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| Preface | |
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| Acknowledgments and Permissions | |
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| Commonly Used Acronyms | |
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| Frequently Cited Research Regulations, Guidelines, and Reports | |
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| List of Contributors | |
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| Scandals and Tragedies of Research with Human Participants: Nuremberg, the Jewish Chronic Disease Hospital, Beecher, and Tuskegee | |
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| U.S. Medical Researchers, the Nuremberg Doctors Trial, and the Nuremberg Code: A Review of Findings of the Advisory Committee on Human Radiation Experiments | |
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| The Jewish Chronic Disease Hospital Case | |
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| Ethics and Clinical Research | |
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| Racism and Research: The Case of the Tuskegee Syphilis Study | |
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| Ethical and Regulatory Guidance for Research with Humans | |
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| The Nuremberg Code | |
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| The Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects | |
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| The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research | |
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| The Common Rule, Title 45 (Public Welfare), Code of Federal Regulations, Part 46 (Protection of Human Subjects), Subparts A--D | |
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| The International Ethical Guidelines for Biomedical Research Involving Human Subjects | |
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| The ICH Harmonised Tripartite Guideline--Guideline for Good Clinical Practice (ICH-GCP Guideline) | |
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| The Ethics of Clinical Trial Design | |
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| The Distinction between Research and Treatment | |
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| Research and Practice | |
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| Demarcating Research and Treatment: A Systematic Approach for the Analysis of the Ethics of Clinical Research | |
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| The Ethics of Randomized Clinical Trials: Clinical Equipoise | |
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| Of Mice but Not Men: Problems of the Randomized Clinical Trial | |
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| Equipoise and the Ethics of Clinical Research | |
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| Randomized Controlled Trials: Lessons from ECMO | |
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| The Role of Placebos in Clinical Research | |
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| The Continuing Unethical Use of Placebo Controls | |
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| Placebo-Controlled Trials and the Logic of Clinical Purpose | |
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| Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments, Part 1: Ethical and Scientific Issues | |
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| The Ethics of Placebo-Controlled Trials: A Middle Ground | |
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| The Ethics of Phase I Research | |
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| On the Nature and Ethics of Phase I Clinical Trials of Cancer Chemotherapies | |
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| The Changing Landscape of Human Experimentation: Nuremberg, Helsinki, and Beyond | |
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| The Ethics of Research Participant Recruitment | |
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| Justifications for the Recruitment of Research Participants | |
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| Philosophical Reflections on Experimenting with Human Subjects | |
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| Experimentation on Trial: Why Should One Take Part in Medical Research? | |
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| Access to Research | |
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| Wanted: Single, White Male for Medical Research | |
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| Why Should We Include Women and Minorities in Randomized Controlled Trials? | |
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| The Duty to Exclude: Excluding People at Undue Risk from Research | |
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| Payment of Research Participants | |
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| What's the Price of a Research Subject? Approaches to Payment for Research Participation | |
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| Justice for the Professional Guinea Pig | |
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| Paying People to Participate in Research: Why Not? | |
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| Informed Consent in Research | |
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| Consent Issues in Human Research | |
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| Informed (But Uneducated) Consent | |
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| A Moral Theory of Informed Consent | |
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| Is Informed Consent Always Necessary for Randomized, Controlled Trials? | |
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| Human Experimentation and Human Rights | |
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| Subject Interview Study | |
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| False Hopes and Best Data: Consent to Research and the Therapeutic Misconception | |
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| "Therapeutic Misconception" and "Recruiting Doublespeak" in the Informed Consent Process | |
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| Clinical Research with Special Populations | |
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| People with Cognitive Impairments | |
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| Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity | |
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| Are Research Ethics Bad for Our Mental Health? | |
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| Caring about Risks: Are Severely Depressed Patients Competent to Consent to Research? | |
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| Children | |
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| The NIH Trials of Growth Hormone for Short Stature | |
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| In loco parentis: Minimal Risk as an Ethical Threshold for Research upon Children | |
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| Minors' Assent, Consent, or Dissent to Medical Research | |
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| Captive Populations: Soldiers, Prisoners, Students | |
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| Convenient and Captive Populations | |
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| Medical Experimentation on Prisoners | |
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| Students, Grades, and Informed Consent | |
