Justice in international clinical research

Developing World Bioethics

Volumn 11, Issue 2, 2011, Pages 75-81

  Pratt, Bridget ^a   Loff, Bebe ^a  

^a MONASH UNIVERSITY   (Australia)

Author keywords

Clinical trials; Global health; Justice; Research ethics

Indexed keywords

ARTICLE; CLINICAL TRIAL (TOPIC); ETHICS; FINANCIAL MANAGEMENT; HEALTH CARE DELIVERY; HUMAN; INTERNATIONAL COOPERATION; PHILOSOPHY; PRACTICE GUIDELINE; SOCIAL BEHAVIOR; SOCIAL JUSTICE;

CLINICAL TRIALS AS TOPIC; GUIDELINES AS TOPIC; HEALTH SERVICES ACCESSIBILITY; HUMANS; INTERNATIONAL COOPERATION; PHILOSOPHY; RESEARCH SUPPORT AS TOPIC; SOCIAL JUSTICE; SOCIAL RESPONSIBILITY;

EID: 79960831460     PISSN: 14718731     EISSN: 14718847     Source Type: Journal    
DOI: 10.1111/j.1471-8847.2010.00296.x     Document Type: Article

References (39)

1. U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research [hereafter Belmont Report]. 1979. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: US Government Printing Office; Council for International Organizations of Medical Sciences (CIOMS). 2002. International Ethical Guidelines for Biomedical Research Involving Human Subjects (revised in). Geneva: CIOMS2002
2. Belmont Report, op. cit. note 1; E. Emanuel, D. Wendler, & C. Grady. What Makes Clinical Research Ethical JAMA 2000 283 2701-2711
3. CIOMS, op. cit. note 1
4. R. Macklin.Double Standards in Medical Research in Developing Countries. New York, NY: Cambridge University Press:200477
5. CIOMS, op. cit. note 1, Guideline 10; World Medical Association (WMA). 2008. Declaration of Helsinki. Seoul: WMA. Available at: [Accessed 9 Jul 2009]; E. Emanuel. 2008. Benefits to Host Countries. In The Oxford Textbook of Clinical Research Ethics. E. Emanuel, R. Crouch et al. eds. New York, NY: Oxford University Press:Nuffield Council on Bioethics (NCB).The Ethics of Research Relating to Healthcare in Developing Countries. London, UK: NCB2002719-728
6. CIOMS, op. cit. note 1, Guideline 10; WMA, op. cit. note 5; Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries [hereafter Emanuel et al.]. Moral Standards for Research in Developing Countries: From 'Reasonable Availability' to 'Fair Benefits'. Hastings Cent Rep 2004 343 17-27
7. S.R. Benatar & T.E. Fleischer Ethical and Policy Implications of Clinical Drug Trials Conducted in Developing Countries. Harvard Health Policy Review 2005 6 97-105
8. CIOMS, op. cit. note 1, Guideline 20; Emanuel et al. op. cit. note 6; Council on Health Research for Development & Global Forum for Health Research [hereafter COHRED]. 2006. Why Health Research Geneva: COHRED; N. Sewankambo & C. Ijsselmuiden. Responsive Research in Developing Countries. Lancet 200837211-13
9. WHO's Roles and Responsibilities in Health Research: Draft WHO Strategy on Research for Health. Geneva: WHO. Available at:WHO. [Accessed 1 Dec 2009]2008
10. A.J. London. Justice and the Human Development Approach to International Research. Hastings Cent Rep 32-33. 2005 35 24-37
11. COHRED, op. cit. note 7; 60th World Health Assembly [hereafter 60th WHA]. WHO's Role and Responsibilities in Health Research. Geneva: WHO. Available at: [Accessed 25 Jun 2009]2007
12. Global Forum for Health Research (GFHR). Monitoring Financial Flows for Health Research 2008: Prioritizing Research for Health Equity. Geneva: GFHR; Benatar & Fleischer, op. cit. note 62008
13. M.M. Mello & S. Joffe.Compact versus Contract - Industry Sponsors' Obligations to their Research Subjects. N Engl J Med 2007 356 26 2737-2743
14. Belmont Report, op. cit. note 1
15. Belmont Report, op. cit. note 1, Part B(3)
16. CIOMS, op. cit. note 1, Guidelines 10, 20 & 21
17. CIOMS, op. cit. note 1, Guideline 10.
18. United Nations Educational, Scientific and Cultural Organization (UNESCO). Universal Declaration on Bioethics and Human Rights. Geneva: UNESCO: Article 152005
19. Emanuel et al., op. cit. note 6
20. A. Ballantyne.Fair Benefits Accounts of Exploitation Require a Normative Principle of Fairness: Response to Gbadegesin and Wendler, and Emanuel et al. Bioethics 2008 22 239-244
21. London, op. cit. note 9
22. GFHR, op. cit. note 10; WHO, op. cit. note 8; WHO Task Force on Research Priorities for Equity in Health & the WHO Equity Team. Priorities for Research to Take Forward the Health Equity Policy Agenda. Bull. World Health Organ 200583948-953
23. London, op. cit. note 9
24. Emanuel, op. cit. note 5
25. H. Shue. Basic Rights: Subsistence, Affluence, and U.S. Foreign Policy. Princeton, NJ: Princeton University Press 1996
26. J.P. Ruger.Global Health Justice. Public Health Ethics 2009 23 261-275
27. T. Pogge.World Poverty and Human Rights. Cambridge, UK: Polity Press; S. Caney. Cosmopolitan Justice and Institutional Design: An Egalitarian Liberal Conception of Global Governance. 2008 Soc Theory Pract 2006 32 725-756
28. O. O'Neill.Global Justice: Whose Obligations In The Ethics of Distance: Morality and the Distant Needy. D.K. Chatterjee, ed. Cambridge, UK: Cambridge University Press: 242-2592004
29. M. Moran Neglected Disease Research and Development: How Much are we Really Spending. PLoS Med e1000030-e100003020096
30. F.A. Thiers, A.J. Sinskey & E.R. Bernt. Trends in the Globalization of Clinical Trials. Nat Rev Drug Discov 2008 713-14
31. K.R.W. Matthews & V. Ho.The Grand Impact of the Gates Foundation. EMBO Rep 2008 409-412
32. K. Lee & A. Mills.Strengthening Governance for Global Health Research. BMJ 2000 321 775-776
33. E.R.M. Cohen et al. Reporting of Informed Consent, Standard of Care and Post-Trial Obligations in Global Randomized Intervention Trials: A Systematic Survey of Registered Trials. Dev World Bioeth 20089274-80
34. R. Saver. At the End of the Clinical Trial: Does Access to Investigational Technology End as Well West New Engl Law Rev 2009 31 411-451
35. F. Luna. Corruption and Research. Bioethics 1999 132 62-271
36. Saver, op. cit. note 35,437
37. Cohen et al., op. cit. note 34
38. R. Pàez & J.E. Garcia de Alba. International Research and Just Sharing of Benefits in Mexico. Dev World Bioeth 2008 92 65-73
39. G.J. Annas. Globalized Clinical Trials and Informed Consent. N Engl J Med 2009 360 2050-2053