Science and Engineering Ethics

, Volume 16, Issue 1, pp 43–58 | Cite as

Liberty to Decide on Dual Use Biomedical Research: An Acknowledged Necessity

Original Paper

Abstract

Humanity entered the twenty-first century with revolutionary achievements in biomedical research. At the same time multiple “dual-use” results have been published. The battle against infectious diseases is meeting new challenges, with newly emerging and re-emerging infections. Both natural disaster epidemics, such as SARS, avian influenza, haemorrhagic fevers, XDR and MDR tuberculosis and many others, and the possibility of intentional mis-use, such as letters containing anthrax spores in USA, 2001, have raised awareness of the real threats. Many great men, including Goethe, Spinoza, J.B. Shaw, Fr. Engels, J.F. Kennedy and others, have recognized that liberty is also a responsibility. That is why the liberty to decide now represents an acknowledged necessity: biomedical research should be supported, conducted and published with appropriate measures to prevent potential “dual use”. Biomedical scientists should work according to the ethical principles of their Code of Conduct, an analogue of Hippocrates Oath of doctors; and they should inform government, society and their juniors about the problem. National science consulting boards of experts should be created to prepare guidelines and control the problem at state level. An international board should develop minimum standards to be applicable by each country. Bio-preparedness is considered another key-measure.

Keywords

Dual-use biomedical research Liberty Epidemics Emerging infections Bioterrorism Biopreparedness Code of conduct Minimum Standards 

Notes

Acknowledgments

First of all, I would like to thank Prof. Andrzej Gorski and the Polish Academy of Sciences for organizing the International conference on Dual-use Biomedical research, 9–10 November, 2007, Warsaw, Poland. I also would like to express my gratitude to Dr Derek F. Brown, Cambridge, HPA, the United Kingdom, for reading the manuscript and for his amendments.

