FEDERAL REGULATIONS FOR
HUMAN SUBJECTS RESEARCH

Belmont Report: ethical principles the IRB utilizes regarding approval of research involving human subjects

Office of Human Research Protections (OHRP): federal office that oversees protection of human subjects:  http://www.hhs.gov/ohrp/         

• Policy Guidances: http://www.hhs.gov/ohrp/policy/index.html
• Human Research Frequently Asked Questions (FAQs): http://www.hhs.gov/ohrp/faq.html 
• IRB Guide book:  http://www.hhs.gov/ohrp/irb/irb_guidebook.htm
• Decision charts: determine category of research http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm

NIH (OER):  FAQs for Research Using Human Specimens, Cell Lines or Data: http://grants.nih.gov/grants/policy/hs/faqs_specimens.htm 

• Regulations, Policies and Guidance: http://grants.nih.gov/grants/policy/hs/hs_policies.htm
• Research with Vulnerable Populations: http://grants.nih.gov/grants/policy/hs/populations.htm
• FAQs from applicants: http://grants.nih.gov/grants/policy/hs/faqs_aps_other.htm

Department of Health and Human Services (DHHS)

• 45 CFR 46: the ultimate, comprehensive law that defines federal regulations governing protection of human subjects

U.S. Food and Drug Administration: federal office that oversees safety of  food supply, medical product safety, emerging health hazards, and bringing new technologies to market: http://www.fda.gov/           

• Center for Biologics and Evaluation: http://www.fda.gov/cber/index.html     
• Clinical Trials: http://www.fda.gov/oashi/clinicaltrials/default.htm    
• Good Clinical Practices in Clinical Trials: http://www.fda.gov/oc/gcp/default.htm     
• Why Volunteer for a Clinical Trial: http://www.fda.gov/opacom/lowlit/cltr.html       
• Form 1571:  Investigational New Drug (IND) Application and Form 1572:   Statement of Investigator (Electronic forms): http://www.fda.gov/opacom/morechoices/fdaforms/default.html

Office of Civil Rights (HIPAA): http://www.hhs.gov/ocr/hipaa/

Department of Defense: http://www.defenselink.mil/sites/