Guidelines for the ethical conduct of medical research involving children

Madlom, M M

doi:10.1136/adc.83.4.369d

Cited by 6 publications

(2 citation statements)

References 3 publications

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“…Decision-making in pediatric research is difficult because children are not considered capable of giving informed consent themselves [1][2][3]. They do, however, have the right to participate in all decisions that concern them [4].…”

Section: Introductionmentioning

confidence: 99%

Understanding the child-doctor relationship in research participation: a qualitative study

et al. 2020

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Background: Children have reported that one reason for participating in research is to help their doctor. This is potentially harmful if associated with coercive consent but might be beneficial for recruitment. We aimed to explore children's perceptions of the child-doctor relationship in research. Methods: This is a multicenter qualitative study with semi structured interviews performed between 2010 and 2011 (United Kingdom) and 2017-2019 (the Netherlands). Interviews took place nationwide at children's homes. We performed a secondary analysis of the two datasets, combining an amplified analysis aimed to enlarge our dataset, and a supplementary analysis, which is a more in-depth investigation of emergent themes that were not fully addressed in the original studies. All participants had been involved in decisions about research participation, either as healthy volunteers, or as patients. Recruitment was aimed for a purposive maximum variation sample, and continued until data saturation occurred. We have studied how children perceived the child-doctor relationship in research. Interviews were audiotaped or videotaped, transcribed verbatim, and thematically analyzed using Atlas.ti software. Results: In total, 52 children were recruited aged 9 to 18, 29 in the United Kingdom and 23 in the Netherlands. Children's decision-making depended strongly on support by research professionals, both in giving consent and during participation. Often, their treating physician was involved in the research process. Familiarity and trust were important and related to the extent to which children thought doctors understood their situation, were medically competent, showed support and care, and gave priority to the individual child's safety. A trusting relationship led to a feeling of mutuality and enhanced children's confidence. This resulted in improving their experiences throughout the entire research process. None of the participants reported that they felt compelled to participate in the research. Conclusions: The child-doctor relationship in pediatric research should be characterized by familiarity and trust. This does not compromise children's voluntary decision but enhances children's confidence and might result in a feeling of mutuality. By addressing the participation of children as an iterative process during which treatment and research go hand in hand, the recruitment and participation of children in research can be improved.

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Section: Introductionmentioning

confidence: 99%

Understanding the child-doctor relationship in research participation: a qualitative study

et al. 2020

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“…parents of preterm infants hospitalised in the NICU), specific ethical considerations had to be taken into account (Modi et al, 2014). In this study, recommendations provided by the Royal College of Paediatrics and the Child Health Ethics Advisory Committee (2000) were used to guide the design of the study including the requirement of informed consent, the way to provide the questionnaires, as well as the support given during data collection (Mclntosh et al, 2000).…”

Section: Methodsmentioning

confidence: 99%

Factors affecting how parents cope with their preterm infant's pain: A cross‐sectional study

Brike

Melnikov

2022

Journal of Clinical Nursing

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Aims and objectives This study examined the relationships between parents' catastrophising about their infants' pain, parental self‐efficacy in the management of their infants' pain, perceived social support and the parental coping strategies for their infants’ pain‐related stress. Background Preterm infants hospitalised in the neonatal intensive care unit experience painful procedures causing stress to their parents. Coping with stress may be emotion‐ or problem‐focused. Adults' coping with their own pain has been associated with pain catastrophising, pain management self‐efficacy and social support. However, little is known about the associations between parents' catastrophising, their self‐efficacy to manage, their perceived social support and their coping strategies when dealing with their infants' pain. Design This was a cross‐sectional, correlational study design. Methods The STROBE guidelines for cross‐sectional studies were followed. Participants included 149 parents of preterm infants hospitalised in a neonatal intensive care unit. They completed measures to assess infant pain catastrophising, self‐efficacy regarding infant pain management, social support and emotion‐ and problem‐focused coping. Results Positive associations were found between parental self‐efficacy regarding infant pain management, social support, parental catastrophising about their infants' pain and problem‐focused coping. Parental catastrophising was positively associated with emotion‐focused coping. Gender moderated the relationships between parental self‐efficacy regarding infant pain management and emotion‐focused coping. Specifically, amongst mothers, the higher their level of self‐efficacy, the lower their emotion‐focused coping. Amongst fathers, the relations were reversed. Conclusions Parents coping with their preterm infants' pain were associated with catastrophising about their infants' pain, self‐efficacy regarding infant pain management and social support. Mothers had different ways to cope emotionally to that of fathers in relation to their self‐efficacy in managing their infants' pain. Relevance to clinical practice Nursing interventions that provide support to parents and promote parental self‐efficacy in managing their infants' pain may allow parents to more effectively cope with their infants' pain. Patient or Public Contribution Patients or public were not involved in setting the research question, the outcome measures and the design or implementation of the study. Parents of preterm infants answered the research questionnaires.

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Is it time to re-think juvenile-onset Rheumatic and Musculoskeletal Diseases? – First steps towards individualised treatments to meet agreed targets

McCann

Hedrich

2021

Clinical Immunology

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Guidelines for the ethical conduct of medical research involving children

Cited by 6 publications

References 3 publications

Understanding the child-doctor relationship in research participation: a qualitative study

Understanding the child-doctor relationship in research participation: a qualitative study

Factors affecting how parents cope with their preterm infant's pain: A cross‐sectional study

Is it time to re-think juvenile-onset Rheumatic and Musculoskeletal Diseases? – First steps towards individualised treatments to meet agreed targets

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