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