Abstract
Obtaining informed consent has become an essential part of modern medical practice. Today, patients and research subjects are actively involved in medical decision-making and are no longer expected to defer responsibility to paternalistic, benevolent doctors. Since the early 1990s, the concept of informed consent has also been employed systematically in connection with indigenous peoples' rights of self-determination. The Convention on Biological Diversity (CBD), for instance, requires that prior informed consent be obtained from indigenous communities before accessing their traditional knowledge, innovations and practices.
This chapter outlines the four steps necessary to conclude a consent process ethically and successfully, namely legitimization to consent, full disclosure, adequate comprehension and voluntary agreement. It concludes that the similarities between obtaining informed consent in the medical context and obtaining prior informed consent in terms of CBD requirements are strong enough to warrant mutual learning. Such learning is particularly appropriate when dealing with the inherent power imbalances between medical staff and research subjects on the one hand, and bio-prospectors and indigenous communities on the other hand. Importantly, in both fields, the autonomy of research subjects and the right to self-determination of indigenous peoples need to be upheld and strengthened with clear, enforceable legislation at national and international level.
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Notes
- 1.
1 For ease of reading, I shall use the word ‘patient’ in the medical context exclusively, even though healthy volunteers can enrol in research studies and are, of course, protected through informed consent procedures.
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2 Such shipments are regulated through the 1989 Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal (www.basel.int/), which entered into force on 5 May 1992, and the 1998 Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (www.pic.int/), which entered into force on 24 February 2004.
- 3.
3 The difference between the two expressions within the context of traditional knowledge will be explained in the section ‘Free prior informed consent’ below.
- 4.
4 The role of the state–which is not depicted in this diagram–is to provide the necessary legal guidelines and enforcement mechanisms to enable the system of informed consent.
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5 I shall not discuss the highly unusual, if ideal, case where it is possible to obtain consent from every single member of a community. In most cases, some form of legitimate subgroup will have to consent on behalf of a group.
- 6.
6 This diagram, like the first one, does not explicitly depict the role of the state. As will be seen later, the CBD gives sovereignty over biological resources and traditional knowledge to the nation state rather than indigenous populations. The diagram presumes the ideal situation, in which the nation state discharges its duty to enable the obtaining of consent from its subpopulations, such as indigenous communities.
- 7.
7 One might ask how benefit-sharing arrangements fit with the prerequisite not to unduly influence decision-makers. This is an unresolved issue, both in medical research when involving severely disadvantaged research subjects, for whom even an initial health assessment (as required for many research projects) could be regarded as undue inducement, and for marginalized communities for whom the commercialisation of traditional knowledge could be the only way, for instance, to obtain funds for their children's health care. In medical ethics, early answers are currently being developed. See, for instance, Ezekiel et al. (2005). In the context of access to traditional knowledge, this is an important gap in the research.
- 8.
9 The Wechsler Adult Intelligence Scale is a general test of intelligence published in 1955 and developed by David Wechsler from tests used to assess military personnel.
- 9.
10 The earliest written record of Hoodia use was by botanist Francis Masson in 1796. Its appetite suppressant qualities were first recorded in 1936 (Wynberg 2004).
- 10.
11 The only states that are not party to the CBD are Andorra, Somalia, the United States of America and the Vatican (Holy See).
- 11.
12 Traditionally, a clearing house was an institution that provided clearing services for financial transactions by helping member banks to add up reciprocal debits and credits and only settle net balances in cash. Today, a clearing house is mostly understood to be an institution that collects and distributes information. The latter applies to the CBD's clearing-house mechanism.
- 12.
- 13.
14 In contrast to extractive industries, such as mining and logging, bioprospecting usually has minimal environmental impact at the point of extraction. But since the issue of the timing of informed consent is very similar in both cases, it is worth looking at recommendations from this sector.
- 14.
15 The gifts mentioned in Table 3.3 were given to community leaders who were not asked to enrol in research themselves.
- 15.
16 See Third World Network reports on biopiracy at www.twnside.org.sg/access_7.htm.
References
Andanda, P. (2005). Module two: informed consent. Developing World Bioethics, 5(1), 14–29.
Arrindell, W. A., Heesink, J.,&Feij, J. A. (1999). The satisfaction with life scale (SWLS): appraisal with 1700 healthy young adults in the Netherlands. Personality and Individual Differences, 26(5), 815–826.
Basel Convention (1992). Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and Their Disposal. www.basel.int/. Accessed 15 August 2008.
Beauchamp, T. L. (2003). Methods and principles in biomedical ethics. Journal of Medical Ethics, 29, 269–274.
