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 CRF part 46 HHS Regulations for the Protection of Human Subjects
• Federal Register Notice: Waiver of the Applicability of Certain Provisions of 45 CFR 46 for DHS conducted or Supported Epidemiologic Research Involving Prisoners as Subjects (PDF)
• 45 CFR parts 160 and 164 Health Insurance Portability and Accontability Act (HIPAA) Regulations for Standards for Privacy of Individually Identifable Health Information
• 42 CFR part 50 Subpart F HHS Regulations for Resonsibility 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 Regualtions for Institutional Review Boards