Resources

Compliance – Federal Government

• Centers for Medicare & Medicaid Services (CMS)
• Code of Federal Regulation
• Department of Health & Human Services
• The Freedom of Information Act (FOIA)
• HHS OIG Main Page
• Tricare
• United States Sentencing Commission

Compliance – Federal Prohibition on Physician Self-Referral (Stark Law)

• Stark Statute (42 USC 1395nn)
• Stark Phase II Final Regulations (42 CFR Sections 411.350-361)

Compliance – State and Local Government

• Medicare Administrative Contractor – PGBA (J11)
• North Carolina Medicaid

Compliance – Fraud/Abuse

• False Claims Act
• Exclusion from Participation in Medicare
• Civil Monetary Penalties Law
• Federal Anti-kickback Statute (42 USC Section 1320a-7b(b))
• Federal Anti-kickback Safe Harbor Regulations (42 CFR Section 1001.952)

Compliance – HIPAA

• HIPAA Complete privacy, security and enforcement regulation
• HIPAA Security Standards – Final Rule
• HIPAA Standards for Electronic Transactions – Final Rule
• HIPAA Standards for Privacy – Final Rule
• ECU HIPAA Privacy and Security Office

Compliance – Research

• NIH Policy for Data Monitoring Boards

Human Subject Protection

• Office of Human Subject Research
• FDA Information for Clinical Investigators
• Protection of Human Subjects – Federal Regulations Title 45 CFR Part 46 (The Common Rule)
• Bioethics Research Resources (NIH)
• The Belmont Report
• NIH Policy for Data Monitoring Boards
• FDA Guidance for IRB and Clinical Investigators (1998 Update)

Resources for Clinical Research at ECU

• The Clinical Trials Office at BSOM
• UMCIRB Page – Use for processing forms, procedure manuals and educational training and materials