Textbook of Research Ethics: Theory and PracticeThe 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. |
Contents
A Brief | 1 |
The Nazi Experiments | 8 |
The Cold War Experiments | 19 |
The Prison Experiments | 25 |
The Tearoom Trade | 31 |
Chapter Summary | 37 |
Approaches to Ethical Analysis | 45 |
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action agency American application approval argued Association authors benefits capacity cause clinical trials Code committee concerns conduct confidentiality consequences considered context court critical decision Department depending determine disclosure discussed disease documents drug duty effect ethical Ethical Review experimentation experiments factors federal findings funding Guidelines harm Health Human Subjects individuals informed consent instance institution Integrity interest International investigator involving issues Journal knowledge lack means Medicine mental misconduct moral nature obtained Office participants particular patients person physicians possible potential practice present Press principles prisoners procedures proposed protect protocol question reasons receive records recruitment refers regulations relating relevant representative requires Research Involving respect responsibility result risk rules sampling scientific Services situation social specific treatment understanding United University various women York