Accuracy of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) for Measuring Children’s Competence to Consent to Clinical Research
Abstract
IMPORTANCE: An objective assessment of children's competence to consent to research participation is currently not possible. Age limits for asking children's consent vary considerably between countries, and, to our knowledge, the correlation between competence and children's age has never been systematically investigated. OBJECTIVES: To test a standardized competence assessment instrument for children by modifying the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), to investigate its reliability and validity, and to examine the correlation of its assessment with age and estimate cutoff ages. DESIGN, SETTING, AND PARTICIPANTS: This prospective study included children and adolescents aged 6 to 18 years in the inpatient and outpatient departments of allergology, gastroenterology, oncology, ophthalmology, and pulmonology from January 1, 2012, through January 1, 2014. Participants were eligible for clinical research studies, including observational studies and randomized clinical trials. EXPOSURES: Competence judgments by experts aware of the 4 relevant criteria-understanding, appreciation, reasoning, and choice-were used to establish the reference standard. The index test was the MacCAT-CR, which used a semistructured interview format. MAIN OUTCOMES AND MEASURES: Interrater reliability, validity, and dimensionality of the MacCAT-CR and estimated cutoff ages for competence. RESULTS: Of 209 eligible patients, we included 161 (mean age, 10.6 years; 47.2% male). Good reproducibility of MacCAT-CR total and subscale scores was observed (intraclass correlation coefficient range, 0.68-0.92). We confirmed unidimensionality of the MacCAT-CR. By the reference standard, we judged 54 children (33.5%) to be incompetent; by the MacCAT-CR, 61 children (37.9%). Criterion-related validity of MacCAT-CR scores was supported by high overall accuracy in correctly classifying children as competent against the reference standard (area under the receiver operating characteristics curve, 0.78). Age was a good predictor of competence on the MacCAT-CR (area under the receiver operating characteristics curve, 0.90). In children younger than 9.6 years, competence was unlikely (sensitivity, 90%); in those older than 11.2 years, competence was probable (specificity, 90%). The optimal cutoff age was 10.4 years (sensitivity, 81%; specificity, 84%). CONCLUSIONS AND RELEVANCE: The MacCAT-CR demonstrated strong psychometric properties. In children aged 9.6 to 11.2 years, consent may be justified when competence can be demonstrated in individual cases by the MacCAT-CR. The results contribute to a scientific underpinning of regulations for clinical research directed toward children.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
In the MacCAT-CR study, the cross-over point was estimated at 10.4 years.
“A change-over occurred between 9.6 and 11.2 years, and the cross-over point was estimated at 10.4 years [8].”
From Medical decision-making in children and adolescents: developmental and neuroscientific aspects (2017) · cites this paper as [8]
Children older than 11.2 years may be competent to consent to clinical research.
“A recent study demonstrated that generally children older than 11.2 years may be competent to consent to clinical research [8].”
From Medical decision-making in children and adolescents: developmental and neuroscientific aspects (2017) · cites this paper as [8]
In the MacCAT-CR study, children of 11.2 years and above generally appeared to be competent, whereas children of 9.6 years and younger were generally not competent.
“The study demonstrated that age limits for children to be deemed competent to decide on research participation could be estimated as follows: children of 11.2 years and above generally appeared to be competent, whereas children of 9.6 years and younger were generally not competent.”
From Medical decision-making in children and adolescents: developmental and neuroscientific aspects (2017) · cites this paper as [8]
The MacCAT could be validly and reliably used in children.
“Results of a recent study on children’s competence to consent to clinical research showed that the MacCAT could also be validly and reliably used in children.”
From Medical decision-making in children and adolescents: developmental and neuroscientific aspects (2017) · cites this paper as [8]
In the MacCAT-CR study, the four domains representing competence appeared to constitute a single trait in children.
“In the same study, the four domains representing competence in most jurisdictions (understanding, appreciation, reasoning, and expressing a choice) appeared to constitute a single trait in children.”
From Medical decision-making in children and adolescents: developmental and neuroscientific aspects (2017) · cites this paper as [8]
In the clinical research context, children of 11.2 years and above were generally competent.
“In the clinical research context, children of 11.2 years and above were generally competent.”
