1932

Abstract

Genomics and biotechnology have generated controversy for decades, about the moral limits of tinkering with and commodifying life, the boundary between nature and technology, the respectful treatment of research participants, and the proper evaluation of emerging technologies. Socio-legal and science and technology studies scholars have demonstrated how the resolution of these questions has serious implications for both science and the law, including the appropriate conduct and direction of scientific research and the construction of legal categories and rights. This article demonstrates that these conflicts also have profound impacts on the politics of science and technology, and particularly approaches to relevant knowledge and expertise. Humanities, social scientific, legal, and lay knowledge asserted themselves through the establishment of human genetics research and battles over the ownership of biological materials and data. However, US political culture—which favors technical and market knowledge—constrained their authority. Cross-national comparison highlights this finding, as other jurisdictions have been more inclusive in their approaches to science and technology governance.

Loading

Article metrics loading...

/content/journals/10.1146/annurev-lawsocsci-041822-041426
2024-10-17
2024-12-07
Loading full text...

Full text loading...

/deliver/fulltext/lawsocsci/20/1/annurev-lawsocsci-041822-041426.html?itemId=/content/journals/10.1146/annurev-lawsocsci-041822-041426&mimeType=html&fmt=ahah

Literature Cited

  1. All of Us Res. Progr. 2023.. Participant partners. All of Us Res. Progr. , Natl. Inst. Health, Washington, DC:, accessed Oct. 2, 2023. https://allofus.nih.gov/about/who-we-are/all-us-participant-partners
    [Google Scholar]
  2. Andrews LB. 1986.. My body, my property. . Hastings Cent. Rep. 16:(5):2938
    [Crossref] [Google Scholar]
  3. Andrews LB, Nelkin D. 1998.. Whose body is it anyway? Disputes over body tissue in a biotechnology age. . Lancet 351::5357
    [Crossref] [Google Scholar]
  4. Babb S. 2020.. Regulating Human Research: IRBs from Peer Review to Compliance Bureaucracy. Redwood City, CA:: Stanford Univ. Press
    [Google Scholar]
  5. Baltimore D. 2016.. Why we need a summit on human gene editing. . Issues Sci. Technol. 32:(3). https://issues.org/why-we-need-a-summit-on-human-gene-editing/
    [Google Scholar]
  6. Banchoff T. 2011.. Embryo Politics: Ethics and Policy in Atlantic Democracies. Ithaca, NY:: Cornell Univ. Press
    [Google Scholar]
  7. Beecher HK. 1966.. Ethics and clinical research. . N. Engl. J. Med. 274::135460
    [Crossref] [Google Scholar]
  8. Biagioli M. 2011.. Patent specification and political representation: how patents became rights. . In Making and Unmaking Intellectual Property, ed. M Biagioli, P Jaszi, M Woodmansee , pp. 2539. Chicago:: Univ. Chicago Press
    [Google Scholar]
  9. Botelho A. 2021.. The insights of radical science in the CRISPR gene-editing era: a history of science for the people and the Cambridge recombinant DNA controversy. . Sci. Cult. 30:(1):74103
    [Crossref] [Google Scholar]
  10. Brown E. 2004.. The dilemmas of German bioethics. . New Atlantis 5::3753
    [Google Scholar]
  11. Burk DL. 2013.. Edifying thoughts of a patent watcher: the nature of DNA. . UCLA Law Rev. Discourse 60::92102
    [Google Scholar]
  12. Bush V. 1945.. Science: the endless frontier. Rep. Pres. , US Gov. Print. Off., Washington, DC:. https://www.nsf.gov/od/lpa/nsf50/vbush1945.htm
    [Google Scholar]
  13. Callahan D. 1996.. Bioethics, our crowd, and ideology. . Hastings Cent. Rep. 26:(6):34
    [Crossref] [Google Scholar]
  14. Cambrosio A, Keating P. 1995.. Exquisite Specificity: The Monoclonal Antibody Revolution. Oxford, UK:: Oxford Univ. Press
    [Google Scholar]
  15. Carpenter D. 2010.. Reputation and Power: Organizational Image and Pharmaceutical Regulation. Princeton, NJ:: Princeton Univ. Press
    [Google Scholar]
  16. Contreras JL. 2021.. The Genome Defense: Inside the Epic Legal Battle to Determine Who Owns Your DNA. Chapel Hill, NC:: Algonquin Books
    [Google Scholar]
