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Volumn 40, Issue 4, 2012, Pages 831-840

Prudent Precaution in Clinical Trials of Nanomedicines

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL TRIAL (TOPIC); ETHICS; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HUMAN; NANOMEDICINE; RISK MANAGEMENT; SOCIAL BEHAVIOR; UNCERTAINTY; UNITED STATES;

EID: 84872167408     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2012.00711.x     Document Type: Article
Times cited : (9)

References (42)
  • 2
    • 0242556414 scopus 로고    scopus 로고
    • "From General Policy to Legal Rule: The Aspirations and Limitations of the Precautionary Principle,"
    • G. E. Marchant, "From General Policy to Legal Rule: The Aspirations and Limitations of the Precautionary Principle, " Environmental Health Perspectives 111, no. 14 (2003): 1799-1803.
    • (2003) Environmental Health Perspectives , vol.111 , Issue.14 , pp. 1799-1803
    • Marchant, G.E.1
  • 4
    • 84872150435 scopus 로고    scopus 로고
    • United Nations Conference on Environment and Development (1992), Rio Declaration on Environment and Development, U.N. Doc. A/CONF.151/5/Rev. 1.
    • United Nations Conference on Environment and Development (1992), Rio Declaration on Environment and Development, U.N. Doc. A/CONF.151/5/Rev. 1.
  • 5
    • 10044288384 scopus 로고    scopus 로고
    • "Towards Understanding Aspects of the Precautionary Principle,"
    • at 261.
    • C. F. Cranor, "Towards Understanding Aspects of the Precautionary Principle, " Journal of Medicine and Philosophy 29, no. 3 (2004): 259-279, at 261.
    • (2004) Journal of Medicine and Philosophy , vol.29 , Issue.3 , pp. 259-279
    • Cranor, C.F.1
  • 6
    • 84872122346 scopus 로고    scopus 로고
    • Science and Environmental Health Network, Wingspread Conference on the Precautionary Principle, January 26, 1998, available at <> (last visited November 26, 2012).
    • Science and Environmental Health Network, Wingspread Conference on the Precautionary Principle, January 26, 1998, available at (last visited November 26, 2012).
  • 7
    • 22844453938 scopus 로고    scopus 로고
    • "Dimensions of the Precautionary Principle,"
    • P. Sandin, "Dimensions of the Precautionary Principle, " Human and Ecological Risk Assessment 5, no. 5 (1999): 889-907.
    • (1999) Human and Ecological Risk Assessment , vol.5 , Issue.5 , pp. 889-907
    • Sandin, P.1
  • 8
    • 84872146415 scopus 로고    scopus 로고
    • Commission of the European Communities (2000), Communication from the Commission on the Precautionary Principle, Brussels, COM(2000) 1.
    • Commission of the European Communities (2000), Communication from the Commission on the Precautionary Principle, Brussels, COM(2000) 1.
  • 9
    • 84872126639 scopus 로고    scopus 로고
    • European Environmental Bureau, EEB Position on the Precautionary Principle, December 1999, available at <> (last visited November 26, 2012).
    • European Environmental Bureau, EEB Position on the Precautionary Principle, December 1999, available at (last visited November 26, 2012).
  • 10
    • 84892878129 scopus 로고    scopus 로고
    • Arbitrary & Capricious: The Precautionary Principle in the European Union Courts (Washington, D.C.: AEI Press, 2004).
    • G. E. Marchant and K. L. Mossman, Arbitrary & Capricious: The Precautionary Principle in the European Union Courts (Washington, D.C.: AEI Press, 2004).
    • Marchant, G.E.1    Mossman, K.L.2
  • 11
    • 14844285422 scopus 로고    scopus 로고
    • "The 'Precautionary Principle' as a Guide for Future Drug Development,"
    • S. Alban, "The 'Precautionary Principle' as a Guide for Future Drug Development, " European Journal of Clinical Investigation 35, Supp. 1 (2005): 33-44
    • (2005) European Journal of Clinical Investigation , vol.35 , Issue.SUPPL. 1 , pp. 33-44
    • Alban, S.1
  • 12
    • 34047128693 scopus 로고    scopus 로고
    • The Precautionary Principle Should Not Be Used as a Basis for Decision-Making
    • M. Peterson, "The Precautionary Principle Should Not Be Used as a Basis for Decision-Making, "EMBO Reports 8, no. 4 (2007): 305-308
    • (2007) EMBO Reports , vol.8 , Issue.4 , pp. 305-308
    • Peterson, M.1
  • 13
    • 70349176236 scopus 로고    scopus 로고
    • Precaution, Cyclooxygenase Inhibition, and Cardiovascular Risk
    • J. M. Ritter, I. Harding, and J. B. Warren, "Precaution, Cyclooxygenase Inhibition, and Cardiovascular Risk, "Trends in Pharmacological Sciences 30, no. 10 (2009): 503-508.
