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Resources

Laws, Policies and Guidelines

Federal Regulations

Office for Human Research Protections (OHRP)

45 CFR 46: Protection of Human Subjects

U.S. Food and Drug Administration (FDA)

Federal Guidelines

National Institutes of Health (NIH)

U.S. Department of Health and Human Services (HHS) ~ Office for Civil Rights (OCR)

HIPAA – National Standards to Protect the Privacy of Personal Health Information

Federal Advisory Committee on Human Subjects Research

Secretary's Advisory Committee on Human Research Protections (SACHRP)

Office for Human Research Protections (OHRP)

Ethical Principles and Guidelines for Human Subjects Research

Nuremberg Code (1949) https://history.nih.gov/research/downloads/nuremberg.pdf
Declaration of Helsinki (1964) https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/
Belmont Report (1997) https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html

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