Resources
This is not an exhaustive list of medical terminology; however, the purpose of this glossary is to help the writers of consent forms explain medical terminology to the lay person in research studies.
UTHSC
Clinical Trials
Ethical Principles and Codes
- The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Research Subjects
- The Nuremberg Code: Directives for Human Experimentation
- World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects
Federal Regulations for Institutional Review Boards and Investigators
- OHRP: Protection of Human Subjects (45 CFR 46)
- FDA: Protection of Human Subjects (21 CFR 50)
- FDA: Institutional Review Boards (21 CFR 56)
- FDA: Investigational New Drug Application (21 CFR 312)
- FDA: Investigational Device Exemptions (21 CFR 812)
Food and Drug Administration (FDA)
- FDA Home Page
- Center for Drug Evaluation and Research
- Center for Devices and Radiological Health
- Good Clinical Practice in FDA-Regulated Clinical Trials
- Information Sheet Guidance: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors
Health Insurance Portability and Accountability Act (HIPAA)
Health Information Technology for Economic and Clinical Health (HITECH)
International Conference on Harmonisation (ICH) Guidelines for Good Clinical Practice (GCP)
Medicare and Research
Office of Human Research Protections (OHRP)
Patient Safety and Quality Improvement Act (PSQIA)
Other Federal Resources
- Code of Federal Regulations (CFR)
- National Aeronautics and Space Administration (NASA)
- National Institutes of Health
- National Science Foundation
- US Consumer Product Safety Commission (CPSC)
- US Department of Agriculture (USDA)
- US Department of Commerce (DOC)
- US Department of Defense (DOD)
- US Department of Education (ED)
- US Department of Energy (DOE)
- US Department of Housing and Urban Development (HUD)
- US Department of Justice (DOJ)
- US Department of Labor (DOL)
- US Department of Transportation (DOT)
- US Department of Veterans Affairs (VA)
- US Environmental Protection Agency (EPA)