    • (2009) Trends in Pharmacological Sciences , vol.30 , Issue.10 , pp. 503-508
    • Ritter, J.M.1    Harding, I.2    Warren, J.B.3
  • 14
    • 79956116537 scopus 로고    scopus 로고
    • "Designing Oversight for Nanomedicine Research in Human Subjects: Systematic Analysis of Exceptional Oversight for Emerging Technologies,"
    • S. M. Wolf and C. M. Jones, "Designing Oversight for Nanomedicine Research in Human Subjects: Systematic Analysis of Exceptional Oversight for Emerging Technologies, " Journal of Nanoparticle Research 13, no. 4 (2011): 1449-1465.
    • (2011) Journal of Nanoparticle Research , vol.13 , Issue.4 , pp. 1449-1465
    • Wolf, S.M.1    Jones, C.M.2
  • 15
    • 84872132240 scopus 로고    scopus 로고
    • quot;Throwing Precaution to the Wind: Why the 'Safe' Choice Can be Dangerous," Boston Globe, available at <> (last visited November 26, 2012).
    • C. Sunstein, "Throwing Precaution to the Wind: Why the 'Safe' Choice Can be Dangerous, " Boston Globe, 2008, available at (last visited November 26, 2012).
    • (2008)
    • Sunstein, C.1
  • 16
    • 76149092191 scopus 로고    scopus 로고
    • Governance of Nanotechnology and Nanomaterials: Principles, Regulation, and Renegotiating the Social Contract
    • 714
    • G. A. Kimbrell, "Governance of Nanotechnology and Nanomaterials: Principles, Regulation, and Renegotiating the Social Contract, "Journal of Law, Medicine & Ethics 37, no. 4 (2009): 706-723, at 714
    • (2009) Journal of Law, Medicine & Ethics , vol.37 , Issue.4 , pp. 706-723
    • Kimbrell, G.A.1
  • 17
    • 79551672488 scopus 로고    scopus 로고
    • Nanotoxicology: An Interdisciplinary Challenge
    • 1269-1272.
    • H. F. Krug and P. Wick, "Nanotoxicology: An Interdisciplinary Challenge, "Angewandte Chemie International Edition 50, no. 6 (2011): 1260-1278, at 1269-1272.
    • (2011) Angewandte Chemie International Edition , vol.50 , Issue.6 , pp. 1260-1278
    • Krug, H.F.1    Wick, P.2
  • 18
    • 78650086812 scopus 로고    scopus 로고
    • "Debunking Some Myths about Nanotoxicology,"
    • at 4778.
    • D. B. Warheit, "Debunking Some Myths about Nanotoxicology, " Nano Letters 10, no. 12 (2010): 4777-4782, at 4778.
    • (2010) Nano Letters , vol.10 , Issue.12 , pp. 4777-4782
    • Warheit, D.B.1
  • 19
    • 84872154540 scopus 로고    scopus 로고
    • Nanotechnology Task Force, U.S. Food and Drug Administration, Nanotechnology, July 25, 2007, at 11, available at (last visited November 26, 2012).
    • Nanotechnology Task Force, U.S. Food and Drug Administration, Nanotechnology, July 25, 2007, at 11, available at (last visited November 26, 2012).
  • 20
    • 84859950790 scopus 로고    scopus 로고
    • "FDA's Approach to Regulation of Products of Nanotechnology,"
    • at 300.
    • M. A. Hamburg, "FDA's Approach to Regulation of Products of Nanotechnology, " Science 336, no. 6079 (2012): 299-300, at 300.
    • (2012) Science , vol.336 , Issue.6079 , pp. 299-300
    • Hamburg, M.A.1
  • 21
    • 84872135821 scopus 로고    scopus 로고
    • and, Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials, Executive Office of the President, 4-5 (June 9, 2011), available at (last visited November 26, 2012).
    • J. P. Holdren, C. R. Sunstein, and I. A. Siddiqui, Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials, Executive Office of the President, 4-5 (June 9, 2011), available at (last visited November 26, 2012).
    • Holdren, J.P.1    Sunstein, C.R.2    Siddiqui, I.A.3
  • 22
    • 36949039462 scopus 로고    scopus 로고
    • "Nanotechnology Safety Concerns Revisited,"
    • and, at 16.
