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| The History of Research with Humans | |
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| Walter Reed and the Yellow Fever Experiments | |
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| The Nazi Medical Experiments | |
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| The Imperial Japanese Experiments in China | |
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| The Randomized Controlled Trial of Streptomycin | |
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| The Salk Polio Vaccine Field Trial of 1954 | |
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| The Jewish Chronic Disease Hospital Case | |
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| The Hepatitis Experiments at the Willowbrook State School | |
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| The Tuskegee Syphilis Experiment | |
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| HIV Research | |
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| The Gelsinger Case | |
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| An Ethical Framework for Biomedical Research | |
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| Codes, Declarations, and Other Ethical Guidance for Research with Humans | |
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| The Nuremberg Code | |
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| The Declaration of Helsinki | |
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| The Belmont Report | |
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| Regulations for the Protection | |
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| International Ethical Guidance from the Council for International Organizations of Medical Sciences | |
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| The Council of Europe | |
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| The European Community Directives on Data Protection and Clinical Trials | |
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| National Bioethics Commissions and Research | |
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| Context, Purpose, and Value of Clinical Research | |
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| Exploitation in Clinical Research | |
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| The Nature, Scope, and Justification of Clinical research: What is Research? Who is a Subject? | |
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| Four Paradigms of Clinical Research and Research Oversight | |
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| The Role of Patient Advocates and Public Representatives in Research | |
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| Scientific Design | |
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| Equipoise and Randomization | |
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| The Ethics of Placebo- Controlled Trials | |
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| Challenge Experiments | |
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| Emergency Research | |
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| Consent for Research with Biological Samples | |
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| Genetic Diagnostic, Pedigree, and Screening Research | |
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| Deception in Clinical Research | |
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| Ethics of Epidemiology: Observational Studies on Human Populations | |
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| Ethical Issues in Behavioral and Social Science Research | |
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| Phase 1 Oncology Research | |
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| Surgical Innovation and Research | |
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| Participant Selection | |
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| What is Fair in Participant Selection? | |
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| Incentives for Research Participants | |
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| Ethical Issues in Recruiting Research Participants | |
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| Ethical Issues in Research Involving Women | |
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| Ethical Issues in Research with Ethnic and Minority Populations | |
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| Research Involving Economically Disadvantaged Participants | |
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| Research Involving Those at Risk for Impaired Decision-making Capacity | |
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| Research with Children | |
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| Captive Populations: Prisoners, Students, and Soldiers | |
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| Research with Identifiable and Targeted Communities | |
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| Research with Health Volunteers | |
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| Research with Fetuses, Embryos, and Stem Cells | |
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| Risk-Benefit Assessments | |
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| Risk-Benefit Analysis and the Net Risks Test | |
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| Assessing the Comparing Potential Benefits and Risks of Harm | |
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| Risk-Benefit Assessment in Pediatric Research | |
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| Independent Review and Oversight | |
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| Institutional Review Boards: Their Origins and the Policies that Govern Them | |
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| Models of Institutional Review Board Function | |
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| Assessing and Comparing Potential Benefits and Risks of Harm | |
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| Data and Safety Monitoring Boards | |
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| The Food and drug Administration and Drug Development: Historic, Scientific, and Ethical Considerations | |
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| Informed Consent | |
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| A History of Informed Consent in Clinical Research | |
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| Philosophical Justifications of Informed Consent in Research | |
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| Legal and Regulatory Standards of Informed Consent in Research | |
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| The Therapeutic Misconception | |
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| Empirical Issues in Informed Consent for Research | |
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| The Assent Requirement in Pediatric Research | |
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| Respect for Human Research Participants | |
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| Confidentiality | |
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| Legal Responsibility to Research Subjects: Liability and Compensation for Injury | |
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| The Obligation to Ensure Standards | |
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| Multi-National Research | |
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| Appropriate Standards | |
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| Benefits to Host Countries | |
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| The Standard of Care in Multi-National Research | |
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| Responsiveness to Host Community Health Needs | |
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| Clinical Investigator Behavior | |
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| Conflicts of Interest in Medical Research: historical Developments | |
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| Conflicts of Interest | |
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| Empirical Data on Obligations of Publication: Authorship and Dissemination | |
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| Index | |