From Medical decision-making in children and adolescents: developmental and neuroscientific aspects (2017) · cites this paper as [8]
Cites
(1990) · Choice Reviews Online · doi:10.5860/choice.27-3338 · Cited by 35,305 · see citing works
Principles of Biomedical Ethics
(2012) · Thieves of Virtue · doi:10.7551/mitpress/9079.003.0009 · Cited by 13,453 · see citing works
Fleiss, J. L., & Cohen, J. (1973) · Educational and Psychological Measurement · doi:10.1177/001316447303300309 · Cited by 3,354 · see citing works
Babyak, M. A. (2004) · Psychosomatic Medicine · doi:10.1097/01.psy.0000127692.23278.a9 · Cited by 2,061 · see citing works
Assessment of Patients' Competence to Consent to Treatment
Appelbaum, P. S. (2007) · New England Journal of Medicine · doi:10.1056/nejmcp074045 · Cited by 1,427 · see citing works
Fischer, G. H., & Molenaar, I. W. (1995) · Springer eBooks · doi:10.1007/978-1-4612-4230-7 · Cited by 1,143 · see citing works
The MacCAT-T: a clinical tool to assess patients' capacities to make treatment decisions
(1997) · Psychiatric Services · doi:10.1176/ps.48.11.1415 · Cited by 704 · see citing works
Informed Consent, Parental Permission, and Assent in Pediatric Practice
Bartholome, W. G. (1995) · PEDIATRICS · doi:10.1542/peds.96.5.981 · Cited by 657 · see citing works
Assessing Decisional Capacity for Clinical Research or Treatment: A Review of Instruments
Dunn, L. B., Nowrangi, M. A., Palmer, B. W., Jeste, D. V., & Saks, E. R. (2006) · American Journal of Psychiatry · doi:10.1176/ajp.2006.163.8.1323 · Cited by 464 · see citing works
MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR)
Kreutzer, J. S., DeLuca, J., & Caplan, B. (2010) · Springer eBooks · doi:10.1007/978-0-387-79948-3_4894 · Cited by 271 · see citing works
Minors' consent to treatment: A developmental perspective.
Grisso, T., & Vierling, L. (1978) · Professional Psychology · doi:10.1037/0735-7028.9.3.412 · Cited by 220 · see citing works
Palmer, B. W., Dunn, L. B., Appelbaum, P. S., Mudaliar, S. R. D., Thal, L. J., Henry, R. R., Golshan, S., & Jeste, D. V. (2005) · Archives of General Psychiatry · doi:10.1001/archpsyc.62.7.726 · Cited by 197 · see citing works
Owen, G. S., Richardson, G., David, A. S., Szmukler, G., Hayward, P., & Hotopf, M. (2008) · BMJ · doi:10.1136/bmj.39580.546597.be · Cited by 172 · see citing works
A Survey of the Use of Off-Label and Unlicensed Drugs in a Dutch Children's Hospital
Jong, G. W. ‘., Vulto, A. G., de Hoog, M., Schimmel, K. J. M., Tibboel, D., & van den Anker, J. N. (2001) · PEDIATRICS · doi:10.1542/peds.108.5.1089 · Cited by 166 · see citing works
Competence of mentally ill patients: a comparative empirical study
VOLLMANN, J., BAUER, A., DANKER-HOPFE, H., & HELMCHEN, H. (2003) · Psychological Medicine · doi:10.1017/s0033291703008389 · Cited by 159 · see citing works
Reliability of mental capacity assessments in psychiatric in-patients
Cairns, R., Maddock, C., Buchanan, A., David, A. S., Hayward, P., Richardson, G., Szmukler, G., & Hotopf, M. (2005) · British Journal of Psychiatry · doi:10.1192/bjp.187.4.372 · Cited by 135 · see citing works
A review of children’s decision‐making competence in health care
Mårtenson, E. K., & Fägerskiöld, A. M. (2008) · Journal of Clinical Nursing · doi:10.1111/j.1365-2702.2006.01920.x · Cited by 124 · see citing works
MacArthur Competence Assessment Tool for Treatment (MacCAT-T)
(2010) · Springer eBooks · doi:10.1007/978-0-387-79948-3_4895 · Cited by 117 · see citing works
Involving children with cancer in decision-making about research participation
Joffe, S., Fernandez, C. V., Pentz, R. D., Ungar, D., Mathew, N. A., Turner, C. W., Alessandri, A. J., WOODMAN, C. L., Singer, D. A., & Kodish, E. D. (2006) · The Journal of Pediatrics · doi:10.1016/j.jpeds.2006.08.027 · Cited by 84 · see citing works
de Vries, M. C., Bresters, D., Engberts, D. P., Wit, J. M., & van Leeuwen, E. (2009) · Pediatric Blood & Cancer · doi:10.1002/pbc.22091 · Cited by 65 · see citing works
de Vries, M. C., Wit, J. M., Engberts, D. P., Kaspers, G. J. L., & van Leeuwen, E. (2010) · Pediatric Blood & Cancer · doi:10.1002/pbc.22510 · Cited by 63 · see citing works
