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doi.org/10.36475/L.A.W.14
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    რეზიუმე - Journal Law and World

    Volume 8, Issue 3

    The Margin of Moral Duty of Human Being to Participate in Biomedical Research

    Authors: Nino Mdinaradze

    Nino Mdinaradze

    Ph.D. Student, New Vision University

    Email: n.mdinaradze1993@gmail.com



    Affiliation: Ph.D. Student, New Vision University

    Abstract: The existing paradigm of biomedical research ethics, based on respecting the free and informed consent of the research participant, originates from the famous Nuremberg Trial (1947), where the Nazi doctors were convicted of killing and torturing prisoners using medical experiments in German Concentration Camps during World War II. Since the second half of the 20th century, several international instruments have been developed to protect the rights of persons involved in research, considering the voluntariness of participation. Nevertheless, scientific community started to discuss the moral basis of mandatory human participation in biomedical research. Even today, some scholars argue that biomedical research creates public goods in the form of health, safety, and knowledge enjoyed almost by all members of society. The moral duty to participate in research is due to the need for public participation in producing public goods. Others suggest that human beings have a moral obligation to take some risks to help others. So, the moral duty to participate in biomedical research relies on the principles of justice, beneficence, etc. Considering the importance of this issue for research ethics, this article discusses the doctrines and theories, including public goods, free-riding, and beneficence, to set the margin of the moral duty of human beings to participate in biomedical research.

    Keywords: Biomedical Research, Reasearch ethics, Moral


    Language: EN

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    Bibliography:

    1. The Nuremberg Code, 1996. British Medical Journal, No 7070, Volume: 313. (In English).
    2. WMA Declaration of Helsinki – Ethical Principles For Medical Research Involving Human Subjects, available at: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects (In English).
    3. The 1966 International Covenant on Civil andPolitical Rights, available at: https://www.ohchr.org/en/instruments-mechanisms/instruments/international-covenant-civil-and-political-rights (In English).
    4. Guideline for Good Clinical Practice (GCP) E6(R2), International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, EMA/CHMP/ ICH, 2017. (In English).
    5. Shuster, E., 1997. Fifty Years Later: The Significance of the Nuremberg Code, The New England Journal of Medicine, 337(20). (In English).
    6. Sade, R. M., 2017. Controversies in Clinical Research Ethics, The Journal of Law, Medicine and Ethics, 45(3). (In English).
    7. Caplan, A. L., 1984. Is There a Duty to Serve as a Subject in Biomedical Research?, IRB: Ethics and Human Research, 6(5). (In English).
    8. Evans, H. M., 2004. Should patients be allowed to veto their participation in clinical research?, Journal of Medical Ethics, 30(2). (In English).
    9. Harris, J., 2005. Scientific Research is a Moral Duty, Journal of Medical Ethics, 31(4). (In English).
    10. Harris, J., 1999. The principles of medical ethics and medical research, Cad. Saúde Pública, Rio de Janeiro, 15 (sup. 1):7-13. (In English).
    11. Rhodes, R., 2005. Rethinking Research Ethics, The American Journal of Bioethics, 5(1). (In English).
    12. Rhodes, R., 2005. Response to Commentators on “Rethinking Research Ethics”, The American Journal of Bioethics, 5(1). (In English).
    13. Rhodes, R., 2008. In Defence of the Duty to Participate in Biomedical Research, The American Journal of Bioethics, 8(10). (In English). “LAW AND WORLD“ 37
    14. Rhodes, R., 2017.When is Participation in Research a Moral Duty?, The Journal of Law, Medicine and Ethics, 45(3). (In English).
    15. Sharp, R. R., Yarborough, M., 2005. Additional Thoughts on Rethinking Research Ethics, The American Journal of Bioethics, 5(1). (In English).
    16. Wachbroit, R., Wasserman, D., 2005. Research Participation: Are We Subject to a Duty?, The American Journal of Bioethics, 5(1). (In English).
    17. De Melo-Martín, I., 2008. A duty to Participate in Research: Does Social Context Matter?, The American Journal of Bioethics, 8(10). (In English).
    18. Rennie, S., 2011. Viewing Research Participation as a Moral Obligation: In Whose Interests?, Hasting Center Report, 41(2). (In English).
    19. Yarborough, M., 2017. Why There Is No Obligation To Participate In Clinical Research, The Journal of Law, Medicine and Ethics, 45(3). (In English).
    20. Schaefer, G. O., Emanuel, E. J., & Wertheimer, A., 2009. The Obligation to Participate in Biomedical Research, The Journal of the American Medical Association, 302(1). (In English).
    21. Seiler, C., 2018. Can there be a moral obligation to participate in biomedical research?, Eur J Clin Invest., 48(e12896). (In English).
    22. Reiss, J., 2021 (Fall). Public Goods, The Stanford Encyclopedia of Philosophy, Edward, N. Zalta (ed.), available at: https://plato.stanford.edu/archives/fall2021/entries/public-goods (In English).
    23. Wendler, D., 2021 (Winter). available at: https://plato.stanford.edu/archives/win2021/entries/clinical-research (In English).