  17. Cook-Deegan R. 1996.. The Gene Wars: Science, Politics, and the Human Genome. New York:: W.W. Norton & Co.
    [Google Scholar]
  18. Coombe RJ. 2011.. Cultural agencies: the legal construction of community subjects and their properties. . In Making and Unmaking Intellectual Property, ed. M Biagioli, P Jaszi, M Woodmansee , pp. 7998. Chicago:: Univ. Chicago Press
    [Google Scholar]
  19. Claw KG, Anderson MZ, Begay RL, Tsosie KS, Fox K, et al. 2018.. A framework for enhancing ethical genomic research with Indigenous communities. . Nat. Commun. 9::2957
    [Crossref] [Google Scholar]
  20. Daemmrich A. 2011.. Pharmacopolitics: Drug Regulation in the United States and Germany. Chapel Hill:: Univ. N.C. Press
    [Google Scholar]
  21. Diamond v. Chakrabarty, 447 US 303 ( 1980.)
  22. Dickersin K, Braun L, Mead M, Millikan R, Wu AM, et al. 2001.. Development and implementation of a science training course for breast cancer activists: Project LEAD (leadership, education and advocacy development). . Health Expect. 4::21320
    [Crossref] [Google Scholar]
  23. Drahos P. 2010.. The Global Governance of Knowledge: Patent Offices and Their Clients. Cambridge, UK:: Cambridge Univ. Press
    [Google Scholar]
  24. Elliott C. 2007.. The tyranny of expertise. . In The Ethics of Bioethics: Mapping the Moral Landscape, ed. LA Eckenwiler, FG Cohn . Baltimore:: Johns Hopkins Univ. Press
    [Google Scholar]
  25. Emily CHC. 2019.. Survival by technopreneurialism: innovation, imaginaries and the new narrative of nationhood in Singapore. . Sci. Technol. Soc. 24:(3):52744
    [Crossref] [Google Scholar]
  26. Epstein S. 1995.. The construction of lay expertise: AIDS activism and the forging of credibility in the reform of clinical trials. . Sci. Technol. Hum. Values 20:(4):40837
    [Crossref] [Google Scholar]
  27. Epstein S. 1996.. Impure Science: AIDS, Activism, and the Politics of Knowledge. Berkeley:: Univ. Calif. Press
    [Google Scholar]
  28. Epstein S. 2007.. Inclusion: The Politics of Difference in Medical Research. Chicago:: Univ. Chicago Press
    [Google Scholar]
  29. Eur. Patent Off. 2007.. Scenarios for the future. Rep. , Eur. Patent Off., Munich, Ger.: https://link.epo.org/web/EPO_scenarios_bookmarked.pdf
    [Google Scholar]
  30. Fidler DP. 2008.. Influenza virus samples, international law, and global health diplomacy. . Emerg. Infect. Dis. 14:(1):8894
    [Crossref] [Google Scholar]
  31. Fisher E. 2005.. Lessons learned from the Ethical, Legal and Social Implications program (ELSI): planning societal implications research for the National Nanotechnology Program. . Technol. Soc. 27::32128
    [Crossref] [Google Scholar]
  32. Foster LA. 2017.. Reinventing Hoodia: Peoples, Plants and Patents in South Africa. Seattle:: Univ. Wash. Press
    [Google Scholar]
  33. Fox K. 2020.. The illusion of inclusion—the “All of Us” research program and Indigenous peoples’ DNA. . New Engl. J. Med. 383:(5):41113
    [Crossref] [Google Scholar]
  34. Fox R, Swazey JP. 2008.. Observing Bioethics. Oxford, UK:: Oxford Univ. Press
    [Google Scholar]
  35. Frederickson DS. 2001.. The Recombinant DNA Controversy: A Memoir: Science, Politics, and the Public Interest 1974–1981. Washington, DC:: ASM Press
    [Google Scholar]
  36. Galasso I. 2024.. Precision medicine for whom? Public health outputs from “Genomics England” and “All of Us” to make up for upstream and downstream exclusion. . Am. J. Bioethics 24::7185
