Home: Table of Contents
Introduction
Scenarios
Bibliography
Chapter 1:
The Ethical Basis of RCRH
The Nature of Science
Research Integrity
Professionalism in Science
Cases
Practical Elements of Responsible Research Conduct
Bibliography
Chapter 2:
Research in Humans
History of Rules About Research in Humans
Definitions
Federal Mandate
Respect for Persons
Beneficence
Justice
Common Rule
Institutional Review Board (IRB) Mission
Cases
Bibliography
Chapter 3:
Ethics and Study Design
Introductory
Ethics Design
Appropriate Risk to Benefit Ratio
Selection of Subject Populations
Cases
Bibliography
Chapter 4:
Conflicts of Interest (COI)
Definitions
Consequences of a COI
Government Intervention
Industry Sponsorship
Professional Societies
Clinical Practice Guidelines
Other Initiatives
COI in Financial Consulting
Cases
Bibliography
Chapter 5:
International Clinical Research
Underlying Conditions
Approval and Monitoring Issues
Study Population Issues
Structural Issues
Epidemiological and Social Science Research
Cases
Bibliography
Chapter 6:
Monitoring Research
Cases
Bibliography
Chapter 7:
Genetics and Stem Cell Research
Genetics
Human Embryonic Stem Cell Research
Bibliography
Chapter 8:
Malfeasance and Misconduct
Definitions
Process
Whistleblowing
Litigation, the New Approach to Research Management
The Importance of Trust
Cases
Bibliography
Search
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