References

  1. 1.
    Beck, V. (2003). Advances in life sciences and bioterrorism. EMBO Reports, 4, S53–S56.CrossRefGoogle Scholar
  2. 2.
    Keuleyan, E. (2007). Dual-use life-sciences research – A problem that necessitates emergent actions. Infectology, XLIV(Suppl. 1), 16–18 (article in Bulgarian, abstract in English).Google Scholar
  3. 3.
    World Health Organization. (2005). Life science research: opportunities and risks for public health. Mapping the issues. WHO/CDS/CSR/LYO/2005.20.Google Scholar
  4. 4.
    World Health Organization. (2007). Scientific working group on life science research and global health security. Report of the First Meeting. Geneva, Switzerland, 16–18 October 2006. WHO/CDS/EPR/2007.4.Google Scholar
  5. 5.
    Marburger, J. (2007). 2007 AAAS Policy Forum. Washington, DC, May, 2007; http://www.aaas.org/spp/rd/forummarburger.pdf.
  6. 6.
    Mathews, J. D., & Smallwood, R. A. (2003). Australian responses to threats of bioterrorism. Microbiology Australia, May:11–13.Google Scholar
  7. 7.
    Green, S. K. (2004). The living code. Physician-scientists and social responsibility. Virtual Mentor, 6(9); http://www.ama-assn.org/ama/pub/category/2790.html.
  8. 8.
    Royal Society. (2004). The individual and collective role scientists can play in strengthening international treaties (www.royalsoc.ac.uk/policy/).
  9. 9.
    Institute of Medicine and National Research Council of the National Academies. Globalization, Biosecurity, and the Future of the Life Sciences.Google Scholar
  10. 10.
    Medical Research Council. (2005). Medical Research Council position statement on bioterrorism and biomedical research. MRC, the UK, September 2005.Google Scholar
  11. 11.
    National Research Council. (2004). NRC report on dual use research. Biotechnology research in an age of terrorism. Report of the NRC of the National Academies.Google Scholar
  12. 12.
    International Committee of the Red Cross. (2004). Preventing hostile use of the life sciences: From ethics and law to best practice. ICRC, Geneva, 11.11.2004 (URL: http://www.icrc.org/web/eng/siteeng0.nsf/html/biotechnology-principles-of-practice-111104).
  13. 13.
    Miller, S. (2007). Terrorism and counter-terrorism. Oxford: The Oxford Blackwell Publishing.Google Scholar
  14. 14.
    Osterholm, M. T. (2001). Bioterrorism: A real modern threat. Emerging Infections, 5, 213–222.Google Scholar
  15. 15.
    Kahn, L. H. (2003). Life scientists and the dual use dilemma. Science, 302(5652), 1894–1895.CrossRefGoogle Scholar
  16. 16.
    Richardson, L. (2004). Buying biosafety – Is the price right. The New England Journal Medicine, 350, 2121–2123.CrossRefGoogle Scholar
  17. 17.
    Moses, H., Braunwald, E, Martin, J. B., & Thier, S. O. (2002). Collaborating with industry – Choices for the Academic Medical Center. The New England Journal of Medicine, 347(17), 1371–1375 (www.nejm.org).CrossRefGoogle Scholar
  18. 18.
    Hirschberg, R., La Montagne, J., & Fauci, A. S. (2004). Biomedical research – An integral component of National Security. The New England Journal of Medicine, 350(21), 2119–2120.CrossRefGoogle Scholar
  19. 19.
    Leitenberg, M. (2003). Distinguishing offensive from defensive biological weapons research. Clinical Reviews in Microbiology, 29(3), 223–257.CrossRefGoogle Scholar
  20. 20.
    Atlas, R. M., & Dando, M. (2006). The dual-use dilemma for the life sciences: Perspectives, conundrums, and global solutions. Biosecurity and Bioterrorism: Biodefense Strategy, Practice and Science, 4(3), 276–286.CrossRefGoogle Scholar
  21. 21.
    Shea, D. A. (2007). Oversight of dual-use biomedical research: The National Science Advisory Board for Biosecurity. CRS Report for Congress. Updated April, 2007.Google Scholar
  22. 22.
    National Science Advisory Board for Biosecurity. (2006). Criteria for identifying dual use research of concern. NSABB Draft Guidance Documents. July 2006; http://www.upmc-biosecurity.org/website/resources/govt_docs/science_biosecurity/nsabb/draft guidance documents.html.
