Children and Decisionmaking in Health Research

Βaylis, Françoise; Downie, Jocelyn; Kenny, Nuala

doi:10.2307/3564418

Cited by 39 publications

(40 citation statements)

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“…The capacity approach to consent is consistent with the developmental literature which suggests that age is not a good proxy for developmental capacity (Alderson, 2007;Baylis, Downie, Kenny, & Baylis, 1999; Miller, Drotar, & Kodish, 2004;Schachter, Kleinman, & Harvey, 2005). Even very young children (e.g., seven years of age) can be capable of understanding study information (Miller et al, 2004), and many developmental researchers agree that around the age of 14, youth have the ability to provide informed consent (Flicker & Guta, 2008; Hester, 2004;Schachter et al, 2005;Scott, 2013).…”

Section: Ethical Guidelines and Legal Considerations In Canada The Tsupporting

confidence: 50%

“…The researcher must also ascertain the child's wishes regarding their participation (i.e., obtain assent) (CIHR et al, 2014). While some have interpreted this to mean that youth are incapable of providing consent and that parental consent is required for their participation in research and evaluation (Gibson, Stasiulis, Gutfreund, McDonald, & Dade, 2011;Scott, 2013), the TCPS2 adopts a capacity approach to consent and does not specify an age of consent (see Box 1).The capacity approach to consent is consistent with the developmental literature which suggests that age is not a good proxy for developmental capacity (Alderson, 2007;Baylis, Downie, Kenny, & Baylis, 1999; Miller, Drotar, & Kodish, 2004;Schachter, Kleinman, & Harvey, 2005). Even very young children (e.g., seven years of age) can be capable of understanding study information (Miller et al, 2004), and many developmental researchers agree that around the age of 14, youth have the ability to provide informed consent (Flicker & Guta, 2008; Hester, 2004;Schachter et al, 2005;Scott, 2013).…”

mentioning

confidence: 51%

“…Through single-time interviews, participants shared their experiences of help-seeking and mental health services and self-reported their current functioning and symptom severity. It is recognized that capacity varies by context, that youth may have the capacity to consent to some studies but not others, and that capacity can change over time (Alderson, 2007;Baylis et al, 1999;CIHR et al, 2014;Gibson et al, 2011;Simpson, 2003). We believe our protocol could be appropriate for evaluation contexts similar to NorthBEAT, for example, in the evaluation of sexual health programs or in other sensitive service areas that youth may not want to share with their parents.…”

Section: Discussionmentioning

confidence: 99%

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NorthBEAT’s Capacity-to-Consent Protocol for Obtaining Informed Consent from Youth Evaluation Participants: An Alternative to Parental Consent

Nadin

Katt

Dewa

et al. 2018

Canadian Journal of Program Evaluation

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Ethical practice compels evaluators to obtain informed consent from evaluation participants. When those participants are minors, parental consent is routinely sought. However, seeking parental consent may not be appropriate in all evaluation contexts. This practice note presents one context (mental health services research in rural Canada Mots clés : capacité, consentement éclairé, jeunesEthical practice compels evaluators to obtain informed consent from evaluation participants. When those participants are minors, parental consent is routinely sought. However, some practitioners have highlighted the need to think critically about that practice, arguing that parental consent is not appropriate in all contexts. This practice note describes one such context and offers an alternative for evaluators to consider when involving youth in evaluation. The project context is described and the informed consent literature is briefly reviewed, emphasizing critiques of the parental consent requirement. The "capacity-to-consent" protocol that was used to obtain consent from youth participants (without parental consent) is then described, followed by a discussion of the protocol and its implications for evaluation practice. CONTExT The NorthBEAT ProjectNorthBEAT (Barriers to Early Assessment and Treatment) is a study that assessed the mental health service needs of youth 1 in Northern Ontario who experience psychosis. A mixed-methods approach was adopted, which included two types of interviews with youth who had experienced psychosis: (1) semi-structured (qualitative) interviews explored participants' help-seeking and mental health service experiences, as well as their perceptions of how services could be improved; (2) structured interviews collected quantitative data to assess participants' symptoms and functional status.Participants were recruited from across Northern Ontario, through agencies where they received services for a severe mental illness; participants were between 13 and 21 years of age. Given the age of the participants, we initially planned to seek parental consent for their participation. Upon reflection, however, the project context caused us to question the appropriateness of seeking parental consent. Concerns about seeking parental consent for youth participation in NorthBEAT Ethical concernsParticipants were recruited from mental health service agencies where they were accessing service for psychosis. Many youth in this region-especially Indigenous youth-do not live in the same location as their parents because they attend school outside of their communities. Some youth seek treatment while living away from their communities. Or, in some cases, their parents do not know the extent of their mental health issues. Requiring parental consent threatened to minimize youth's right to privacy with respect to their health information. Practical concernsParticipants were recruited from 10 programs across Northern Ontario. This is a region with a vast geography and scarce population; many residents live in ru...

