메뉴 건너뛰기




Volumn 26, Issue 6, 2012, Pages 305-314

Realizing benefit sharing - the case of post-study obligations

Author keywords

Benefit sharing; Human genetics; International justice; International research ethics; Post study obligations

Indexed keywords


EID: 84862628429     PISSN: 02699702     EISSN: 14678519     Source Type: Journal    
DOI: 10.1111/j.1467-8519.2010.01857.x     Document Type: Article
Times cited : (21)

References (53)
  • 1
    • 84862629042 scopus 로고    scopus 로고
    • Conflict of interest statement: No conflicts declared
    • Conflict of interest statement: No conflicts declared
  • 2
    • 84862629045 scopus 로고    scopus 로고
    • Source:Modified from
    • Source:Modified from A. Nyika etal., 2009.
    • (2009)
    • Nyika, A.1
  • 3
    • 36248977595 scopus 로고    scopus 로고
    • Leveraging Genetic Resources or Moral Blackmail? Indonesia and Avian Flu Virus Sample Sharing
    • A.L. Caplan & D.R. Curry Leveraging Genetic Resources or Moral Blackmail? Indonesia and Avian Flu Virus Sample Sharing. Am J Bioeth 2007; 7 (11): 1-2.
    • (2007) Am J Bioeth , vol.7 , Issue.11 , pp. 1-2
    • Caplan, A.L.1    Curry, D.R.2
  • 4
    • 48249145735 scopus 로고    scopus 로고
    • Towards Mutual Trust, Transparency and Equity in Virus Sharing Mechanism: The Avian Influenza Case of Indonesia
    • 487 (our emphasis).
    • E.R. Sedyaningsih at al. Towards Mutual Trust, Transparency and Equity in Virus Sharing Mechanism: The Avian Influenza Case of Indonesia. Ann Acad Med Singapore 2008; 37(6): 482-488, p. 487 (our emphasis).
    • (2008) Ann Acad Med Singapore , vol.37 , Issue.6 , pp. 482-488
    • Sedyaningsih, E.R.1
  • 6
    • 84862608591 scopus 로고
    • United Nations. Convention on Biological Diversity. Preamble. Rio de Janeiro, 5 June Available at: [Accessed 16 Dec 2009]
    • United Nations. Convention on Biological Diversity. Preamble. Rio de Janeiro, 5 June 1992. Available at: [Accessed 16 Dec 2009].
    • (1992)
  • 7
    • 38049081004 scopus 로고    scopus 로고
    • Influenza Virus Samples, International Law, and Global Health Diplomacy
    • D.P. Fidler Influenza Virus Samples, International Law, and Global Health Diplomacy. Emerg Infect Dis 2008; 14(1): 88-94.
    • (2008) Emerg Infect Dis , vol.14 , Issue.1 , pp. 88-94
    • Fidler, D.P.1
  • 8
    • 84862635914 scopus 로고    scopus 로고
    • Convention on Biological Diversitry (CBD). 2005. Decision II/11. Access to Genetic Resources. Montreal: UNEP/CBD: paragraph 2. '[The Conference of the Parties][r]eaffirms that human genetic resources are not included within the framework of the Convention.'
    • Convention on Biological Diversitry (CBD). 2005. Decision II/11. Access to Genetic Resources. Montreal: UNEP/CBD: paragraph 2. '[The Conference of the Parties][r]eaffirms that human genetic resources are not included within the framework of the Convention.'
  • 9
    • 84862608578 scopus 로고    scopus 로고
    • at al. Concentric Circles of the Benefit Sharing Debate and Disconnects with Technology: Challenges for a Global ABS Regime. Unpublished manuscript presented at: Genomics and Benefit Sharing with Developing Countries - from Biodiversity to Human Genomics 6 November 2009; Hilton, Montreal, Canada.