  23. 23.
    National Science Advisory Board for Biosecurity. (2006). Tools for the responsible communication of research with dual use potential. NSABB Draft Guidance Documents. July 2006; http://www.upmc-biosecurity.org/website/resources/govt_docs/science_biosecurity/nsabb/draftguidancedocuments.html.
  24. 24.
    National Science Advisory Board for Biosecurity. (2006). Considerations in developing a code of conduct in the life sciences. NSABB Draft Guidance Documents. July 2006; http://www.upmc-biosecurity.org/website/resources/govt_docs/science_biosecurity/nsabb/draftguidancedocuments.html.
  25. 25.
    National Science Advisory Board for Biosecurity. (2006). Addressing biosecurity concerns related to the synthesis of select agents. NSABB. December 2006; http://www.upmc-biosecurity.org/website/resources/govt_docs/science_biosecurity/nsabb/.
  26. 26.
    Barniakov, D., & Andreev, A. (Eds.) (1968). Thoughts and aphorisms. Collection. Sofia. Narodna kultura (in Bulgarian).Google Scholar
  27. 27.
    Liberty Fund Inc. (2007). http://www.libertyfund.org/browse.asp#.
  28. 28.
    de Montaigne, M. (1910). Essays of Montaigne. Vol. 9., trans. Charles Cotton, revised by William Carew Hazlett. New York. Edwin C. Hill. (On Physiognomy, paragraph 147); http://oll.liberty.fund.org/title/1750/91302/2062745.
  29. 29.
    de Spinoza, B. (1891). The Chief works of Benedict de Spinoza. Vol. I, transl. R.H.M. Elwes. Revised Ed. London. George Bell and Sons. (A Theologo-political treatise. Chap. XVI., p. 206); http://olllibertyfund.org.
  30. 30.
    Kant, I. (1886). The Metaphysics of Etthics, trans. J.W. Semple. Edinburgh., T. & T. Clark (3rd ed.) (Introduction by H. Calderwood, paragraph 576); http://oll.libertyfund.org/title/1443/56224/1351906.
  31. 31.
    Plato. (1892). The Dialogues of Plato, Vol.1, transl. B.Jowett, M.A., in five volumes, 3rd ed. Oxford. Oxford University Press. (Charmides, Lysis, Laches, Protagoras, Euthydemus, Cratylus, Phaedrus, Ion, Symposium. Phaedrus, paragraph 4257); http://oll.libertyfund.org/title/111/39482/876719.
  32. 32.
    Tumpey, T. M., Garcia-Sastre, A., Mikulasova, A., Taubenberger, J. K., Swayne, D. E., Palese, P., & Basler, C. F. (2002). Existing antivirals are effective against influenza viruses with genes from the 1918 pandemic virus. PNAS, 99, 13849–13854.CrossRefGoogle Scholar
  33. 33.
    Taubenberger, J. K., Reid, A. H., Lourens, R. M., Wang, R., Jin, G., & Fanning, T. G. (2005). Characterization of the 1918 influenza virus polymerase genes. Nature, 437(7060), 889–893.CrossRefGoogle Scholar
  34. 34.
    Jackson, R. J., Ramsay, A. J., Christensen, C. D., Beaton, S., Hall, D. F., & Ramshaw, I. A. (2001). Expression of mouse interleukin-4 by a recombinant ectromelia virus suppresses cytolytic lymphocyte responses and overcomes genetic resistance to mousepox. Journal of Virology, 75, 1205–1210.CrossRefGoogle Scholar
  35. 35.
    Cello, J., Paul, A. V., & Wimmer, E. (2002). Chemical synthesis of poliovirus cDNA: Generation of infectious virus in the absence of natural template. Science, 297, 1016–1018.CrossRefGoogle Scholar
  36. 36.
    Couzin, J. (2002). Active poliovirus baked from scratch. Science, 297, 5579: 174.Google Scholar
  37. 37.
    Racaniello, V. R., & Baltimore, D. (1981). Cloned poliovirus complementary DNA is infectious in mammalian cells. Science, 214, 4523 (1981):916.Google Scholar
  38. 38.
    Fischer, J. E. (2006). Stewardship or Censorship? Balancing biosecurity. The public health, and the benefits of scientific openness. A white paper commissioned by the Policy, Ethics and Law Core of the SERCEB; Washington, DC. the Henry Stimson Center.Google Scholar
  39. 39.
