Regulation, Policy, Education and Standards Links

Regulation, Polices and Guidance

Office of Human Rights Protections (OHRP)
FDA
FDA Devices
FDA Device Guidance
FDA Device Advice
FDA Information Sheet Guidance
Good Clinical Practice
HIPAA Information
NIH Human Subjects Research
OHRP Guidance on Engagement of Institutions in Human Subjects Research
OHRP Guidance on Research Involving Coded Private Information or Biological Specimens
OHRP Human Subjects Decision Charts
21 CFR 50 Protection of Human Subjects
21 CFR 56 Institutional Review Boards
21 CFR 312 Investigational New Drug Application
21 CFR 812 Investigational Device Exemption
45 CFR 46 (Common Rule)

Education

CITI Human Subjects Training Program
CITI Instructions

Ethical Codes and Standards

Declaration of Helsinki
Nuremberg Code
Belmont Report
Council for International Organizations of Medical Sciences (CIOMS)
International Compilation of Human Subjects Protections