Resources

Glossary of Lay Terms

Ethical Principles and Codes

• The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Research Subjects (http://ohsr.od.nih.gov/guidelines/belmont.html)
• The Nuremberg Code: Directives for Human Experimentation (http://ohsr.od.nih.gov/guidelines/nuremberg.html)
• World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (http://www.fda.gov/oc/health/helsinki89.html)

Federal Regulations for Institutional Review Boards

• OHRP: Protection of Human Subjects (45 CFR 46) (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm)
• FDA: Protection of Human Subjects (21 CFR 50) (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50)
• FDA: Institutional Review Boards (21 CFR 56) (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56)
• FDA: Investigational New Drug Application (21 CFR 312) (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312)
• FDA: Investigational Device Exemptions (21 CFR 812) (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=812)

Food and Drug Administration (FDA)

• FDA Home Page (http://www.fda.gov)
• Center for Drug Evaluation and Research (http://www.fda.gov/cder/)
• Good Clinical Practice in FDA-Regulated Clinical Trials (http://www.fda.gov/oc/gcp/default.htm)
• Information Sheet Guidances: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors (http://www.fda.gov/oc/ohrt/irbs/default.htm)

International Conference on Harmonisation (ICH) Guidelines for Good Clinical Practice (GCP)

• (http://www.ich.org/cache/compo/475-272-1.html)
  

National Institutes of Health (NIH)

• NIH Home Page (http://www.nih.gov)
• NIH Clinical Trials Database (http://clinicaltrials.gov)
• NIH Health Information (http://health.nih.gov/)
• NIH Office of Biotechnology Activities (http://www4.od.nih.gov/oba/)
• HIPAA Privacy Rule: Information for Researchers (http://privacyruleandresearch.nih.gov/)

Office of Human Research Protections (OHRP)

• OHRP Home Page (http://hhs.gov/ohrp)
• OHRP Guidebook (http://www.hhs.gov/ohrp/irb/irb_guidebook.htm)
• OHRP IRB Glossary of Terms (http://www.hhs.gov/ohrp/irb/irb_glossary.htm)
• International Compilation of Human Research Protections - 2009 Edition (http://www.hhs.gov/ohrp/international/HSPCompilation.pdf)

US Department of Health and Human Services (DHHS)

• DHHS Home Page (http://www.hhs.gov/)
• DHHS Office for Civil Rights – HIPAA (http://www.hhs.gov/ocr/hipaa/)

Other Federal Resources

• Code of Federal Regulations (CFR) (http://www.gpoaccess.gov/cfr/index.html)
• National Aeronautics and Space Administration (NASA) (http://www.nasa.gov/home/index.html)
• National Science Foundation (http://www.nsf.gov/)
• US Consumer Product Safety Commission (CPSC) (http://www.cpsc.gov/)
• US Department of Agriculture (USDA) (http://www.usda.gov/wps/portal/usdahome)
• US Department of Commerce (DOC) (http://www.commerce.gov/)
• US Department of Defense (DOD) (http://www.defenselink.mil/)
• US Department of Education (ED) (http://www.ed.gov/index.jhtml)
• US Department of Energy (DOE) (http://www.energy.gov/)
• US Department of Housing and Urban Development (HUD) (http://www.hud.gov/)
• US Department of Justice (DOJ) (http://www.usdoj.gov/)
• US Department of Labor (DOL) (http://www.dol.gov/)
• US Department of Transportation (DOT) (http://www.dot.gov/)
• US Department of Veterans Affairs (VA) (http://www.va.gov/)
• US Environmental Protection Agency (EPA) (http://www.epa.gov/)

Contact Us

UTHSC IRB office
910 Madison
Suite 600
Memphis, TN 38163

Phone: (901) 448-4824