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Biosensors: Ethical, Regulatory, and Legal Issues

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Handbook of Cell Biosensors

Abstract

The highest attainable standard of health is a fundamental human right as envisaged in important international human rights instruments. Biosensors have the prospect to introduce revolutionary changes in the promotion, preservation, and protection of human health, which are fundamental to enjoy other human rights. The biosensors are also promising in the monitoring of various components of the environment and biodiversity, and thus, can be used to attain some of the 2030 United Nations Sustainable Development Goals. With all the promises, there remain some legal, regulatory, and ethical challenges and concerns as well. This is because, in the different stages of the cradle-to-grave life cycle of scientific research and product development, many stakeholders are involved, and various legal and ethical issues evolve. While the ongoing R&D activities should be continued for the betterment of mankind, consideration of relevant ethical and legal issues should not be ignored. Various international and national bodies, having the authority to guide effective regulation and development of scientific and technological applications, have already developed some general regulatory tools, which are either process or product based and can be used in the context of biosensors also, though there is a dearth of such instrument exclusively in the context of biosensors. As this may not be possible to cover every single legal and ethical issues relating to biosensors precisely, this chapter highlights some of the important legal and ethical issues relating to the biosensor.

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References

  • Altenstetter C (2017) Medical technology in Japan: the politics of regulation. Routledge

    Google Scholar 

  • Bhalla N et al (2016) Introduction to biosensors. Essays Biochem 60(1):1–8

    PubMed  PubMed Central  Google Scholar 

  • Bidmanova S et al (2016) Fluorescence-based biosensor for monitoring of environmental pollutants: from concept to field application. Biosens Bioelectron 84:97–105

    CAS  PubMed  Google Scholar 

  • Chen Y-J et al (2018) A comparative study of medical device regulations: US, Europe, Canada, and Taiwan. Ther Innov Regul Sci 52(1):62–69

    CAS  PubMed  Google Scholar 

  • Dana GV et al (2012) Four steps to avoid a synthetic-biology disaster. Nature 483(7387):29–29

    CAS  PubMed  Google Scholar 

  • Dar FA, Qazi G, Pirzadah TB (2020) Nano-biosensors: NextGen diagnostic tools in agriculture. In: Nanobiotechnology in agriculture. Springer, pp 129–144

    Google Scholar 

  • Donders Y (2011) The right to enjoy the benefits of scientific progress: in search of state obligations in relation to health. Med Health Care Philos 14(4):371–381

    PubMed  PubMed Central  Google Scholar 

  • Faden RR, Beauchamp TL (1986) A history and theory of informed consent. Oxford University Press, New York

    Google Scholar 

  • Farré M et al (2009) Sensors and biosensors in support of EU directives. TrAC Trends Anal Chem 28(2):170–185

    Google Scholar 

  • Fatoyinbo HO, Hughes MP (2012) Biosensors. In: Bhushan B (ed) Encyclopedia of nanotechnology. Springer Netherlands, Dordrecht, pp 329–345

    Google Scholar 

  • Foster KR, Vecchia P, Repacholi MH (2000) Science and the precautionary principle. Science 288(5468):979–981

    CAS  PubMed  Google Scholar 

  • French CE et al (2011) Synthetic biology and the art of biosensor design. In: The science and applications of synthetic and systems biology: workshop summary. National Academies Press, Washington, DC

    Google Scholar 

  • Gerke S et al (2019) Ethical and legal issues of ingestible electronic sensors. Nat Electron 2(8):329–334

    Google Scholar 

  • Gilbert SG (2020) Precautionary principle. In: Information resources in toxicology. Elsevier, pp 489–494

    Google Scholar 

  • Gold BD (1993) Congressional activities regarding misconduct and integrity in science. In: Responsible science: ensuring the integrity of the research process, committee on science, engineering, and public policy, panel on scientific responsibility and the conduct of research. National Academies Press

    Google Scholar 

  • Griffiths D, Hall G (1993) Biosensors – what real progress is being made? Trends Biotechnol 11(4):122–130

    CAS  PubMed  Google Scholar 

  • Guinée JB et al (2017) Setting the stage for debating the roles of risk assessment and life-cycle assessment of engineered nanomaterials. Nat Nanotechnol 12(8):727

    PubMed  Google Scholar 

  • Gupta S, Kakkar V (2020) Development of environmental biosensors for detection, monitoring, and assessment. In: Nanomaterials and environmental biotechnology. Springer, pp 107–125

    Google Scholar 

  • Kansu E, Ruacan S (2002) Research ethics and scientific misconduct in biomedical research. In: Research and publishing in neurosurgery. Springer, Vienna, pp 11–15

    Google Scholar 

  • Karim ME (2005) Citizen’s right to privacy: Reflection in the international instruments and national laws. Bangladesh J Law 9(1–2):35–68

    Google Scholar 

  • Karim M (2010) Health as human rights under national and international legal framework: Bangladesh perspective. JE Asia Int’l L 3:337

