Biography

Michael has an MA (by Research and Thesis) and PhD from the interdisciplinary Institute for Science and Society (ISS) at the University of Nottingham. He also holds a BSc in Biology from the University of St. Andrews (2000). Michael has recently acted as Principal Investigator on the ESRC-funded project 'Biomodifying technologies and experimental space’, (2017-2020) and is now working on the 'sister' prohect BioGov: Governing biomodification in the life sciences' with professor Kaye. Both projects involve collaboration between researchers from the Universities of Oxford, Sussex and York to examine three '‘gateway technologies’ with wide-ranging applications in medicine and the life sciences; gene editing, induced pluripotent stem cells, and 3D printing of living material. Each of these technologies enables researchers to modify living biological tissue in novel and increasingly patient-orientated and customized ways, which challenge the suitability of traditional manufacturing, governance and reimbursement pathways designed for small molecule pharmaceuticals or medical devices.

Michael has previously worked on the IMI STEMBANCC project at Oxford (2012-2017), providing governance and ethical support to this European public-private partnership in stem cell biobanking. He has also been a researcher on the European Framework Programme 7 'Regenerative Medicine in Europe' (REMEDiE) project at the University of York and with the Health Technology and Society group at the University of Exeter. More details his research, review activity and publications can be found via ResearchGate and his ORCID profile.

Publications

Recent additions

  • Umemura, M. and M Morrison, 'Comparative lessons in regenerative medicine readiness: learning from the UK and Japanese experience' (2021) 16 Regenerative Medicine
    DOI: 10.2217/rme-2020-0136
    This paper explores how ‘regenerative readiness’ varies between different national research and healthcare systems. Here, ‘readiness’ refers to both the readiness of a given technology and the ability of a given setting to adopt a new technology. We compare two settings that have taken active yet dissonant approaches to improve readiness: the UK and Japan. Existing scholarship observes that disruptive technologies such as regenerative medicine require many adaptations to become useable and function along the principles of their design. We incorporate the sociotechnical systems framework to consider the range of adaptive measures taken across elements of the sociotechnical system for novel technological adoption. Building upon existing works on technology readiness and institutional readiness, we also expand the conceptualization of readiness toward system-wide readiness.
  • Stephens, N., M Morrison, Martin, P. and Hogle, L., 'Spatiotemporal readiness is key to preparing regenerative medicine for the clinic' (2021) 16 Regenerative Medicine
    DOI: 10.2217/rme-2020-0164
    As regenerative medicine products scale up, researchers turn their attention beyond the ongoing technical challenges of collecting, preserving and delivering gene- and cell-based products to manufacturing and business operations, including process control, automation, supply chain and logistics, and the viability of business model alternatives. Assessing readiness for clinical use, however, requires an integrated assessment across all of these crucial components, including how well they fit together (or not), how synergies might enable platform opportunities and, critically, what kinds of infrastructures should be created to support a range of cell- and tissue-based products and services. Infrastructures reveal the way that futures are anticipated while shaping things in the present [1]. Yet large investments, including major changes to physical facilities, organizational structures and processes, can make it difficult to change things later [2]. There is much at stake, then, for institutional readiness in terms of having robust, yet adaptable, infrastructures. We suggest that analysis of the spatial and temporal aspects of infrastructure is a useful way to take a more integrated view across all manufacturing phases, participants and components of regenerative medicine when assessing institutional readiness. We use the concept of institutional readiness [3] as a way to frame the interrelation of material technologies, knowledge bases and social and economic factors affecting translation. We focus on the UK and use the term ‘advanced therapy medicinal products’ to encompass the variety of cell-, tissue- and gene-based therapies that involve altering biological characteristics. Although it is self-evident that there are specific spatial and temporal needs for different cell types and delivery models, we discuss major planning issues that all share.
  • M Morrison, 'Policy briefing: Trends in customization and personalization of advanced therapies' (2021) RegMedNet.com
    Biomodifying technologies policy briefing 3#
    This briefing looks at the potential for ‘customization’ and ‘personalization’ in the clinical translation of therapies based on gene editing, induced pluripotent stem cells (iPSCs) and 3D bioprinting. Customization and personalization involve tailoring some part of a product or process to a specific situation and context, which in medicine is often done to meet the requirements of an individual patient. While scope for personalized ‘one-off’ therapies remains limited, a variety of forms of ‘mass customization’, at the level of both therapeutic products and manufacturing processes, could complement mass-produced cell and gene therapies. Future policy developments need to evaluate whether to support one or several forms of manufacturing within the UK healthcare sector, as each requires different forms of support, skill sets from the workforce and logistical and regulatory hurdles to viability.

