Clinical Research Support
Office for Human Research Studies (OHRS)
External Regulatory Guidance
1) Resource Links
2) Federal Agencies Guidelines and Regulations
3) Forms for Federal Agencies
4) Ethical Principles of Human Subjects Protection
- The Belmont Report
- IRB Guidebook
Provides help for IRB members and researchers in understanding the regulations and standards that govern research with human subjects and outlines issues to consider in designing and reviewing research proposals.
- The Nuremberg Code
A 10 point code of human experimentation ethics developed during the military war crimes trial.
- Declaration of Helsinki
The World Medical Association's ethical principles for medical research involving human subjects.
- ICH Consolidated Guidance
Web site for International Conference on Harmonization (ICH) guidance for ethical and quality standards for research involving humans (also see FDA link for E6 Good Clinical Practice below)
5) Certificates of Confidentiality