Research Integrity Office - Regulations
Federal Regulations & Guidelines
Department of Health and Human Services (DHHS)
- OHRP - Office for Human Research Protections, DHHS, home page
- 45 CFR 46 - DHHS Regulations for the Protection of Human Subjects
- 45 CFR Parts 160, 162 and 164 - 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)
- 21 CFR 50 - FDA regulations for Protection of Human Subjects
- 21 CFR 56 - FDA regulations for Institutional Review Boards
- 21 CFR 312 - FDA regulations for Investigational New Drugs
- 21 CFR 812 - FDA regulations for Investigational Device Exemptions
- 21 CFR 814.100 - 126 - FDA regulations for Humanitarian Use Devices
- Information for Clinical Investigators - Guidance for clinical investigators involved in clinical trials of investigational drugs
- FDA Information Sheets - Guidance for IRBs and clinical investigators on interpreting 21 CFR 50 and 56
Good Clinical Practice (GCP)
- Good Clinical Practice: - Consolidated Guidance - guidance for investigators, sponsors, and IRBs
- Good Clinical Practice in FDA-Regulated Clinical Trials - FDA web site for investigators conducting clinical trials
Ethical Codes
- Belmont Report - Ethical Principles and Guidelines for the Protection of Human Subjects of Research
- Declaration of Helsinki - Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects
- Nuremberg Code - Directives for Human Experimentation