The Oxford Textbook of Clinical Research EthicsEzekiel J. Emanuel The Oxford Textbook of Clinical Research Ethics is the first systematic and comprehensive reference on clinical research ethics. Under the editorship of experts from the National Institutes of Health of the United States, the book offers a wide-ranging and systematic examination of all aspects of research with human beings. Considering historical triumphs of research as well as tragedies, the textbook provides a framework for analysing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the textbook examines issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent as well as focused consideration of international research ethics, conflicts of interests and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research with human beings. |
Contents
Introduction | 3 |
A Selected History of Research With Humans | 7 |
Codes Declarations and Other Ethical Guidance for Research With Humans | 121 |
Context Purpose and Value of Clinical Research | 199 |
Scientic Design | 243 |
Participant Selection | 375 |
RiskBenet Assessments | 501 |
Independent Review and Oversight | 539 |
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Advisory American assessment Available Belmont Report benefits Bioethics biological biomedical research cancer clinical research clinical trials Common Rule concerns conduct deception decision Declaration of Helsinki developing disease drug effective England Journal enroll Epidemiology equipoise ethical issues evaluation experimental experiments exploitation gene groups guidelines harm Human Radiation Experiments Human Research individuals infection informed consent Institute institutional review boards intervention investigators Journal of Medicine medical research ment minimal risk National Bioethics National Commission Nazi Nuremberg Nuremberg Code oncology Online participate in research patients persons Phase physicians placebo placebo-controlled trials polio population potential practice procedures Protection of Human protocol Public Health randomized RCTs recruitment research ethics Research Involving Human research participants research subjects response samples scientific social standard streptomycin syphilis therapeutic therapy tion treatment Tuskegee Tuskegee Syphilis Study United University Press vaccine vulnerable women yellow fever