REGULATORY GUIDANCE
regulatory GUIDANCE AT PRINCIPAL:
P R I N C I P A L I R B is compliant with regulations that relate to research participants within the Code of Federal Regulations (CFR). We are compliant with the Food and Drug Administration (FDA) Code of Federal Regulations, Title 21, Parts 50 ,54, 56 ,312 and 812, the Department of Health and Human Services (DHSS) Regulations, Title 45, Part 46, International Conference on Harmonization (ICH) Guidelines for Good Clinical Practices (GCP), as well as local and state laws.
The FDA and OHRP have authorized IRBs to approve, defer, require modification and disapprove research.
Below you may find links for some of the information above.
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Links to regulatory documents and videos:
• Link to OHRP video about general informed consent requirements I
• Link to OHRP video about general informed consent requirements II
• Link to OHRP video on reviewing and reporting Unanticipated problems and adverse events
• FDA training on Medical Devices
• Belmont Report Educational Video
• The Belmont Report (Part One: Basic Ethical Principles)
• The Belmont Report (Part Two: Applying the Principles)
• Office of Human Research Protections
• CDRH
• Informed Consent: FDA Title 21, Part 50
• Financial Disclosure: FDA Title 21, Part 54
• IRB Guidance: FDA Title 21, Part 56​
• FDA Regulations Relating to Good Clinical Practice and Clinical Trials​
• Investigational New Drug: FDA Title 21, Part 312
• Applications for FDA Approval to Market a New Drug (21 CFR Part 314)
•. Bioavailability and Bioequivalence Requirements (21 CFR Part 320)
• Investigational Device Exemption: FDA Title 21, Part 812
• Premarketing Approval of Medical Devices: FDA Title 21, Part 814
• FDA GUIDANCE ON CONDUCT OF CLINICAL TRIALS OF MEDICAL PRODUCTS DURING COVID-19