411 - A Qualitative Study about Children’s Vulnerability in Medical Research: Protection and Empowerment

Friday, April 28, 2023

5:15 PM – 7:15 PM ET

Poster Number: 411
Publication Number: 411.106

Malou L. Luchtenberg, University of Groningen, University Medical Center Groningen, Medical Center Leeuwarden, Leeuwarden, Friesland, Netherlands; Els L. M. Maeckelberghe, University Medical Center Groningen, Groningen, Groningen, Netherlands; A.A. Eduard Verhagen, Nniversity Medical Center Groningen, dept of pediatrics, Groningen, Groningen, Netherlands; Louise Locock, University of Aberdeen, Aberdeen, Scotland, United Kingdom; Florencia Luna, FLACSO-CONICET, Ciudad Autónoma de Buenos Aires, Ciudad Autonoma de Buenos Aires, Argentina

Presenting Author(s)

Malou L. Luchtenberg, MD PhD (she/her/hers)

Postdoc researcher and medical doctor (trainee not in specialist training) in Pediatrics
University of Groningen, University Medical Center Groningen, Medical Center Leeuwarden
Leeuwarden, Friesland, Netherlands

Background: Medical research guidelines often label children as vulnerable. This may cause both overprotection and underprotection, resulting in unnecessary exclusion of children from medical research. Additionally, it may lead to children being unable to safeguard their own interests. A contextual and dynamic approach to vulnerability could help to provide more appropriate protection.

Objective: To explore ways to how to address children’s vulnerability in practice. To that end, we explored children’s experiences in research and used them to provide practical guidance for researchers and research ethics committee members.

Design/Methods: Qualitative study of 52 interviews with children aged 9-18 about their experiences of participation in medical research in the Netherlands and UK. Interviews were audiotaped, transcribed verbatim, and thematically analyzed using Atlas.ti software. Themes were derived from what children themselves stated as important, and from their recommendations to researchers and future participants.

Results: Children focused mainly on improving their participation rather than on protection. Both personal as well as contextual factors played a role and often interacted. Burden due to interventions or timing of procedures were important in children’s consideration to participate. Disease or previous research experiences could foster decision-making. Tailored information and support from parents, peers, and professionals made children feel at ease and taken seriously. All factors contributed to children’s knowledge, capability, and confidence in making decisions about participation in research as well as during participation.

Conclusion(s): In exploring vulnerability we found that children do not focus so much on protection as on support that leads to empowerment. Identifying layers of vulnerability – not all children are equally vulnerable – both protects and empowers children. We identified four potential layers of vulnerability related to (1) information, (2) burden involved in participating in research, (3) having a disease or (4) participating as a healthy volunteer without any acquaintance with research. If we want to support children in their evolving capacity, we should give sufficient weight to their voices. This makes them greatly dependent on the responsibility of others such as researchers and parents. We formulated responsibilities relating to involvement, support, and information supply. Insight in these layers and obligations may contribute to proper protection and empowerment of children participating in research.