Journal Article (31)

Umemura, M. and M Morrison, 'Comparative lessons in regenerative medicine readiness: learning from the UK and Japanese experience' (2021) 16 Regenerative Medicine
DOI: 10.2217/rme-2020-0136
This paper explores how ‘regenerative readiness’ varies between different national research and healthcare systems. Here, ‘readiness’ refers to both the readiness of a given technology and the ability of a given setting to adopt a new technology. We compare two settings that have taken active yet dissonant approaches to improve readiness: the UK and Japan. Existing scholarship observes that disruptive technologies such as regenerative medicine require many adaptations to become useable and function along the principles of their design. We incorporate the sociotechnical systems framework to consider the range of adaptive measures taken across elements of the sociotechnical system for novel technological adoption. Building upon existing works on technology readiness and institutional readiness, we also expand the conceptualization of readiness toward system-wide readiness.
Takashima, K., M Morrison and Minari, J., 'Reflection on the enactment and impact of safety laws for regenerative medicine in Japan' (2021) Stem Cell Reports
DOI: https://doi.org/10.1016/j.stemcr.2021.04.017
Japan's Act on the Safety of Regenerative Medicine (ASRM) created an innovative regulatory framework intended to safely promote the clinical development of stem cell-based interventions (SCBIs) while subjecting commercialized unproven SCBIs to greater scrutiny and accountability. This article reviews ASRM’s origins, explains its unprecedented scope, and assesses how it envisions the regulation of SCBIs. This analysis is used to highlight three key insights that are pertinent to the current revision of the ASRM: clarifying how the concept of safety should be defined and assessed in research and clinical care settings; revisiting risk criteria for review of SCBIs; and taking stronger measures to support the transition from unproven interventions to evidence-based therapies. Finally, the article reflects on lessons drawn from Japanese experiences in dealing with unproven SCBIs for international endeavours to regulate SCBIs.
Stephens, N., M Morrison, Martin, P. and Hogle, L., 'Spatiotemporal readiness is key to preparing regenerative medicine for the clinic' (2021) 16 Regenerative Medicine
DOI: 10.2217/rme-2020-0164
As regenerative medicine products scale up, researchers turn their attention beyond the ongoing technical challenges of collecting, preserving and delivering gene- and cell-based products to manufacturing and business operations, including process control, automation, supply chain and logistics, and the viability of business model alternatives. Assessing readiness for clinical use, however, requires an integrated assessment across all of these crucial components, including how well they fit together (or not), how synergies might enable platform opportunities and, critically, what kinds of infrastructures should be created to support a range of cell- and tissue-based products and services. Infrastructures reveal the way that futures are anticipated while shaping things in the present [1]. Yet large investments, including major changes to physical facilities, organizational structures and processes, can make it difficult to change things later [2]. There is much at stake, then, for institutional readiness in terms of having robust, yet adaptable, infrastructures. We suggest that analysis of the spatial and temporal aspects of infrastructure is a useful way to take a more integrated view across all manufacturing phases, participants and components of regenerative medicine when assessing institutional readiness. We use the concept of institutional readiness [3] as a way to frame the interrelation of material technologies, knowledge bases and social and economic factors affecting translation. We focus on the UK and use the term ‘advanced therapy medicinal products’ to encompass the variety of cell-, tissue- and gene-based therapies that involve altering biological characteristics. Although it is self-evident that there are specific spatial and temporal needs for different cell types and delivery models, we discuss major planning issues that all share.
Martin, P., M Morrison, Turkmendag I and Nerlich B, 'Genome editing: the dynamics of continuity, convergence, and change in the engineering of life' (2020) 39 New Genetics and Society 219
DOI: https://doi.org/10.1080/14636778.2020.1730166
Genome editing enables very accurate alterations to DNA. It promises profound and potentially disruptive changes in healthcare, agriculture, industry, and the environment. This paper presents a multidisciplinary analysis of the contemporary development of genome editing and the tension between continuity and change. It draws on the idea that actors involved in innovation are guided by “sociotechnical regimes” composed of practices, institutions, norms, and cultural beliefs. The analysis focuses on how genome editing is emerging in different domains and whether this marks continuity or disruption of the established biotechnology regime. In conclusion, it will be argued that genome editing is best understood as a technology platform that is being powerfully shaped by this existing regime but is starting to disrupt the governance of biotechnology. In the longer term is it set to converge with other powerful technology platforms, which together will fundamentally transform the capacity to engineer life.
M Morrison, Mourby, M., Gowans, H. and Coy, S., 'Governance of research consortia: challenges of implementing Responsible Research and Innovation within Europe' (2020) 16 Life Sciences, Society and Policy
DOI: https://doi.org/10.1186/s40504-020-00109-z
Responsible Research and Innovation (‘RRI’) is a cross-cutting priority for scientific research in the European Union and beyond. This paper considers whether the way such research is organised and delivered lends itself to the aims of RRI. We focus particularly on international consortia, which have emerged as a common model to organise large-scale, multi-disciplinary research in contemporary biomedical science. Typically, these consortia operate through fixed-term contracts, and employ governance frameworks consisting of reasonably standard, modular components such as management committees, advisory boards, and data access committees, to co-ordinate the activities of partner institutions and align them with funding agency priorities. These have advantages for organisation and management of the research, but can actively inhibit researchers seeking to implement RRI activities. Conventional consortia governance structures pose specific problems for meaningful public and participant involvement, data sharing, transparency, and ‘legacy’ planning to deal with societal commitments that persist beyond the duration of the original project. In particular, the ‘upstream’ negotiation of contractual terms between funders and the institutions employing researchers can undermine the ability for those researchers to subsequently make decisions about data, or participant remuneration, or indeed what happens to consortia outputs after the project is finished, and can inhibit attempts to make project activities and goals responsive to input from ongoing dialogue with various stakeholders. Having explored these challenges, we make some recommendations for alternative consortia governance structures to better support RRI in future.
M Morrison, 'Making bio-objects mobile: behind the scenes of a translational stem cell banking consortium' (2020) BioSocieties
DOI: https://doi.org/10.1057/s41292-020-00207-3
The concept of bio-objectification describes how the ‘raw materials’ of living cells and tissues are subject to both technical manipulations and ontological transformations to produce novel ‘bio-objects’ such as cell lines and transgenic animals. Bio-objects are conceptually fluid, but also subject to literal circulation through biobanks and repositories. Making bio-objects mobile means producing them in such a way that they are capable of travelling across jurisdictions, institutional boundaries, and of moving between public and private sectors. This paper uses one particular bio-object—the human induced pluripotent stem cell (hiPSC), and a particular context, a European consortium dedicated to creating an open access repository of hiPSC—to explore what making mobilisable bio-objects entails. The bio-object not only has multiple strands of identity—legal, ethical, political, technical— but this identity is distributed across, and inscribed in, a variety of paper documents, digital records, as well as the biological material. Making bio-objects mobile means putting these heterogeneous components into circulation, which can entail travel through different infrastructures and at different speeds. Moreover, contemporary legal and ethical requirements for the use of human biomaterials require the formation of durable connections that tie bio-objects to places and persons of origin as a condition of mobility.
M Morrison, 'STS and enhancement technologies: A programme for future research' (2015) 28 Science and Technology Studies

