Textbook of Research Ethics: Theory and Practice

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Springer Science & Business Media, 8 mai 2007 - 256 pagini
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 consists of theories, principles or relationships, or the accumulation of information on which they are based, that can be corroborated by accepted scientific techniques of observation and inference. 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.
 

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Cuprins

A Brief
1
The Nazi Experiments
8
Regulations Governing Human Experimentation
14
The Prison Experiments
25
The Tearoom Trade
31
Chapter Summary
37
Approaches to Ethical Analysis
45
Ethical Issues Before the Study Begins
71
Chapter Summary
108
Obligation to Inform
159
Legal Issues in Research
171
Limits on Confidentiality
196
Chapter Summary
212
2
241
811
249
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Ethical Review Committees
89

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