Common Rule (45 CFR 46): Federal regulation governing human subjects research, including requirements for informed consent, IRB review, and protection of research participants
HIPAA Privacy Rule: Federal law protecting personal health information, setting standards for patient privacy and security of medical records
HITECH Act: Federal legislation addressing electronic health records, strengthening privacy and security protections for health data
FDA Regulations: Federal regulations governing research involving human subjects, particularly relevant if biobank samples may be used in FDA-regulated research
Genetic Information Nondiscrimination Act (GINA): Federal law prohibiting discrimination based on genetic information in health insurance and employment
State Privacy Laws: Various state-specific regulations governing privacy protections, which may exceed federal requirements
State Genetic Testing Laws: State-specific regulations governing genetic testing and use of genetic information
State Biobanking Regulations: State-specific requirements for collection, storage, and use of biological specimens
OECD Guidelines: International guidelines for human biobanks and genetic research databases, providing best practices for operation
UNESCO Declaration: International declaration setting principles for collection, processing, use and storage of human genetic data
NIH Guidelines: Research guidelines from the National Institutes of Health, particularly relevant for federally funded research
IRB Requirements: Institutional Review Board requirements for human subject research and biospecimen collection
Material Transfer Agreement Requirements: Regulations governing the transfer of biological materials between institutions
FTC Data Security Regulations: Federal Trade Commission requirements for protecting sensitive data from breaches and unauthorized access
State Data Breach Laws: State-specific requirements for notification and response in case of data breaches
CDC/OSHA Guidelines: Federal safety guidelines for handling biological materials and maintaining laboratory safety