    Notes:

    1. The Nuremberg Code was adopted in August 1947 at a trial in Nuremberg (Germany), also known as the Doctors Trial. Nazi doctors were convicted of killing and torturing prisoners using medical experiments in German Concentration Camps during World War II at the Nuremberg Trials. A tribunal investigating World War II crimes has set the standard for the need for voluntary, informed consent by people involved in medical experiments. See further: International Military Tribunal (1950), Trials of war criminals before the Nuremberg Military Tribunals under Control Council law no.10, Washington, D.C.: Government Printing Office, in Shuster, E., 1997. Fifty Years Later: The Significance of the Nuremberg Code, The New England Journal of Medicine, 337(20), p. 1436.
    2. Annas, G. J., Grodin, M. A., 1992. The Nazi doctors and the Nuremberg Code: human rights in human experimentation, New York: Oxford University Press, p. 227-39. Annas, G. J., Grodin, M. A., 1996. Legacies of Nuremberg: medical ethics and human rights, JAMA, 276, p. 1682-3, in Shuster, E., 1997. p. 1436.
    3. According to article 1 of the Nuremberg Code, the voluntary consent of the human subject is required for conducting a medical examination (“The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent. should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion…”), See. The Nuremberg Code, 1996. British Medical Journal, No 7070, Volume: 313, p. 1448. See further: Sade, R. M., 2017. Controversies in Clinical Research Ethics, The Journal of Law, Medicine and Ethics, 45(3), p. 292.
    4. In 1964, at 18the General Assembly of the World Medical Association in Helsinki, the Declaration of Ethical Principles for Medical Research Involving Human Subjects was adopted, available at: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects [Last Seen 15.08.2022].
    5. See. Article 7, available at: https://www.ohchr.org/en/instruments-mechanisms/instruments/international-covenant-civil-and-political-rights [Last Seen 15.08.2022].
    6. Guideline for Good Clinical Practice (GCP) E6(R2), International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use,EMA/CHMP/ICH, 2017.
    7. Mcdermott, W., 1967. The changing mores of biomedicalresearch, Annals of Internal Medicine, 67(7), p.39-42, inCaplan, A. L., 1984. Is There a Duty to Serve as a Subject inBiomedical Research?, IRB: Ethics and Human Research, 6(5), p. 2.
    8. Ibid.
    9. Caplan, A. L., 1984. p. 2.
    10. Ramsey, P., 1970. The Patient as Person, New Haven: Yale University Press. Rutstein, D. D., 1969. The ethical design of human experiments, Daedalus, 98, p. 523-541. Jonas, H., 1969. Philosophical reflections on experimenting with human subjects, Daedalus, 98, p. 219-247, in Caplan, A. L., 1984. p. 2.
    11. Jonas, H., 1969. p. 219-247, in Caplan, A. L., 1984. p. 2.
    12. Caplan, A. L., 1984. p. 2.
    13. Evans, H. M., 2004. Should patients be allowed to vetotheir participation in clinical research?, Journal of MedicalEthics, 30(2). Harris, J.,2005. Scientific Research is a MoralDuty, Journal of Medical Ethics, 31(4). Rhodes, R., 2005.Rethinking Research Ethics, The American Journal of Bioethics, 5(1). Rhodes, R., 2005. Response to Commentatorson “Rethinking Research Ethics”, The American Journal ofBioethics, 5(1). Rhodes, R., 2008. In Defence of the Duty toParticipate in Biomedical Research, The American Journalof Bioethics, 8(10). Rhodes, R., 2017.When is Participationin Research a Moral Duty?, The Journal of Law, Medicineand Ethics, 45(3).
    14. Rhodes, R., 2005. Rethinking Research Ethics, Am J Bioeth, 5(1), in De Melo-Martín, I., 2008. p. 28. Comp. Rennie, S., 2011. p. 42.
    15. Ibid.
    16. Sharp, R. R., Yarborough, M., 2005. Additional Thoughts on Rethinking Research Ethics, The American Journal of Bioethics, 5(1). Wachbroit, R., Wasserman, D., 2005. Research Participation: Are We Subject to a Duty?, The American Journal of Bioethics, 5(1). De Melo-Martín, I., 2008. A duty to Participate in Research: Does Social Context Matter?, The American Journal of Bioethics, 8(10). Rennie, S., 2011. Viewing Research Participation as a Moral Obligation: In Whose Interests?, Hasting Center Report, 41(2). Yarborough, M., 2017. Why There Is No Obligation To Participate In Clinical Research, The Journal of Law, Medicine and Ethics, 45(3).
