Human Subjects Research Policies and Regulations

UCSC IRB SOPs

• UCSC IRB Standard Operating Procedures

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UC policies

• University of California Policies and Guidelines for Human Subjects Research

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Regulations

• NIH funded human subjects research
• Common Rule
• FDA
• Belmont Report (1979): Discusses the basic ethical principles on which U.S. human subjects protection regulation is based – Respect for Persons, Beneficence & Justice.
• Declaration of Helsinki (1964): The World Medical Association’s ethical principles for medical research involving human subjects.
• Nuremberg Code (1949): A 10 point code of human experimentation ethics developed during the military war crimes trials.