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Precision Medicine

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Handbook of Bioethical Decisions. Volume I

Part of the book series: Collaborative Bioethics ((CB,volume 2))

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Abstract

Precision medicine combines genetic, environmental and lifestyle variability to inform disease diagnosis, treatment and prevention, allowing exact medical interventions both on individual and population levels. Data-driven precision medicine measures constitute an informational intervention that is dynamic in time, space and in terms of actors and groups involved, as well as regarding the relevance of results and the causality of decisions. Correspondingly, normative guidance for decision making is characterised by strong proceduralisation. When justifying data processing, the changing role of patients in relation to data processing needs to be respected. It not only influences the design of informed consent, but significantly impacts data security in response to identified risks. Further issues in precision medicine include dealing with anonymisation as well as the return of research results. New tools such as machine learning and its application through neurotechnologies pose challenges to patients’ autonomy, benefit production, sharing, justice and equity. In response to the need for dynamic guidance to engage with these particular challenges, procedural measures and tools framing conduct of precision medicine have emerged, including codes of conduct, closer ethics committee scrutiny and data stewardship models. These tools enable ethics-by-design and contribute to coordination between ethical and legal rules.

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Notes

  1. 1.

    An extensive reappraisal of the scholarly literature on dealing with additional findings and the return of results of (translational) research, including its semantic description, cannot possibly be reproduced here. For examples, cf. Wolf et al., 2008; Knoppers & Dam, 2011; Hayden, 2012; Green et al., 2013; Zawati et al., 2014; Pereira et al., 2016; Wolf & Evans, 2018; Dyke et al., 2019; Clayton et al., 2021.

  2. 2.

    For a conceptual presentation of the relationship between bioethics and biolaw, cf. only Knowles, 2001; Ashcroft, 2008; Sperling, 2008; Lecaros, 2019; Valdés, 2019.

  3. 3.

    Codes of Conduct are also anchored in EU data protection law, cf. Art. 40 of the EU General Data Protection Regulation (GDPR).

  4. 4.

    Cf. Recital 33 of the GDPR. According to this (non-binding) provision, data subjects should be allowed to give their consent to certain areas of scientific research when in keeping with recognised ethical standards for scientific research. Hereby, compliance with recognized ethical standards can be fulfilled by adhering to ethics committees’ authorisation of the research planned.

  5. 5.

    Proposal for a Regulation of the European Parliament and of the Council on European data governance (Data Governance Act). COM/2020/767 final. https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52020PC0767&from=EN

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  1. University of Heidelberg, Heidelberg, Germany

    Fruzsina Molnár-Gábor

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  1. Institute of Science and Innovation in Medicine (ICIM), Universidad del Desarrollo, Santiago, Chile

    Erick Valdés

  2. Institute of Science and Innovation in Medicine (ICIM), Universidad del Desarrollo, Santiago, Chile

    Juan Alberto Lecaros

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Molnár-Gábor, F. (2023). Precision Medicine. In: Valdés, E., Lecaros, J.A. (eds) Handbook of Bioethical Decisions. Volume I. Collaborative Bioethics, vol 2. Springer, Cham. https://doi.org/10.1007/978-3-031-29451-8_23

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