Resources

Glossary of Lay Terms - This is not an exhaustive list of medical terminology; however, the purpose of this glossary is to help the writers of consent forms with common terms or explaining medical terminology to the lay person in research studies.

ClinicalTrials.gov (http://www.clinicaltrials.gov/)

Ethical Principles and Codes

• The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Research Subjects (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html)
• The Nuremberg Code: Directives for Human Experimentation (http://www.hhs.gov/ohrp/archive/nurcode.html)
• World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (http://www.wma.net/en/30publications/10policies/b3/index.html)

Federal Regulations for Institutional Review Boards

• OHRP: Protection of Human Subjects (45 CFR 46) (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html)
• 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/)
• Center for Devices and Radiological Health (http://www.fda.gov/MedicalDevices/default.htm)
• 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)

HIPAA

• HHS - Health Information Privacy (http://www.hhs.gov/ocr/privacy)
• NIH - Privacy Rule (http://privacyruleandresearch.nih.gov/)

Health Information Technology for Economic and Clinical Health (HITECH)

• HITECH Breach Notification Interim Final Rule (http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/breachnotificationifr.html)

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

• (http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html)
  

Medicare

• Centers for Medicare & Medicaid Services (http://www.cms.gov)
• Federal Health Insurance for the Aged and Disabled (http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=adb4b40edc4cb1387d9f5684816d5c91&rgn=div5&view=text&node=42:2.0.1.2.5&idno=42)
• Medicare (http://www.medicare.gov)
• Medicare Coverage – Clinical Trials (https://www.cms.gov/Medicare/Coverage/ClinicalTrialPolicies/downloads/finalnationalcoverage.pdf)
• Medicare Coverage of Cancer Clinical Trials (http://www.cancer.gov/clinicaltrials/conducting/developments/ncd179n)
• Medicare National Coverage Determinations Manual (http://www.cms.gov/manuals/downloads/ncd103c1_part4.pdf)
• Medicare and Clinical Research Studies (http://www.medicare.gov/Publications/Pubs/pdf/02226.pdf)

Office of Human Research Protections (OHRP)

• OHRP Home Page (http://www.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 - 2010 Edition (http://archive.hhs.gov/ohrp/international/HSPCompilation.pdf)

Patient Safety and Quality Improvement Act (PSQIA)

• (http://www.hhs.gov/ocr/privacy/psa/understanding/index.html)

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 Institutes of Health (http://www.nih.gov)
• 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
Fax: (901) 448-5103
Email: irb@uthsc.edu