Informed Consent and Benefit Sharing in Genetic Research and Biobanking in India

Some Common Impediments in Practice
  • Prasanna Kumar Patra
  • Margaret Sleeboom-Faulkner
Conference paper
Part of the Veröffentlichungen des Instituts für Deutsches, Europäisches und Internationales Medizinrecht, Gesundheitsrecht und Bioethik der Universitäten Heidelberg und Mannheim book series (IMGB, volume 33)


In this paper an attempt is made to understand common impediments in the application of two bioethical principles – informed consent and benefit sharing – in genetic and biobanking research in field situations in India. These evolving principles are discussed and addressed in contemporary national and international bioethical guidelines that reflect the nature of the population and technological systems that they deal with. Notably, the importance of these two principles is that they aim, on the one hand, to protect research participants from exploitation, harm and injustice and, on the other, to impose legal and ethical obligations upon those individuals and institutions conducting research and/or business enterprises. The major considerations that will be addressed by this paper are: firstly, whether there is a true, valid and ‘informed’ consent procedure that will be practicable, particularly in illiterate, resource-poor and marginalized social settings; and secondly, whether human genetic materials can be considered as resources or property and promoted for benefit sharing arrangements, as has been the case with respect to non-human genetic materials. The study draws on primary information collected in India during December 2006 and May 2007.