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Section: Ethical Guidelines and Legal Considerations In Canada The Tsupporting

confidence: 50%

mentioning

confidence: 51%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

NorthBEAT’s Capacity-to-Consent Protocol for Obtaining Informed Consent from Youth Evaluation Participants: An Alternative to Parental Consent

Nadin

Katt

Dewa

et al. 2018

Canadian Journal of Program Evaluation

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“…Despite broad-based support for empirical studies examining children's understanding of what it means to assent to research and their preference for involvement in research, 5,8,[15][16][17][18][19][20][21][22][23] existing studies have focused primarily on healthy children using hypothetical cases 18,[24][25][26][27] on decision-making preferences of adolescents with cancer. [28][29][30][31] Few studies have examined children's understanding of their disease and its treatment [32][33] and the extent of their desire to be included in research-related decisions.…”

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confidence: 99%

The Experiences of Children Enrolled in Pediatric Oncology Research: Implications for Assent

2010

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BACKGROUND: Most children with cancer enroll in clinical research trials. Whenever possible, children must provide their assent before enrolling in research studies. We studied what children aged 7 to 18 with cancer understand about research, their research-related treatment, and their preferences for inclusion in decision-making. PROCEDURE: Thirty-seven face-to-face, audiorecorded interviews using a novel, semi-structured tool, the quality-of-assent instrument, were conducted. Exploratory univariate and bivariate analyses of the quantitative data elucidated patterns and trends of understanding and preferences. RESULTS: Nineteen of the 37 children (51%) did not know or recall that their treatment was considered research, and 19 of 22 (86%) did not understand their doctor when he or she discussed the trial. More children enrolled in trials to help future children with cancer (27 of 37 [73%]), than to get better personally (22 of 37 [60%]). Irrespective of age, children with Hodgkin's disease, germ-cell tumors, and leukemia had significantly greater research awareness and appreciation than children with other cancers (P = .019 and P < .001, respectively). Although all children wanted to be involved in decision-making, 18 of 37 (49%) did not have or recall having a role in deciding to enroll in their trial, and 14 of 37 (38%) did not feel free to dissent to trial enrollment. Only 4 of 37 children (11%) discussed increased decision-making roles with parents, and only 7 of 37 (19%) discussed them with their doctors. CONCLUSIONS: Most children have limited understanding of research despite physicians' explanations. Many children reported that they feel minimally involved in the decision to enroll in clinical trials. Tools to assist investigators ascertain that children understand what they are agreeing to when they assent to research and to determine their preferences for inclusion in research may help make assent more meaningful.

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“…Freedman, a noted bioethicist, has raised a general concern about unclear wording of research policies pertaining to the developing child. 12 This lack of clarity has adversely influenced interpretation 15 and has resulted in inconsistent application of guidelines by REBs. Simpson has argued that the TCPS policy on free and informed consent (section 2) fails to recognize the child's developing decisional capacities and recommended that the role of children in decision making about research participation be reconsidered.…”

Section: The Role Of the Reb As Enforcermentioning

confidence: 99%

Ethics of Involving Children in Health-Related Research: Applying a Decision-Making Framework to a Clinical Trial

Kelly¹,

MacKay‐Lyons²

2010

Physiotherapy Canada

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Purpose: This paper explores ethical issues related to the involvement of children in health-related research through the application of a conceptual model (the Miller and Kenny framework) to a current clinical trial on casting protocols for equinus gait of children with cerebral palsy (CP). Summary of key points: The direct involvement of children in health-related research is important for maintaining and improving standards of paediatric clinical care. Ethical considerations around investigations involving this highly vulnerable population are complex, however, requiring the involvement of many levels of decision makers-government, research ethics boards (REBs), health care providers, parents, and children. The Miller and Kenny framework is useful in distinguishing these levels and heightening awareness of the complexities of the issues around engaging children in research. Considerations include the role of parents/caregivers in decision making, individual assessment of the child's decisional capacities, close attention to the child's context and life experience, provision of developmentally appropriate information about the research study, and careful assessment of dissent prior to withdrawing the child from the study. Recommendations: Physical therapists involved in paediatric clinical practice and/or research must be knowledgeable about ethical principles, policies, and REB requirements. The Miller and Kenny framework is a helpful guide to clarify decision-making roles around children's participation in research.Key Words: assent, children, dissent, ethical issues, REB requirements, research participation Kelly B, MacKay-Lyons MJ. Ethics of involving children in health-related research: applying a decision-making framework to a clinical trial. Physiother Can. 2010;62:338-346 RÉ SUMÉObjectif : Cet article se penche sur les questions qui entourent la participation des enfants à la recherche en santé par l'application d'un modè le conceptuel (la structure dite de Miller et Kenny) à un essai clinique en cours sur les mé thodes de moulage de plâ tres dans les cas de pied bot é quin chez les enfants qui souffrent de paralysie cé ré brale (PC). Ré sumé des principaux points : La participation directe des enfants à la recherche en santé est importante pour le maintien et l'amé lioration des normes lié es à leurs soins cliniques. Les considé rations é thiques en ce qui a trait aux recherches qui mettent à contribution ce segment trè s vulné rable de la population sont complexes et elles exigent l'engagement de dé cideurs à plusieurs é chelons-gouvernements, comité s d'é thique en recherche, fournisseurs de soins de santé , parents et enfants eux-mê mes. La structure de Miller et Kenny est utile pour é tablir une distinction entre ces divers paliers et pour accroître la sensibilisation aux complexité s des enjeux lié s à la participation des jeunes à la recherche. Parmi les considé rations é thiques à prendre en compte, mentionnons le rô le des parents ou des personnes qui s'occupent de l'enfant dans la pri...

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Children and Decisionmaking in Health Research

Cited by 39 publications

References 0 publications

NorthBEAT’s Capacity-to-Consent Protocol for Obtaining Informed Consent from Youth Evaluation Participants: An Alternative to Parental Consent

NorthBEAT’s Capacity-to-Consent Protocol for Obtaining Informed Consent from Youth Evaluation Participants: An Alternative to Parental Consent

The Experiences of Children Enrolled in Pediatric Oncology Research: Implications for Assent

Ethics of Involving Children in Health-Related Research: Applying a Decision-Making Framework to a Clinical Trial

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