Assessing children’s competence to consent in research by a standardized tool: a validity study
Hein, I. M., Troost, P. W., Lindeboom, R., de Vries, M. C., Zwaan, C. M., & Lindauer, R. (2012) · BMC Pediatrics · doi:10.1186/1471-2431-12-156 · Cited by 48 · see citing works
Self-citationIssues Related to Children Participating in Clinical Research
Knox, C. A., & Burkhart, P. V. (2007) · Journal of Pediatric Nursing · doi:10.1016/j.pedn.2007.02.004 · Cited by 47 · see citing works
Altavilla, A., Manfredi, C., Baiardi, P., Dehlinger-Kremer, M., Galletti, P., Pozuelo, A. A., Chaplin, J. E., & Ceci, A. (2011) · Acta Paediatrica · doi:10.1111/j.1651-2227.2011.02401.x · Cited by 25 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
Medical decision-making in children and adolescents: developmental and neuroscientific aspects
Grootens-Wiegers, P., Hein, I. M., van den Broek, J. M., & de Vries, M. C. (2017) · BMC Pediatrics · doi:10.1186/s12887-017-0869-x · Cited by 357 · see citing works
Self-citationPetran, M. E., Dragoș, D., & Gîlcă, M. (2020) · Journal of Ethnobiology and Ethnomedicine · doi:10.1186/s13002-020-00364-6 · Cited by 239 · see citing works
Hein, I. M., de Vries, M. C., Troost, P. W., Meynen, G., van Goudoever, J. B., & Lindauer, R. (2015) · BMC Medical Ethics · doi:10.1186/s12910-015-0067-z · Cited by 200 · see citing works
Self-citationThe neurologist's role in supporting transition to adult health care
Brown, L. W., CAMFIELD, P. R., Capers, M., Cascino, G. D., Ciccarelli, M. R., de Gusmão, C. M., Downs, S. M., Majnemer, A., Miller, A. B., SanInocencio, C., et al. (2016) · Neurology · doi:10.1212/wnl.0000000000002965 · Cited by 116 · see citing works
Assessing Medical Decision-Making Competence in Transgender Youth
Vrouenraets, L. J. J. J., de Vries, A. L. C., de Vries, M. C., van der Miesen, A. I. R., & Hein, I. M. (2021) · PEDIATRICS · doi:10.1542/peds.2020-049643 · Cited by 77 · see citing works
Self-citationWijngaarde, R. O., Hein, I. M., Daams, J. G., van Goudoever, J. B., & Ubbink, D. T. (2021) · European Journal of Pediatrics · doi:10.1007/s00431-021-04055-6 · Cited by 63 · see citing works
Self-citationUsing digital multimedia to improve parents’ and children's understanding of clinical trials
Tait, A. R., Voepel‐Lewis, T., & Levine, R. L. (2015) · Archives of Disease in Childhood · doi:10.1136/archdischild-2014-308021 · Cited by 59 · see citing works
Antal, H. M. A., Bunnell, H. T., McCahan, S. M., Pennington, C. A., Wysocki, T., & Blake, K. (2017) · Journal of Biomedical Informatics · doi:10.1016/j.jbi.2017.01.011 · Cited by 58 · see citing works
Assessing an Adolescent's Capacity for Autonomous Decision-Making in Clinical Care
Michaud, P., Blum, R. W., Benaroyo, L., Zermatten, J., & Baltag, V. (2015) · Journal of Adolescent Health · doi:10.1016/j.jadohealth.2015.06.012 · Cited by 57 · see citing works
Key factors in children’s competence to consent to clinical research
Hein, I. M., Troost, P. W., Lindeboom, R., Benninga, M. A., Zwaan, C. M., van Goudoever, J. B., & Lindauer, R. (2015) · BMC Medical Ethics · doi:10.1186/s12910-015-0066-0 · Cited by 50 · see citing works
Self-citationInformed Consent in Pediatric Research
Leibson, T., & Koren, G. (2014) · Pediatric Drugs · doi:10.1007/s40272-014-0108-y · Cited by 46 · see citing works
Children’s Understanding of Informed Assents in Research Studies
Cotrim, H., Granja, C., Carvalho, A. S., Cotrim, C., & Martins, R. (2021) · Healthcare · doi:10.3390/healthcare9070871 · Cited by 45 · see citing works
Hein, I. M., Troost, P. W., Lindeboom, R., Christiaans, I., Grisso, T., van Goudoever, J. B., & Lindauer, R. (2015) · Journal of Genetic Counseling · doi:10.1007/s10897-015-9835-7 · Cited by 41 · see citing works
Self-citationThe Influence of Age, Health Literacy, and Affluence on Adolescents’ Capacity to Consent to Research
Nelson, L. R., Stupiansky, N. W., & Ott, M. A. (2016) · Journal of Empirical Research on Human Research Ethics · doi:10.1177/1556264616636232 · Cited by 40 · see citing works
