Common Rule (45 CFR 46): Primary federal regulation governing human subjects research protection in the United States, establishing basic provisions for IRB oversight, informed consent, and compliance monitoring

FDA Regulations (21 CFR 50, 56): Federal regulations specific to research involving FDA-regulated products, including drugs, devices, and biological products

HIPAA Privacy Rule: Federal law protecting sensitive patient health information from being disclosed without patient consent, crucial for research involving medical records or health information

FERPA: Family Educational Rights and Privacy Act - Federal law protecting the privacy of student education records, relevant for research in educational settings

State Privacy Laws: Various state-specific regulations governing privacy and data protection, which may impose additional requirements beyond federal regulations

State Medical Consent Laws: State-specific regulations governing medical consent procedures and requirements, including age of consent and capacity to consent

IRB Requirements: Institutional Review Board specific guidelines and protocols for research approval and oversight at the institutional level

Declaration of Helsinki: International ethical principles for medical research involving human subjects, widely recognized as the cornerstone document for human research ethics

Vulnerable Populations Protections: Special additional protections required for research involving vulnerable populations such as children, prisoners, pregnant women, and mentally disabled persons

Documentation Requirements: Specific requirements for documenting informed consent, including required elements, record retention, and proof of consent process