• Belmont Report
• Declaration of Helsinki
• Council for International Organizations of Medical Sciences (CIOMS) - International Ethical Guidelines for Biomedical Research Involving Human Subjects

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

• 21 CFR part 50 FDA Regulations for the Protection of Human Subjects
• 21 CFR part 56 FDA Regulations for Institutional Review Boards

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.