Research Integrity Office - Regulations
Federal Regulations & Guidelines
Department of Health and Human Services (DHHS)
- - Office for Human Research Protections, DHHS, home page
- - DHHS Regulations for the Protection of Human Subjects
- - Health Insurance Reform: Security Standards; Final Rule
- Expedited Guidelines - Categories of Research That May Be Reviewed by the IRB through an Expedited Review Procedure
Food and Drug Administration (FDA)
- - FDA regulations for Protection of Human Subjects
- - FDA regulations for Institutional Review Boards
- - FDA regulations for Investigational New Drugs
- - FDA regulations for Investigational Device Exemptions
- - FDA regulations for Humanitarian Use Devices
- - Guidance for clinical investigators involved in clinical trials of investigational drugs
- - Guidance for IRBs and clinical investigators on interpreting 21 CFR 50 and 56
Good Clinical Practice (GCP)
- - Consolidated Guidance - guidance for investigators, sponsors, and IRBs
- - FDA web site for investigators conducting clinical trials
Ethical Codes
- - Ethical Principles and Guidelines for the Protection of Human Subjects of Research
- - Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects
- - Directives for Human Experimentation