Marsh, V., Mwangome, N., Jao, I., Wright, K., Molyneux, S. C., & Davies, A. (2019) · BMC Medical Ethics · doi:10.1186/s12910-019-0375-9 · Cited by 40 · see citing works
Strode, A. E., & Essack, Z. (2017) · South African Medical Journal · doi:10.7196/samj.2017.v107i9.12525 · Cited by 33 · see citing works
Hostiuc, S., Rusu, M. C., Negoi, I., & Drima, E. P. (2018) · BMC Psychiatry · doi:10.1186/s12888-017-1580-z · Cited by 33 · see citing works
Sims, J. P., & Nolen, C. (2020) · Journal of Empirical Research on Human Research Ethics · doi:10.1177/1556264620983134 · Cited by 33 · see citing works
Why do children decide not to participate in clinical research: a quantitative and qualitative study
Hein, I. M., Troost, P. W., de Vries, M. C., Knibbe, C. A. J., van Goudoever, J. B., & Lindauer, R. (2015) · Pediatric Research · doi:10.1038/pr.2015.74 · Cited by 32 · see citing works
Self-citationRole of Development on Youth Decision-Making and Recovery From Gender-Affirming Surgery
Bernacki, J. M., & Weimer, A. K. (2019) · Clinical Practice in Pediatric Psychology · doi:10.1037/cpp0000294 · Cited by 30 · see citing works
Williams, R. L., Meredith, A. H., & Ott, M. A. (2018) · Current Opinion in Obstetrics & Gynecology · doi:10.1097/gco.0000000000000497 · Cited by 30 · see citing works
Decision-making capacity for research participation among addicted people: a cross-sectional study
Morán‐Sánchez, I., Maldonado, A. L., Sánchez-Muñoz, M., Aguilera-Alcaraz, B., & Pérez-Cárceles, M. D. (2016) · BMC Medical Ethics · doi:10.1186/s12910-015-0086-9 · Cited by 31 · see citing works
Daly, A. (2020) · The International Journal of Children s Rights · doi:10.1163/15718182-02803011 · Cited by 29 · see citing works
Koechlin, H., Locher, C., & Prchal, A. (2020) · Children · doi:10.3390/children7100179 · Cited by 29 · see citing works
Enrolling Minors in COVID-19 Vaccine Trials
Mintz, K. T., Jardas, E. S., Shah, S. K., Grady, C., Danis, M., & Wendler, D. S. (2021) · PEDIATRICS · doi:10.1542/peds.2020-040717 · Cited by 28 · see citing works
Vrouenraets, L. J. J. J., de Vries, A. L. C., Arnoldussen, M., Hannema, S. E., Lindauer, R., de Vries, M. C., & Hein, I. M. (2022) · European Child & Adolescent Psychiatry · doi:10.1007/s00787-022-02076-6 · Cited by 27 · see citing works
Self-citationMadden, L. L., Shilling, V. M., Woolfall, K., Sowden, E., Smyth, R. L., Williamson, P. R., & Young, B. (2016) · Child Care Health and Development · doi:10.1111/cch.12347 · Cited by 27 · see citing works
Transition of Children with Neurological Disorders
Tilton, A. H. (2018) · Current Neurology and Neuroscience Reports · doi:10.1007/s11910-018-0822-x · Cited by 25 · see citing works
Kebbe, M., Perez, A. J., Buchholz, A., Scott, S. D., McHugh, T.-L., Richard, C., Dyson, M. P., & Ball, G. D. C. (2019) · Patient Education and Counseling · doi:10.1016/j.pec.2019.01.017 · Cited by 24 · see citing works
Pediatric Deep Brain Stimulation for Dystonia: Current State and Ethical Considerations
Muñoz, K. A., Blumenthal‐Barby, J., Storch, E. A., Torgerson, L. N., & Lázaro‐Muñoz, G. (2020) · Cambridge Quarterly of Healthcare Ethics · doi:10.1017/s0963180120000316 · Cited by 23 · see citing works
Zupanc, M. L. (2020) · Seminars in Pediatric Neurology · doi:10.1016/j.spen.2020.100853 · Cited by 23 · see citing works
Massetti, T., Crocetta, T. B., Guarnieri, R., da Silva, T. D., Leal, A. F., Voos, M. C., & Monteiro, C. B. D. M. (2018) · Clinics · doi:10.6061/clinics/2018/e207 · Cited by 22 · see citing works
Adolescent neurocognitive development and decision-making abilities regarding gender-affirming care
Ravindranath, O., Perica, M. I., Parr, A. C., Ojha, A., McKeon, S. D., Montano, G. T., Ullendorff, N., Luna, B., & Edmiston, E. K. (2024) · Developmental Cognitive Neuroscience · doi:10.1016/j.dcn.2024.101351 · Cited by 27 · see citing works
Shared decision-making in adolescent healthcare: a literature review of ethical considerations
Sobode, O. R., Jegan, R., Toelen, J., & Dierickx, K. (2024) · European Journal of Pediatrics · doi:10.1007/s00431-024-05687-0 · Cited by 20 · see citing works
Is decision-making capacity an “essentially contested” concept in pediatrics?
