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Principles of clinical research.
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ISBN: 1871816459 Year: 2001 Publisher: Petersfield Wrightson biomedical publishing,

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Biomedical research ethics : Updating international guidelines : A consultation.
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ISBN: 9290360739 Year: 2000 Publisher: Geneva CIOMS,

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Records the papers and commentaries, with an edited discussion, presented at an international consultation convened by the Council for International Organizations of Medical Sciences (CIOMS) to guide revision of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The Guidelines, first issued in 1982 and then revised in 1993, are being updated and expanded to address a number of new and especially challenging ethical issues. These include issues raised by international collaborative trials of drugs in developing countries, especially expensive drugs, and the use of placebo controls in randomized clinical trials. Others arise from the complexity of research in human genetics, including stem-cell research, and in reproductive biology. Throughout, particular attention is given to the difficult questions that arose during the heated debate over trials in developing countries, of short-duration zidovudine (AZT) therapy to reduce perinatal transmission of HIV. The International Ethical Guidelines for Biomedical Research Involving Human Subjects set out a code of research ethics that is widely used by ethical review committees and other bodies responsible for reviewing and overseeing the ethical design of studies and conduct of research. The revision of the Guidelines is being coordinated by CIOMS, in collaboration with WHO. The consultation centered on seven specially commissioned papers, authored by international experts that explore some of the more difficult issues in depth. Each is followed by an invited commentary, often expressing opposing views, and a summary of the issues or conclusions that emerged during the subsequent debate. The first paper, on justice in international research, deals with the question of whether proposals for research to be conducted in a developing country should make provision for future access of the population involved to the interventions under investigation. Also considered are questions that arise when research uses populations in developing countries to investigate interventions that will be of exclusive benefit to the industrialized world. Case studies of recent drug trials and their research protocols are discussed to illustrate circumstances in which use of populations in developing countries is justified or constitutes exploitation. Ethical challenges of the randomized controlled trial are considered in the second paper, which includes a discussion on the equitable distribution of benefits and risks, the use of placebo for controls, and the obligation to ensure that the participation of controls does not compromise their medical care or endanger their health. A paper on informed consent in international health research considers how cultural factors influence communication and language in the informed-consent process and respect for privacy and confidentiality in the research. Subsequent papers address issues in genetics research and reproductive biology, including the moral status of fetuses and the use of embryos in research, and examine the contribution which international human rights instruments can make in the application of the general principles of ethics to research involving human subjects. The final paper gives an overview of capacity building and the role of communities in international biomedical research.

Die Forschungs- und Technologiepolitik der Europäischen Gemeinschaft als Referenzgebiet für das europäische Verwaltungsrecht.
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ISBN: 354044081X Year: 2003 Publisher: Berlin Springer,

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Kaum eine Universität oder Forschungsorganisation kommt an der EG-Forschungsförderung vorbei. Indes haben im Auswahlverfahren besonders Antragsteller Erfolg, die verstehen, über welche politischen Verfahren und rechtlichen Instrumente sich die primärrechtlichen Zielbestimmungen in Förderentscheidungen der EG-Eigenverwaltung umsetzen. Erst recht erleichtert bei der operationellen Durchführung ein systematischer Überblick über die prozeduralen Rahmenbedingungen und über die komplexe Struktur des Forschungsvertrages den Projektkoordinatoren das Navigieren. Das vorliegende Buch beschreibt die Forschungs- und Technologiepolitik der Europäischen Gemeinschaft einschließlich der rechtlichen Forschungsgrenzen. Es ordnet die prägenden Instrumente rechtlich und zeigt unter Berücksichtigung jüngerer Gerichtsentscheidungen Rechtsschutzmöglichkeiten sowie vertragliche Kündigungsrechte auf.

What price better health? Hazards of the research imperative
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ISBN: 0520227719 Year: 2003 Publisher: Berkeley, Calif. University of California Press

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The idea that we have an unlimited moral imperative to pursue medical research is deeply rooted in American society and medicine. This work exposes the ways in which such a seemingly high and humane ideal can be corrupted and distorted into a harmful practice.


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Droit et éthique des manipulations génétiques appliquées à l'homme : approche européenne et internationale.
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ISBN: 2912359562 Year: 2001 Publisher: Bordeaux Les Etudes hospitalières,

Fraud and misconduct in biomedical research.

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It is important to be aware of the legal and ethical frameworks within which research is undertaken and of the steps that are available to prevent fraudulent and dishonest research being undertaken and written up. This book, originally put together by Stephen Lock, an editor of the British Medical Journal, and now revised extensively by Michael Farthing, editor of the gastroenterology journal Gut, provides an overview of the entire topic. Background material on the regulatory frameworks, in North America as well as Europe, is laid out in detail, and the history of fraud and misconduct is illustrated admirably by contributions from Stephen Lock and Frank Wells, a co-editor and expert in ethical and legal issues relating to the pharmaceutical industry. A series of slightly less riveting accounts of individual country’s approaches to research fraud follows, with the best chapters coming towards the end, where personal experiences are used to illuminate the devastating effects that involvement in research fraud can have for patients and practitioners. Michael Farthing has contributed an excellent editorial view on research misconduct to conclude the book.

Writing clinical research protocols : ethical considerations.
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ISBN: 9780122107511 0122107519 Year: 2006 Publisher: Burlington Elsevier Academic Press,

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Introduction to the art and science of clinical research -- What you need to know about clinical research ethics -- What you need to know about the regulation of clinical research -- Designing a clinical research study -- Selecting subjects for clinical studies -- Risks and benefits in clinical research -- Recruiting subjects -- Informed consent -- Privacy and confidentiality -- The "ethics" section -- Procedures and methods -- Statistics, data collection and management, and record keeping -- Use of human biological materials -- Special issues raised by evolving areas of clinical research -- Case histories : learning from experience.

Due consideration : controversy in the age of medical miracles.
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ISBN: 047118344X Year: 1998 Publisher: New York John Wiley & sons,

What kind of life : the limits of emdical progress.
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ISBN: 0878405739 Year: 1994 Publisher: Washington Georgetown University Press,

The ethical dimensions of the biological and health sciences.
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ISBN: 0521008867 Year: 2002 Publisher: Cambridge Cambridge University Press,

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