Research ethics committee members’ perspectives on paediatric research: a qualitative interview study

Abstract

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.

A comparative ethical analysis of the Egyptian clinical research law

“…Northern European countries are still considered to be leading countries in research (Sweden is the 3 rd country in terms of research and development expenditures (% of GDP) after Israel and Korea in 2020 – [ 28 ] and have a long tradition of bioethics practices and reflections (e.g., Helsinki’s declaration in 2000 [ 29 ]). Specifically, Sweden is included in the study as an example of a Nordic country with an evidence-based culture of health policymaking [ 30 ] and constant interest for ethical inquiry in under-researched vulnerable populations [ 31 – 33 ]. In 2004, Sweden enforced “The Act concerning the Ethical Review of Research Involving Humans” (SFS nr: 2003:460) that sharpened ethical review procedures for biomedical research way earlier than other countries (e.g.…”