    • S. Chaturvedi at al. Concentric Circles of the Benefit Sharing Debate and Disconnects with Technology: Challenges for a Global ABS Regime. Unpublished manuscript presented at: Genomics and Benefit Sharing with Developing Countries - from Biodiversity to Human Genomics 6 November 2009; Hilton, Montreal, Canada.
    • Chaturvedi, S.1
  • 10
    • 0036620266 scopus 로고    scopus 로고
    • Carving up the Commons - Emergence of a New International Regime for Germplasm Development and Transfer
    • W. Falcon & C. Fowler Carving up the Commons - Emergence of a New International Regime for Germplasm Development and Transfer. Food Policy 2002; 27: 197-222.
    • (2002) Food Policy , vol.27 , pp. 197-222
    • Falcon, W.1    Fowler, C.2
  • 11
    • 79951772857 scopus 로고    scopus 로고
    • Access and Benefit-sharing in Practice: Trends in Partnerships across Sectors
    • S. Laird & R. Wynberg. 2008. Access and Benefit-sharing in Practice: Trends in Partnerships across Sectors. CBD Technical Series: 122-128
    • (2008) CBD Technical Series , pp. 122-128
    • Laird, S.1    Wynberg, R.2
  • 12
    • 84862601640 scopus 로고    scopus 로고
    • Options for Non-Monetary Benefit-Sharing: an inventory. Rome: FAO
    • B. Visser, etal. 2005. Options for Non-Monetary Benefit-Sharing: an inventory. Rome: FAO
    • (2005)
    • Visser, B.1
  • 13
    • 84862635922 scopus 로고    scopus 로고
    • See Box 1, Articles 14 and 33 of Helsinki.
    • See Box 1, Articles 14 and 33 of Helsinki.
  • 14
    • 40649099658 scopus 로고    scopus 로고
    • Should Post-trial Provision of Beneficial Experimental Interventions be Mandatory in Developing Countries?
    • Z. Zhiyong Should Post-trial Provision of Beneficial Experimental Interventions be Mandatory in Developing Countries? J Med Ethics 2008; 34: 188-192.
    • (2008) J Med Ethics , vol.34 , pp. 188-192
    • Zhiyong, Z.1
  • 15
    • 2342427920 scopus 로고    scopus 로고
    • The standard of care debate: against the myth of an 'international consensus opinion'
    • World Medical Association (WMA). 2008. Declaration of Helsinki. Seoul, October 2008. Available at: [Accessed 16 Dec 2009]. We assume with Udo Schuklenk that the Declaration of Helsinki has the most reasonable claim to be taken seriously world-wide and shall therefore restrict references to guidelines to the Declaration. When comparing the Declaration of Helsinki with other influential guidelines, Schuklenk writes: 'an international consensus among smallish operators with impressive names is not a sufficient reason to do away with the authority of the WMA, which represents more members of the medical profession in one single country, let alone across the world, than the rest of the organisations and institutions mentioned...combined.' See
    • World Medical Association (WMA). 2008. Declaration of Helsinki. Seoul, October 2008. Available at: [Accessed 16 Dec 2009]. We assume with Udo Schuklenk that the Declaration of Helsinki has the most reasonable claim to be taken seriously world-wide and shall therefore restrict references to guidelines to the Declaration. When comparing the Declaration of Helsinki with other influential guidelines, Schuklenk writes: 'an international consensus among smallish operators with impressive names is not a sufficient reason to do away with the authority of the WMA, which represents more members of the medical profession in one single country, let alone across the world, than the rest of the organisations and institutions mentioned...combined.' See U. Schuklenk The standard of care debate: against the myth of an 'international consensus opinion'. J Med Ethics 2004; 30: 194-197.
    • (2004) J Med Ethics , vol.30 , pp. 194-197
    • Schuklenk, U.1
  • 16
    • 84862597623 scopus 로고    scopus 로고
    • Post-Trial Obligations
    • See, for instance
    • See, for instance, and D. Schroeder Post-Trial Obligations. Reciis 2008; 2 (Sup1) Sup 63-73.
