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Protocol Ethics

Focus Area: Ethics, Conduct, and Oversight

Frameworks:

• Ethics, Essential Elements, and Points to Consider Reference Document (Toolkit)

Proceedings, Publications, & Public Comments:

• NIH and FDA Draft Clinical Trial Protocol Template for Phase 2 and 3 IND/IDE Studies (Public Comments)
• Incorporating Ethical Principles into Clinical Research Protocols (Publication)
• Global Clinical Trials: Ethics, Harmonization and Commitments to Transparency (Publication)
• Comments on Declaration of Helsinki (Public Comments)
• A Tool to Help Address Key Ethical Issues in Research (Publication)

Presentations:

• Introducing ‘Essential Elements of Ethics’ (Presentation)

Other Resources:

• Essential Elements of Ethics User Statistics Dec 2017 (Resource)
• Essential Elements of Ethics E-Learning (Training Material)

Sponsor Resources:

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