Ethical and Regulatory Questions Related to Engineered Molecular Systems (NCCR-MSE)
[Status: Active]
This project investigates the ethical and regulatory implications of Engineered Molecular Systems (MSE) for clinical innovation, focusing on societal appraisal, clinical translation, and regulatory standards. It utilizes integrated empirical and normative research, alongside stakeholder engagement, to develop ethical guidelines and a comprehensive regulatory roadmap for MSE technologies.
Project Team
Effy Vayena (Project Lead)
Alessandro Blasimme
Renan Goncalves Leonel da Silva
Description
Molecular Systems Engineering (MSE) constitutes a novel approach to clinical innovation that considerably expands the toolbox of molecular sciences and healthcare both theoretically and technically. The prospects of this emerging field to bring about scientific and clinical innovation crucially depend on proactively addressing potential ethical and regulatory bottlenecks.
Such issues include three major domains, that is: issues associated with society’s appraisal of the novel bio-technological characteristics of engineered molecular systems; the ethical and legal aspects linked to the clinical translation of MSE into healthcare applications; and the development of appropriate regulatory standards for the assessment of MSE applications by regulatory agencies.
To address those issues, this project brings new empirical research and analytical competences on ethics and regulatory issues of MSE technologies. Normative and empirical research on the ethics of MSE will result in specific ethical guidelines to guide the long-term development of the field in the future. As far as regulatory aspects are concerned, relevant national and international stakeholders – including regulators – will be engaged and a regulatory roadmap for MSE will be developed.
da Silva, R. G. L., Blasimme, A., Vayena, E., & Ormond, K. E. (2024). How Do Molecular Systems Engineering Scientists Frame the Ethics of Their Research?. AJOB Empirical Bioethics, 15(3), 226-235. external page https://doi.org/10.1080/23294515.2024.2302994
da Silva, R. G. L., & Blasimme, A. (2024). From lab to society: Fostering clinical translation of molecular systems engineering. Bioengineering & Translational Medicine, 9(1), e10564. external page https://doi.org/10.1002/btm2.10564
Gonçalves Leonel da Silva, R. (2024). Field Definition as Alignment Work: Constructing Molecular Systems Engineering in the Virtual Arena. Field Definition as Alignment Work: Constructing Molecular Systems Engineering in the Virtual Arena (July 30, 2024). https://ssrn.com/abstract=4910616
da Silva, R. G. L., Schweizer, J., Kamenova, K., Au, L., Blasimme, A., & Vayena, E. (2024). Organizational change of synthetic biology research: Emerging initiatives advancing a bottom-up approach. Current Research in Biotechnology, 7, external page 100188.
da Silva, R. G. L., Au, L., & Blasimme, A. (2024). Organizational aspects of tissue engineering clinical translation: insights from a qualitative case study. Translational Medicine Communications, 9(1), 17. external page https://doi.org/10.1186/s41231-024-00179-7
da Silva, R. G. L., & Blasimme, A. (2023). Organ chip research in Europe: players, initiatives, and policies. Frontiers in Bioengineering and Biotechnology, 11, 1237561. external page https://doi.org/10.3389/fbioe.2023.1237561
da Silva, R. G. L. (2024). The advancement of artificial intelligence in biomedical research and health innovation: challenges and opportunities in emerging economies. Globalization and Health, 20(1), 44. external page https://doi.org/10.1186/s12992-024-01049-5
Brocher Foundation Workshop – Geneva (2025)
In the expert meeting “Research With Human Stem-Cell-Based Embryo Models: Defining Ethical Boundaries,” Dr. Blasimme presented on “Regulating Embryo Models in Switzerland.” The talk addressed the adequacy of existing legal and ethical standards and examined how national governance structures are adapting to scientific advances in embryo modeling.
Science and Democracy Network Meeting – ETH Zurich (2025)
At the 23rd Annual Science and Democracy Network Meeting, co-hosted by Harvard STS and ETH Zurich, Alessandro Blasimme, Renan Leonel Da Silva, and Robert Strutt presented “Unfolding Life, Remaking Orders: Stem Cell Models and the Politics of Embryonic Life.” The talk examined how embryo modeling reconfigures the normative and political orders that govern the life sciences.
STS Circle Seminar – Harvard University (2024)
As part of the STS Circle at Harvard, Dr. Blasimme delivered a seminar exploring the civic epistemologies and regulatory imaginaries reshaped by embryo model research. The presentation highlighted how emerging biological practices challenge traditional ethical regimes and call for new normative frameworks.
Fellows Retreat of the National Centre of Competence in Research "Molecular Systems Engineering" (2025)
Presentation title: What do molecular systems engineering scientists think about the ethics of their research?. 2023.
Life Sciences Seminar Series - Fachhochschule Nordwestschweiz FHNW (2023)
Presentation title: Understanding knowledge ecosystems of translational bioengineering: the case of organ chips.
EASST Annual Meeting of the European Association for the Study of Science and Technology (2022)
Presentation title: Designing functional bodies: artificial molecular machines and the future of biomedical innovation.
Fellows Retreat of the National Centre of Competence in Research - Molecular Systems Engineering (2022)
Presentation title: The global scientific landscape of molecular systems engineering: key players and future trends.
Brookhaven Collaborations Summer - US nanomaterials sciences and engineering network (2022)
Presentation title: Where knowledge systems meet: engineering at the nano-scalein Europe and United States.
Seminar Series of the Robert K Merton Center for Science Studies, Humboldt University of Berlin (2022)
Presentation title: Reordering bioengineering: Localizing rationales and epistemic traditions of the research on life-inspired functional systems.
Workshop on Molecular engineering, Biomedicine and Society (2022)
We held a workshop on Molecular engineering, Biomedicine and Society in Zurich, Switzerland on June 13 2022. The event consisted of an interdisciplinary panel/meeting of experienced researchers - as well as policy-makers and leaders of civil society initiatives - with a solid background from Science and Technology Studies, Molecular Systems Engineering, Nanotechnology, Bioethics, Synthetic Biology, and Biomedical engineering. The event aimed to understand the configuration of contemporary knowledge Infrastructures in molecular engineering technologies, and it interfaces with the global biomedical and healthcare research. During the workshop, we explored emerging challenges and implications of innovations in this field in society, Science and Technology Policy, and on the ethics of engineering living systems biology. If you would like to watch the workshop video records see: https://video.ethz.ch/events/2022/molecular_engineeringws.html (available at the ETH Video Portal).
4S Annual Meeting of the Society for Social Studies of Science (2021)
Presentation title: Toward Social Study of Molecular System Engineering: evidence from European scientific consortia.
