Hostname: page-component-586b7cd67f-rdxmf Total loading time: 0 Render date: 2024-11-26T05:24:53.035Z Has data issue: false hasContentIssue false
  • English
  • Français

Ethical Assessment and Reflection in Research and Development of Non-Conformité Européene Marked Medical Devices

Published online by Cambridge University Press:  07 September 2020

PATRIK K. TELLÉUS  and
WINNIE JENSEN
Get access Rights & Permissions [Opens in a new window]

Abstract

Today there are multiple implantable medical devices on the market. The type of implants that interface the body’s tissues has been considered to have particular strong ethical implications. This article describes a development of a novel practice for ethical assessment and reflection within medical device research and development of non-CE marked medical devices, taking the perspective of both the ethicist and the researcher. The research case was an EU funded project where the aim was to develop and compare the efficiency of invasive and non-invasive technological medical devices to create meaningful sensations as a novel therapy for phantom limb pain. An Independent Ethical Advisor (IEA) with a regulatory and advisory role was assigned to the project, allowing us to investigate the projects deliberate incorporation of ethics. In the article we suggest and applied a novel framework based on action research for combining ethical assessment with building ethical reflection. The case analyse five different activities / elements: 1) the use of informed consent; 2) a survey amongst the research partners; 3) a workshop session; 4) observation of consortium meetings; and 5) an interview with a participating patient.

Keywords

NeuroethicsResearch ethicsAction researchbiotechnology ethics
Type
Articles
Information
Cambridge Quarterly of Healthcare Ethics , Volume 29 , Special Issue 4: Clinical Neuroethics , October 2020 , pp. 592 - 606
Copyright
© The Author(s), 2020. Published by Cambridge University Press

