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Research ethics committee members’ perspectives on paediatric research: a qualitative interview study
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.ORCID iD: 0000-0002-7262-3464
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.ORCID iD: 0000-0002-4069-812X
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, Physiotherapy.ORCID iD: 0000-0002-0609-5683
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.ORCID iD: 0000-0001-6011-6740
2023 (English)In: Research Ethics, ISSN 1747-0161, E-ISSN 2047-6094, Vol. 19, no 4, p. 494-518Article in journal (Refereed) Published
Abstract [en]

Research ethics committees (RECs) have a crucial role in protecting children in research. However, studies on REC members’ perspectives on paediatric research are scarce. We conducted a qualitative study to explore Swedish scientific REC members’ perspectives on ethical aspects in applications involving children with severe health conditions. The REC members considered promoting participation, protecting children and regulatory adherence to be central aspects. The results underscored the importance of not neglecting ill children’s rights to adapted information and participation. REC members supported a contextual and holistic approach to vulnerability and risk, which considers the child’s and parents’ psychological wellbeing and the child’s integrity, both short and long term. The ethical complexity of paediatric research requires continuous ethical competence development within RECs.

Place, publisher, year, edition, pages
Sage Publications, 2023. Vol. 19, no 4, p. 494-518
Keywords [en]
paediatric research, research ethics, human research ethics committee, ethical review board, recruitment, informed consent, assent, qualitative research
National Category
Medical Ethics
Research subject
Ethics; Medical Science; Pediatrics
Identifiers
URN: urn:nbn:se:uu:diva-504898DOI: 10.1177/17470161231179663ISI: 001003835000001Scopus ID: 2-s2.0-85162648546OAI: oai:DiVA.org:uu-504898DiVA, id: diva2:1768968
Funder
Swedish Childhood Cancer Foundation, PR2019-0107Available from: 2023-06-16 Created: 2023-06-16 Last updated: 2025-12-08Bibliographically approved
In thesis
1. Toward best ethical practices for including children in childhood cancer research
Open this publication in new window or tab >>Toward best ethical practices for including children in childhood cancer research
2026 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

This thesis is based on an empirical-ethical approach with the overall aim to explore and describe ethical aspects of including assent-aged children in childhood cancer research, and to develop empirically informed, ethically grounded guidance for research practice.

Study I was a qualitative interview study with healthcare professionals in Swedish pediatric oncology. The aim was to investigate their perspectives on ethical values, challenges, and opportunities to strengthen ethical aspects in recruitment of children with cancer to research, and their perspectives on ethical competence. Manifest inductive qualitative content analysis generated five categories: establishing relationships and trust, meeting informational needs, acknowledging vulnerability, balancing roles and interests, and ensuring ethical competence.

Study II was a qualitative interview study with members of the Swedish Ethical Review Authority. The aim was to explore their perspectives on ethical values, challenges, and opportunities to strengthen ethical aspects of participant recruitment in pediatric research, and their perspectives on ethical competence. Manifest inductive reflexive thematic analysis generated three themes: promoting participation, protecting children, and regulatory adherence.

Study III was a qualitative interview study with children, siblings, and parents who had participated in childhood cancer research. The aim was to describe how they experience children’s participation in assent. Latent inductive reflexive thematic analysis generated two themes: a moral and emotional commitment to research, and relational assent: trust, loyalty, andparental constraint.

Study IV was a prescriptive normative study aimed at developing ethically grounded guidance for children’s participation in assent. Using reflective equilibrium, a normative analysis was conducted based on empirical findings from Studies I–III, previous research, moral judgments, ethical principles, and relevant guidelines. The study proposed that childhood cancer research should not only respect children’s autonomy but also actively promote it, acknowledging that relationships and trust can both enable and constrain autonomy.

This thesis contributes to a context-specific understanding of ethical aspects in childhood cancer research, particularly concerning autonomy and vulnerability. It highlights the need to actively support children’s autonomy and participation in assent and the importance of ethical competence in navigating ethical, relational, and clinical complexities in research recruitment. Further, it provides empirically informed normative guidance for research practice.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2026. p. 79
Series
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 2222
Keywords
assent, children, pediatric research ethics, pediatric oncology, research recruitment, relational autonomy, vulnerability, ethical competence
National Category
Medical and Health Sciences
Research subject
Medical Science
Identifiers
urn:nbn:se:uu:diva-572711 (URN)978-91-513-2701-3 (ISBN)
Public defence
2026-02-06, Sal IV, Universitetshuset, Biskopsgatan 3, Uppsala, 13:00 (Swedish)
Opponent
Supervisors
Funder
Swedish Childhood Cancer Foundation, [PR2019-0107; KP2022-0011]
Note

Zoom-link: https://uu-se.zoom.us/j/63452852810

Available from: 2026-01-15 Created: 2025-12-08 Last updated: 2026-01-20

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Norberg Wieslander, KajsaHöglund, Anna TFrygner Holm, SaraGodskesen, Tove

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