Accuracy of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) for Measuring Children’s Competence to Consent to Clinical Research

Hein, Irma; Troost, Pieter W.; Lindeboom, Robert; Benninga, Marc A.; Zwaan, C. Michel; Goudoever, Johannes B. van; Lindauer, Ramón

doi:10.1001/jamapediatrics.2014.1694

Cited by 124 publications

(115 citation statements)

References 29 publications

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“…When the intellectual age cannot be approximated, the chronologic age of 7 is usually the cut-off point [31]. As shown above, new evidence suggests that the majority of children younger than 9 years of age lack the capacity necessary to meaningfully consent [8,9]. These studies are in agreement with a study by Schwartz [32], where the perceptions of children with growth hormone deficiency were assessed.…”

Section: Assentsupporting

confidence: 67%

“…Importantly, the new scale judged 37.9 % of the children incompetent to give consent. Not surprising, age predicted competence, and similar to Ondrusek's study, in children younger than 9.6 years of age competence was unlikely at sensitivity of 90 % [9]. The authors suggested that in children aged 9.4-11.2 years, consent can be justified based on tested competence.…”

Section: Measuring Children's Capacity To Consent To Researchsupporting

confidence: 60%

“…Recently Hein et al [9] proposed a standardized competence assessment instrument for children by modifying an existing tool, the MacArthur Competence Assessment Tool for Clinical Research. They tested this new tool for validity and reliability and correlated its assessment with children's age in an attempt to define cut-off for its use.…”

Section: Measuring Children's Capacity To Consent To Researchmentioning

confidence: 99%

“…As reflected above, a major component in children's ability to consent to research is their capacity to understand, appreciate, reason and freely choose [9]. While trying to protect children from excessive risk, there is evidence that the existing establishment is not congruent in the way it evaluates children's ability to consent.…”

Section: Consent By Minorsmentioning

confidence: 99%

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Informed Consent in Pediatric Research

Leibson

Koren

2014

Pediatr Drugs

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Pediatric drug research is gradually becoming more and more accepted as the norm for assessing whether a drug is safe and efficacious for infants and children. The process of informed consent and assent for these trials presents a major challenge. The aim of this review is to map historical, ethical and legal aspects relevant to the challenges of informed consent in the setting of pediatric drug research. The impact of age, level of maturity and life circumstances on the process of obtaining informed consent as well as the relations between consent and assent are discussed. There appears to be a lack of regulatory clarity in the area of pediatric clinical trials; while numerous statements have been made regarding children's rights to autonomy and their ability to care for themselves and for younger ones, the ever changing status of adolescence is still difficult to translate to informed consent. This may delay scientific and clinical advancement for children who are at the very junction of being independent and not needing parental permission. Obtaining consent and assent for pediatric clinical trials is a delicate matter, as both parent and child need to agree to participate. The appropriate transfer of information to guardians and the children, especially concerning potential risks and benefits, is at the heart of informed consent, as it serves to protect both patient and physician. As many adults lack health literacy, one must ensure that guardians receive relevant information at a level and in forms they can understand regarding the trials their children are asked to participate in. Key PointsThe appropriate transfer of information to guardians and the children, especially concerning potential risks and benefits, is at the heart of informed consent, as it serves to protect both patient and physician.There is compelling evidence that most children younger than 9 years of age lack the capacity to consent for participation in clinical trials.In some jurisdictions, institutional review boards approve the participation in drug research of healthy volunteering children during early adolescence.

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Section: Assentsupporting

confidence: 67%

Section: Measuring Children's Capacity To Consent To Researchsupporting

confidence: 60%

Section: Measuring Children's Capacity To Consent To Researchmentioning

confidence: 99%

Section: Consent By Minorsmentioning

confidence: 99%

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Informed Consent in Pediatric Research

Leibson

Koren

2014

Pediatr Drugs

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“…We used the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) modified for children (5,17), and a semistructured interview format to assess children's decision-making competence concerning research participation. We also asked the parents to assess their own children's decision-making competence concerning research participation.…”

mentioning

confidence: 99%

Why do children decide not to participate in clinical research: a quantitative and qualitative study

et al. 2015

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Background: More pediatric drug trials are needed, but although specific pediatric regulations warrant safety, recruitment of children for these trials remains one of the main difficulties. Therefore, we investigated potential determining factors of nonparticipation in clinical research, in order to optimize research participation of children by recommending improved recruitment strategies. Methods: Between 1 January 2012 and 1 January 2014, we performed a prospective study among161 pediatric patients, aged 6 to 18 y, who were eligible for clinical research. We quantitatively analyzed the association of potential explanatory variables (e.g., age, cognitive development, experience, ethnicity) with nonparticipation and qualitatively analyzed interviews on reasons for nonparticipation. results: Sixty percent of the children did not participate in the research project on offer (39% decided not to participate, 21% were indecisive). Lower age, less disease experience, and less complex research with lower risk were predictive for not participating. Time constraint and extra burden were expressed as decisive reasons for not participating. conclusions: Strategies to optimize research participation should be aimed at younger children and their families, who are logistically challenged and unfamiliar with health care and research. Recommendations include informing pediatric patients and their families of the value of research; minimizing logistic burdens; and improving accessibility.

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