    [Crossref] [Google Scholar]
  37. Gold ER, Gallochat A. 2001.. The European Biotech Directive: past as prologue. . Eur. Law J. 7:(3):33166
    [Crossref] [Google Scholar]
  38. Gottweis H. 2002.. Stem cell policies in the United States and Germany: between bioethics and regulation. . Policy Stud. J. 30:(4):44469
    [Crossref] [Google Scholar]
  39. Halliburton M. 2017.. India and the Patent Wars: Pharmaceuticals in the New Intellectual Property Regime. Ithaca, NY:: Cornell Univ. Press
    [Google Scholar]
  40. Harrison CH. 2002.. Neither Moore nor the market: alternative models for compensating contributors of human tissue. . Am. J. Law Med. 28::77105
    [Crossref] [Google Scholar]
  41. Harry D. 1995.. The Human Genome Diversity Project and its implications for Indigenous peoples. Brief Pap., Inf. Intell. Prop. Rights 6 , Indig. Peoples Counc. Biocolonialism, Nixon, NV:. http://www.ipcb.org/publications/briefing_papers/files/hgdp.html
    [Google Scholar]
  42. Harry D. 2009.. Indigenous peoples and gene disputes. . Chicago-Kent Law Rev. 84:(1):14796
    [Google Scholar]
  43. Hayden C. 2003.. When Nature Goes Public: The Making and Unmaking of Bioprospecting in Mexico. Princeton, NJ:: Princeton Univ. Press
    [Google Scholar]
  44. Heimer C. 2010.. Bureaucratic ethics: IRBs and the legal regulation of human subjects research. . Annu. Rev. Law Soc. Sci. 6::60126
    [Crossref] [Google Scholar]
  45. Hilgartner S. 2009.. Intellectual property and the politics of emerging technology: inventors, citizens, and powers to shape the future. . Chicago-Kent Law Rev. 84:(1):197224
    [Google Scholar]
  46. Hilgartner S. 2017.. Reordering Life: Knowledge and Control in the Genomics Revolution. Cambridge, MA:: MIT Press
    [Google Scholar]
  47. Hogan AJ. 2021.. Life Histories of Genetic Disease: Patterns and Prevention in Postwar Medical Genetics. Baltimore:: Johns Hopkins Univ. Press
    [Google Scholar]
  48. Jasanoff S. 1991.. Acceptable evidence in a pluralistic society. . In Acceptable Evidence: Science and Values in Risk Management, ed. DG Mayo, RD Hollander , pp. 2947. Oxford, UK:: Oxford Univ. Press
    [Google Scholar]
  49. Jasanoff S. 1997.. Science at the Bar: Law, Science, and Technology in America. Cambridge, MA:: Harvard Univ. Press
    [Google Scholar]
  50. Jasanoff S. 2005.. Designs on Nature: Science and Democracy in Europe and the United States. Princeton, NJ:: Princeton Univ. Press
    [Google Scholar]
  51. Jasanoff S. 2006.. States of Knowledge: The Co-Production of Science and the Social Order. Abingdon, UK:: Routledge
    [Google Scholar]
  52. Jasanoff S. 2011.. Reframing Rights: Bioconstitutionalism in the Genetic Age. Cambridge, MA:: MIT Press
    [Google Scholar]
  53. Jasanoff S. 2012.. Taking life: private rights in public nature. . In Lively Capital: Biotechnologies, Ethics, and Governance in Global Markets, ed. K Sunder Rajan , pp. 15583. Durham, NC:: Duke Univ. Press
    [Google Scholar]
  54. Jasanoff S. 2018.. Science, common sense, & judicial power in U.S. courts. . Daedalus 147:(4):1527
    [Crossref] [Google Scholar]
  55. Jasper JM. 2014.. Nuclear Politics: Energy and the State in the United States, Sweden, and France. Princeton, NJ:: Princeton Univ. Press
    [Google Scholar]
