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What makes research ethical?
Goal of Clinical Research
Ethics of Clinical Research
National Research Act
Ethics Codes and Guidelines
The Belmont Report
Clinical Research vs Clinical Practice
Regulations in the U.S.
45CFR.46 Protection of Human Subjects
Existing Guidance
7 Principles Ethical Framework
Valuable Scientific Question
Social Value
Valid scientific methodology
Scientific validity
Fair subject selection
Favorable risk-benefit
Risks in research
Benefits in research
Independent Review
Criteria for IRB review
(45CRF.46.111 and 21CFR.56.111)
Challenges in Independent Review
Informed Consent
Informed Consent (2)
Respect for enrolled subjects
Framework
Ethical Framework
Changing Landscape
Links to more information
8 Ethical Requirements
Collaborative Partnerships
Collaborative Partnerships (2)
Social Value
Scientific Validity
Informed Consent (3)
Informed Consent (4)
Respect for Human Subjects
Respect for Human Subjects (2)
8 Ethical Requirements
8 Ethical Requirements (2)
Revised Common Rule
Informed Consent Process
Informed Consent Process (2)
Informed Consent Process (3)
Role of FDA
FDA Regulations
Title 21, Code of Federal Regulations
FDA Regulations
Title 21, Code of Federal Regulations (2)
21 CFR 312
IND and GCP consolidated guideline
(ICH E6)
Clinical Trials Phases
Clinical Trials Phase 2
Clinical Trials Phase 3
Clinical Hold in Phase 1
Clinical Hold in Phase 2 & 3
Quality & safety issues
Manufacturing Biological Products
Clinical Considerations
Institutional Review Board (IRB)
21 CFR 56
Institutional Review Board (2)
Expanded Access to INDs
21 CFR 312 Subpart H (2009)
Expedited Programs
The Common Rule
