Abstract
The philosophical principle behind benefit sharing is simple. Those who contribute to scientific research ought to share in its benefits. This is a matter of justice. If benefit sharing does not take place, exploitation may have occurred. Such exploitation is particularly problematic if it involves vulnerable populations. To counter the claim that contributors to research ought to receive benefits, the spectre of ‘undue inducement’ has been raised: vulnerable populations should not be offered benefits for taking part in research, otherwise they might consent to participate against their better judgment – and the more vulnerable the population is, the more of an inducement even the smallest benefit could be. Global research ethics aims to avoid both the exploitation of research participants and undue inducement; as neither is morally acceptable. This chapter charts the philosophical groundings of the debate by defining vulnerability, exploitation and undue inducement. It concludes that in research which involves only minimal risk for participants, such as the donation of genetic samples, concerns about undue inducement are largely misplaced, and should not be used by researchers and funders to circumvent their clear benefit sharing responsibilities.
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Notes
- 1.
This section is based on Schroeder and Gefenas (2009).
- 2.
- 3.
The examples cited are medical and nursing students, subordinate hospital and laboratory personnel, employees of pharmaceutical companies, and members of the armed forces or police.
- 4.
In this case, researchers are also in a position to empower her by, for instance, facilitating verbal, recorded consent, if this is acceptable to her.
- 5.
For a further discussion of this distinction see Silvers (2004, p. 56).
- 6.
Joel Feinberg (1988, p. 14) gives a good example of morally neutral exploitation between humans: that of one driver following the lights of another car in dense fog.
- 7.
A placebo-controlled trial involves some participants being given a medicine with active ingredients, for instance a new drug against malaria, while others, known as the control group, are given a sham, a placebo treatment, which is expected to have no effect. Neither the participants nor the researchers know who has received which treatment until after the results are analysed.
- 8.
A proven standard of care is a treatment that already exists for the illness under consideration. Hence the ethical demand to test any new drug against an existing one that is known to be effective, rather than a placebo, is part of the ‘standard of care’ debate.
- 9.
For a discussion of the exploitative character of such studies see Annas and Grodin (1998).
- 10.
See Richard Ashcroft’s (2008, pp. 3–6) discussion of what he calls the ‘undecidability presumption’.
- 11.
The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (CBD 2010a) was adopted at the tenth meeting of the Conference of the Parties to the CBD on 29 October 2010, in Nagoya, Japan. The access and benefit-sharing scheme formalized in the Nagoya protocol replaced the voluntary Bonn Guidelines on Access to Genetic Resources and the Fair and Equitable Sharing of the Benefits Arising out of their Utilization.
- 12.
The exclusion of human genetic resources is explicitly stated in the Bonn Guidelines (2002: paragraph 9), but not mentioned in the Nagoya Protocol itself. When the Nagoya Protocol was adopted, it was made clear that ‘genetic resources’ did not include ‘human genetic resources’ in decision I/5: ‘The Conference of the Parties … [a]grees, bearing in mind decision II/11, paragraph 2, and without prejudice to the further consideration of this issue by the Conference of the Parties serving as the meeting of the Parties to the Protocol, that human genetic resources are not included within the framework of the Protocol’ (CBD 2010b).
- 13.
This section is based on Arnason and Van Niekerk (2009).
- 14.
For a more thorough discussion of this argument see Wilkinson and Moore (1997, p. 377).
- 15.
- 16.
The non-physical risks involved in these studies (in which only tissue samples and health data are collected from the subjects) include violations of privacy, such as sensitive information about the research subject finding its way to employers, insurers or law enforcement; stigmatization, for example research on an illness in a certain group leading to an association of the group with that illness; and distress or other psychological harm, when test results reveal, for instance, a significant medical problem or false paternity. Coding and, in particular, the anonymization of samples and data reduce most of these risks significantly. The collection of tissue samples and health data for databases, as well as the re-use of samples and data for purposes other than those originally intended, adds further risks and complications.