    • S. T. Stern and S. E. McBride, "Nanotechnology Safety Concerns Revisited, " Toxicological Science 101, no. 1 (2008): 4-21, at 16.
    • (2008) Toxicological Science , vol.101 , Issue.1 , pp. 4-21
    • Stern, S.T.1    McBride, S.E.2
  • 23
    • 78349281526 scopus 로고    scopus 로고
    • Exposure Assessment Approaches for Engineered Nanomaterials
    • L. C. Abbott and A. D. Maynard, "Exposure Assessment Approaches for Engineered Nanomaterials, "Risk Analysis 30, no. 11 (2010): 1634-1644.
    • (2010) Risk Analysis , vol.30 , Issue.11 , pp. 1634-1644
    • Abbott, L.C.1    Maynard, A.D.2
  • 24
    • 34249290440 scopus 로고    scopus 로고
    • "Ethical Issues in Clinical Trials Involving Nanomedicine,"
    • and, at 436.
    • D. B. Resnik and S. S. Tinkle, "Ethical Issues in Clinical Trials Involving Nanomedicine, " Contemporary Clinical Trials 28, no. 4 (2007): 433-441, at 436.
    • (2007) Contemporary Clinical Trials , vol.28 , Issue.4 , pp. 433-441
    • Resnik, D.B.1    Tinkle, S.S.2
  • 27
    • 79952654904 scopus 로고    scopus 로고
    • A Method to Estimate the Cost in Lives of Ethics Board Review of Biomedical Research
    • See generally, S. N. Whitney and C. E. Schneider, "A Method to Estimate the Cost in Lives of Ethics Board Review of Biomedical Research, "Journal of Internal Medicine 269, no. 4 (2011): 396-406.
    • (2011) Journal of Internal Medicine , vol.269 , Issue.4 , pp. 396-406
    • Whitney, S.N.1    Schneider, C.E.2
  • 29
    • 79958271494 scopus 로고    scopus 로고
    • "Engineered Nanoparticles in Consumer Products: Understanding a New Ingredient,"
    • at A122.
    • R. Kessler, "Engineered Nanoparticles in Consumer Products: Understanding a New Ingredient, " Environmental Health Perspectives 119, no. 3 (2011): A121-A125, at A122.
    • (2011) Environmental Health Perspectives , vol.119 , Issue.3
    • Kessler, R.1
  • 30
    • 79953078284 scopus 로고    scopus 로고
    • "Engineered Nanomaterials: Exposures, Hazards, and Risk Prevention,"
    • and, at 2.
    • R. A. Yokel and R. C. McPhail, "Engineered Nanomaterials: Exposures, Hazards, and Risk Prevention, " Journal of Occupational Medicine and Toxicology 6, no. 7 (2011): 1-27, at 2.
    • (2011) Journal of Occupational Medicine and Toxicology , vol.6 , Issue.7 , pp. 1-27
    • Yokel, R.A.1    McPhail, R.C.2
  • 31
    • 20644449754 scopus 로고    scopus 로고
    • "Nanotoxicity: An Emerging Discipline Evolving from Studies of Ultrafine Particles,"
    • and, at 837.
    • G. Oberdörster, E. Oberdörster, and J. Oberdörster, "Nanotoxicity: An Emerging Discipline Evolving from Studies of Ultrafine Particles, " Environmental Health Perspectives 113, no. 7 (2005): 823-839, at 837.
    • (2005) Environmental Health Perspectives , vol.113 , Issue.7 , pp. 823-839
    • Oberdörster, G.1    Oberdörster, E.2    Oberdörster, J.3
  • 32
    • 77951142313 scopus 로고    scopus 로고
    • "Commercially Manufactured Engineered Nanomaterials for Environmental and Health Studies: Important Insights Provided by Independent Characterization,"
    • and, 201): -, at 715.
    • H. Park and V. H. Grassian, "Commercially Manufactured Engineered Nanomaterials for Environmental and Health Studies: Important Insights Provided by Independent Characterization, " Environmental and Toxicological Chemistry 29, no. 3 (201): 715-721, at 715.
    • Environmental and Toxicological Chemistry , vol.29 , Issue.3 , pp. 715-721
    • Park, H.1    Grassian, V.H.2
  • 33
    • 79960031926 scopus 로고    scopus 로고
    • "Don't Define Nanomaterials,"
    • at 31
    • A. Maynard, "Don't Define Nanomaterials, " Nature 475, no. 1 (2011): 31, at 31
    • (2011) Nature , vol.475 , Issue.1 , pp. 31
    • Maynard, A.1
  • 34
    • 79952097548 scopus 로고    scopus 로고
    • The New Toxicology of Sophisticated Materials: Nanotoxicology and Beyond
    • S112.
