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Research Integrity Office
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
- Exempt Guidelines - Categories of Research That May Be Reviewed by the IRB through an Exempt Review Procedure
- Expedited Guidelines - Categories of Research That May Be Reviewed by the IRB through an Expedited Review Procedure
Food and Drug Administration (FDA)
Good Clinical Practice (GCP)
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
