Historical Basis
Forums
Government
Federal Regulation
Health and Human Services
- Office for Human Research Protections
- Food and Drug Administration
- Guidance for Institutional Review Boards and Clinical Investigators (1998 Update)
- 21 CFR 50 – Protection of Human Subjects
- 21 CFR 56 - Institutional Review Boards
- 21 CFR 312 – Investigational New Drug Application
- 21 CFR 812 – Investigational Device Exemption
- IRB Information Sheet – Drugs and Biologics
- FDA Guidance on Informed Consent
- Screening Tests Prior to Study Enrollment
- Recruiting Study Subjects
- Investigational New Drug (IND) Application
Privacy Rules - FERPA/PPRA/HIPAA/GINA
- Family Educational Rights and Privacy Act (FERPA)
- Protection of Pupil Rights Amendment (PPRA)
- Office for Civil Rights – HIPAA
- OHRP HIPAA/Privacy Rule Information
- National Institutes of Health
- Clinical Research and the HIPAA Rule
- Health Services Research and the HIPAA Rule
- HIPAA Privacy Rule Booklet for Research
- Guidance information for the Genetic Information Nondiscrimination Act (GINA)