    • A. D. Maynard, D. B. Warheit, and M. A. Philibert, quot;The New Toxicology of Sophisticated Materials: Nanotoxicology and Beyond,"Toxicological Sciences 120, Suppl. 1 (2011): S109-S129, at S112.
    • (2011) Toxicological Sciences , vol.120 , Issue.SUPPL. 1
    • Maynard, A.D.1    Warheit, D.B.2    Philibert, M.A.3
  • 35
    • 64949196677 scopus 로고    scopus 로고
    • "Balancing Uncertain Risks and Benefits in Human Subjects Research,"
    • at 339.
    • R. Barke, "Balancing Uncertain Risks and Benefits in Human Subjects Research, " Science, Technology & Human Values 34, no. 3 (2009): 337-364, at 339.
    • (2009) Science, Technology & Human Values , vol.34 , Issue.3 , pp. 337-364
    • Barke, R.1
  • 36
    • 76149100245 scopus 로고    scopus 로고
    • "What Does the History of Technology Regulation Teach Us About Nano Oversight,"
    • and, at 725-726.
    • G. E. Marchant, D. J. Sylvester, and K. W. Abbott, "What Does the History of Technology Regulation Teach Us About Nano Oversight, " Journal of Law, Medicine & Ethics 37, no. 4 (2009): 724-731, at 725-726.
    • (2009) Journal of Law, Medicine & Ethics , vol.37 , Issue.4 , pp. 724-731
    • Marchant, G.E.1    Sylvester, D.J.2    Abbott, K.W.3
  • 37
    • 18044368279 scopus 로고    scopus 로고
    • "The Precautionary Principle and Risk Perception: Experimental Studies in the EMF Area,"
    • P. M. Wiedemann and H. Schütz, "The Precautionary Principle and Risk Perception: Experimental Studies in the EMF Area, " Environmental Health Perspectives 113, no. 4 (2005): 402-405.
    • (2005) Environmental Health Perspectives , vol.113 , Issue.4 , pp. 402-405
    • Wiedemann, P.M.1    Schütz, H.2
  • 38
    • 84872156081 scopus 로고    scopus 로고
    • ETC Group, quot;Nanotech Product Recall Underscores Need for Nanotech Moratorium: Is the Magic Gone?" April 7, 2006, available at <> (last visited November 26, 2012).
    • ETC Group, "Nanotech Product Recall Underscores Need for Nanotech Moratorium: Is the Magic Gone?" April 7, 2006, available at (last visited November 26, 2012).
  • 39
    • 0041920900 scopus 로고    scopus 로고
    • Ethics of Phase 1 Oncology Studies: Reexamining the Arguments and Data
    • M. Agrawal and E. Emanuel, "Ethics of Phase 1 Oncology Studies: Reexamining the Arguments and Data, " JAMA 290, no. 8 (2003): 1075-1082.
    • (2003) JAMA , vol.290 , Issue.8 , pp. 1075-1082
    • Agrawal, M.1    Emanuel, E.2
  • 40
    • 36849015815 scopus 로고    scopus 로고
    • "Ethics at Phase 0: Clarifying the Issues,"
    • at 727.
    • J. Kimmelman, "Ethics at Phase 0: Clarifying the Issues, " Journal of Law, Medicine & Ethics 35, no. 8 (2007): 727-733, at 727.
    • (2007) Journal of Law, Medicine & Ethics , vol.35 , Issue.8 , pp. 727-733
    • Kimmelman, J.1
  • 41
    • 84872142694 scopus 로고    scopus 로고
    • Office of Science Policy, National Institutes of Health, quot;About Recombinant DNA Advisory Committee,"available at <> (last visited November 26, 2012).
    • Office of Science Policy, National Institutes of Health, "About Recombinant DNA Advisory Committee, "available at (last visited November 26, 2012).
  • 42
    • 10044232852 scopus 로고    scopus 로고
    • The Precautionary Principle and the Regulation of U.S. Food and Drug Safety,"
    • at 348-349.
    • E. Soule, "The Precautionary Principle and the Regulation of U.S. Food and Drug Safety, " Journal of Medicine and Philosophy 29, no. 3 (2004): 333-350, at 348-349.
    • (2004) Journal of Medicine and Philosophy , vol.29 , Issue.3 , pp. 333-350
    • Soule, E.1


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