Campbell, A., Gillett, G.,&Jones, G. (2001). Medical ethics (3rd ed). Oxford: Oxford University Press.
Cariño, J. (2005). Indigenous peoples' right to free, prior, informed consent: reflections on concept and practice. Arizona Journal of International and Comparative Law, 22(1), 19–39.
Chokshi, D. A., Thera, M. A., Parker, M., Diakite, M., Makani, J., Kwiatkowski, D. P., et al. (2007). Valid consent for genomic epidemilogy in developing countries. Public Library of Science Medicine, 4(4), e95.
CBD (1992a). Convention on Biological Diversity. www.cbd.int/doc/legal/cbd-un-en.pdf. Accessed 15 August 2008.
CBD (1992b). Traditional Knowledge and the Convention on Biological Diversity, p. 1. www.cbd.int/doc/publications/8j-brochure-en.pdf. Accessed 15 August 2008.
CBD (2000). Article 8(j) and Related Provisions, Decision V/16, Decisions Adopted by the Conference of the Parties to the Convention on Biological Diversity at Its Fifth Meeting, Nairobi, 15–26 May, UNEP/CBD/COP/5/23. www.cbd.int/doc/decisions/COP-05-dec-en.pdf. Accessed 14 April 2008.
CBD (2001). Report of the Second Meeting of the Ad Hoc, Open-Ended, Inter-Sessional Working Group on Article 8(j) and Related Provisions of the Convention on Biological Diversity, UNEP/CBD/WG8J/2/6 ADD1. www.cbd.int/doc/meetings/tk/wg8j-02/official/wg8j-02-06-add1-en.doc. Accessed 14 August 2008.
CBD (2002). Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of Their Utilization, Decision VI/24, 2002, Secretariat of the Convention on Biological Diversity, Quebec. www.cbd.int/doc/publications/cbd-bonn-gdls-en.pdf. Accessed 22 March 2008.
CBD (2004). Akwé: Kon Voluntary Guidelines for the Conduct of Cultural, Environmental and Social Impact Assessments Regarding Developments Proposed to Take Place on, or Which are Likely to Impact on, Sacred Sites and on Lands and Waters Traditionally Occupied or Used By Indigenous and Local Communities, Secretariat of the Convention on Biological Diversity, Quebec. www.cbd.int/doc/publications/akwe-brochure-en.pdf. Accessed 15 August 2008.
CIOMS (2002). International ethical guidelines for biomedical research involving human subjects, Council for International Organizations of Medical Sciences, Geneva. www.cioms.ch/frame_ guidelines_nov_2002.htm. Accessed 15 August 2008.
Daes, E.I.A. (2001). Prevention of discrimination and protection of indigenous peoples and minorities: indigenous people and their relationship to land, E/CN.4/Sub.2/2001/21, United Nations Economic and Social Council. www.unhchr.ch/Huridocda/Huridoca.nsf/(Symbol)/E.CN.4.Sub.2.2001.21.En?Opendocument. Accessed 13 August 2008.
Diallo, D. A., Doumbo, O. K., Plowe, C. V., Wellems, T. E., Emanuel, E. J.,&Hurst, S. A. (2005). Community permission for medical research in developing countries. Clinical Infectious Diseases, 41, 255–259.
Diener, E. (2000). Subjective well-being: the science of happiness and a proposal for a national index. American Psychologist, 55(1), 34–43.
Ezekiel, J. E., Currie, X. E.,&Herman, A. (2005). Undue inducement in clinical research in developing countries: is it a worry? Lancet, 366, 336–340.
Gillon, R. (1985). Philosophical medical ethics. Chichester: Wiley.
Haira, A. (2006). Prior informed consent an introduction. www.med.govt.nz/templates/MultipageDocumentTOC____19320.aspx#P112_14121. Accessed 15 August 2008.
Harris, J. (2005). Scientific research is a moral duty. Journal of Medical Ethics, 31, 242–248.
Herodotus. (1995). The histories III 38, vol 2. Cambridge, MA: Harvard University Press.
ICESCR (1966). International Covenant on Economic, Social and Cultural Rights. www.unhchr.ch/html/menu3/b/a_cescr.htm. Accessed 15 August 2008.
ILO (1989). Convention (No. 169) Concerning Indigenous and Tribal Peoples in Independent Countries, International Labour Organization, Geneva. www.ilo.org/ilolex/cgi-lex/convde.pl?C169. Accessed 30 July 2008.
IRIN (2003). Marginalised San win royalties from diet drug. Science in Africa. www.scienceina-frica.co.za/2003/may/san.htm. Accessed 15 August 2008.