    DaSilva, E. J. (1999). Biological warfare, bioterrorism, biodefence and the biological and toxin weapon convention. Electronic Journal of Biotechnology, 2(3), 99–110; http://www.ejb.org/content/vol2/issue3/full/2/.Google Scholar
  40. 40.
    Frishknecht, F. (2003). The history of biological warfare. EMBO Reports, 4, S47–S52.CrossRefGoogle Scholar
  41. 41.
    Della-Porta, A. J. (2003). Bioterrorism: An historical perspective. Microbiology Australia, 6–10.Google Scholar
  42. 42.
    Guillemin, J. (2006). Scientists and the history of biological weapons. European Molecular Biology Organization Reports, 7, S45–S49.Google Scholar
  43. 43.
    Borio, L. L. (2005). Plague as an agent of bioterrorism. In G. L. Mandell, J. E. Bennett, & R. Dolin (Eds.), Principles and practice of infectious diseases (6th ed., pp. 3601–3606). Philadelphia, PA: Elsevier Churchill Livingstone.Google Scholar
  44. 44.
    Lucey, D. (2005). Anthrax. In G. L. Mandell, J. E. Bennett, & R. Dolin (Eds.), Principles and practice of infectious diseases (6th ed., pp. 3618–3623). Philadelphia, PA: Elsevier Churchill Livingstone.Google Scholar
  45. 45.
    Rotz, L. D., Cono, J., & Damon, I. (2005). Smallpox and bioterrorism. In G. L. Mandell, J. E. Bennett, & R. Dolin (Eds.), Principles and practice of infectious diseases (6th ed., pp. 3612–3617). Philadelphia, PA: Elsevier Churchill Livingstone.Google Scholar
  46. 46.
    Wenberg, A. N. (2005). Zoonoses. In G. L. Mandell, J. E. Bennett, & R. Dolin (Eds.), Principles and practice of infectious diseases (6th ed., pp. 3630–3636). Philadelphia, PA: Elsevier Churchill Livingstone.Google Scholar
  47. 47.
    Chang, M.-H., Glynn, M. K., & Groseclose, S. L. (2003). Endemic, notifiable bioterrorism-related diseases, United States, 1992–1999. Emerging Infectious Diseases, 9(5), 556–564.Google Scholar
  48. 48.
    Fauci, A. S., Touchette, N. A., & Folkers, G. K. (2005). Emerging infectious diseases: A 10-year perspective from the National Institute of Allergy and Infectious Diseases. Emerging Infectious Diseases, 11(4), 519–525. (www.cdc.gov/eid).Google Scholar
  49. 49.
    Kool, J. L. (2005). Risk of person to person transmission of pneumonic plagues. Clinical Infectious Diseases, 40(8), 1166–1172.CrossRefGoogle Scholar
  50. 50.
    Koplan, J. P. (2002). Protecting the Nation’s Health in an Era of Globalization: CDC’s Global Infectious Disease Strategy. Atlanta, Georgia.Google Scholar
  51. 51.
    National Centers for Infectious Diseases. (2007). Infectious disease information. Emergency infectious diseases; http://www.cdc.gov/ncidod/diseases/eid/disease-sites.htm.
  52. 52.
    The Health Protection Agency & the National Radiobiological Protection Board. (2004). Initial Investigation and Management of Outbreaks and Incidents of Unusual Illnesses. A Guide for Hospital Clinicians. Version 3 (http://www.hpa.org.uk/infections/topics_az/deliberaterelease/).
  53. 53.
    The Health Protection Agency & the National Radiobiological Protection Board. (2004). Initial Investigation and Management of Outbreaks and Incidents of Unusual Illnesses. A Guide for Local Laboratories. Version 3. (http://www.hpa.org.uk/infections/topics_az/deliberaterelease/).
  54. 54.
    Siegel, J. D., Rhinehart, E., Jackson M., Chiarello, L., & The Healthcare Infection Control Practices Advisory Committee. (2007). 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings. Center for Diseases Control and Prevention. June 2007, (http://www.cdc.gov/ncidod/dhqp/pdf/isolation2007.pdf).
  55. 55.
    Peters, C. J. (2005). Bioterrorism: Viral hemorrhagic fevers. In G. L. Mandell, J. E. Bennett, & R. Dolin (Eds.), Principles and practice of infectious diseases (6th ed., pp. 3626–3629). Philadelphia, PA: Elsevier Churchill Livingstone.Google Scholar
  56. 56.
    The Health Protection Agency. (2007). HPA Centre for infections. Guidelines for Action in the Event of a deliberate release: Viral Haemorrhagic Fevers. Version 2.3 (http://www.hpa.org.uk/infections/topics_az/deliberate_release/default.htm).
