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Volumn 37, Issue 1, 2009, Pages 12-18

Vulnerability as a regulatory category in human subject research

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; ETHICS; GOVERNMENT REGULATION; HUMAN; HUMAN EXPERIMENT; LEGAL ASPECT; MEDICAL RESEARCH; NOMENCLATURE; PRACTICE GUIDELINE; RESEARCH SUBJECT; UNITED STATES; VULNERABLE POPULATION;

EID: 61349185283     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2009.00346.x     Document Type: Article
Times cited : (61)

References (35)
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    • For differing approaches to these questions, see, e.g., no. no. no. no. at
    • 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.
    • (2008) Bioethics , Issue.4
    • Hurst, S.A.1    Vladeck, B.C.2    Leavitt, F.J.3    Levine, C.4    Kipnis, K.5
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    • 45 CFR 46.107(a).
    • 45 CFR 46.107(a).
  • 3
    • 61349147795 scopus 로고    scopus 로고
    • 45 CFR 46.111(a)(4).
    • 45 CFR 46.111(a)(4).
  • 4
    • 61349134176 scopus 로고    scopus 로고
    • 45 CFR 46.111(b).
    • 45 CFR 46.111(b).
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    • 45 CFR 46.107(a).
    • 45 CFR 46.107(a).
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    • 45 CFR 46.111(a)(4) and (b).
    • 45 CFR 46.111(a)(4) and (b).
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    • 45 CFR 46.111(a)(4).
    • 45 CFR 46.111(a)(4).
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    • Id.
    • Id.
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    • 45 CFR 46.201 (subpart b), 45 CFR 46.301 (subpart c), 45 CFR 46.401 (subpart d), respectively.
    • 45 CFR 46.201 (subpart b), 45 CFR 46.301 (subpart c), 45 CFR 46.401 (subpart d), respectively.
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    • National Bioethics Advisory Committee (NBAC). Commissioned Papers and Staff Analysis, Bethesda, Maryland, at
    • 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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    • World Medical Association, Declaration of Helsinki, WMA General Assembly, 1964, as amended through. at A(8).
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    • (2004)
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    • Id.
    • Id.
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    • Id.
    • Id.
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    • Id.
    • Id.
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    • Assessing Risks and Potential Benefits and Evaluating Vulnerability
    • National Bioethics Advisory Commission (NBAC). Reports and Recommendations, Bethesda, Maryland, at 87.
    • 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.
    • (2001) Ethical and Policy Issues in Research Involving Human Participants, Vol. i
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    • Id., at 88.
    • Id., at 88.
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    • Id., at 89.
    • Id., at 89.
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    • See. NBAC, supra note 17, at 85.
    • See NBAC, supra note 17, at 85.
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    • Id.
    • Id.
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    • See supra note 6.
    • See supra note 6.
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    • See. supra note 1.
    • See Levine, supra note 1.
    • Levine1
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    • Id.
    • Id.
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    • See. supra note 1.
    • See Hurst, supra note 1.
    • Hurst1
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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
    • 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.
    • (1979)
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    • 49149107558 scopus 로고    scopus 로고
    • Research with Decisionally Incapacitated Human Subjects: An Argument for a Systemic Approach to Risk-Benefit Assessment
    • 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
    • For an attempt at such a justification in connection with decisionally impaired adults, see C. H. Coleman Research with Decisionally Incapacitated Human Subjects: An Argument for a Systemic Approach to Risk-Benefit Assessment Indiana Law Journal 83, no. 3 (2008 743 789. For proposed justifications for research with children, see, e.g., D. L. Coleman The Legal Ethics of Pediatric Research Duke Law Journal 57, no. 3 (2007 517 624. and P. Litton Non-Beneficial Pediatric Research and the Best Interests Standard: A Legal and Ethical Reconciliation Yale Journal of Health Policy, Law and Ethics 8 (2008 359 420.
    • (2008) Indiana Law Journal , pp. 359-420
    • Coleman, C.H.1    Coleman, D.L.2    Litton, P.3
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    • See. CIOMS, supra note 12; NBAC "Guidelines," supra note 17, respectively.
    • See CIOMS, supra note 12; NBAC "Guidelines," supra note 17, respectively.
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    • Clinical Research with Economically Disadvantaged Populations
    • Cf. and. no.
    • Cf. C.C. Denny and C. Grady Clinical Research with Economically Disadvantaged Populations Journal of Medical Ethics 33, no. 7 (2007 382 385.
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    • Denny, C.C.1    Grady, C.2
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    • Moral Standards for Research in Developing Countries: From 'Reasonable Availability' to 'Fair Benefits'
    • See Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries. no. no. and. no
    • See Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries Moral Standards for Research in Developing Countries: From 'Reasonable Availability' to 'Fair Benefits' Hastings Center Report 34, no. 3 (2004 17 27. J. Arras Fair Benefits in International Medical Research Hastings Center Report 34, no. 3 (2004 3. S. Gbadegesin and D. Wendler Protecting Communities in Health Research from Exploitation Bioethics 20, no. 5 (2006 248 253.
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    • Arras, J.1    Gbadegesin, S.2    Wendler, D.3
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    • The "mutually advantageous exploitation" model is critiqued by A. Ballantyne, "fair Benefits Accounts of Exploitation Require a Normative Principle of Fairness: Response to Gbadegesin and Wendler, and Emanuel et al.
    • no.
    • The "mutually advantageous exploitation" model is critiqued by A. Ballantyne, "Fair Benefits Accounts of Exploitation Require a Normative Principle of Fairness: Response to Gbadegesin and Wendler, and Emanuel et al. Bioethics 22, no. 4 (2008 239 244.
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    • See. NBAC, supra note 17, at 92.
    • See NBAC, supra note 17, at 92.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.