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| Against Special Protections for Medical Students | |
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| Special Topics in Research Ethics | |
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| Genetics Research | |
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| Structuring the Review of Human Genetics Protocols: Gene Localization and Identification Studies | |
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| Structuring the Review of Human Genetics Protocols, Part II: Diagnostic and Screening Studies | |
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| Structuring the Review of Human Genetics Protocols, Part III: Gene Therapy Studies | |
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| Protecting the Privacy of Family Members in Survey and Pedigree Research | |
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| Stored Human Biological Specimens | |
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| Statement on Informed Consent for Genetic Research | |
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| Informed Consent for Genetic Research on Stored Tissue Samples | |
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| Use of Human Tissues in Research: Clarifying Clinician and Researcher Roles and Information Flows | |
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| Human Embryos and Stem Cells | |
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| Report of the Human Embryo Research Panel, Volume 1 | |
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| The Inhuman Use of Human Beings: A Statement on Embryo Research | |
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| Ethical Issues in Human Stem Cell Research | |
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| Creating Embryos for Research: On Weighing Symbolic Costs | |
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| Drug Challenge and Drug Washout Studies | |
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| Drug-Free Research in Schizophrenia: An Overview of the Controversy | |
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| Psychiatric Symptom-Provoking Studies: An Ethical Appraisal | |
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| Research with Communities | |
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| A Model Agreement for Genetic Research in Socially Identifiable Populations | |
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| Groups as Gatekeepers to Genomic Research: Conceptually Confusing, Morally Hazardous, and Practically Useless | |
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| Protecting Communities in Research: Current Guidelines and Limits of Extrapolation | |
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| Protecting Communities in Biomedical Research | |
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| International Research | |
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| Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries | |
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| Human Rights and Maternal-Fetal HIV Transmission Prevention Trials in Africa | |
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| AZT Trials and Tribulations | |
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| Fair Benefits for Research in Developing Countries | |
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| Ethical Imperialism? Ethics in International Collaborative Clinical Research | |
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| Ethics Are Local: Engaging Cross-Cultural Variation in the Ethics for Clinical Research | |
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| Ethical and Regulatory Challenges in a Randomized Control Trial of Adjuvant Treatment for Breast Cancer in Vietnam | |
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| The Behavior of Clinical Investigators: Conflicts of Interest | |
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| Understanding Financial Conflicts of Interest | |
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| Finder's Fees for Research Subjects | |
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| Conflicts of Interests and the Validity of Clinical Trials | |
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| In Whose Best Interest? Breaching the Academic-Industrial Wall | |
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| Scientific Misconduct | |
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| Altering Data: Fraud, Fabrication, and Falsification | |
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| Pressure to Publish and Fraud in Science | |
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| Science, Statistics, and Deception | |
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| Data Torturing | |
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| Preventing Scientific Misconduct | |
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| Rules of Authorship | |
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| When Authorship Fails: A Proposal to Make Contributors Accountable | |
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| Problems in the Publication of Research Methods and Findings | |
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| Underreporting Research Is Scientific Misconduct | |
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| The CONSORT Statement: Revised Recommendations for Improving the Quality of Reports of Parallel-Group Randomized Trials | |
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| Challenges to the Institutional Review Board System | |
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| Monitoring Clinical Research: An Obligation Unfulfilled | |
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| Ethics Review for Sale? Conflict of Interest and Commercial Research Review Boards | |
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| The Institutional Review Board and Beyond: Future Challenges to the Ethics of Human Experimentation | |
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| A Central Institutional Review Board for Multi-institutional Trials | |
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| Informed Consent Forms | |
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| Phase I Treatment of Adults with Recurrent Supratentorial High-Grade Glioma with Gliadel Wafers Plus Temodar | |
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| A Phase I Study of Intra-arterial Onyx-015 for Squamous Cell Cancer of the Head and Neck | |
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| Cohort-Varying Information Insert for Form for Consent to Participate in a Phase I Study | |
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| Nitric Oxide Inhalation Therapy for Myocardial Ischemia in Patients with Coronary Artery Disease | |
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| Double-Blind Drug Crossover and Withdrawal Project | |
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| Information and Consent Letter for Hemochromatosis Study | |
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| National Action Plan on Breast Cancer (NAPBC) Consent Form for Use of Tissue for Research | |
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| Patient Written Consent Form for Review of Medical Records | |
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| A Descriptive Study of the Views and Experiences of Persons Involved in a Measles Vaccine Study | |
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| Index | |