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Toward best ethical practices for including children in childhood cancer research
Uppsala universitet, Medicinska och farmaceutiska vetenskapsområdet, Medicinska fakulteten, Institutionen för folkhälso- och vårdvetenskap, Centrum för forsknings- och bioetik.ORCID-id: 0000-0002-7262-3464
2026 (engelsk)Doktoravhandling, med artikler (Annet vitenskapelig)
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.

sted, utgiver, år, opplag, sider
Uppsala: Acta Universitatis Upsaliensis, 2026. , s. 79
Serie
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 2222
Emneord [en]
assent, children, pediatric research ethics, pediatric oncology, research recruitment, relational autonomy, vulnerability, ethical competence
HSV kategori
Forskningsprogram
Medicinsk vetenskap
Identifikatorer
URN: urn:nbn:se:uu:diva-572711ISBN: 978-91-513-2701-3 (tryckt)OAI: oai:DiVA.org:uu-572711DiVA, id: diva2:2019792
Disputas
2026-02-06, Sal IV, Universitetshuset, Biskopsgatan 3, Uppsala, 13:00 (svensk)
Opponent
Veileder
Forskningsfinansiär
Swedish Childhood Cancer Foundation, [PR2019-0107; KP2022-0011]
Merknad

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

Tilgjengelig fra: 2026-01-15 Laget: 2025-12-08 Sist oppdatert: 2026-01-20
Delarbeid
1. Ethical concerns when recruiting children with cancer for research: Swedish healthcare professionals' perceptions and experiences.
Åpne denne publikasjonen i ny fane eller vindu >>Ethical concerns when recruiting children with cancer for research: Swedish healthcare professionals' perceptions and experiences.
2023 (engelsk)Inngår i: BMC Medical Ethics, E-ISSN 1472-6939, Vol. 24, nr 1, s. 23-, artikkel-id 23Artikkel i tidsskrift (Fagfellevurdert) Published
Abstract [en]

BACKGROUND: Research is crucial to improve treatment, survival and quality of life for children with cancer. However, recruitment of children for research raises ethical challenges. The aim of this study was to explore and describe ethical values and challenges related to the recruitment of children with cancer for research, from the perspectives and experiences of healthcare professionals in the Swedish context. Another aim was to explore their perceptions of research ethics competence in recruiting children for research.

METHODS: An explorative qualitative study using semi-structured interviews with key informants. Seven physicians and ten nurses were interviewed. Interviews were analysed using inductive qualitative content analysis.

RESULTS: The respondents' ethical challenges and values in recruitment mainly concerned establishing relationships and trust, meeting informational needs, acknowledging vulnerability, and balancing roles and interests. Ensuring ethical competence was raised as important, and interpersonal and communicative skills were highlighted.

CONCLUSION: This study provides empirical insight into recruitment of children with cancer, from the perspectives of healthcare professionals. It also contributes to the understanding of recruitment as a relational process, where aspects of vulnerability, trust and relationship building are important, alongside meeting informational needs. The results provide knowledge on the complexities raised by paediatric research and underpin the importance of building research ethics competence to ensure that the rights and interests of children with cancer are protected in research.

sted, utgiver, år, opplag, sider
BioMed Central (BMC), 2023
Emneord
Assent, Ethical challenges, Ethics, Healthcare professionals, Informed consent, Paediatric oncology, Qualitative research, Research recruitment, Shared decision-making
HSV kategori
Forskningsprogram
Etik; Pediatrik
Identifikatorer
urn:nbn:se:uu:diva-500405 (URN)10.1186/s12910-023-00901-4 (DOI)000949309100001 ()36918868 (PubMedID)2-s2.0-85150245004 (Scopus ID)
Forskningsfinansiär
Swedish Childhood Cancer Foundation, PR2019-0107
Tilgjengelig fra: 2023-04-17 Laget: 2023-04-17 Sist oppdatert: 2025-12-08bibliografisk kontrollert
2. Research ethics committee members’ perspectives on paediatric research: a qualitative interview study
Åpne denne publikasjonen i ny fane eller vindu >>Research ethics committee members’ perspectives on paediatric research: a qualitative interview study
2023 (engelsk)Inngår i: Research Ethics, ISSN 1747-0161, E-ISSN 2047-6094, Vol. 19, nr 4, s. 494-518Artikkel i tidsskrift (Fagfellevurdert) 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.

sted, utgiver, år, opplag, sider
Sage Publications, 2023
Emneord
paediatric research, research ethics, human research ethics committee, ethical review board, recruitment, informed consent, assent, qualitative research
HSV kategori
Forskningsprogram
Etik; Medicinsk vetenskap; Pediatrik
Identifikatorer
urn:nbn:se:uu:diva-504898 (URN)10.1177/17470161231179663 (DOI)001003835000001 ()2-s2.0-85162648546 (Scopus ID)
Forskningsfinansiär
Swedish Childhood Cancer Foundation, PR2019-0107
Tilgjengelig fra: 2023-06-16 Laget: 2023-06-16 Sist oppdatert: 2025-12-08bibliografisk kontrollert
3. Children’s participation in assent to paediatric oncology research: experiences of children, siblings and parents
Åpne denne publikasjonen i ny fane eller vindu >>Children’s participation in assent to paediatric oncology research: experiences of children, siblings and parents
Vise andre…
(engelsk)Manuskript (preprint) (Annet vitenskapelig)
HSV kategori
Identifikatorer
urn:nbn:se:uu:diva-572709 (URN)
Forskningsfinansiär
Swedish Childhood Cancer Foundation, [TJ2015-0005, PR2016-013, PR2019-0107, KP2022-0011]
Tilgjengelig fra: 2025-12-05 Laget: 2025-12-05 Sist oppdatert: 2025-12-08
4. Why children’s research assent matters: Exploring three dimensions of autonomy
Åpne denne publikasjonen i ny fane eller vindu >>Why children’s research assent matters: Exploring three dimensions of autonomy
Vise andre…
2026 (engelsk)Inngår i: Nursing Ethics, ISSN 0969-7330, E-ISSN 1477-0989Artikkel i tidsskrift (Fagfellevurdert) Published
Abstract [en]

Children's assent is an ethical and legal requirement for research that involves them. Nevertheless, studies suggest that children with cancer are not always involved in research decisions. This raises important ethical questions about how children's participation in assent should be supported and on what ethical grounds. In this paper, we explore three dimensions of autonomy in research with children: autonomy as a right, as a value, and as relational. We argue that it is important not only to respect children's autonomy but to also promote it as a value, by actively supporting children's autonomy. Central to this approach is an understanding of how relationships and trust can both enable and constrain children's autonomy. We suggest that children's autonomy may be supported in practice through capacity-sensitive participation, child-adapted and iterative information provision. This requires ongoing dialogue that is responsive to children's emotional, cognitive, and relational contexts, with particular attention to fears, decision-making challenges, and voluntariness. While concern for the well-being of children with cancer is essential, it should not be used as a justification to exclude them from the assent process. Respect for children as persons should guide recruitment to paediatric oncology research.

Emneord
assent; children; clinical trials; healthcare professionals; informed consent; paediatric oncology
HSV kategori
Identifikatorer
urn:nbn:se:uu:diva-572707 (URN)10.1177/09697330261424347 (DOI)
Forskningsfinansiär
Swedish Childhood Cancer Foundation, [PR2019-0107; KP2022-0011]
Tilgjengelig fra: 2025-12-05 Laget: 2025-12-05 Sist oppdatert: 2026-03-26

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