Textbook of Research Ethics Theory and Practice
The International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS and WHO, 1993: 11) defines “research” as referring to a class of activities designed to develop or contribute to generalizable knowledge. Generalizable knowledge
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TEXTBOOK OF RESEARCH ETHICS Theory and Practice
Sana Loue Case Western Reserve University Cleveland, Ohio
KLUWER ACADEMIC PUBLISHERS New York, Boston, Dordrecht, London, Moscow
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0-306-46839-5 0-306-46448-9
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A long habit of not thinking a thing wrong gives it a superficial appearance of being right, and raises at first a formidable outcry in defense of custom. Thomas Paine, Common Sense, 1776
PREFACE The International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS and WHO, 1993: 11) defines “research” as referring to a class of activities designed to develop or contribute generalizable knowledge. Generalizable knowledge consists theories, principles or relationships, or the accumulation information on which they are based, that can be corroborated accepted scientific techniques of observation and inference.
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The International Guidelines for the Ethical Review of Epidemiological Studies (CIOMS, 1991) recognizes that it may be difficult to distinguish between research and program evaluation. It offers the following guidance: “The defining attribute of research is that it is designed to produce new, generalizable knowledge, as distinct from knowledge pertaining only to a particular individual or programme” (CIOMS, 1991, Guideline 52,23). Health research includes both medical and behavioral studies that relate to health. Research can be conducted in conjunction with patient care (clinical research), or it can be conducted outside of the context of clinical care. Research may involve only observation, or it may require, instead or in combination, a physical, chemical, or psychological intervention. Research may generate new records or may rely on already-existing records. Frank Press (Committee on the Conduct of Science, 1989: v) has observed that: [o]ne of the most appealing features of research is the great degree of personal freedom accorded scientists—freedom to pursue exciting opportunities, to exchange ideas freely with other scientists, to challenge conventional knowledge. Excellence in science requires such freedoms, and the institutions that support science in the United States have found ways to safeguard them. However, modern science, while strong in many ways, is also fragile in important respects.. . .
One such respect relates to the lack of universal agreement regarding human rights and their implementation, specifically in the research context. Although international declarations and guidelines exist, they represent aspirational goals rather than a code designed to regulate conduct in specific situations (se
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