    • (2008) Reciis , vol.2 , Issue.SUP1 , pp. 63-73
    • Schroeder, D.1
  • 17
    • 30644459710 scopus 로고    scopus 로고
    • Equitable treatment for HIV/AIDS clinical trial participants: a focus group study of patients, clinical researchers, and administrators in western Kenya
    • 55
    • D. N. Shaffer etal. Equitable treatment for HIV/AIDS clinical trial participants: a focus group study of patients, clinical researchers, and administrators in western Kenya. Journal of Medical Ethics 2006; 32: 55-60, p55.
    • (2006) Journal of Medical Ethics , vol.32 , pp. 55-60
    • Shaffer, D.N.1
  • 18
    • 84862629031 scopus 로고    scopus 로고
    • Barack Obama's new health care bill might bring the US system in line with European welfare state systems.
    • Barack Obama's new health care bill might bring the US system in line with European welfare state systems.
  • 19
    • 79958251021 scopus 로고    scopus 로고
    • Double Standards and Benefit Sharing
    • See for a more detailed discussion
    • See for a more detailed discussion D. Schroeder Double Standards and Benefit Sharing. Monash Bioeth Rev 2008; 27(4): 45-51.
    • (2008) Monash Bioeth Rev , vol.27 , Issue.4 , pp. 45-51
    • Schroeder, D.1
  • 20
    • 1542357575 scopus 로고    scopus 로고
    • What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research
    • E.J. Emanuel etal. What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research. J Infect Dis 2004; 189: 930-937; K. Leisinger Corporate Responsibilities for Access to Medicines. J Bus Ethics 2009; 85: 3-23; Nuffield Council on Bioethics. 2002. The Ethics of Research Related to Healthcare in Developing Countries. Available at: [Accessed 30 Apr 2010].
    • (2004) J Infect Dis , vol.189 , pp. 930-937
    • Emanuel, E.J.1
  • 21
    • 65049086302 scopus 로고    scopus 로고
    • Corporate Responsibilities for Access to Medicines
    • K. Leisinger Corporate Responsibilities for Access to Medicines. J Bus Ethics 2009; 85: 3-23
    • (2009) J Bus Ethics , vol.85 , pp. 3-23
    • Leisinger, K.1
  • 22
    • 84862601649 scopus 로고    scopus 로고
    • Nuffield Council on Bioethics. 2002. The Ethics of Research Related to Healthcare in Developing Countries. Available at: [Accessed 30 Apr 2010]
    • Nuffield Council on Bioethics. 2002. The Ethics of Research Related to Healthcare in Developing Countries. Available at: [Accessed 30 Apr 2010]
  • 23
    • 84862601652 scopus 로고    scopus 로고
    • United Nations. 1948. The Universal Declaration of Human Rights. Paris. 10 December 1948. Available at: [Accessed 25 Nov 2009].
    • United Nations. 1948. The Universal Declaration of Human Rights. Paris. 10 December 1948. Available at: [Accessed 25 Nov 2009].
  • 24
    • 84862601651 scopus 로고    scopus 로고
    • United Nations. 1966. International Covenant on Economic, Social and Cultural Rights. 16 December 1966. Available at: [Accessed 25 Nov 2009].
    • United Nations. 1966. International Covenant on Economic, Social and Cultural Rights. 16 December 1966. Available at: [Accessed 25 Nov 2009].
  • 25
    • 84862601644 scopus 로고    scopus 로고
    • United Nations. 1979. Convention on the Elimination of All Forms of Discrimination against Women. 18 December 1979. Available at: [Accessed 25 Nov2009].
    • United Nations. 1979. Convention on the Elimination of All Forms of Discrimination against Women. 18 December 1979. Available at: [Accessed 25 Nov2009].
  • 26
    • 84862608580 scopus 로고    scopus 로고
    • United Nations. 1989. Convention on the Rights of the Child. 20 November 1989. Available at: [Accessed 25 Nov 2009].
