General Data Protection Regulation - Europe
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
Office of Human Research Protections (OHRP)
- Current Revised Common Rule - 45 CFR 46 (2018 Requirements) - Fully Effective 1/21/2019
- Previous Common Rule - 45 CFR 46 (Pre-2018 Requirements)
Studies reviewed and approved prior to 1/21/2019 will be subject to these requirements unless an IRB/ERC takes action to move them to the new requirements upon annual renewal review. - Decision Charts
- Current Exempt Review Categories - §46.104
- Previous Exempt Review Categories - §46.101(b)
- Expedited Review Categories - §46.110
- Federalwide Assurance - Search for Assurance, IORG or IRB Numbers
- International Research
- Informed Consent Tips
- OHRP Guidance Documents
US Department of Education
US Food and Drug Administration (FDA)
- List of Regulations (FDA 21 CFR 50 and 21 CFR 56)
- Running Clinical Trials - Good Clinical Practice Program