  56. Jeungst ET. 1996.. Self-critical federal science? The ethics experiment within the U.S. Human Genome Project. . Soc. Philos. Policy 13:(2):6395
    [Crossref] [Google Scholar]
  57. Jones JH. 1993.. Bad Blood: The Tuskegee Syphilis Experiment. New York:: Free
    [Google Scholar]
  58. Kagan RA. 2003.. Adversarial Legalism: The American Way of Law. Cambridge, MA:: Harvard Univ. Press
    [Google Scholar]
  59. Kahn J. 2000.. Biotechnology and the legal constitution of the self: managing identity in science, the market, and society. . Hastings Law J. 51:(5):90952
    [Google Scholar]
  60. Kahn M. 2019.. The contract between science and society: a South African case study. . Sci. Public Policy 46:(1):11625
    [Crossref] [Google Scholar]
  61. Kanellopoulou N. 2009.. Advocacy groups as research organizations: novel approaches in research governance. . In The Limits to Governance: The Challenge of Policymaking for the New Life Sciences, ed. C Lyall, T Papaioannou, J Smith , pp. 193216. Farnham, UK:: Ashgate
    [Google Scholar]
  62. Kelly SE. 2003.. Public bioethics and publics: consensus, boundaries, and participation in biomedical science policy. . Sci. Technol. Hum. Values 28:(3):33864
    [Crossref] [Google Scholar]
  63. Kent M, García-Deister V, López-Beltrán C, Ventura Santos R, Schwartz-Marín E, Wade P. 2015.. Building the genomic nation: ‘Homo Brasilis’ and the ‘Genoma Mexicano’ in comparative cultural perspective. . Soc. Stud. Sci. 45:(6):83961
    [Crossref] [Google Scholar]
  64. Kevles D. 1998.. In the Name of Eugenics: Genetics and the Uses of Human Heredity. Cambridge, MA:: Harvard Univ. Press
    [Google Scholar]
  65. Klawiter M. 2008.. The Biopolitics of Breast Cancer: Changing Cultures of Disease and Activism. Minneapolis:: Univ. Minn. Press
    [Google Scholar]
  66. Kleinman D. 1995.. Politics on the Endless Frontier: Postwar Research Policy in the United States. Durham, NC:: Duke Univ. Press
    [Google Scholar]
  67. Krimsky S. 1982.. Genetic Alchemy: The Social History of the Recombinant DNA Controversy. Cambridge, MA:: MIT Press
    [Google Scholar]
  68. Landecker H. 1999.. Between beneficence and chattel: the human biological in law and science. . Sci. Context 12:(1):20325
    [Crossref] [Google Scholar]
  69. Landecker H. 2007.. Culturing Life: How Cells Became Technologies. Cambridge, MA:: Harvard Univ. Press
    [Google Scholar]
  70. Löfstedt RE, Vogel D. 2001.. The changing character of regulation: a comparison of Europe and the United States. . Risk Anal. 21:(3):399416
    [Crossref] [Google Scholar]
  71. Lytle MH. 2007.. The Gentle Subversive: Rachel Carson, Silent Spring, and the Rise of the Environmental Movement. Oxford, UK:: Oxford Univ. Press
    [Google Scholar]
  72. Magnus D, Caplan A, McGee G, eds. 2002.. Who Owns Life? Buffalo, NY:: Prometheus Books
    [Google Scholar]
  73. Marshall E. 2004.. Patient advocate named co-inventor on patent for the PXE disease gene. . Science 305:(5688):1226
    [Crossref] [Google Scholar]
  74. Metzler I. 2011.. Between church and state: stem cells, embryos, and citizens in Italian Politics. . In Reframing Rights: Bioconstitutionalism in the Genetic Age, ed. S Jasanoff , pp. 10524. Cambridge, MA:: MIT Press
    [Google Scholar]
  75. Montoya MH. 2011.. Making the Mexican Diabetic: Race, Science, and the Genetics of Inequality. Berkeley:: Univ. Calif. Press
    [Google Scholar]
