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Ethical and regulatory aspects of clinical research : readings and commentary

Author: Ezekiel J Emanuel
Publisher: Baltimore : Johns Hopkins University Press, 2003.
Edition/Format:   Print book : EnglishView all editions and formats
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Professionals in need of such training and bioethicists will be interested.

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Additional Physical Format: Online version:
Ethical and regulatory aspects of clinical research.
Baltimore : Johns Hopkins University Press, 2003
(OCoLC)607061245
Online version:
Ethical and regulatory aspects of clinical research.
Baltimore : Johns Hopkins University Press, 2003
(OCoLC)609122368
Material Type: Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: Ezekiel J Emanuel
ISBN: 0801878136 9780801878138
OCLC Number: 52471681
Description: xxxv, 490 pages ; 28 cm
Contents: 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.
Responsibility: edited by Ezekiel J. Emanuel [and 4 others].
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Provides excellent material on a broad variety of ethical topics in clinical research. The editors are commended for the wise and diverse selection of articles and the broad range of sources of Read more...

 
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