Clercq, E. D., Ruhe, K. M., Rost, M., & Elger, B. S. (2017) · Medicine Health Care and Philosophy · doi:10.1007/s11019-017-9768-z · Cited by 20 · see citing works
Noroozi, M. O., Singh, I., & Fazel, M. S. (2018) · Evidence-Based Mental Health · doi:10.1136/ebmental-2018-300032 · Cited by 20 · see citing works
When Does A Minor’s Legal Competence To Make Health Care Decisions Matter?
Weithorn, L. A. (2020) · PEDIATRICS · doi:10.1542/peds.2020-0818g · Cited by 19 · see citing works
Weisleder, P. (2020) · Frontiers in Pediatrics · doi:10.3389/fped.2020.00025 · Cited by 18 · see citing works
Fisher, C. B., Puri, L. I., Macapagal, K. R., Feuerstahler, L. M., Ahn, J., & Mustanski, B. S. (2020) · AIDS and Behavior · doi:10.1007/s10461-020-03077-9 · Cited by 18 · see citing works
Hoffman, L. F., Francis, N. K., Catallozzi, M., Francis, J., Stanberry, L. R., & Rosenthal, S. L. (2016) · Journal of Adolescent Health · doi:10.1016/j.jadohealth.2016.01.007 · Cited by 17 · see citing works
Using Children's Voice to Optimize Pediatric Participation in Medical Decision Making
Grootens‐Wiegers, P., Hein, I. M., & Staphorst, M. S. (2018) · The American Journal of Bioethics · doi:10.1080/15265161.2017.1418928 · Cited by 17 · see citing works
Self-citationLittle patients, large risks: An overview on patient safety management in pediatrics settings
Nicolì, S., Benevento, M., Ferorelli, D., Mandarelli, G., & Solarino, B. (2022) · Frontiers in Pediatrics · doi:10.3389/fped.2022.919710 · Cited by 18 · see citing works
Paediatric biobanking for health: The ethical, legal, and societal landscape
Casati, S., Ellul, B., Mayrhofer, M. T., Lavitrano, M., Caboux, É., & Kozlakidis, Z. (2022) · Frontiers in Public Health · doi:10.3389/fpubh.2022.917615 · Cited by 16 · see citing works
El consentimiento informado en el menor maduro: comprensión y capacidad de decisión
Boceta, R., Martínez-Casares, O., & Albert, M. (2020) · Anales de Pediatría · doi:10.1016/j.anpedi.2020.10.011 · Cited by 19 · see citing works
Four steps to preserving adolescent confidentiality in an electronic health environment
Williams, R. L., & Taylor, J. F. (2016) · Current Opinion in Obstetrics & Gynecology · doi:10.1097/gco.0000000000000305 · Cited by 15 · see citing works
Béranger, A., Bouazza, N., de Sigy, A. D. H., Foubert-Wenc, A.-C., Davous, D., Aerts, I., Geoerger, B., Auvrignon, A., Brethon, B., Leblond, P., et al. (2018) · Archives of Disease in Childhood · doi:10.1136/archdischild-2018-315237 · Cited by 15 · see citing works
Ethical Considerations for Social Work Research With Vulnerable Children and Their Families
Sadzaglishvili, S., Gotsiridze, T., & Lekeshvili, K. (2021) · Research on Social Work Practice · doi:10.1177/1049731521996457 · Cited by 14 · see citing works
Adolescent Assent and Reconsent for Biobanking: Recent Developments and Emerging Ethical Issues
Kasperbauer, T. J., & Halverson, C. M. E. (2021) · Frontiers in Medicine · doi:10.3389/fmed.2021.686264 · Cited by 16 · see citing works
Hein, I. M., Daams, J. G., Troost, P. W., Lindeboom, R., & Lindauer, R. (2015) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd011099.pub2 · Cited by 14 · see citing works
Self-citationPuberty Suppression for Pediatric Gender Dysphoria and the Child’s Right to an Open Future
Jorgensen, S. C. J., Athéa, N., & Masson, C. (2024) · Archives of Sexual Behavior · doi:10.1007/s10508-024-02850-4 · Cited by 13 · see citing works
The informed consent in the mature minor: Understanding and decision-making capacity
Boceta, R., Martínez-Casares, O., & Albert, M. (2021) · Anales de Pediatría (English Edition) · doi:10.1016/j.anpede.2020.10.011 · Cited by 13 · see citing works