    • United Nations. 1989. Convention on the Rights of the Child. 20 November 1989. Available at: [Accessed 25 Nov 2009].
  • 27
    • 84862608587 scopus 로고    scopus 로고
    • United Nations. 1978. Declaration of Alma-Ata. Alma-Ata. 6-12 September 1978. Available at: [Accessed 25 Nov 2009].
    • United Nations. 1978. Declaration of Alma-Ata. Alma-Ata. 6-12 September 1978. Available at: [Accessed 25 Nov 2009].
  • 28
    • 84862601647 scopus 로고    scopus 로고
    • United Nations Committee on Economic, Social and Cultural Rights. 2000. Substantive Issues Arising in the Implementation of the International Covenant on Economic, Social and Cultural Rights. General Comment No. 14 (2000). Geneva, 25 April-12 May 2000. Available at: [Accessed 25 Nov 2009].
    • United Nations Committee on Economic, Social and Cultural Rights. 2000. Substantive Issues Arising in the Implementation of the International Covenant on Economic, Social and Cultural Rights. General Comment No. 14 (2000). Geneva, 25 April-12 May 2000. Available at: [Accessed 25 Nov 2009].
  • 29
    • 84862635920 scopus 로고    scopus 로고
    • United Nations. 2000. Millennium Development Goals. Available at: [Accessed 25 Nov 2009].
    • United Nations. 2000. Millennium Development Goals. Available at: [Accessed 25 Nov 2009].
  • 30
    • 84862601650 scopus 로고    scopus 로고
    • Promotion and Protection of all Human Rights, Civil, Political, Economic, Social and Cultural Rights, including the Right to Development, a Report of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. United Nations, A/HRC/11/12 6, 7, 28.
    • A. Grover. 2009. Promotion and Protection of all Human Rights, Civil, Political, Economic, Social and Cultural Rights, including the Right to Development, a Report of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. United Nations, A/HRC/11/12, pp. 6, 7, 28.
    • (2009)
    • Grover, A.1
  • 31
    • 84862608586 scopus 로고    scopus 로고
    • This is not the space to detail justice issues within the international economic order and make a case for their avoidability. This has been done excellently elsewhere, see T. Pogge. 2008. World Poverty and Human Rights. 2nd edn. Cambridge: Polity Press; P. Singer. 2009. The Life You Can Save. London: Picador; J. Sachs. 2005. The End of Poverty. London: Penguin Books.
    • This is not the space to detail justice issues within the international economic order and make a case for their avoidability. This has been done excellently elsewhere, see T. Pogge. 2008. World Poverty and Human Rights. 2nd edn. Cambridge: Polity Press; P. Singer. 2009. The Life You Can Save. London: Picador; J. Sachs. 2005. The End of Poverty. London: Penguin Books.
  • 32
    • 63649119921 scopus 로고    scopus 로고
    • Vulnerability: Sex Workers in Nairobi's Majengo
    • For more information on the case, see
    • For more information on the case, see P. Andanda Vulnerability: Sex Workers in Nairobi's Majengo. Cambridge Quarterly of Healthcare Ethics 2009; 18: 138-146.
    • (2009) Cambridge Quarterly of Healthcare Ethics , vol.18 , pp. 138-146
    • Andanda, P.1
  • 33
    • 58049151944 scopus 로고    scopus 로고
    • Helsinki Discords: FDA, Ethics, and International Drug Trials
    • J. Kimmelman, C. Weijer & E.M. Meslin Helsinki Discords: FDA, Ethics, and International Drug Trials. Lancet 2009; 373: 13-14.
    • (2009) Lancet , vol.373 , pp. 13-14
    • Kimmelman, J.1    Weijer, C.2    Meslin, E.M.3
  • 34
    • 84926185576 scopus 로고    scopus 로고
    • Double Standards in Medical Research in Developing Countries. Cambridge: Cambridge University Press
    • R. Macklin. 2004. Double Standards in Medical Research in Developing Countries. Cambridge: Cambridge University Press: 84.
