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[Children as medical research subjects]
1Den nasjonale forskningsetiske komité for medisin, Oslo.
Summary
This study reviewed 105 Norwegian research ethics proposals involving children. While most were approved, 16 were invasive, highlighting the need to balance child protection with research inclusion.
Area of Science:
- Medical Ethics
- Pediatric Research
- Research Governance
Context:
- Historical review of research ethics committee practices in Norway (1987-1997).
- International perspective on ethical considerations for including children in research.
- Evolving standards for child research subjects following historical abuses.
Purpose:
- To evaluate the review practices of a regional medical research ethics committee concerning child participants.
- To analyze the types of research involving children approved over a decade.
- To discuss ethical challenges and justifications for research on children.
Summary:
- The committee reviewed 105 project proposals involving children, approving most with modifications and advising against only nine.
- Sixteen approved projects were classified as invasive and non-therapeutic.
- The review process reflects a shift towards including children in research, balancing protection with the need for pediatric data.
Impact:
- Identifies a historical trend of cautious but generally permissive ethical review for pediatric research.
- Highlights the ethical dilemma of protective exclusion hindering medical advancements for children.
- Advocates for a revised approach to child research inclusion, aligning with evolving international guidelines like those from the National Institutes of Health.