Capacity to Consent to Research Among Adolescent-Parent Dyads in Rakai, Uganda
Kreniske, P., Hoffman, S., Ddaaki, W. G., Nakyanjo, N., Spindler, E., Ssekyewa, C., Isabirye, D., Nakubulwa, R., Nabakka, P., Daniel, L., et al. (2022) · The Journal of Pediatrics · doi:10.1016/j.jpeds.2022.11.012 · Cited by 12 · see citing works
Michaud, P. (2016) · Springer eBooks · doi:10.1007/978-3-319-40743-2_18 · Cited by 12 · see citing works
Perspectives of adolescents on decision making about participation in a biobank study: a pilot study
Grootens‐Wiegers, P., Visser, E. G., van Rossum, A. M. C., van Waardhuizen, C. N., de Wildt, S. N., Sweep, B., van den Broek, J. M., & de Vries, M. C. (2017) · BMJ Paediatrics Open · doi:10.1136/bmjpo-2017-000111 · Cited by 12 · see citing works
Wiener, L. S., Viola, A., Wilfond, B. S., Wendler, D. S., & Grady, C. (2014) · Journal of Empirical Research on Human Research Ethics · doi:10.1177/1556264614563249 · Cited by 12 · see citing works
Fukuda, Y., & Fukuda, K. (2018) · BMC Medical Ethics · doi:10.1186/s12910-018-0330-1 · Cited by 12 · see citing works
Knopf, A., Draucker, C. B., Fortenberry, J. D., Ott, M. A., Arrington‐Sanders, R., Reirden, D. H., Schneider, J. A., Straub, D. M., Ofner, S., Bakoyannis, G., et al. (2023) · Journal of Adolescent Health · doi:10.1016/j.jadohealth.2022.11.241 · Cited by 11 · see citing works
Decisional capacity to consent to treatment in children and adolescents: A systematic review
Parmigiani, G., Benevento, M., Solarino, B., Margari, A., Ferorelli, D., Buongiorno, L., Catanesi, R., Carabellese, F., CASALE, A. D., Ferracuti, S., et al. (2024) · Psychiatry Research · doi:10.1016/j.psychres.2024.116343 · Cited by 12 · see citing works
Adolescent Confidentiality and Women’s Health
Schapiro, N. A., & Mejia, J. (2018) · Nursing Clinics of North America · doi:10.1016/j.cnur.2018.01.002 · Cited by 11 · see citing works
Banking the Future: Adolescent Capacity to Consent to Biobank Research
McGregor, K. A., & Ott, M. A. (2019) · Ethics & Human Research · doi:10.1002/eahr.500023 · Cited by 11 · see citing works
Online Pediatric Research: Addressing Consent, Assent, and Parental Permission
Brothers, K. B., Clayton, E. W., & Goldenberg, A. J. (2020) · The Journal of Law Medicine & Ethics · doi:10.1177/1073110520917038 · Cited by 11 · see citing works
The challenges of research participation by children
Bloomfield, F. H. (2015) · Pediatric Research · doi:10.1038/pr.2015.75 · Cited by 10 · see citing works
Rodríguez-Domínguez, F. J., Osuna-García, T., Guillén, A., Pérez-Cárceles, M. D., & Osuna, E. (2023) · Children · doi:10.3390/children10121844 · Cited by 9 · see citing works
Benfatto, G., Regulatory Group, Longo, L., Mansueto, S., Gozzo, L., Vitale, D. C., Amato, S., Basile, F., Blanco, A., Borzı̀, V., et al. (2021) · BMC Medical Ethics · doi:10.1186/s12910-021-00605-7 · Cited by 9 · see citing works
Ethical considerations in placebo-controlled randomised clinical trials
Kaufman, K. R. (2015) · BJPsych Open · doi:10.1192/bjpo.bp.115.000919 · Cited by 9 · see citing works
Koonrungsesomboon, N., Charoenkwan, P., Natesirinilkul, R., Fanhchaksai, K., Sakuludomkan, W., & Morakote, N. (2022) · BMC Medical Ethics · doi:10.1186/s12910-022-00856-y · Cited by 8 · see citing works
Child’s objection to non-beneficial research: capacity and distress based models
Waligóra, M., Różyńska, J. K., & Piasecki, J. (2015) · Medicine Health Care and Philosophy · doi:10.1007/s11019-015-9643-8 · Cited by 8 · see citing works
