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Ethical Challenges

5. Current and Unresolved Issues

The Belmont Principles were intended as ethical guidelines. Application of each principle by the research investigators and by the ethics review committee requires judgment, interpretation and ethical analysis in the context of a given situation, e.g. a specific research proposal and cultural context. Ethical dilemmas arise in situations in which ethical principles conflict. Both science and social attitudes have changed in the 40 years since the Belmont Report was published. Interpretation of the principles and accepted opinion about what constitutes ethical behavior has evolved. Research is conducted on a global scale, and has become increasingly complex and integrative. There is now greater diversity within research environments, and more attention to community engagement and the potential value of the research to the community.

These issues have stimulated debate about whether the Belmont Principles are sufficient and appropriate guidelines to protect human subjects and about whether ethics review committees —the main system for approval and oversight of human welfare in research — have become too burdensome. The proposed changes to the Common Rule are designed to address these concerns and changes in the scientific landscape. As society and research practices change, ethical issues persist. Some of the major current issues will follow.