    17. Schaefer, G. O., Emanuel, E. J., & Wertheimer, A., 2009. The Obligation to Participate in Biomedical Research, The Journal of the American Medical Association, 302(1), p. 3. Seiler, C., 2018. Can there be a moral obligation to participate in biomedical research?, Eur J Clin Invest., 48(e12896), p. 2.
    18. Samuelson, Paul A., 1954. The Pure Theory of Public Expenditure, The Review of Economics and Statistics, 36(4), p. 387, in Reiss, J., 2021 (Fall). Public Goods, The Stanford Encyclopedia of Philosophy, Edward, N. Zalta (ed.), available at: https://plato.stanford.edu/archives/fall2021/entries/public-goods [Last Seen 16.08.2022].
    19. Rivalrous and excludable goods are called private goods. Food, clothes and flats are paradigmatic examples of private goods. See. Reiss, J., 2021 (Fall). available at: https://plato.stanford.edu/archives/fall2021/entries/public-goods [Last Seen 16.08.2022].
    20. “… A corollary of the non-excludability characteristic is that there are limitations to consumers’ consumption decisions regarding the public good, if it is produced. Individuals might have different preferences for the level of security provided by national defense, but once nation-al defense is in place, they will consume the level that has been produced, not more or less of it. One cannot “opt out” of the consumption of a public good. Similarly, while everyone might like clean air, individuals will differ in their degree of tolerance of pollution. But once “clean air” has been produced, consumers must consume it independently of their preferences”. See. Reiss, J., 2021 (Fall). available at: https://plato.stanford.edu/archives/fall2021/entries/public-goods [Last Seen 16.08.2022].
    21. Head, J. G. & Shoup, C. S., 1969. Public Goods, Private Goods, and Ambiguous Goods, The Economic Journal, 79(315), p. 567–572, in Schaefer, G. O., Emanuel, E. J., & Wertheimer, A., 2009. p. 3. Rennie, S., 2011. p. 42.
    22. Schaefer, G. O., Emanuel, E. J., & Wertheimer, A., 2009. p. 3.
    23. Olson, M.,1965. The Logic of Collective Action, Cambridge, MA: Harvard University Press, in Schaefer, G. O., Emanuel, E. J., & Wertheimer, A., 2009. p. 3.
    24. Samuelson, P. A., 1955. Diagrammatic exposition of a theory of public expenditure, The Review of Economics and Statistics, 37(4), p. 350–356, in Schaefer, G. O., Emanuel, E. J., & Wertheimer, A., 2009. p. 3.
    25. Schaefer, G. O., Emanuel, E. J., & Wertheimer, A., 2009. p. 3.
    26. Ibid.
    27. Ibid.
    28. Ibid.
    29. Ibid.
    30. Rennie, S., 2011. p. 43.
    31. Sharp, R. R. & Yarborough, M., 2005. p. 41.
    32. De Melo-Martín, I., 2008. p. 32.
    33. Rhodes, R., 2005. Response to Commentators on “Rethinking Research Ethics”, The American Journal of Bioethics, 5(1), p.17. Rhodes, R., 2008. p. 38.
    34. Sharp, R. R. & Yarborough, M., 2005. p. 40.
    35. Ibid.
    36. Schaefer, G. O., Emanuel, E. J., & Wertheimer, A., 2009. p. 8
    37. Schaefer, G. O., Emanuel, E. J., & Wertheimer, A., 2009. p. 3, comp. Seiler, C., 2018. p. 2.
    38. Schaefer, G. O., Emanuel, E. J., & Wertheimer, A., 2009. p. 3.
    39. Sharp, R. R. & Yarborough, M., 2005. p. 41, comp. Rennie, S., 2011. p. 43.
    40. Sharp, R. R. & Yarborough, M., 2005. p. 41.
    41. Wendler, D., 2021 (Winter). available at: https://plato.stanford.edu/archives/win2021/entries/clinical-research [Last Seen 16.08.2022].
    42. Rennie, S., 2011. p. 43.
    43. Ibid.
    44. Schaefer, G. O., Emanuel, E. J., & Wertheimer, A., 2009. p. 3.
    45. Schaefer, G. O., Emanuel, E. J., & Wertheimer, A., 2009. p. 3. De Melo-Martín, I., 2008. p. 28.
    46. Reiss, J., 2021 (Fall). available at: https://plato.stanford.edu/archives/fall2021/entries/public-goods [Last Seen 16.08.2022].
