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Part I BACKGROUND AND REGULATORY CONTEXT 1 Historical Antecedents 2 The Changing Face of Research: New Regulations, New Players, New Places, New Agendas 3 The Federal and State Regulatory Structure 4 Institutional Review Boards 5 Conflicts of Interest Part II REVIEWING RESEARCH PROPOSAL: GENERAL CONSIDERATIONS 6 Risk-Benefit Assessment 7 Informed Consent 8 Recruiting and Paying Subjects 9 Research and Justice: Promoting The Inclusion of Women and Minorities 10 Confidentiality 11 Monitoring of Ongoing Research 12 Compensation for Research Injuries Part III REVIEWING RESEARCH PROPOSALS: SPECIAL SITUATIONS 13 Researches with Children 14 Adults Who Lack Decision-Making Capacity 15 Prisoners 16 Members of the Armed Services 17 Fetuses and Embryos 18 Researches Involving Emerging Technologies 19 International Research Appendix A U.S. Code of Federal Regulations Title 45—Public Welfare and Human Services Part 46—Protection of Human Subjects Appendix B Department of Health and Human Services Categories of Research that may be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure Appendix C Food and Drug Administration Significant Differences in FDA and HHS Regulations for Protection of Human Subjects Appendix D Nuremberg Code Appendix E Declaration of Helsinki Appendix F The Belmont Report Ethical Principles & Guidelines for Research Involving Human Subjects Table of Cases Index