Zeng, L., Liang, W., Pan, J., Cao, Y., Liu, J. L., Wang, Q., Wang, L., Zou, Y., Wang, K., Kong, L., et al. (2016) · Journal of Alzheimer s Disease · doi:10.3233/jad-150858 · Cited by 8 · see citing works
Enhancing the informed consent process in psychiatric outpatients with a brief computer-based method
Morán‐Sánchez, I., Maldonado, A. L., & Pérez-Cárceles, M. D. (2016) · Psychiatry Research · doi:10.1016/j.psychres.2016.08.045 · Cited by 8 · see citing works
Anticipatory Waivers of Consent for Pediatric Biobanking
Hartsock, J. A., Schwartz, P. H., Waltz, A. C., & Ott, M. A. (2019) · Ethics & Human Research · doi:10.1002/eahr.500008 · Cited by 8 · see citing works
Felnhofer, A., Goreis, A., Bussek, T., Kafka, J. X., König, D., Klier, C. M., Zesch, H. E., & Kothgassner, O. D. (2019) · Journal of Child and Family Studies · doi:10.1007/s10826-019-01449-x · Cited by 9 · see citing works
Weithorn, L. A., & Reiss, D. R. (2019) · SSRN Electronic Journal · doi:10.2139/ssrn.3450277 · Cited by 8 · see citing works
Medical Research Involving Children – Giving Weight to Children’s Views
Dorscheidt, J. H. H. M., & Hein, I. M. (2018) · The International Journal of Children s Rights · doi:10.1163/15718182-02601006 · Cited by 7 · see citing works
Self-citationChildren Are Different: Liability Issues in Working With Suicidal and Dangerous Youths
Ash, P. (2019) · FOCUS The Journal of Lifelong Learning in Psychiatry · doi:10.1176/appi.focus.20190018 · Cited by 7 · see citing works
Co‐creation of information materials within the assent process: From theory to practice
Fons‐Martínez, J., Ferrer‐Albero, C., & Díez‐Domingo, J. (2022) · Health Expectations · doi:10.1111/hex.13675 · Cited by 7 · see citing works
Capacity to consent: a scoping review of youth decision-making capacity for gender-affirming care
Marino, L. G., Boguszewski, K. E., Stephens, H. F., & Taylor, J. F. (2024) · BMC Medical Ethics · doi:10.1186/s12910-024-01107-y · Cited by 6 · see citing works
Independent adolescent consent to mental health care: an ethical perspective
Rowan, C. B. (2023) · Ethics & Behavior · doi:10.1080/10508422.2023.2237147 · Cited by 6 · see citing works
Knopf, A., Ott, M. A., Draucker, C. B., Fortenberry, J. D., Reirden, D. H., Arrington‐Sanders, R., Schneider, J. A., Straub, D. M., Baker, R. A., Bakoyannis, G., et al. (2020) · JMIR Research Protocols · doi:10.2196/16509 · Cited by 6 · see citing works
Michaud, P., Takeuchi, Y. L., Mazur, A., Hadjipanayis, A., & Ambresin, A. (2023) · Frontiers in Pediatrics · doi:10.3389/fped.2023.1120324 · Cited by 5 · see citing works
Dyer, J., Shah, S. K., Agot, K. E., Wilson, K. S., Bosire, R., Badia, J., Inwani, I. W., Beima‐Sofie, K., Richardson, B. A., John-Stewart, G. C., et al. (2022) · Journal of the Association of Nurses in AIDS Care · doi:10.1097/jnc.0000000000000336 · Cited by 5 · see citing works
Stakeholders’ Views on Information Needed in a Patient Decision Aid for Microtia Reconstruction
Ronde, E. M., van de Lücht, V. A. P., Lachkar, N., Ubbink, D. T., & Breugem, C. C. (2023) · The Cleft Palate-Craniofacial Journal · doi:10.1177/10556656221146584 · Cited by 5 · see citing works
Berg, K. L., Mihaila, I., Feinstein, R. T., Shiu, C. A., Gussin, H. A., Acharya, K., Gladstone, T. R. G., Bernard, L., Best, M., Renz, E., et al. (2023) · Contemporary Clinical Trials · doi:10.1016/j.cct.2023.107374 · Cited by 5 · see citing works
Hagström, J., Hägglund, M., & Blease, C. (2025) · BMC Medical Ethics · doi:10.1186/s12910-025-01182-9 · Cited by 5 · see citing works
Consent and Assent in Pediatric Research: Whose Right Is It Anyway?