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Notes

Hansson, SO. Implant ethics. Journal of Medical Ethics 2005;31:519–525. doi:10.1136/jme.2004.009803.CrossRefGoogle ScholarPubMed
The EU Medical Device Directive.Google Scholar
Collingwood, D. The Social Control of Technology. London, UK: Pinter; 1980.Google Scholar
Koepsell, D. On genies and bottles: Scientists’ moral responsibility and dangerous technology R&D. Science and Engineering Ethics 2010;16:119–133. doi:10.1007/s11948-009-9158-x.Google ScholarPubMed
Douglas, HE. The moral responsibilities of scientists (Tensions between autonomy and responsibility). American Philosophical Quarterly 2003;40(1):59–68.Google Scholar
Moreno, JD. Ethics consultation as moral engagement. In: Kuhse, H, Singer, P, eds. Bioethics—An Anthology. 2nd ed. Malden, MA: Blackwell Publishing; 2006, at 707–14.Google Scholar
Tsai, TC, Harasym, PH, Coderre, S, McLaughlin, K, Donnon, T. Assessing ethical problem solving by reasoning rather than decision making. Medical Education 2009;43:1188–1197. doi:10.1111/j.1365-2923.2009.03516.x.CrossRefGoogle ScholarPubMed
Svantesson, M, Anderzén-Carlsson, A, Thorsén, H, Kallenberg, K, Ahlström, G. Interprofessional ethics rounds concerning dialysis patients: Staff’s ethical reflections before and after rounds. Journal of Medical Ethics 2008;34:407–413. doi:10.1136/jme.2007.023572.CrossRefGoogle ScholarPubMed
Riis, O. Ethical theory and popular ethics. In: Nykänen, H, Riis, O, Zeller, J, eds. Theoretical and Applied Ethics. Aalborg: Aalborg University Press; 2013, at 95–113.Google Scholar
Poikkeus, T, Suhonen, R, Katajisto, J, Leino-Kilpi, H. Organisational and individual support for nurses’ ethical competence: A cross-sectional survey. Nursing Ethics 2018;25(3):376–392. doi:10.1177/0969733016642627.CrossRefGoogle ScholarPubMed
Nortvedt, F, Engelsrud, G. “Imprisoned” in pain: Analyzing personal experiences of phantom pain. Medicine, Health Care and Philosophy 2014;17(4):599–608. doi:10.1007/s11019-014-9555-z.CrossRefGoogle ScholarPubMed
Jensen, W. Natural sensory feedback for phantom limb pain modulation and therapy. Biosystems and Biorobotics 2017;15:719–723. doi:10.1007/978-3-319-46669-9_118.CrossRefGoogle Scholar
Guiho, T, Andreu, D, López-Alvarez, VM, Cvancara, P, Hiairrassary, A, Granata, G, et al. Advanced 56 channels stimulation system to drive intrafascicular electrodes. Biosystems and Biorobotics 2017;15:743–747. doi:10.1007/978-3-319-46669-9_122.CrossRefGoogle Scholar
Yoshida, K, Malec, J, Comoglio, C, Mosier, K, Lontis, R, Larsen, K, et al. Evaluation of the effect of sensory feedback on phantom limb pain in multi-center clinical trials. Biosystems and Biorobotics 2017;15:725–730. doi:10.1007/978-3-319-46669-9_119.CrossRefGoogle Scholar
Granata, G, Di Iorio, R, Romanello, R, Iodice, F, Raspopovic, S, Petrini, F, et al. Phantom somatosensory evoked potentials following selective intraneural electrical stimulation in two amputees. Clinical Neurophysiology 2018;129(6):1117–1120. doi:10.1016/j.clinph.2018.02.138.CrossRefGoogle ScholarPubMed
Roles and functions of Ethical Advisors/Ethical Advisory Boards in EC-Funded Projects.Google Scholar
Reason, P, Bradbury, H, eds. The SAGE Handbook on Action Research: Participative Inquiry and Practice. 2nd ed. London, UK: SAGE Publications; 2008. doi:10.1177/1476750311414740.Google Scholar
Eikeland, O. Phrónêsis, aristotle, and action research. International Journal of Action Research 2006;2(1):5–53.Google Scholar
Greenwood, DJ, Levin, M. Introduction to Action Research: Social Research for Social Change. 2nd ed. London: SAGE Publications; 2007.CrossRefGoogle Scholar
A, Crary. Wittgenstein and the Moral Life: Essays in Honor of Cora Diamond. Cambridge, MA: MIT Press; 2007. doi:10.1086/587764.Google Scholar
Telléus, PK. Begreppslig betänksamhet—Att filosofiskt bidrag till den tillämpade etiken. [Conceptual deliberation—A philosophical contribution to applied ethics] [dissertation]. Aalborg, Denmark: Aalborg University; 2013.Google Scholar
Biggs, J, Collis, KF. Evaluating the Quality of Learning: The SOLO Taxonomy. Cambridge, MA: Academic Press; 1982. doi:10.1177/089202068700100412.Google Scholar
Bernstein, J. Disciplinarity and transdisciplinarity in the study of knowledge. Informing Science: The International Journal of an Emerging Transdiscipline 2017;17:241–273. doi:10.28945/2047.CrossRefGoogle Scholar
Buanes, A, Jentoft, S. Building bridges: Institutional perspectives on interdisciplinarity. Futures 2009;41:446–454. doi:10.1016/j.futures.2009.01.010.Google Scholar
Frodeman, R. Sustainable Knowledge: A Theory of Interdisciplinarity. New York, NY: Palgrave Macmillan; 2014. doi:10.1057/9781137303028.CrossRefGoogle Scholar
See note 25, Frodeman 2014.Google Scholar
Telléus, PK. On rational demand: A sensible answer to the request of ethical awareness within the Aalborg model. In: Krogh, L, Aarup Jensen, A, eds. Visions, Challenges and Strategies—PBL Principles and Methodologies in a Danish and Global Perspective. Aalborg: Aalborg University Press; 2013, at 315–34.Google Scholar
Boix Mansilla, V, Duraisingh, ED. Targeted assessment of students’ interdisciplinary work: An empirically grounded framework proposed. The Journal of Higher Education 2007;78(2):215–237. doi:10.1353/jhe.2007.0008.CrossRefGoogle Scholar
Hung, W, Jonassen, DH, Liu, R. Problem-based learning. In: Spector, JM, van Merriënboer, JJG, Merrill, MD, Driscoll, M, eds. Handbook of Research on Educational Communications and Technology. Mahwah, NJ: Erlbaum; 2008, at 485–506.Google Scholar
Ploug, T, Holm, S. Informed consent and routinisation. Journal of Medical Ethics 2013;39(4):214–8. doi:10.1136/medethics-2012-101056.CrossRefGoogle ScholarPubMed
von Schomberg, R. Prospects for technology assessment in a framework of responsible research and innovation. In: Dusseldorp, M, Beecroft, R, eds. Technikfolgen Abschätzen Lehren: Bildungspotenziale Transdisziplinärer Methoden. Wiesbaden, Germany: Springer Fachmedien; 2012. doi:10.1007/978-3-531-93468-6_2.Google Scholar
Williams, B. Ethics. In: Grayling, AC, ed. Philosophy—A Guide through the Subject. Oxford: Oxford University Press; 1995, at 545–82.Google Scholar
Merton, RK. The normative structure of science. In: The Sociology of Science—Theoretical and Empirical Investigations. Chicago: The University of Chicago Press; 1973.Google Scholar
Popper, K. The moral responsibility of the scientist. Secur Dialogue 1971;2:279–83.Google Scholar
Belsey, A. The moral responsibility of the scientist. Philosophy 1978;53(203):113–8.Google Scholar