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Children as research subjects: a dilemma
1Department of Medical Humanities, Brody School of Medicine, East Carolina University, Greenville, North Carolina 27834-4354, USA. kopelmanlo@mail.ecu.edu
The Journal of Medicine and Philosophy
|March 23, 2001
Summary
Protecting children in research requires balancing group benefits against individual rights. Current guidelines are restrictive, necessitating improved risk assessment and ethical frameworks for child research subjects.
Area of Science:
- Bioethics
- Pediatric Research Ethics
- Child Welfare in Research
Background:
- International codes like the Nuremberg Code and Declaration of Helsinki present significant ethical challenges for pediatric research.
- These codes often restrict or prohibit essential research involving children due to consent requirements and limitations on non-therapeutic studies.
- Existing policies from organizations like CIOMS and US Federal Research Guidelines allow for ethical review but lack clarity on balancing risks and benefits, particularly concerning 'minimal risk'.
Purpose of the Study:
- To analyze the ethical complexities of conducting research with children as a group while safeguarding individual rights.
- To critique the limitations of existing international and national ethical guidelines for pediatric research.
- To propose pathways for improving ethical frameworks governing research involving child subjects.
Main Methods:
- Review and analysis of key international ethical codes (Nuremberg Code, Declaration of Helsinki).
- Examination of current national policies and guidelines (e.g., CIOMS, US Federal Research Guidelines).
- Conceptual analysis of ethical balancing, risk assessment, and moral judgments in research ethics.
Main Results:
- The Nuremberg Code and Declaration of Helsinki are deemed overly restrictive for pediatric research.
- Current policies permit research ethics committees to authorize studies but lack precise definitions for key concepts like 'minimal risk' and clear methods for risk-benefit balancing.
- Several areas for improvement in consequentialist approaches to research ethics are identified.
Conclusions:
- There is a critical need to refine ethical guidelines for research involving children.
- Improving risk assessment standardization and clarifying moral judgments are crucial steps.
- Acknowledging non-negotiable duties to children and moving beyond simplistic utilitarianism are essential for ethical progress in pediatric research.
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