Ethical Guidelines & Regulations
Ethical Guidelines
- Belmont Report
- Declaration of Helsinki
- Council for International Organizations of Medical Sciences (CIOMS) - International Ethical Guidelines for Biomedical Research Involving Human Subjects
Regulations
HHS Regulations:
- 45 CFR part 46 HHS Regulations for the Protection of Human Subjects
- 45 CFR parts 160 and 164 Health Insurance Portability and Accountability Act (HIPAA) Regulations for Standards for Privacy of Individually Identifiable Health Information
- 42 CFR part 50, Subpart F HHS Regulations for Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought
FDA Regulations:
- 21 CFR part 50 FDA Regulations for the Protection of Human Subjects
- 21 CFR part 56 FDA Regulations for Institutional Review Boards
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