Table 1

Details of data of the original interview study on children’s experiences in medical research

Study characteristics
AimTo explore children’s experiences in medical research to obtain recommendations from their perspectives on how to improve children’s involvement in research.
Setting and research teamSingle-centre study conducted by a team of researchers at University Medical Center Groningen, the Netherlands. The research team consisted of an ethicist (EM), paediatrician (EV) and MD/PhD student (ML). All members were trained researchers and/or had previous experience in conducting qualitative research.
Recruitment and samplingRecruitment through health providers from several hospitals, national patient support groups, social media and by word-of-mouth. Purposive maximum variation sample: children, patients as well as healthy volunteers between 9 and 18 years old who were invited to participate in different types of medical research in the Netherlands and who either took part or declined to take part. The participants had no prior relationships with the members of the research team.
Informed consentInformed consent given by one parent and the child or, in accordance with Dutch law, from 16 years and older by the child only.
Data collectionTwenty-three semi-structured, in-depth interviews, lasting between 30 and 100 min, with children about their experiences in taking part in medical research, including recommendations for improvement of children’s involvement in informed consent procedures and the research itself. A topic guide was developed based on a previous study in the UK. Interviews performed by ML took place at children’s homes and were recorded on audio or video, transcribed verbatim and returned to the participants. No comments from participants were received. Data collection continued until we reached data saturation of main themes.
Ethical approvalThe conclusion of the Medical Ethics Review Board of the University Medical Center Groningen was that this study, no. M16.192386, 10 May 2016, fell beyond the scope of the Dutch Medical Research Involving Human Subjects Act.