    Google Scholar 

  • Karim ME, Munir AB (2016) Nanotechnology and international environmental law: a preliminary assessment. In: Advanced environmental analysis, pp 348–380

    Google Scholar 

  • Karim ME et al (2015) Too enthusiastic to care for safety: present status and recent developments of nanosafety in ASEAN countries. Technol Forecast Soc Chang 92:168–181

    Google Scholar 

  • Karim ME et al (2018) Polymer nanocomposites and related legal issues: an overview. In: New polymer nanocomposites for environmental remediation. Elsevier, pp 679–698

    Google Scholar 

  • Kumar MN (2008) A review of the types of scientific misconduct in biomedical research. J Acad Ethics 6(3):211–228

    Google Scholar 

  • Levi-Faur D (2011) Regulation and regulatory governance. In: Levi-Faur D (ed) Handbook on the politics of regulation. Edward Elgar Publishing, Cheltenham, pp 3–21

    Google Scholar 

  • Luna R et al (2016) Cyber threats to health information systems: a systematic review. Technol Health Care 24(1):1–9

    PubMed  Google Scholar 

  • Mallardi V (2005) The origin of informed consent. Acta Otorhinolaryngol Ital 25(5):312–327

    CAS  PubMed  Google Scholar 

  • Marmot M et al (2012) WHO European review of social determinants of health and the health divide. Lancet 380(9846):1011–1029

    PubMed  Google Scholar 

  • Mufamadi M, Sekhejane P (2017) Nanomaterial-based biosensors in agriculture application and accessibility in rural smallholding farms: food security. In: Nanotechnology. Springer, pp 263–278

    Google Scholar 

  • Munir AB, Siti HM, Md Ershadul K (2018) Data protection law in Asia. Sweet & Maxwell/Thomson Reuters

    Google Scholar 

  • Muralikrishna, I.V. and V. Manickam, Chapter five – life cycle assessment, in Environmental management, I.V. Muralikrishna and V. Manickam, Editors. 2017, Butterworth-Heinemann Oxford. p. 57–75

    Google Scholar 

  • Olson N, Bae J (2019) Biosensors—publication trends and knowledge domain visualization. Sensors 19(11):2615

    CAS  Google Scholar 

  • Owen R (2014) The UK Engineering and Physical Sciences Research Council's commitment to a framework for responsible innovation. J Resp Innov 1(1):113–117

    Google Scholar 

  • Rabin RL, Picard AJ (2018) Reassessing the regulation of high-risk medical device cases. DePaul L Rev 68:309

    Google Scholar 

  • Saini R et al (2019) Advances in whole cell-based biosensors in environmental monitoring. In: Tools, techniques and protocols for monitoring environmental contaminants. Elsevier, pp 263–284

    Google Scholar 

  • Salieri B et al (2018) Life cycle assessment of manufactured nanomaterials: where are we? Nano Impact 10:108–120

    Google Scholar 

  • Sha R, Badhulika S, Mulchandani A (2017) Graphene-based biosensors and their applications in biomedical and environmental monitoring. In: Label-free biosensing. Springer, pp 261–290

    Google Scholar 

  • Smith R (2016) Statutory regulation needed to expose and stop medical fraud. Br Med J Publ Group

    Google Scholar 

  • Steneck NH (1994) Research universities and scientific misconduct: history, policies, and the future. J High Educ 65(3):310–330

    Google Scholar 

  • Steneck NH, Bulger RE (2007) The history, purpose, and future of instruction in the responsible conduct of research. Acad Med 82(9):829–834

    PubMed  Google Scholar 

  • Stevenson H et al (2019) A rapid response electrochemical biosensor for detecting Thc in saliva. Sci Rep 9(1):1–11

    Google Scholar 

  • Verma N, Singh M (2005) Biosensors for heavy metals. Biometals 18(2):121–129

    CAS  PubMed  Google Scholar 

  • Vilariño N et al (2009) Use of biosensors as alternatives to current regulatory methods for marine biotoxins. Sensors 9(11):9414–9443

    PubMed  Google Scholar 

  • Wan X, Ho TY, Wang B (2019) Engineering prokaryote synthetic biology biosensors. In: Handbook of cell biosensors, pp 1–37

    Google Scholar 

  • Wells F, Farthing M (2008) Fraud and misconduct in biomedical research. CRC Press

    Google Scholar 

  • Wyndham JM, Harris T (2014) Introduction: science, technology and human rights: lessons learned from the right to water and sanitation. Sci Eng Ethics 20(4):827–831

    PubMed  Google Scholar 

  • Yáñez-Sedeño P et al (2014) Biosensors in forensic analysis. A review. Anal Chim Acta 823:1–19

    PubMed  Google Scholar 

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Correspondence to Mohammad Ershadul Karim .

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Karim, M.E. (2020). Biosensors: Ethical, Regulatory, and Legal Issues. In: Thouand, G. (eds) Handbook of Cell Biosensors. Springer, Cham. https://doi.org/10.1007/978-3-319-47405-2_23-1

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  • DOI: https://doi.org/10.1007/978-3-319-47405-2_23-1

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