    • (2004) , pp. 84
    • Macklin, R.1
  • 35
    • 84862629036 scopus 로고    scopus 로고
    • Due to space constraints, we cannot discuss potential differences between sponsors and funders in this context.
    • Due to space constraints, we cannot discuss potential differences between sponsors and funders in this context.
  • 36
    • 84862601646 scopus 로고    scopus 로고
    • National Health Council. 1997. Resolution No 251. 7 August 1997. Available at: [Accessed 25 Mar 2007].
    • National Health Council. 1997. Resolution No 251. 7 August 1997. Available at: [Accessed 25 Mar 2007].
  • 37
    • 34248649345 scopus 로고    scopus 로고
    • Factors influencing the effectiveness of research ethics committees
    • C.A. Schuppli & D. Fraser Factors influencing the effectiveness of research ethics committees. J Med Ethics 2007; 33: 294-301.
    • (2007) J Med Ethics , vol.33 , pp. 294-301
    • Schuppli, C.A.1    Fraser, D.2
  • 38
    • 66549089489 scopus 로고    scopus 로고
    • Composition, Training Needs and Independence of Ethics Review Committees across Africa: Are the Gate-keepers Rising to the Emerging Challenge?
    • 193.
    • A. Nyika etal. Composition, Training Needs and Independence of Ethics Review Committees across Africa: Are the Gate-keepers Rising to the Emerging Challenge? J Med Ethics 2009; 35: 189-193, p. 193.
    • (2009) J Med Ethics , vol.35 , pp. 189-193
    • Nyika, A.1
  • 39
    • 1342287922 scopus 로고    scopus 로고
    • Ethical Review of Health Research: a Perspective from Developing Country Researchers
    • A.A. Hyder etal. Ethical Review of Health Research: a Perspective from Developing Country Researchers. J Med Ethics 2004; 30: 68-72.
    • (2004) J Med Ethics , vol.30 , pp. 68-72
    • Hyder, A.A.1
  • 40
    • 84862601639 scopus 로고    scopus 로고
    • Trade and Industry Committee of Parliament of United Kingdom. 2002. TradeandIndustry - Twelfth Report. Available at: [Accessed 24 Oct 2009].
    • Trade and Industry Committee of Parliament of United Kingdom. 2002. TradeandIndustry - Twelfth Report. Available at: [Accessed 24 Oct 2009].
  • 41
    • 84862608582 scopus 로고    scopus 로고
    • Drug Development: The Current Odds. Corante. Available at: [Accessed 24 Oct 2009].
    • D. Lowe. 2004. Drug Development: The Current Odds. Corante. Available at: [Accessed 24 Oct 2009].
    • (2004)
    • Lowe, D.1
  • 42
    • 2342430973 scopus 로고    scopus 로고
    • Ethical Issues in Clinical Trials in Developing Countries
    • Stat Med 2002; 21: 2853-2858; & The Ethics of Research Related to Health Care in Developing Countries. J Med Ethics
    • B. Brody Ethical Issues in Clinical Trials in Developing Countries. Stat Med 2002; 21: 2853-2858; J.R. McMillan & C. Conlon The Ethics of Research Related to Health Care in Developing Countries. J Med Ethics. 2004; 30: 204-206.
    • (2004) , vol.30 , pp. 204-206
    • Brody, B.1    McMillan, J.R.2    Conlon, C.3
  • 43
    • 13444269667 scopus 로고    scopus 로고
    • HIV Prevention Research and Global Inequality: Steps Towards Improved Standard of Care
    • 42.
    • K. Shapiro & S.R. Benatar HIV Prevention Research and Global Inequality: Steps Towards Improved Standard of Care. J Med Ethics 2005; 31: 39-47, p. 42.
