Ethical and regulatory aspects of clinical research : readings and commentary

TitleEthical and regulatory aspects of clinical research : readings and commentary
Publication TypeBook
Year of Publication2003
AuthorsEmanuel, EJ
PublisherJohns Hopkins University Press
Publication Languageeng
ISBN NumberISBN: 0801878136
Accession Number52471681
Keywords-- , and , aspecten.; , aspects.; , Clinical , ethical , ethics , Ethics, , ethics.; , Ethische , experimentation , Human , in , Medical , MEDICINE , Moral , Regelgeving. , research , Research.; , Subjects.; , trials
AbstractA collection of essays including the following: 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 -- 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) --; 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 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 -- 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? -- 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 -- 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 -- 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 -- 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 -- 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 -- 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.
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