Ethical Challenges in Conducting Pediatric Homoeopathic Clinical Research: A Narrative Review
Abstract
Clinical research involving children is essential for improving pediatric healthcare, but it raises ethical concerns that are different from those encountered in adults. Children have developing cognitive and decision-making abilities and therefore require additional safeguards during research participation. At the same time, excluding children from research can result in inadequate evidence for interventions that are subsequently used in pediatric practice. These considerations are particularly relevant to homoeopathic clinical research, where individualized prescribing, subjective symptom assessment, treatment modification and the use of individualized medicines can create additional methodological and ethical questions. The present narrative review discusses the major ethical challenges associated with pediatric homoeopathic clinical research, including vulnerability of children, informed consent, child assent, parental permission, risk-benefit assessment, privacy and confidentiality, compensation, ethics committee oversight, research in resource-limited settings and scientific integrity. International frameworks including the Declaration of Helsinki, CIOMS guidelines, ICH Good Clinical Practice and WHO guidance are considered alongside Indian requirements, particularly the ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants and the ICMR National Ethical Guidelines for Biomedical Research Involving Children. The relevance of the 2025 ICMR addendum on Research in Integrative Medicine and the Good Clinical Practice Guidelines for Clinical Trials in homoeopathy is also discussed. Particular attention is given to placebo use, rescue treatment, individualized prescribing, outcome assessment and the need to avoid therapeutic misconception. Ethical pediatric homoeopathic research requires protection of the child's welfare together with adequate scientific rigor, transparency and responsible reporting.