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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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Research Ethics: Cases and Materials

Robin Levin Penslar - Business & Economics - 1995 - 346 pages
...Controversies in Social Science (New York: Praeger, 1986). 7. Federal regulations define "minimal risk" to mean "that the probability and magnitude of harm or discomfort...the performance of routine physical or psychological examination or tests" (45 Code of Federal Regulations 46.io2[i]). 8. A good discussion of this question...
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Idea to Product: The Process

Nancy J. Alexander, Anne C. Wentz - Medical - 1996 - 226 pages
...following circumstances pertain: 1. the research involves no more than minimal risk to the subjects ("Minimal risk" means that the probability and magnitude...routine physical or psychological examinations or tests (45 CFR 2. the waiver, or alteration, of consent will not adversely affect the rights and welfare of...
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Birth to Death: Science and Bioethics

David C. Thomasma, Thomasine Kimbrough Kushner - Business & Economics - 1996 - 404 pages
...other than those already mentioned. According to the definition in the federal regulations: "Minimal mk means that the probability and magnitude of harm or...physical or psychological examinations or tests." Examples of procedures presenting no more than minimal risk are: routine immunizations, modest changes...
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Ethics and Epidemiology

Steven Scott Coughlin, Tom L. Beauchamp - Epidemiology - 1996 - 332 pages
...46.405 (c), and at § 46.406 (d). 15. Id. at §46. 116 (d). 16. The regulations define "minimal risk" as "the probability and magnitude of harm or discomfort...physical or psychological examinations or tests." 45 CFR § 46.102 (h)(i). Tom L. Beauchamp et al. "Ethical Guidelines for Epidemiologists," Journal...
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Ethics in Neurobiological Research with Human Subjects: The Baltimore ...

Adil E. Shamoo - Medical - 1996 - 340 pages
...participation. The Belmont Report, supra note 18, at 11, quoted in Goldner, supra note 3 at 97-98 52. " 'Minimal risk' means that the probability and magnitude...physical or psychological examinations or tests," 21 CFR §50.3 (1994); 45 CFR §46.102(i). 53. 21 CFR §50.25 (1994) (FDA); 45 CFR § 46.116. 54. Id....
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Oversight of NIH and FDA: Bioethics and the Adequacy of Informed Consent ...

United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources - Medical - 1997 - 244 pages
...consist of, or where further information may be obtained:; "Minimal risk* in both FDA and HHS regulations means that, "the probability and magnitude of harm...encountered in daily life or during the performance of • An explanation of whom to contact for answers to pertinent questions about research and research...
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Oversight of NIH and FDA: Bioethics and the Adequacy of Informed Consent ...

United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources - Medical - 1997 - 246 pages
...of, or where further information may be obtained1; 1"Minimal risk" in both FDA and KHS regulations means that, "the probability and magnitude of harm...encountered in daily life or during the performance of • An explanation of whom to contact for answers to pertinent questions about research and research...
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Beyond Consent: Seeking Justice in Research

Jeffrey P. Kahn, Anna C. Mastroianni, Jeremy Sugarman - Medical - 1998 - 205 pages
...commensurate with that child's situation. Recall that the federal regulations define "minimal risk" as "the probability and magnitude of harm or discomfort...routine physical or psychological examinations or tests."21 Note that this definition omits the phrase "of healthy children" that is found in the National...
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From the Source: A Guide for Implementing Perinatal Addiction Prevention and ...

Marjorie Rosenweig, Rachel Greenberg, Karen Lyon, Susan Kouner - 1998 - 206 pages
...of the Code of Federal Regulations, Section 46.102(i) as 'the probability and magnitude of harm and discomfort anticipated in the research are not greater...physical or psychological examinations or tests." (Office for the Prevention of Research Risk [OPRR], 1991) A. Identify and describe any potential risks...
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The Code of Federal Regulations of the United States of America

Administrative law - 1998 - 460 pages
...event of an investigation conducted by a team of individuals, is the responsible leader of that team. (i) Minimal risk means that the probability and magnitude...of themselves than those ordinarily encountered in dally life or during the performance of routine physical or psychological examinations or tests. (j)...
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