  57. 57.
    Booth, C. M., Matukas, L. M., Tomlinson, G. A., Rachlis, A. R., Rose, D., et al. (2003). Clinical features and short-term outcomes of 144 patients with SARS in the Greater Toronto area. JAMA, 289, 2801–2809.CrossRefGoogle Scholar
  58. 58.
    Center for Diseases Control and Prevention. (2003). Outbreak of severe acute respiratory syndrome-worldwide. Morbidity and Mortality Weekly Report, 52, 241–248.Google Scholar
  59. 59.
    Drosten, C., Gunter, S., Preiser, W., et al. (2003). Identification of a novel coronavirus in patients with severe acute respiratory syndrome. The New England Journal Medicine, 348, 1967–1976.CrossRefGoogle Scholar
  60. 60.
    Monto, A. S. (2005). The threat of an avian influenza pandemic. The New England Journal Medicine, 352, 323–325.CrossRefGoogle Scholar
  61. 61.
    Belay, E. D., & Schonberger, L. D. (2005). The public Health Impact of Prion Diseases. Annual Reviews in Public Health, 26, 191–212.CrossRefGoogle Scholar
  62. 62.
    Field, H., Young, P., Yob, J. M., Mill, J. N., Less, H., & Mackenzie, J. (2001) The natural history of Hendra and Nipah viruses. Microbes and Infection, 3(4), 307–314.CrossRefGoogle Scholar
  63. 63.
    Chua, K. B., Bellini, W. J., Rota, P. A., Harcourt, B. H., Tamin, A., Lam, S. K., et al. (2000). Nipah virus: a recently emergent deadly paramyxovirus. Science, 288(5470), 1432–1435.CrossRefGoogle Scholar
  64. 64.
    World Health Organization. (2007). The Global MDR-TB & XDR–TB Response Plan 2007–2008. Stop TB Partnership. WHO/HTM/TB/2007.387 http://oll.libertyfund.org/title/111/39482/876719.
  65. 65.
    Resnik, D. B., & Shamoo, A. E. (2005). Bioterrorism and the responsible conduct of biomedical research. Drug Development Research, 63, 121–133.CrossRefGoogle Scholar
  66. 66.
    Cornelinssen, F. (2006). Adequate regulation: a stop-gap measure, or part of a package? European Molecular Biology Organization Reports, 7, S50–S54.Google Scholar
  67. 67.
    Revill, J., & Dando, M. R. (2006). A hippocratic oath fore life scientists. EMBO Reports, 7, S55–S60.CrossRefGoogle Scholar
  68. 68.
    van Aken, J. (2006). When risk outweighs benefit. European Molecular Biology Organization Reports, 7, S10–S13.Google Scholar
  69. 69.
    European Commission. (2007). Green Paper on bio-preparedness. EC, Brussels, 11.7.2007 (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:52007DC0399:EN:NOT accessed on 20.9.2007).
  70. 70.
    Mackenzie, J. S. (2003). Australian Biosecurity CRC for Emergency Infectious Diseases (AB-CRC). Microbiology Australia, May: 38–39.Google Scholar
  71. 71.
    Ostfield, M. L. (2007). Developing options for global biosecurity: Assessing progress and evaluating new mechanisms. Remarks to the Partnership for Global Security, Carnegie Endowment for International Peace, Washington, DC, March, 9, 2007; http://www.state.go/g/oes/bbh.
  72. 72.
    Heinrich, J. (2001). Bioterrorism. Review of Public Health Preparedness Programs. US General Accounting Office. GAO-02-149; http://gao.gov/new.item/do23149.pdf.
  73. 73.
    Hupert, N., Cuomo, J., Callahan, M. A., Mushlin, A. I., & Morse, S. S. (2004). Community-based mass prophylaxis: A planning guide for public health preparedness. Agency for Healthcare Research and Quality, US DHHS, Rockville, MD, AHRQ Pub No 04-0044.Google Scholar
  74. 74.
    Adele-Wigert, I, & Bonin, S. (2007). Part two: International organizations. In A. Wenger, V. Mauer, & M. Dunn (Eds.), S. Bonin. International biodefence handbook. An inventory of national and international biodefence practices and polices. (pp. 273–336). Center for Security Studies, ETH Zurich.Google Scholar

Copyright information

© Springer Science+Business Media B.V. 2008

Authors and Affiliations

  1. 1.Department of Clinical MicrobiologyMedical Institute, Ministry of the InteriorSofiaBulgaria

Personalised recommendations