ISE (2006). Code of ethics, International Society of Ethnobiology. http://ise.arts.ubc.ca/_common/docs/ISECodeofEthics2006_000.pdf. Accessed 29 April 2008.
IUCN (2004). Facilitating prior informed consent in the context of genetic resources and traditional knowledge, World Conservation Union. http://pdf.wri.org/ref/perrault_04_facilitating.pdf. Accessed 15 August 2008 (parts also published as Perrault, 2004–see below).
Jones, J. H. (1993). Bad blood: the Tuskegee experiment. New York: Free Press.
Kollapen, J. (2004). Report on the inquiry into human rights violations in the Khomani San community. Johannesburg: South African Human Rights Commission.
Loue, S. (2000). Textbook of research ethics: theory and practice. New York: Kluwer.
MacKay, F. (2004). Indigenous peoples' right to free, prior and informed consent and the World Bank's extractive industries review, Forest Peoples Programme.
Macklin, R. (2004). Double standards in medical research in developing countries. Cambridge: Cambridge University Press.
Nakagawa, M. (2004). Overview of prior informed consent from an international perspective. Sustainable Development Law and Policy, Special Issue: Prior Informed Consent, 4(2), 27–28.
NBAC (2001). Ethical and policy issues in international research: clinical trials in developing countries, National Bioethics Advisory Commission, Bethesda, MD. www.bioethics.gov/reports/ past_commissions/nbac_international.pdf. Accessed 15 August 2008.
Nuremberg Code (1947). www.hhs.gov/ohrp/references/nurcode.htm. Accessed 15 August 2008.
Page, A. (2004). Indigenous peoples' free prior and informed consent in the inter-American human rights system. Sustainable Development Law and Policy, Special Issue: Prior Informed Consent, 4(2), 66–74.
Pappworth, M. H. (1967). Human guinea pigs experimentation on man. London: Routledge&K Paul.
Pellegrino, E. D.,&Thomasma, D. C. (1993). The virtues in medical practice. Oxford: Oxford University Press.
Perrault, A. (2004). Facilitating prior informed consent in the context of genetic resources and traditional knowledge. Sustainable Development Law and Policy, Special Issue: Prior Informed Consent, 4(2), 27–28.
RC (2004) Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade. www.pic.int/. Accessed 15 August 2008.
SAIIC (1997). Working document on the implementation of article 8(j) and related articles, Second International Indigenous Forum on Biodiversity, Madrid, 20–23 November, South and Meso American Indian Rights Center. http://saiic.nativeweb.org/biodiv2.html. Accessed 29 April 2008.
Schuklenk, U.,&Kleinsmidt, A. (2006). North-South benefit sharing arrangements in bio-prospecting and genetic research. Developing World Bioethics, 6(3), 135–143.
Srinivas, K. R. (2008). Traditional knowledge and intellectual property rights: a note on some issues, some solutions and some suggestions. Asian Journal of WTO and International Health Law and Policy, 3(1), 81–120.
Sullivan, K. A. (2003). Neurological assessment of mental capacity. Neuropsychology Review, 14(3), 131–142.
UN (2007). United Nations Declaration on the Rights of Indigenous Peoples, Adopted by United Nations General Assembly Resolution 61/295 on 13 September. www.un.org/esa/socdev/unpfii/documents/DRIPS_en.pdf. Accessed 29 April 2008.
Wear, S. (1998). Informed consent: patient autonomy and clinician beneficence within health care. Washington, DC: Georgetown University Press.
Wertheimer, A. (1996). Exploitation. Princeton, NJ: Princeton University Press.
WIPO (2001). Survey on existing forms of intellectual property protection for traditional knowledge, World Intellectual Property Organization, WIPO/GRTKF/IC/2/5. www.wipo.int/edocs/mdocs/tk/en/wipo_grtkf_ic_2/wipo_grtkf_ic_2_5.doc. Accessed 29 April 2008.
WMA (2002). Declaration of Helsinki, World Medical Association, Article 23. www.wma.net/e/policy/b3.htm. Accessed 14 August 2008.
World Bank (2003). Striking a better balance: the World Bank Group and extractive industries, Washington, DC: World Bank. http://siteresources.worldbank.org/INTOGMC/Resources/ finaleirmanagementresponse.pdf. Accessed 14 August 2008.
Wynberg, R. (2004). Rhetoric, realism and benefit sharing. Journal of World Intellectual Property, 7, 851–876.
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Schroeder, D. (2009). Informed Consent: From Medical Research to Traditional Knowledge. In: Wynberg, R., Schroeder, D., Chennells, R. (eds) Indigenous Peoples, Consent and Benefit Sharing. Springer, Dordrecht. https://doi.org/10.1007/978-90-481-3123-5_3
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