously ill children participate in making difficult medical decisions for their child. In some cases, parents face situations where their initial goals, such as curing the condition, may have become exceedingly unlikely. While some parents continue to pursue these goals, others relinquish their initial goals and generate new goals such as maintaining the child’s quality of life. We call this process of transitioning from one set of goals to another regoaling.DiscussionRegoaling involves factors that either promote or inhibit the regoaling process, including disengagement from goals, reengagement in new goals, positive and negative affect, and hopeful thinking. We examine these factors in the context of parental decision making for a seriously ill child, presenting a dynamic conceptual model of regoaling. This model highlights four research questions that will be empirically tested in an ongoing longitudinal study of medical decision making among parents of children with serious illness. Additionally, we consider potential clinical implications of regoaling for the practice of pediatric palliative care.SummaryThe psychosocial model of regoaling by parents of children with a serious illness predicts that parents who experience both positive and negative affect and hopeful patterns of thought will be more likely to relinquish one set of goals and pursue a new set of goals. A greater understanding of how parents undergo this transition may enable clinicians to better support them through this difficult process.

Testicular tissue cryopreservation in prepubertal male children: an analysis of parental decision-making.

Infertility is an unfortunate treatment‐related consequence for some pediatric malignancies as well as some non‐malignant conditions treated with stem cell transplant. Unlike pubertal males, prepubertal males cannot produce semen for cryopreservation. This manuscript reports on the acceptability and safety of a multi‐institutional protocol for offering testicular tissue cryopreservation to families of prepubertal male children at highest risk for infertility. Data on decision influences, decision‐making control, and emotional state when considering this option are described.

Measuring Children's Decision-Making Involvement Regarding Chronic Illness Management

OBJECTIVES To develop a measure of decision-making involvement in children and adolescents with cystic fibrosis, diabetes, and asthma. METHODS Parent-child dyads completed the Decision-Making Involvement Scale (DMIS) and measures of locus of control and family communication. DMIS items were subjected to exploratory and confirmatory factor analysis (CFA). Temporal stability and construct validity were assessed. RESULTS The parent form was reduced to 20 items representing five factors. CFA showed that the five factors were an acceptable fit to the parent- and child-report data. Internal consistency values ranged from 0.71 to 0.91. Temporal stability was supported by moderate-substantial intraclass correlation coefficients. DMIS subscales were associated with child age, child locus of control, and family communication. CONCLUSIONS The DMIS can be used to inform our understanding of the transition to greater independence for illness management. Additional research is needed to examine outcomes of decision-making involvement, including treatment adherence and responsibility.

Parent–Child Roles in Decision Making About Medical Research

Our objective is to understand how parents and children perceive their roles in decision making about research participation. Forty-five children (ages 4–15 years) with or without a chronic condition and 21 parents were the participants. A semistructured interview assessed perceptions of up to 4 hypothetical research scenarios with varying levels of risk, benefit, and complexity. Children were also administered the Peabody Picture Vocabulary Test, Third Edition, to assess verbal ability, as a proxy for the childs cognitive development. The audiotaped interviews were transcribed and analyzed for themes related to parent and child decision-making roles. Both parents and children varied in their perceptions of decision-making roles. Child perceptions of parental influence on decision making as knowledge-based increased with cognitive development, whereas perceptions of parental influence as power-based decreased. Both children and parents commented that they would collaborate with each other when making decisions. Collaborative decision making appeared to increase with cognitive development. These findings suggest that approaches to child assent and parent permission should consider the parent–child relationship and how children and families typically make decisions. Future research is necessary to explain variation in the process of research decision making across children and families, explore the role of collaboration on childrens decision-making skills, and understand developmental trajectories and mechanisms related to research decision making.

Hope and Persuasion by Physicians During Informed Consent

PURPOSE To describe hopeful and persuasive messages communicated by physicians during informed consent for phase I trials and examine whether such communication is associated with physician and parent ratings of the likelihood of benefit, physician and parent ratings of the strength of the physicians recommendation to enroll, parent ratings of control, and parent ratings of perceived pressure. PATIENTS AND METHODS Participants were children with cancer (n = 85) who were offered a phase I trial along with their parents and physicians. Informed consent conferences (ICCs) were audiotaped and coded for physician communication of hope and persuasion. Parents completed an interview (n = 60), and physicians completed a case-specific questionnaire. RESULTS The most frequent hopeful statements related to expectations of positive outcomes and provision of options. Physicians failed to mention no treatment and/or palliative care as options in 68% of ICCs and that the disease was incurable in 85% of ICCs. When physicians mentioned no treatment and/or palliative care as options, both physicians and parents rated the physicians strength of recommendation to enroll in the trial lower. CONCLUSION Hopes and goals other than cure or longer life were infrequently mentioned, and a minority of physicians communicated that the disease was incurable and that no treatment and/or palliative care were options. These findings are of concern, given the low likelihood of medical benefit from phase I trials. Physicians have an important role to play in helping families develop alternative goals when no curative options remain.

The Decision Making Control Instrument to Assess Voluntary Consent

Background. The decision to participate in a research intervention or to undergo medical treatment should be both informed and voluntary. Objective. The aim of the present study was to develop an instrument to measure the perceived voluntariness of parents making decisions for their seriously ill children. Methods. A total of 219 parents completed questionnaires within 10 days of making such a decision at a large, urban tertiary care hospital for children. Parents were presented with an experimental form of the Decision Making Control Instrument (DMCI), a measure of the perception of voluntariness. Data obtained from the 28-item form were analyzed using a combination of both exploratory and confirmatory factor analytic techniques. Results. The 28 items were reduced to 9 items representing 3 oblique dimensions: Self-Control, Absence of Control, and Others’ Control. The hypothesis that the 3-factor covariance structure of our model was consistent with that of the data was supported. Internal consistency for the scale as a whole was high (0.83); internal consistency for the subscales ranged from 0.68 to 0.87. DMCI scores were associated with measures of affect, trust, and decision self-efficacy, supporting the construct validity of the new instrument. Conclusion. The DMCI is an important new tool that can be used to inform our understanding of the voluntariness of treatment and research decisions in medical settings.

Child and Parent Perceptions of Monitoring in Chronic Illness Management: A Qualitative Study

BACKGROUND The management of a childhood chronic illness can be challenging because it can involve frequent and complex treatment tasks that must be carried out on a daily basis. Parental monitoring of the treatment regimen and child disclosure of health-related information may impact effective illness management but are not well understood. METHODS The present study utilized qualitative methods to examine parental monitoring-related behaviours, youth disclosure of health-related information, and both perceptions about, and reactions to, these behaviours in a sample of youth diagnosed with a chronic illness (e.g. asthma, diabetes and cystic fibrosis) and parents of youth with one of these illnesses. RESULTS Parents solicited information from youth verbally, observed symptoms, reminded youth about treatments and tracked indicators of treatment adherence (e.g. dose counters; glucose meters). Youth reactions varied from acceptance to irritation. Youth behaviours included withholding information and freely disclosing spontaneously and in response to requests. CONCLUSIONS Findings derived from this qualitative methodology demonstrate convergence with findings from quantitative studies on this topic, add to the literature related to parental monitoring of chronic illness management and suggest several avenues for future research.