    • (2005) J Med Ethics , vol.31 , pp. 39-47
    • Shapiro, K.1    Benatar, S.R.2
  • 44
    • 84862601638 scopus 로고    scopus 로고
    • Of course, one could argue that comprehensive health care during a study is too little in terms of benefit sharing. However, if comprehensive health care is offered to study participants and their families, sometimes over decades, as may be the case for some Nairobi sex workers, this claim seems dubious.
    • Of course, one could argue that comprehensive health care during a study is too little in terms of benefit sharing. However, if comprehensive health care is offered to study participants and their families, sometimes over decades, as may be the case for some Nairobi sex workers, this claim seems dubious.
  • 45
    • 84862629033 scopus 로고    scopus 로고
    • UNESCO. 2005. Universal Declaration on Bioethics and Human Rights. 19 October 2005. Available at: [Accessed 24 Oct 2009].
    • UNESCO. 2005. Universal Declaration on Bioethics and Human Rights. 19 October 2005. Available at: [Accessed 24 Oct 2009].
  • 46
    • 84862608581 scopus 로고    scopus 로고
    • Note
    • Council for International Organizations of Medical Sciences (CIOMS). 2002. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva. 2002. Available at: [Accessed 9 Apr 2009].
  • 47
    • 11444265912 scopus 로고    scopus 로고
    • The Ethics of Research in Developing Countries: Assessing Voluntariness
    • C. Pace & E. Emanuel The Ethics of Research in Developing Countries: Assessing Voluntariness. Lancet 2005; 365: 11-12.
    • (2005) Lancet , vol.365 , pp. 11-12
    • Pace, C.1    Emanuel, E.2
  • 48
    • 0031875308 scopus 로고    scopus 로고
    • Human Rights and Maternal-fetal HIV Transmission Prevention Trials in Africa
    • G. J. Annas & M. A. Grodin Human Rights and Maternal-fetal HIV Transmission Prevention Trials in Africa. Am J Public Health 1998; 88: 560-563.
    • (1998) Am J Public Health , vol.88 , pp. 560-563
    • Annas, G.J.1    Grodin, M.A.2
  • 49
    • 57349125037 scopus 로고    scopus 로고
    • Benefits to Research Subjects in International Trials: Do They Reduce Exploitation or Increase Undue Inducement?
    • A. Ballantyne Benefits to Research Subjects in International Trials: Do They Reduce Exploitation or Increase Undue Inducement? Dev World Bioeth 2008; 8(3): 178-191.
    • (2008) Dev World Bioeth , vol.8 , Issue.3 , pp. 178-191
    • Ballantyne, A.1
  • 50
    • 84862601643 scopus 로고    scopus 로고
    • Building Capacity for Ethical Review in Developing Countries. SciDevNet 1 June. Available at: [Accessed 9 Apr 2009].
    • Z.A. Bhutta. 2004. Building Capacity for Ethical Review in Developing Countries. SciDevNet 1 June. Available at: [Accessed 9 Apr 2009].
    • (2004)
    • Bhutta, Z.A.1
  • 51
    • 0035318620 scopus 로고    scopus 로고
    • Solidarity and Equity: New Ethical Frameworks for Genetic Databases
    • B.M. Knoppers. Editorial. Genetic Benefit Sharing. Science 2000; 290(5489)
    • B.M. Knoppers. Editorial. Genetic Benefit Sharing. Science 2000; 290(5489); K. Berg & R. Chadwick Solidarity and Equity: New Ethical Frameworks for Genetic Databases. Nature Reviews 2001; 2: 318-321.
    • (2001) Nature Reviews , vol.2 , pp. 318-321
    • Berg, K.1    Chadwick, R.2
  • 52
    • 84862601641 scopus 로고    scopus 로고
    • CIOMS, op. cit. note 45.
    • CIOMS, op. cit. note 45.
  • 53
    • 84862601642 scopus 로고    scopus 로고
    • Grover, op. cit. note 29.
    • Grover, op. cit. note 29.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.