Genetic Research Tribal Community Benefit Sharing Biobanking Research Human Genome Diversity Project 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. Andada P (2005) Module two: Informed consent. Dev World Bioeth 5 (1): 14-29Google Scholar
  2. Anuradha RV (1998) Sharing with the Kanis: a case study from Kerala, India. Kalpavriksha Mimeo, New Delhi.Google Scholar
  3. Berg K (2001) The ethics of benefit sharing. Clin Genet (2001)59: 240-243Google Scholar
  4. Cardinal G, Deschenes M, Knoppers BM et al (2003) Statement of principles on ethical conduct of human genetic research involving populations.Google Scholar
  5. Caulfield T (2002) Gene banks and blanket consent. Nat Rev Genet 3: 577.Google Scholar
  6. Chokshi DA, Kwaiatkowski DP (2005) Ethical challenges in genomic epidemiology in developing countries. Genomics Soc Pol l.1(1): 1-15Google Scholar
  7. CIOMS (The Council of International Organizations of Medical Sciences) (2002) International Ethical Guidelines for Biomedical Research Involving Human Subjects: guidelines 4,5 and 6Google Scholar
  8. DBT (Department of Biotechnology, Government of India) (2002) Ethical Policies on Human Genome, Genetic Research and Services. Accessed on 12 February 2007Google Scholar
  9. Deschenes M, Cardinal G, Knoppers BM et al (2001) Human genetic research, DNA banking and consent: a question of ‘form’? Clin Genet 59: 221-239Google Scholar
  10. Dickenson D (2004) Consent, commodification and benefit sharing in genetic research. Dev World Bioeth 4 (2): 109-124Google Scholar
  11. Elger BS, Caplan AL (2006) Consent and anonymization in research involving biobanks. Eur Mol Biol Organ Rep 7 (7): 661-666Google Scholar
  12. Godard B, Schmidtke J, Cassiman JJ et al (2003) Data storage and DNA banking for biomedical research: informed consent, confidentiality, equality issues, ownership, return of benefits. A professional perspective. Eur J Hum Genets 11 (2): 88-S122Google Scholar
  13. Greely HT (2001) Informed consent and other ethical issues in human population genetics. Ann Rev Genet 35: 785-800Google Scholar
  14. Hansson MG (2006) Building on relationships of trust in biobank research. J Med Ethics 31: 415-418Google Scholar
  15. HUGO (Humane Genome Organization) Ethics Committee (2000). Statement on Benefit Sharing. Accessed on 6 January 2006Google Scholar
  16. HUGO (Human Genome Organization) (2000) Statement on Benefit Sharing. Vancouver, 9 April. statement_on_Benefit_Sharing.htm Accessed on 6 January 2006Google Scholar
  17. ICMR (Indian Council of Medical Research) (2000) Ethical Guidelines for Biomedical Research on Human Subjects. ICMR Bulletin 30:10:107-116.Google Scholar
  18. ICMR (Indian Council of Medical Research) (2006) Ethical Guidelines for Biomedical Research on Human Participants. Published by Director-General, Indian Council of Medical Research, New Delhi.Google Scholar
  19. Iype G (2002) And benefits for all. The Rediff Special News October 11. Accessed 16 March 2007Google Scholar
  20. Juengst ET (2003) Community Engagement in Genetic Research: The “Slow Code” of Research Ethics? In: Knoppers BM (ed) Populations and Genetics – Legal and Socio-Ethical Perspectives. Martinus Nijhoff Publishers, Leiden/BostonGoogle Scholar
  21. Kegley J (2004) Challenges to informed consent. Challenges to informed consent. Eur Mol Biol Organ Rep 5 (9): 832-836Google Scholar
  22. Knoppers BM (2000) Population genetics and benefit sharing. Com Genet 3: 212-214Google Scholar
  23. Knoppers BM (2000) Genetic benefit sharing (editorial). Science 290: 5489, 49Google Scholar
  24. NARC (North American Regional Committee) (1996) Human Genome Diversity Project. Houst Law Rev 33: 1431-1473Google Scholar
  25. NBRI (National Botanical Research Institute) (2002) P. Pushpagandan Model of benefit sharing. director %20data /index10.htm Accessed on 7 April 2006Google Scholar
  26. NCB (Nuffield Council on Bioethics) (2002) The ethics of research related to health care in developing countries. LondonGoogle Scholar
  27. Patra PK, Sleeboom-Faulkner M (2007) Genetic biobanking in India – a community based perspective on ways and means of data generation. Taiwan J Law Technol Pol 4:67-97Google Scholar
  28. Pushpagadan P (1988) ‘Arogyappacha’ (Trichopus zeylanicus): The ‘Ginseng’ of Kani tribes of Agasthyar Hills (Kerala) for Evergreen Health and Vitality. Anc Sci Life 8: 13-16Google Scholar
  29. Schroeder D, Lasen-Diaz C (2006) Sharing the benefits of genetic resources: from biodiversity to human genetics. Dev World Bioeth 6(3): 135-143Google Scholar
  30. Schuklenk U, Kleinsmidt A (2006) North-South benefit sharing arrangements in bioprospecting and genetic research: a critical ethical and legal analysis. Dev World Bioeth 6(3): 122-134Google Scholar
  31. Tri-Council of Canada (1997) Medical Research Council, Natural Sciences and Engineering Research Council: Social Sciences and Humanities Research Council, Code of Conduct for Research Involving Humans. Ministry of Supply and Services Canada, OttawaGoogle Scholar
  32. Tsai D (2006) Mediating media effects within public participatory opinion in structuring Taiwan Bio-bank. Paper presented at 2006 ELSI Symposium on Reexamining the ELSI Implication of Biobanking – A Cross Culture Perception held at Taipei 17-18 SeptemberGoogle Scholar
  33. United Nations Educational, Scientific and Cultural Organization (UNESCO) (2005) Universal Declaration on Bioethics and Human Rights. Article 15(1). Accessed on 24 May 2007Google Scholar
  34. Upvall M and S Hashwani (2001). Negotiating the informed-consent process in developing countries: a comparison of Swaziland and Pakistan.48 (3) pp. 188-192.Google Scholar
  35. Willkinson, T.M. (2004) Individualism and Ethics of research on Humans. HEC Forum16 (1): 6-26Google Scholar
  36. WMO (World Medical Organization) (1996) Declaration of Helsinki.BMJ; 313 (7070): 1448-1449Google Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2012

Authors and Affiliations

  • Prasanna Kumar Patra
    • 1
  • Margaret Sleeboom-Faulkner
    • 1
  1. 1.Department of AnthropologyUniversity of SussexSussexUK

Personalised recommendations