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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

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