Principles, Policies & Regulations

Ethical Principles and Guidelines

• Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
• Nuremberg Code
• World Medical Association Declaration of Helsinki
• CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
• International Conference on Harmonization Good Clinical Practice Guidelines

Policies

• UB Federal Wide Assurance with DHHS
• UB Standard Operating Procedures UBSOP5.8.doc.

Regulations

Office for Human Research Protections

• Protection of Human Subjects 45 CFR 46 - OPRR
• Protecting Human Research Subjects: Institutional Review Board Guidebook (NIH/OPRR)
• Certificates of Confidentiality
• Department of Health and Human Services

Food and Drug Administration

• FDA Information and Regulations
• Good Clinical Practice in FDA-Regulated Clinical Trials
• Protection of Human Subjects 21 CFR 50
• Institutional Review Boards 21 CFR 56
• Investigational New Drug Application 21 CFR 312
• Investigational Device Exemptions 21 CFR 812
• Code of Federal Regulations
• Center for Drug Evaluation and Research - Information for Clinical Investigators
• Center for Biomedical Evaluation and Research
• Data and Safety Monitoring
• FDA Forms