Part 1 Scandals and Tragedies of Research with Human Participants: Nuremberg, the Jewish Chronic Disease Hospital, Beecher, and Tuskegee -- U.S. medical researchers, the Nuremberg doctors trial, and the Nuremberg Code: a review of findings of the Advisory Committee on Human Radiation Experiments -- The Jewish Chronic Disease Hospital case -- Ethics and clinical research -- Racism and research: the case of the Tuskegee Syphilis Study

Part 2 Ethical and Regulatory Guidance for Research with Humans -- The Nuremberg Code -- The declaration of Helsinki: ethical principles for medical research involving human subjects -- The Belmont report: ethical principles and guidelines for the protection of human subjects of research -- The common rule, Title 45 (Public Welfare), code of federal regulations, Part 46 (Protection of human subjects), subparts A-D -- The international ethical guidelines for biomedical research involving human subjects -- The ICH harmonised tripartite guidelines guideline for good clinical practice (ICH-GCP guideline)

Part 3 The Ethics of Clinical Trail Design -- Research and practice -- Demarcating research and treatment: a systemic approach for the analysis of the ethics of clinical research -- Of mice but not men: problems of the randomized clinical trial -- Equipoise and the ethics of clinical research -- Randomized controlled trials: lessons from ECMO -- The continuing unethical use of placebo controls -- Placebo-controlled trials and the Logic of Clinical Purpose -- Placebo-controlled trials and active-control trials in the evaluation of new treatments, pt. 1: ethical and scientific issues -- The ethics of placebo-controlled trials: a middle ground -- On the nature and ethics of phase I clinical trials of cancer chemotherapies -- The changing landscape of human experimentation: Nuremberg, Helsinki, and beyond

Part 4 The Ethics of Research Participant Recruitment -- Philosophical reflections on experimenting with human subjects -- Experimentation on trial: why should one take part in medical research? -- Wanted: single, white male for medical research -- Why should we include women and minorities in randomized controlled trials? -- The duty to exclude: excluding people at undue risk from research -- What's the price of a research subject? Approaches to payment for research participation -- Justice for the professional guinea pig -- Paying people to participate in research: why not?

Part 5 Informed Consent in Research -- Consent issues in human research -- Informed (but uneducated) consent -- A moral theory of informed consent -- Is informed consent always necessary for randomized, controlled trials? -- Human experimentation and human rights -- Subject interview study -- False hopes and best data: consent to research and the therapeutic misconception -- "Therapeutic misconception" and "recruiting doublespeak" in the informed consent process

Part 6 Clinical Research with Special Populations -- Research involving persons with mental disorders that may affect decisionmaking capacity -- Are research ethics bd for our mental health? -- Caring about risks: are severely depressed patients competent to consent to research? -- The NIH trials of growth hormone for short stature -- In loco parentis: minimal risk as an ethical threshold for research upon children -- Minors' assent, consent, or dissent to medical research -- Convenient and captive populations -- Medical experimentation on prisoners -- Students, grades, and informed consent -- Against special protections for medical students

Part 7 Special Topics in Research Ethics -- Structuring the review of human genetics protocols: gene localization and identification studies -- Structuring the review of human genetics protocols, pt. II: diagnostic and screening studies -- Structuring the review of human genetics protocols, pt. III: gene therapy studies -- Protecting the privacy of family members in survey and pedigree research -- Statement on informed consent for genetic research -- Informed consent for genetic research on stored tissue samples -- Use of human tissues in research: clarifying clinician and researcher roles and information flows -- Report of the human embryo research panel, v. 1 -- The inhuman use of human beings: a statement on embryo research -- Ethical issues in human stem cell research -- Creating embryos for research: on weighing symbolic costs -- Drug-free research in schizophrenia: an overview of the controversy -- Psychiatric symptom-provoking studies: an ethical appraisal -- A model agreement for genetic research in socially identifiable populations -- Groups as gatekeepers to genomic research: conceptually confusing, morally hazardous, and practically useless -- Protecting communities in research: current guidelines and limits of extrapolation -- Protecting communities in biomedical research -- Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries -- Human rights and maternal-fetal HIV transmission prevention trials in Africa -- AZT trials and tribulations -- Fair benefits for research in developing countries -- Ethical imperialism? Ethics in international collaborative clinical research -- Ethics are local: engaging cross-cultural variation in the ethics for clinical research -- Ethical and regulatory challenges in a randomized control trial of adjuvant treatment for breast cancer in Vietnam

Part 8 The Behavior of Clinical Investigators : Conflicts of Interest -- Understanding financial conflicts of interest -- Finder's fees for research subjects -- Conflicts of interests and the validity of clinical trials -- In whose best interest? Breaching the academic-industrial wall

Part 9 Scientific Misconduct -- Pressure to publish and fraud in science -- Science, statistics, and deception -- Data torturing -- Preventing scientific misconduct -- When authorship fails: a proposal to make contributors accountable -- Underreporting research is scientific misconduct -- The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials

Part 10 Challenges to the Institutional Review Board System -- Monitoring clinical research: an obligation unfulfilled -- Ethics review for sale? Conflict of interest and commercial research review boards -- The institutional review board and beyond: future challenges to the ethics of human experimentation -- A central institutional review board for multi-institutional trials

All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical trial process: designing the trial, recruiting participants, ensuring informed consent, studying special populations, and conducting international research. Concluding chapters address conflicts of interest, scientific misconduct, and challenges to the IRB system. The appendix provides sample informed consent forms. This book will be used in undergraduate courses on research ethics and in schools of medicine and public health by students who are or will be carrying out clinical research. Professionals in need of such training and bioethicists also will be interested