  76. Moore v. Regents of the University of California, 51 Cal 3d 120 ( 1990.)
  77. Moore A. 2010.. Public bioethics and public engagement: the politics of “proper talk. .” Public Underst. Sci. 19:(2):1972011
    [Crossref] [Google Scholar]
  78. Moore K. 2013.. Disrupting Science: Social Movements, American Scientists, and the Politics of the Military, 1945–1975. Princeton, NJ:: Princeton Univ. Press
    [Google Scholar]
  79. Mulkay M. 1997.. The Embryo Research Debate: Science and the Politics of Reproduction. Cambridge, UK:: Cambridge Univ. Press
    [Google Scholar]
  80. Natl. Res. Counc. 1997.. Evaluating Human Genetic Diversity. Washington, DC:: Natl. Acad. Press
    [Google Scholar]
  81. Nelson J. 2015.. More than Medicine: A History of the Feminist Women's Health Movement. New York:: NYU Press
    [Google Scholar]
  82. Novas C. 2006.. The political economy of hope: patients’ organizations, science and biovalue. . BioSocieties 1::289305
    [Crossref] [Google Scholar]
  83. Orentlicher D. 1999.. The misperception that bioethics and the law lag behind advances in biotechnology: a response to Michael H. Shapiro. . Indiana Law Rev. 33::16372
    [Crossref] [Google Scholar]
  84. Park SS. 2018.. The challenge to gene patents as feminist patent litigation. . Technol. Innov. 19::659670
    [Crossref] [Google Scholar]
  85. Parthasarathy S. 2007.. Building Genetic Medicine: Breast Cancer, Technology, and the Comparative Politics of Health Care. Cambridge, MA:: MIT Press
    [Google Scholar]
  86. Parthasarathy S. 2010.. Breaking the expertise barrier: understanding activist strategies in science and technology policy domains. . Sci. Public Policy 37:(5):35567
    [Crossref] [Google Scholar]
  87. Parthasarathy S. 2015.. Governance lessons for CRISPR/Cas9 from the missed opportunities of Asilomar. . Ethics Biol. Eng. Med. 6:(3–4):30512
    [Crossref] [Google Scholar]
  88. Parthasarathy S. 2017.. Patent Politics: Life Forms, Markets, and the Public Interest in the United States and Europe. Chicago:: Univ. Chicago Press
    [Google Scholar]
  89. Paul D. 1995.. Controlling Human Heredity: 1865 to the Present. Atlantic Highlands, NJ:: Hum. Press Int. Control Nat. ed.
    [Google Scholar]
  90. Pitt J, Diaconescu A. 2014.. The algorithmic governance of common-pool resources. . In From Bitcoin to Burning Man and Beyond: The Quest for Identity and Autonomy in a Digital Society, ed. JH Clippinger, D Bollier , pp. 13345. Amherst, MA:: Off Commons Books
    [Google Scholar]
  91. Pottage A. 1998.. The inscription of life in law: genes, patents, and bio-politics. . Modern Law Rev. 61:(5):74065
    [Crossref] [Google Scholar]
  92. Pres. Comm. Stud. Ethical Probl. Med. Biomed. Behav. Res. 1983.. Screening and Counseling for Genetic Conditions: A Report on the Ethical, Social, and Legal Implications of Genetic Screening, Counseling, and Education Programs. Washington, DC:: US Gov. Print. Off.
    [Google Scholar]
  93. Rabinow P. 1997.. Making PCR: A Story of Biotechnology. Chicago:: Univ. Chicago Press
    [Google Scholar]
  94. Rapp R. 1988.. Chromosomes and communication: the discourse of genetic counseling. . Med. Anthropol. Q. 2:(2):14357
    [Crossref] [Google Scholar]
  95. Reardon J. 2004.. Race to the Finish: Identity and Governance in an Age of Genomics. Princeton, NJ:: Princeton Univ. Press
    [Google Scholar]
  96. Reardon J, Tallbear K. 2012.. Your DNA is our history: genomics, anthropology, and the construction of whiteness as property. . Curr. Anthropol. 53:(S5):S233S45
    [Crossref] [Google Scholar]
  97. Rothman DJ. 1990.. Human experimentation and the origins of bioethics in the United States. . In Social Science Perspectives on Medical Ethics, ed. G Weisz , pp. 185200. Dordrecht, Neth:.: Springer
    [Google Scholar]
  98. Rotimi C, Marshall PA. 2010.. Tailoring the process of informed consent in genetic and genomic research. . Genome Med. 2::20
    [Crossref] [Google Scholar]
