Links to regulatory documents:
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
Video clip on Belmont Report
The Nuremberg Code
Declaration of Helsinki
FDA Information sheets
Office of Human Research Protections
OHRP Guidebook
CDRH Device Advice
CDRH
Informed Consent: FDA Title 21, Part 50
Financial Disclosure: FDA Title 21, Part 54
IRB Guidance: FDA Title 21, Part 56
Investigational New Drug: FDA Title 21, Part 312
Investigational Device Exemption: FDA Title 21, Part 812
Premarketing Approval of Medical Devices: FDA Title 21, Part
