OVPR - Institutional Review Board (IRB) - Guidelines & Regulations

General:
Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research The Nuremberg code Declaration of Helsinki Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations Guidelines for Assessing the Decision-Making Capacities of Potential Research Subjects with Cognitive Impairment, Am J Psychiatry 155:11, November 1998

Department of Health and Human Services (DHHS):

45 CFR 46 - DHHS Regulations for the Protection of Human Subjects Institutional Review Board Guidebook - OHRP guidance for IRB members & investigators 45 CFR 46.160 and 164 - Health Insurance Portability and Accountability Act (HIPAA) Privacy Regulations
Food and Drug Administration (FDA):
21 CFR 50 - FDA regulations for Protection of Human Subjects 21 CFR 54 Financial disclosure by clinical investigators 21 CFR 56 - FDA regulations for Institutional Review Boards 21 CFR 312 - FDA regulations for Investigational New Drugs 21 CFR 314 - Applications for FDA approvak to market a new drug 21 CFR 812 - FDA regulations for Investigational Device Exemptions 21 CFR 814.100 - 126 - FDA regulations for Humanitarian Use Devices Good Clinical Practice in FDA-Regulated Clinical Trials - FDA web site for investigators conducting clinical trials