Federal Food, Drug, and Cosmetic Act (FDCA): Primary federal law governing food and drug safety in the US, including clinical trials and research
21 CFR Part 50: Federal regulations concerning protection of human subjects in clinical trials, including informed consent requirements
21 CFR Part 56: Regulations governing Institutional Review Boards (IRBs) and their oversight of clinical research
21 CFR Part 312: Regulations regarding Investigational New Drug Applications and conduct of clinical trials
21 CFR Part 54: Requirements for financial disclosure by clinical investigators to ensure transparency and prevent conflicts of interest
45 CFR Part 46: The Common Rule - basic provisions for human subjects protection in research
HIPAA Privacy Rule: Federal regulations protecting patient health information privacy in clinical research
HIPAA Security Rule: Standards for securing electronic protected health information in clinical research
Good Clinical Practice (GCP) Guidelines: International quality standards for clinical trials involving human subjects
ICH Guidelines: International Conference on Harmonisation guidelines for clinical research standards across regions
State-specific Regulations: Various state laws and regulations that may impose additional requirements on clinical research
NIH Guidelines: National Institutes of Health requirements for funded research and clinical trials
Stark Law: Federal law prohibiting physician self-referral in clinical research contexts
Anti-Kickback Statute: Federal law preventing improper financial incentives in clinical research
ClinicalTrials.gov Requirements: Federal requirements for registration and reporting of clinical trials
Informed Consent Requirements: Federal and state requirements for obtaining and documenting participant informed consent
Intellectual Property Laws: Federal and state laws governing ownership and protection of research innovations and data
Export Control Regulations: Federal regulations controlling the export of research data and materials internationally
IRB Requirements: Institutional Review Board specific requirements for research approval and oversight
Institutional Policies: Institution-specific policies and procedures governing clinical research conduct
