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It has also posed some troubling ethical questions.
Public attention was drawn to these questions by reported abuses of human subjects in biomedical experiments, especially during the Second World War.
During the Nuremberg War Crime Trials, the Nuremberg code was drafted as a set of standards for judging physicians and scientists who had conducted biomedical experiments on concentration camp prisoners. This code became the prototype of many later codes intended to assure that research involving human subjects would be carried out in an ethical manner.
The codes consist of rules, some general, others specific, that guide the investigators or the reviewers of research in their work. Such rules often are inadequate to cover complex situations; at times they come into conflict, and they are frequently Appendix dorder completed essay to interpret or apply.
Broader ethical principles will provide a basis on which specific rules may be formulated, criticized and interpreted. Three principles, or general prescriptive judgments, that are relevant to research involving human subjects are identified in this statement.
Other principles may also be relevant. These three are comprehensive, however, and are stated at a level of generalization that should assist scientists, subjects, reviewers and interested citizens to understand the ethical issues inherent in research involving human subjects.
These principles cannot always be applied so as to resolve beyond dispute particular ethical problems. The objective is to provide an analytical framework that will guide the resolution of ethical problems arising from research involving human subjects.
This statement consists of a distinction between research and practice, a discussion of the three basic ethical principles, and remarks about the application of these principles.
Back to Top A. Boundaries Between Practice and Research It is important to distinguish between biomedical and behavioral research, on the one hand, and the practice of accepted therapy on the other, in order to know what activities ought to undergo review for the protection of human subjects of research.
The distinction between research and practice is blurred partly because both often occur together as in research designed to evaluate a therapy and partly because notable departures from standard practice are often called 'experimental' when the terms 'experimental' and 'research' are not carefully defined.
For the most part, the term 'practice' refers to interventions that are designed solely to enhance the well being of an individual patient or client and that have a reasonable expectation of success. The purpose of medical or behavioral practice is to provide diagnosis, preventive treatment or therapy to particular individuals.
By contrast, the term 'research' designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to general-izable knowledge expressed, for example, in theories, principles, and statements of relationships.
Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective. When a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research.
The fact that a procedure is 'experimental,' in the sense of new, untested or different, does not automatically place it in the category of research.
Radically new procedures of this description should, however, be made the object of formal research at an early stage in order to determine whether they are safe and effective. Thus, it is the responsibility of medical practice committees, for example, to insist that a major innovation be incorporated into a formal research project.
Research and practice may be carried on together when research is designed to evaluate the safety and efficacy of a therapy.
This need not cause any confusion regarding whether or not the activity requires review; the general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects.D-1 Appendix D.
Examples of Screening and Assessment Tools for Substance Use Disorders. questionnaires that are completed by the respondent. Both types are provided here. The oral screens This list is in alphabetical order based on the tool acronym.
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