Regulatory References

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 Defense (DOD)

Department of Education (ED)

Department of Energy (DOE)

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)

FDA Information Sheet Guidances

Clinical Trials.gov

NIH and Clinical Research

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

OHRP Guidebook

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)

The Belmont Report

The Nuremberg Code

World Medical Association Declaration of Helsinki

Collaborative IRB Training Initiative (CITI)

Guidelines for Good Clinical Practice (GCP)