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
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 |
Ethical Review Committees | 89 |
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45 Code African American agency American Bioethics Biomedical Research Involving CIOMS clinical trials Code of Federal conduct confidentiality conflict of interest confounder consent form context court decision deontology Department of Health disclosure discussed disease documents drug effect Epidemiological Studies CIOMS Ethical Review ethical review committee evaluation experiment experimental exposure Federal Regulations section funding Guidelines for Biomedical Guidelines for Ethical harm Helsinki Declaration human experimentation individual’s individuals informed consent instance institutional review board International Guidelines intervention investigator Involving Human Subjects Journal Medicine mental Nazi Nuremberg Code OPRR participate in research patients person physicians placebo plaintiff potential principles procedures prospective participant protect protocol Racial Hygiene recruitment relating relevant requires Research Integrity Research Involving Human research participants responsibility result Review of Epidemiological sampling scientific misconduct specific statute study design subpoena therapy treatment United United States Code University vulnerable women