    47. Rennie, S., 2011. p. 41-42, comp. Barry, B., 1995. Justice as impartiality, Oxford: Clarendon Press, p. 228, in Harris, J., 2005. p. 242.
    48. Harris, J., 2005., in De Melo-Martín, I., 2008. p. 28.
    49. Ibid.
    50. Ibid. See further: „… Because biomedical research offers our best chance for achieving that end, and because we cannot will an end without also willing the necessary means to achieve it, we are duty-bound to participate in research “., Rhodes, R., 2008. p. 37-38.
    51. Rennie, S., 2011. p. 42.
    52. Wendler, D., 2021 (Winter). available at: https://plato.stanford.edu/archives/win2021/entries/clinical-research [Last Seen 16.08.2022].
    53. Ross, W. D., 2002. The Right and the Good, Oxford: Clarendon Press, in Schaefer, G. O., Emanuel, E. J., & Wertheimer, A., 2009. p. 4.
    54. Schaefer, G. O., Emanuel, E. J., & Wertheimer, A., 2009. p. 4.
    55. Ibid.
    56. Ibid.
    57. Rhodes, R., 2017. p. 319.
    58. Ibid.
    59. Rennie, S., 2011. p. 41.
    60. Rennie, S., 2011. p. 42, comp. „Being a free rider is, however, unfair and people always have a moral reason not to act unfairly. This moral reason is probably enough to justify an enforceable obligation but we do not have to use compulsion as a strategy of first resort“, See. Harris, J., 2005. p. 243.
    61. Rennie, S., 2011. p. 42.
    62. Wolf, S., Moral Obligations and Social Commands, in Metaphysics and the Good: Themes from the Philosophy of Robert Merrihew Adams, 2009. Oxford University Press, p. 343-367, in Rennie, S., 2011. p. 42.
    63. Wendler, D., 2021 (Winter). available at: https://plato.stanford.edu/archives/win2021/entries/clinical-research [Last Seen 16.08.2022].
    64. Harris, J., 1999. The principles of medical ethics and medical research, Cad. Saúde Pública, Rio de Janeiro, 15 (sup. 1):7-13, p. 12.
    65. Wachbroit, R., Wasserman, D., 2005. p. 48.
    66. Rennie, S., 2011. p. 42.
    67. Brassington, I., 2007. John Harris’ Argument for a Duty to Research, Bioethics, 21(3), p. 160-68, in Rennie, S., 2011. p. 42, comp. De Melo-Martín, I., 2008. p. 29.
    68. Wachbroit, R., Wasserman, D., 2005. p. 49.
    69. Rhodes, R., 2005. Response to Commentators on “Rethinking Research Ethics”, The American Journal of Bioethics, 5(1), W15-W18, p. 17.
    70. Rennie, S., 2011. p. 43.
    71. Ibid.
    72. Ibid.
    73. Bekelman, J. E., Li Y., Gross, P. C., 2003.Scope and Impact of Financial Conflicts of Interest in Biomedical Research: A Systematic Review, Journal of the American Medical Association, 289, p. 454-65, in Rennie, S., 2011. p. 43.
    74. Rennie, S., 2011. p. 43.
    75. Wendler, D., 2021 (Winter). The Ethics of Clinical Research, The Stanford Encyclopedia of Philosophy, Edward, N. Zalta (ed.), available at: https://plato.stanford.edu/ archives/win2021/entries/clinical-research [Last Seen 16.08.2022].
    76. Ibid.
    77. Simmons, A. J., 1979. Moral Principles and Political Obligations, Princeton University Press, in: Caplan, A. L., 1984. p. 3.
    78. Ibid.
    79. Ibid.
    80. Wendler, D., 2021 (Winter). available at: https://plato.stanford.edu/archives/win2021/entries/clinical-research [Last Seen 16.08.2022].
    81. Brock, D. W., 1994. “Ethical issues in exposing children to risks in research,” Chapter 3 (pp. 81–101) of Grodin and Glantz (eds.), Children as Research Subjects, New York: Oxford University Press, in Wendler, D., 2021. (Winter). available at: https://plato.stanford.edu/archives/win2021/entries/clinical-research [Last Seen 16.08.2022].
    82. Wendler, D., 2021. (Winter). available at: https://plato.stanford.edu/archives/win2021/entries/clinical-research [Last Seen 16.08.2022].
    83. Ibid.
    84. Gauthier, D., 1990. Morals by Agreement, Oxford: Clarendon Press, in Wendler, D., 2021. (Winter). available at: https://plato.stanford.edu/archives/win2021/entries/clinical-research [Last Seen 16.08.2022].
    85. Rennie S., Viewing Research Participation as a Moral Obligation: In Whose Interests?, Hasting Center Report, 41(2), 2011, 46.
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