related documents

Research Subjects Review Board

Regulations & Other References

HIPAA - Office for Civil Rights

HIPAA Regulations

NIH Monitoring Guidance

Federalwide Assurance (FWA) Document

The Belmont Report

Declaration of Helsinki

International Conference on Harmonization GCP Guidelines

CIOMS Ethical Guidelines

On Being a Scientist

CFR Titles 21 and Volumes - All Volumes

CFR Title 45 Part 46

FDA Information Sheets

CFR Title 21 Part 50 (Protection of Human Subjects)

CFR Title 21 Part 56 (FDA IRB Regs)

CFR Title 21 Part 312 (FDA IND Regs)

CFR Title 21 Part 812 (FDA IDE Regs)

FDA Forms (e.g., 1572)