ArticleJournal of medical ethics2005
Children's understanding of the risks and benefits associated with research.
Article in Journal of medical ethics, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00571311 (Parental Permission and Adolescent Assent and Decision Making in Clinical Research), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Parental Permission and Adolescent Assent and Decision Making in Clinical Research
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Understanding Ethical Issues of Research Participation From the Perspective of Participating Children and Adolescents: A Systematic Review.Worldviews on evidence-based nursing · 2017Pooled it
- Ethical key issues and fundamental rights in paediatric research.European journal of clinical pharmacology · 2011Trial
- A randomized study of a method for optimizing adolescent assent to biomedical research.AJOB empirical bioethicsTrial
- Community Stakeholders' Perspectives on Recruiting Young Adolescents (Age 10-14) in Sexual Health Research.Healthcare (Basel, Switzerland) · 2025Article
- Ethical Considerations for Engaging Youth Living with HIV in Research: Perspectives from Youth, Their Caregivers and Subject Matter Experts in Kenya.Journal of empirical research on human research ethics : JERHRE · 2023Article
- Children's Understanding of Informed Assents in Research Studies.Healthcare (Basel, Switzerland) · 2021Article
- Moral structuring of children during the process of obtaining informed consent in clinical and research settings.BMC medical ethics · 2020Article
- Article
- A didactic approach to presenting verbal and visual information to children participating in research protocols: the comic book informed assent.Clinics (Sao Paulo, Brazil) · 2018Article
- Clinical trials of contraceptive agents in those under 16 years of age: are they necessary, ethical or legal?Archives of disease in childhood · 2014Article
- Child's assent in research: age threshold or personalisation?BMC medical ethics · 2014Article
- Empirically-derived Knowledge on Adolescent Assent to Pediatric Biomedical Research.AJOB primary research · 2013Article
- Do Illustrations Improve Children's Comprehension of Assent Documents?The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2012Article
- Overcoming burdens in the regulation of clinical research in children. Proceedings of a consensus conference, in historical context.International journal of pediatric endocrinology · 2011Article
- Ethical principles and legal requirements for pediatric research in the EU: an analysis of the European normative and legal framework surrounding pediatric clinical trials.European journal of pediatrics · 2009Article
- Ethics takes time, but not that long.BMC medical ethics · 2007Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe objective of the current study was to maximise the amount of information children and adolescents understand about the risks and benefits associated with participation in a biomedical research study.
designParticipants were presented with one of six hypothetical research protocols describing how to fix a fractured thigh using either a "standard" cast or "new" pins procedure. Risks and benefits associated with each of the treatment options were manipulated so that for each one of the six protocols there was either a correct or ambiguous choice. PARTICIPANTS AND
settingTwo hundred and fifty one children, ages 6-15 (53% boys), and 237 adults (30% men) were interviewed while waiting for a clinic appointment at the Hospital for Sick Children.
resultsUsing standardised procedures and questionnaires, it was determined that most participants, regardless of age group, were able to understand the basic purpose and procedures involved in the research, and most were able to choose the "correct" operation. The younger children, however, showed an overall preference for a cast operation, whereas the older participants were more likely to choose the pins.
conclusionsBy creating age appropriate modules of information, children as young as six years can understand potentially difficult and complex concepts such as the risks and benefits associated with participation in biomedical research. It appears, however, that different criteria were used for treatment preference, regardless of associated risks; older participants tended to opt for mobility (the pins procedure) whereas younger participants stayed with the more familiar cast operation.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.