Hammer, M. J. (2016) · Oncology nursing forum · doi:10.1188/16.onf.281-283 · Cited by 5 · see citing works
Civil capacity in transition-age youth with history of central nervous system compromise: a review
Donders, J. (2016) · The Clinical Neuropsychologist · doi:10.1080/13854046.2016.1263362 · Cited by 5 · see citing works
Cognitive impairment following traumatic brain injury in Uganda: Prevalence and associated factors
Kintu, T. M., Katengeke, V., Kamoga, R., Nguyen, T., Najjuma, J. N., Kitya, D., Wakida, E. K., Obua, C., & Rukundo, G. Z. (2023) · PLOS Global Public Health · doi:10.1371/journal.pgph.0001459 · Cited by 5 · see citing works
Meinck, F., Franchino-Olsen, H., Hafstad, G. S., Jud, A., Liel, C., Nikolaidis, G., & Græsholt‐Knudsen, T. (2025) · Child Abuse & Neglect · doi:10.1016/j.chiabu.2025.107679 · Cited by 5 · see citing works
Parental experiences of the informed consent process in randomized clinical trials—A Nordic study
Mogensen, N., Kreicbergs, U. C., Albertsen, B. K., Lähteenmäki, P. M., Heyman, M. M., & Harila‐Saari, A. H. (2023) · Pediatric Blood & Cancer · doi:10.1002/pbc.30684 · Cited by 4 · see citing works
“Undoing” Capacity: The Capability Approach in Pediatrics
Clercq, E. D., Streuli, J. C., Ruhe, K., & Elger, B. S. (2019) · Perspectives in biology and medicine · doi:10.1353/pbm.2019.0016 · Cited by 4 · see citing works
Frost, L., Erio, M. T., Whitworth, H. S., Marwerwe, M. G., Hayes, R., Baisley, K. J., de Sanjosé, S., Watson‐Jones, D., & Mitchell, K. R. (2024) · BMC Medical Ethics · doi:10.1186/s12910-024-01122-z · Cited by 3 · see citing works
Vega, P. V., Miranda‐Castillo, C., & Vargas, I. (2024) · Andes pediatrica · doi:10.32641/andespediatr.v95i1.4968 · Cited by 6 · see citing works
Lee, J., Kim, H.-H., & Budge, S. L. (2024) · Harvard Review of Psychiatry · doi:10.1097/hrp.0000000000000404 · Cited by 3 · see citing works
Respect for Persons in the Psychiatric Treatment of Children and Adolescents
Conrad, R. C., & Brumbaugh, B. J. (2021) · Psychiatric Clinics of North America · doi:10.1016/j.psc.2021.08.007 · Cited by 3 · see citing works
Shircliff, K., Cummings, C., & Borgogna, N. C. (2024) · Research on Child and Adolescent Psychopathology · doi:10.1007/s10802-024-01274-x · Cited by 3 · see citing works
Tanaka, K., Hayakawa, M., Mori, M., Maeda, N., Nagata, M., & Horibe, K. (2023) · BMC Medical Ethics · doi:10.1186/s12910-023-00907-y · Cited by 3 · see citing works
Consent to research participation: understanding and motivation among German pupils
Reetz, J. E., Richter, G., Borzikowsky, C., Glinicke, C., Darabaneanu, S., & Buyx, A. (2021) · BMC Medical Ethics · doi:10.1186/s12910-021-00661-z · Cited by 3 · see citing works
Daly, A. (2020) · SSRN Electronic Journal · doi:10.2139/ssrn.3995591 · Cited by 3 · see citing works
van Vugt, A. S., Zijlmans, J., Lindauer, R., & van Dam, L. (2023) · Drug Science Policy and Law · doi:10.1177/20503245231198477 · Cited by 2 · see citing works
Self-citationZhang, S., Cho, S., Duan, F., Feng, H., Zhang, Q., & Ma, M. (2026) · Frontiers in Human Neuroscience · doi:10.3389/fnhum.2025.1712662 · Cited by 2 · see citing works
- Authors
- Hein, I. M., Troost, P. W., Lindeboom, R., Benninga, M. A., Zwaan, C. M., van Goudoever, J. B., & Lindauer, R. J. L.
- Affiliations
- Amsterdam UMC Location University of Amsterdam (NL)
- Erasmus MC (NL)
- Department of Pediatrics, Emma Children’s Hospital, Academic Medical Center, Amsterdam, the Netherlands5Department of Pediatrics, VU University Medical Center, Amsterdam, the Netherlands
- Corresponding author
- Hein, Irma M.
- Venue
- JAMA Pediatrics
- Publisher
- American Medical Association (AMA)
- Published
- 2014-12-01
- Volume
- 168
- Issue
- 12
- Pages
- 1147
- ISSN
- 1072-4710 (ISSN-L)
- 2168-6203
- OpenAlex
- W2027083136
- Cited by
- 148
- References
- 24
- Citations by year
- 2026: 5 · 2025: 8 · 2024: 21 · 2023: 16 · 2022: 11 · 2021: 17 · 2020: 17 · 2019: 9 · 2018: 11 · 2017: 5 · 2016: 13 · 2015: 13 · 2014: 2
- FWCI
- 10.35
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Archives of Pediatrics and Adolescent Medicine (publishedVersion)
- PubMed (publishedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
- Pure Amsterdam UMC (submittedVersion)
- Topics
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Ethics and Legal Issues in Pediatric Healthcare
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Social Sciences › Psychology › Clinical Psychology › Healthcare Decision-Making and Restraints
- Keywords
- capacity to consent, children's participation in research, informed consent, competency assessment instrument, inter-rater reliability, criterion validity, children and adolescents, clinical research
- MeSH terms
- Adolescent, Age Factors, Child, Female, Humans, Male, Prospective Studies, Psychometrics, Surveys and Questionnaires, Sensitivity and Specificity, Reproducibility of Results, Mental Competency, Comprehension, Biomedical Research, Informed Consent By Minors
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
