Federal Regulations, Policies, and Reports(links to various sites)
Ethical Principles and Codes
Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects
World Medical Association Declaration of Helsinki
Nuremberg Code
Food and Drug Administration
FDA Forms
FDA Home Page
FDA Information Sheets- IRB Operations and Clinical Investigation Requirements
FDA On-Line Resources for Investigators Conducting Clinical Trials
Good Clinical Practices in FDA Regulated Clinical Trials
Institutional Review Boards 21 CFR 56 - FDA
Investigational Device Exemptions(21 CFR 812)
Investigational Device Exemptions Manual (Overview of the Regulations, How to Submit an IDE, Guidance and Policies)
Investigational Device Exemptions, Treatment Use(21 CFR 812.36)
Protection of Human Subjects 21 CFR 50
Use of Investigational Products When Subjects Enter a Second Institution
Department of Health and Human Services
NIH Home Page
NIH Certificates of Confidentiality Information
NIH Further Guidance on Data a Safety Monitoring for Phase I and II Trials
NIH Financial Conflicts of Interest and Research Objectivity: Investigators & IRBs Issues
NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Research
NIH Guidance on Reporting Adverse Events to IRBs for Multicenter Clinical Trials
NIH Policy for Data and Safety Monitoring
NIH Required Education in the Protection of Human Subjects
National Cancer Institute - Cancer Dictionary
Office of Extramural Research Map
Office for Human Research Protections
OHRP Document Library
Protecting Human Research Subjects: IRB Guidebook(OHRP)
Protection of Human Subjects(45 CFR 46)
Points to Consider When Planning a Genetic Study That Involves Members of Named Populations
NIH Guidelines on Stem Cell Research
Stem Cell Registry
Department of Energy
Human Genome Project
Protecting Human Subjects
National Science Foundation
Interpreting the common rule for the protection of human subjects in behavioral and social science research
HIPAA Office of Civil Rights
OCR Guidance Explaining Significant Aspects of the Privacy Rule
OCR Guidance on Research
HIPAA Privacy Rule and Public Health (Guidance from CDC & USHHS)
United States Department of Health & Human Services
HIPPA Privacy Rule and Research
Other Useful Links
Journal of Medical Ethics
Talking Glossary of Genetics
Last Update
9/15/05
