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1
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42149124992
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Vulnerability in Research and Health Care: Describing the Elephant in the Room
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For differing approaches to these questions, see, e.g., no. no. no. no. at
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For differing approaches to these questions, see, e.g., S. A. Hurst Vulnerability in Research and Health Care: Describing the Elephant in the Room Bioethics 22, no. 4 (2008 191 202. B. C. Vladeck How Useful Is 'Vulnerable' as a Concept Health Affairs 26, no. 5 (2007 1231 1234. F. J. Leavitt Is Any Research Population Not Vulnerable Cambridge Quarterly of Healthcare Ethics 15, no. 7 (2006 81 88. C. Levine The Limitations of 'Vulnerability' as a Protection for Human Research Participants American Journal of Bioethics 4, no. 3 (2004 44 49. K. Kipnis Vulnerability in Research Subjects: A Bioethical Taxonomy Ethical and Policy Issues in Research Involving Human Participants, Vol. II, 2001, at G1 G13.
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Bioethics
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Hurst, S.A.1
Vladeck, B.C.2
Leavitt, F.J.3
Levine, C.4
Kipnis, K.5
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2
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61349198243
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45 CFR 46.107(a).
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45 CFR 46.107(a).
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3
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61349147795
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45 CFR 46.111(a)(4).
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45 CFR 46.111(a)(4).
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4
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61349134176
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45 CFR 46.111(b).
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45 CFR 46.111(b).
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5
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61349197553
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45 CFR 46.107(a).
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45 CFR 46.107(a).
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6
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61349187026
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45 CFR 46.111(a)(4) and (b).
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45 CFR 46.111(a)(4) and (b).
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7
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61349143116
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45 CFR 46.111(a)(4).
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45 CFR 46.111(a)(4).
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8
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61349144326
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Id.
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Id.
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9
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61349122074
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45 CFR 46.201 (subpart b), 45 CFR 46.301 (subpart c), 45 CFR 46.401 (subpart d), respectively.
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45 CFR 46.201 (subpart b), 45 CFR 46.301 (subpart c), 45 CFR 46.401 (subpart d), respectively.
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10
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61349195859
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Federal Agency Survey on Policies and Procedures for the Protection of Human Subjects in Research
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National Bioethics Advisory Committee (NBAC). Commissioned Papers and Staff Analysis, Bethesda, Maryland, at
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National Bioethics Advisory Committee (NBAC) Federal Agency Survey on Policies and Procedures for the Protection of Human Subjects in Research Ethical and Policy Issues in Research Involving Human Participants, Vol. II : Commissioned Papers and Staff Analysis, Bethesda, Maryland, 2001, at J-14.
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Ethical and Policy Issues in Research Involving Human Participants, Vol. II
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11
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61349092298
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World Medical Association, Declaration of Helsinki, WMA General Assembly, 1964, as amended through. at A(8).
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World Medical Association, Declaration of Helsinki, WMA General Assembly, 1964, as amended through 2004, at A(8).
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(2004)
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13
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61349181967
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Id.
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Id.
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14
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61349164905
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Id.
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Id.
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15
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61349134844
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International Conference on Harmonisation (ICH) Harmonized Tripartite Guideline, at 1.16.
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International Conference on Harmonisation (ICH) Harmonized Tripartite Guideline, Guideline for Good Clinical Practice, 1996, at 1.16.
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Guideline for Good Clinical Practice
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61349176537
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Id.
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Id.
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61349089865
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Assessing Risks and Potential Benefits and Evaluating Vulnerability
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National Bioethics Advisory Commission (NBAC). Reports and Recommendations, Bethesda, Maryland, at 87.
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National Bioethics Advisory Commission (NBAC) Assessing Risks and Potential Benefits and Evaluating Vulnerability Ethical and Policy Issues in Research Involving Human Participants, Vol. I : Reports and Recommendations, Bethesda, Maryland, 2001, at 87.
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61349088640
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Id., at 88.
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Id., at 88.
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61349105979
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Id., at 89.
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Id., at 89.
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61349148705
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See. NBAC, supra note 17, at 85.
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See NBAC, supra note 17, at 85.
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61349126201
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Id.
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Id.
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61349117439
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See supra note 6.
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See supra note 6.
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61349162383
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See. supra note 1.
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See Levine, supra note 1.
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Levine1
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61349188360
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Id.
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Id.
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61349195218
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See. supra note 1.
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See Hurst, supra note 1.
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Hurst1
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61349136311
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The justice-based dimensions of vulnerability were explicitly recognized in the Belmont Report. See The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report
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The justice-based dimensions of vulnerability were explicitly recognized in the Belmont Report. See The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report, 1979.
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Research with Decisionally Incapacitated Human Subjects: An Argument for a Systemic Approach to Risk-Benefit Assessment
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For an attempt at such a justification in connection with decisionally impaired adults, see. no. For proposed justifications for research with children, see, e.g., no. and
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See. CIOMS, supra note 12; NBAC "Guidelines," supra note 17, respectively.
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See CIOMS, supra note 12; NBAC "Guidelines," supra note 17, respectively.
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Cf. and. no.
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no.
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Probing Informed Consent in Schizophrenia Research
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