  99. Saini A. 2019.. Superior: The Return of Race Science. Boston:: Beacon
    [Google Scholar]
  100. Silbey S, ed. 2008.. Law and Science: Regulation of Property, Practices, and Products, Vol. 2. Farnham, UK:: Ashgate
    [Google Scholar]
  101. Silbey S, Ewick P. 2003.. The architecture of authority: the place of law in the space of science. . In The Place of Law, ed. A Sarat, L Douglas, M Umphrey , pp. 75108. Ann Arbor:: Univ. Mich. Press
    [Google Scholar]
  102. Silverman C. 2011.. Understanding Autism: Parents, Doctors, and the History of a Disorder. Princeton, NJ:: Princeton Univ. Press
    [Google Scholar]
  103. Skloot R. 2011.. The Immortal Life of Henrietta Lacks. New York:: Crown
    [Google Scholar]
  104. Solovey M. 2020.. Social Science for What? Battles over Public Funding for the “Other Sciences” at the National Science Foundation. Cambridge, MA:: MIT Press
    [Google Scholar]
  105. Stark L. 2012.. Behind Closed Doors: IRBs and the Making of Ethical Research. Chicago:: Univ. Chicago Press
    [Google Scholar]
  106. Strathern M. 1996.. Potential property. Intellectual rights and property in persons. . Soc. Anthropol. 4:(1):1732
    [Crossref] [Google Scholar]
  107. Strathern M. 2001.. The patent and the Malanggan. . In Beyond Aesthetics: Art and the Technologies of Enchantment, ed. C Pinney, N Thomas , pp. 25986. Abingdon, UK:: Routledge
    [Google Scholar]
  108. Sunder Rajan K. 2015.. Courting innovation: the constitution of Indian biomedicine. . In Science and Democracy: Making Knowledge and Making Power in the Biosciences and Beyond, ed. S Hilgartner, CA Miller, R Hagendijk , pp. 5673. Abingdon, UK:: Routledge
    [Google Scholar]
  109. Swanson K. 2009.. The emergence of the professional patent practitioner. . Technol. Cult. 50:(3):51948
    [Crossref] [Google Scholar]
  110. Terry SF. 2007.. Advocacy groups as research organizations: the PXE International example. . Nat. Rev. Genet. 8::15764
    [Crossref] [Google Scholar]
  111. Thompson C. 2013.. Good Science: The Ethical Choreography of Stem Cell Research. Cambridge, MA:: MIT Press
    [Google Scholar]
  112. Tsai Y, Lee W. 2021.. An imagined future community: Taiwan Biobank, Taiwanese genome, and nation-building. . BioSocieties 16::88115
    [Crossref] [Google Scholar]
  113. Van Hoyweghen I, Aarden E. 2022.. One for all, all for one? Containing the promise of solidarity in precision medicine. . Crit. Public Health 32:(4):56879
    [Crossref] [Google Scholar]
  114. Vegter MW, Landeweerd L, Zwart HAE. 2022.. N = many me's: self-surveillance for Precision Public Health. . BioSocieties 17::7998
    [Crossref] [Google Scholar]
  115. Warnock M. 1990.. Government commissions. . In Human Embryos and Research: Proceedings of the European Bioethics Conference in Mainz, 7–9 November 1988, ed. U Bertazzoni, P Fasella, A Klepsch, P Lange , pp. 15968. Frankfurt, Ger:: Campus Verlag
    [Google Scholar]
  116. Washington H. 2008.. Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times. New York:: Anchor Books
    [Google Scholar]
  117. Weiner C. 2001.. Drawing the line in genetic engineering: self-regulation and public participation. . Perspect. Biol. Med. 44:(2):20820
    [Crossref] [Google Scholar]
  118. Wilson D. 2014.. The Making of British Bioethics. Manchester, UK:: Manch. Univ. Press
    [Google Scholar]
  119. Wright S. 1994.. Molecular Politics: Developing American and British Regulatory Policy for Genetic Engineering, 1972–1982. Chicago:: Univ. Chicago Press
    [Google Scholar]
  120. Yesley MS. 2008.. What's ELSI got to do with it? Bioethics and the Human Genome Project. . New Genet. Soc. 27:(1):16
    [Crossref] [Google Scholar]
  121. Zwart H, Nelis A. 2009.. What is ELSA genomics?. EMBO Rep. 10::54044
    [Crossref] [Google Scholar]
/content/journals/10.1146/annurev-lawsocsci-041822-041426
Loading
  • Article Type: Review Article
This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error