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" Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological... "
Code of Federal Regulations: Containing a Codification of Documents of ... - Page 124
1996
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Biological Anthropology and Ethics: From Repatriation to Genetic Identity

Trudy R. Turner - Social Science - 2005 - 342 pages
...do with children rarely involves much risk of physical or emotional harm. Minimal risk is defined as "the probability and magnitude of harm or discomfort...physical or psychological examinations or tests." (45 CFR 46.102). This is a definition that certainly leaves room for interpretation, especially as...
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Kinder in klinischen Studien - Grenzen medizinischer Machbarkeit?

Christoph Brochhausen - Children - 2005 - 222 pages
...without a disorder or condition may be exposed during the course of research. Minimal risk is defined as "the probability and magnitude of harm or discomfort...physical or psychological examinations or tests." Is this in the actual daily life of the particular research subject? The daily life of all similar...
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Writing Clinical Research Protocols: Ethical Considerations

Evan DeRenzo, Joel Moss - Medical - 2005 - 320 pages
...is minimal risk (45 CFR 46; Appendix, No. 15). Minimal risk, according to DHHS regulations (46.102), means that the probability and magnitude of harm or...the performance of routine physical or psychological tests. This definition has been consistently interpreted to refer to risk that is inherent in the daily...
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Ethics and Research with Children: A Case-Based Approach

Eric Kodish M.D. - Philosophy - 2005 - 376 pages
...alleviate a serious problem affecting the health or welfare of children. "Minimal risk" is defined as "the probability and magnitude of harm or discomfort...of routine physical or psychological examinations" (45 CFR 46.102(i)). While the regulations do not explicitly distinguish between children of different...
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Agent GCP and the Bloody Consent Form Guidebook

Daniel Farb, Bruce Gordon - Medical - 2005 - 337 pages
...wherever you want to go!" Michele groaned. "All right, all right!" The car displayed: Ooh, yeah! CARMATE: "Minimal risk means that the probability and magnitude...than those ordinarily encountered in daily life." True or false? Answer: True. This also includes the chance and level of harm or discomfort during the...
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Intellectual Disability: Understanding Its Development, Causes ...

James C. Harris M.D. - Medical - 2005 - 448 pages
...The common rule for protection of human subjects includes the following definition of minimal risk: Minimal risk means that the probability and magnitude...themselves than those ordinarily encountered in daily life during the performance of routine physical and psychological examinations or tests. (Field and Behrman,...
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Pediatric PET Imaging

Martin Charron - Medical - 2006 - 616 pages
...in Figure 7.1. In subsection 46.102 (i), the CFR suggests the following definition for minimal risk: Minimal risk means that the probability and magnitude...routine physical or psychological examinations or tests. Given that the study's risk classification determines its approval, this definition is a paramount...
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What the Doctor Didn't Say: The Hidden Truth about Medical Research

Jerry Menikoff, Edward P. Richards - Philosophy - 2006 - 336 pages
...minimal risk on children is permissible. Minimal risk is defined in the federal regulations as meaning that "the probability and magnitude of harm or discomfort...routine physical or psychological examinations or tests."10 This definition leaves a number of issues open to interpretation. For example, different...
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Measuring Stress in Humans: A Practical Guide for the Field

Gillian H. Ice, Gary D. James - Science - 2006 - 263 pages
...expedited review as long or longer than a full-board review, from the viewpoint of the researcher. probability and magnitude of harm or discomfort anticipated...physical or psychological examinations or tests." (Title 45 CFR Part 46, 2001, 102 (i)). In 1998, guidelines defining these procedures and to whom they...
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Institutional Review Board: Management and Function

Elizabeth A. Bankert, Robert J. Amdur - Institutional review boards (Medicine) - 2006 - 568 pages
...the course of research that does not offer the prospect of direct benefit. Minimal risk is defined as "the probability and magnitude of harm or discomfort...routine physical or psychological examinations or tests."1'5'5"'1021'" The National Commission initially stipulated that this standard should be indexed...
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