References
Annas G, Grodin M (1998) Human rights and maternal-fetal HIV transmission prevention trials in Africa. Am J Public Health 88(4):560–563
Arnason G, Van Niekerk A (2009) Undue fear of inducements in research in developing countries. Camb Q Healthc Ethics 18(2):122–129
Ashcroft R (2008) Fair process and the redundancy of bioethics: a polemic. Public Health Ethics 1(1):3–9
Barclay L (2008) Exploitation and double standards in research in developed countries. Monash Bioeth Rev 27(4):37–44
Bentley JP, Thacker PG (2004) The influence of risk and monetary payment on the research participation decision making process. J Med Ethics 30:293–298
Berg K, Chadwick R (2001) Solidarity and equity: new ethical frameworks for genetic databases. Nature Rev 2:318–321
Bonn Guidelines (2002) The Bonn Guidelines on Access to Genetic Resources and the Fair and Equitable Sharing of the Benefits Arising out of their Utilization. Secretariat of the Convention on Biological Diversity, Quebec. http://www.cbd.int/doc/publications/cbd-bonn-gdls-en.pdf
Carroll R (2011) Guatemala victims of US syphilis study still haunted by the ‘devil’s experiment’. The Guardian, 8 June. http://www.guardian.co.uk/world/2011/jun/08/guatemala-victims-us-syphilis-study
CBD (2010a) Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity. http://www.cbd.int/abs/doc/protocol/nagoya-protocol-en.pdf
CBD (2010b) COP 10 Decision X/1. Access to genetic resources and the fair and equitable sharing of benefits arising from their utilization. http://www.cbd.int/decision/cop/?id=12267
CIOMS (2002) International ethical guidelines for biomedical research involving human subjects. Council for International Organizations of Medical Sciences. http://www.cioms.ch/publications/layout_guide2002.pdf
Feinberg J (1988) Harmless wrongdoing. Oxford University Press, Oxford
Forster H, Emanuel E, Grady C (2001) The 2000 revision of the Declaration of Helsinki: a step forward or more confusion? The Lancet 358(9291):1449–1453
Hawkins J, Emanuel E (2008) Exploitation and developing countries. Princeton University Press, Princeton
Hurst SA (2008) Vulnerability in research and health care: describing the elephant in the room? Bioethics 22(4):191–202
Jecker NS (2004) Protecting the vulnerable. Am J Bioeth 4(3):60–62
Kant I (1998 [1785]) Groundwork of the metaphysics of morals. Cambridge University Press, Cambridge
Kipnis K (2001) Vulnerability in research subjects: a bioethical taxonomy. In: National Bioethics Advisory Commission (eds) Ethical and policy issues in research involving human participants, vol II. http://bioethics.georgetown.edu/nbac/human/overvol2.pdf
Knoppers BM (2000) Editorial: genetic benefit sharing. Science 290(5489):49
Le Carré J (2001) A lot of very greedy people. The Guardian, 12 Febr. http://www.guardian.co.uk/world/2001/feb/12/aids.wto
Lemmens T, Nwabueze R (2007) Commentary 17.2: Culturally sensitive compensation in clinical research. In: Lavery JV, Grady C, Wahl ER, Emanuel EJ (eds) Ethical issues in international biomedical research: a case book. Oxford University Press, Oxford, pp 287–294
Levine C, Faden RR, Grady C, Hammerschmidt D, Eckenwiler L, Sugarman J (2004) The limitations of ‘vulnerability’ as a protection for human research participants. Am J Bioeth 4(3):44–49
Macklin R (2003) Vulnerability and protection. Bioethics 17(5–6):472–486
Macklin R (2004) Double standards in medical research in developing countries. Cambridge University Press, Cambridge
Mayer R (2007) What’s wrong with exploitation? J Appl Philos 24(2):137–150
Mfutso-Bengu JM, Taylor TE (2002) Ethical jurisdictions in biomedical research. Trends Parasitol 18(5):231–234
Pogge T (2008) World poverty and human rights, 2nd edn. Polity Press, Cambridge
Rogers AC (1997) Vulnerability, health and health care. J Adv Nurs 26:65–72
Ruof MC (2004) Vulnerability, vulnerable populations and policy. Kennedy Inst Ethics J 14(4):411–425
Scheper-Hughes N (2003) Keeping an eye on the global traffic in human organs. The Lancet 361:1645–1648
Schroeder D (2008) Double standards and benefit sharing. Monash Bioeth Rev 27(4):45–51
Schroeder D, Gefenas E (2009) Vulnerability: too vague and too broad? Camb Q Healthc Ethics 18:113–121
Schroeder D, Gefenas E (2011) Realizing benefit sharing: the case of post-study obligations. Bioethics. doi:10.1111/j.1467-8519.2010.01857.x
Schroeder D, Lasen-Diaz C (2006) Sharing the benefits of genetic resources: from biodiversity to human genetics. Dev World Bioeth 5(3):135–143
Schwartz J (1995) What’s wrong with exploitation? Nous 29:158–164
Scott N, Seglow J (2007) Altruism. Open University Press, Maidenhead
Shaffer DN, Yebei VN, Ballidawa JB, Sidle JE, Greene JY, Melsin EM, Kimaizo SJN, Tierney WM (2006) Equitable treatment for HIV/AIDS clinical trial participants: a focus group study of patients, clinical researchers, and administrators in western Kenya. J Med Ethics 32:55–60
Shi L (2001) The convergence of vulnerable characteristics and health insurance in the U.S. Soc Sci Med 53(4):519–529
Silvers A (2004) Historical Vulnerability and Special Scrutiny. Am J Bioeth 4(3):56–57
Tangwa G (2009) Research with vulnerable human beings. Acta Trop 112S:S16–S20
UN (1948) Universal Declaration of Human Rights. United Nations. http://www.un.org/en/documents/udhr/
Wilkinson M, Moore A (1997) Inducement in research. Bioethics 11(5):373–389
Williams G, Schroeder D (2004) Human genetic banking: altruism, benefit and consent. New Genetics Soc 23(1):89–103
WMA (2004) Declaration of Helsinki: ethical principles for medical research involving human subjects. Adopted by the 18th World Medical Association General Assembly, Helsinki, Finland, June 1964, as revised by the WMA General Assembly, Tokyo.
WMA (2008) Declaration of Helsinki: Ethical principles for medical research involving human subjects. Adopted by the 18th World Medical Association General Assembly, Helsinki, Finland, June 1964, latest revision by the 59th WMA General Assembly, Seoul, Korea, October. http://www.wma.net/en/30publications/10policies/b3/index.html
Wood A (1995) Exploitation. Soc Philos Policy 12:150–151
World Health Assembly (2011) The Pandemic Influenza Preparedness (PIP) Framework for the sharing of influenza viruses and access to vaccines and other benefits. http://www.who.int/influenza/pip/en/
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Arnason, G., Schroeder, D. (2013). Exploring Central Philosophical Concepts in Benefit Sharing: Vulnerability, Exploitation and Undue Inducement. In: Schroeder, D., Cook Lucas, J. (eds) Benefit Sharing. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-6205-3_2
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