Regulatory References
Federal Agencies
Office of Human Research Protections Office (OHRP)
FDA - Center for Drug Evaluation and Research (CDER)
FDA - Center for Devices and Radiological Health (CDRH)
FDA - Center for Biologics Evaluation and Research (CBER)
Center for Disease Control and Prevention
National Science Foundation (NSF)
Office of Naval Research (ONR)
Department of Veteran's Affairs
U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID)
U.S. Army Research Laboratory (ARL)
DHHS Office for Civil Rights - HIPAA
DHHS Office of Research Integrity
NIH Office of Biotechnology Activities (OBA)
Useful Federal References
FDA Information Sheet Guidances
DHHS Protection of Human Subjects: 45 CFR 46
FDA Protection of Human Subjects: 21 CFR 50
FDA Institutional Review Board: 21 CFR 56
FDA Investigational New Drug Application: 21 CFR 312
FDA Investigational Device Exemptions: 21 CFR 812
State of California
California Health and Human Services - Committee for the Protection of Human Subjects
Research Advisory Panel of California
California Information Practices Act, Civil Code, Section 1798.24 (SB13)
Ethical Principles and Codes
World Medical Association Declaration of Helsinki
Other Useful References
Collaborative IRB Training Initiative (CITI)
Guidelines for Good Clinical Practice (GCP)
Last Updated 6-11-2012
Regulatory and Other Useful References