Internet Publication (4)

M Morrison, 'Policy briefing: Trends in customization and personalization of advanced therapies' (2021) RegMedNet.com
Biomodifying technologies policy briefing 3#
This briefing looks at the potential for ‘customization’ and ‘personalization’ in the clinical translation of therapies based on gene editing, induced pluripotent stem cells (iPSCs) and 3D bioprinting. Customization and personalization involve tailoring some part of a product or process to a specific situation and context, which in medicine is often done to meet the requirements of an individual patient. While scope for personalized ‘one-off’ therapies remains limited, a variety of forms of ‘mass customization’, at the level of both therapeutic products and manufacturing processes, could complement mass-produced cell and gene therapies. Future policy developments need to evaluate whether to support one or several forms of manufacturing within the UK healthcare sector, as each requires different forms of support, skill sets from the workforce and logistical and regulatory hurdles to viability.
M Morrison, 'Policy briefing: Accelerating innovation: speed and timing in translational research' (2020) RegMedNet.com
Biomodifying technologies Policy briefing 2#
This briefing examines issues of time and timing in the clinical translation of therapies based on gene editing, induced pluripotent stem cells, and 3D bioprinting. Co-ordinating timing is a perennial challenge for innovation across sectors, but it takes on particular importance in medicine, with the current impetus for getting promising new therapies to patients more quickly. Producing and delivering advanced therapies requires co-ordination between developers, manufacturers, investors, regulators and clinical staff in hospitals. Policy support could beneficially target innovation in supporting technologies that improve the speed of manufacture and delivery, but a distinction needs to be made between instances where state support is appropriate and those best left to market-led initiatives. Support is warranted to better align the timeframes of regulation and of healthcare budgets to account for the uncertain, often non-linear development trajectories of our case study technologies. We also recommend that patient and public input be sought as to the acceptability of risk-sharing arrangements to enable faster translation in the NHS.
M Morrison, 'Policy briefing: Making ‘good targets’ for translational research' (2020) RegMedNet.com
This is the first of four policy briefings from the Biomodifying technologies project. In this briefing, the team set out our understanding of a ‘good clinical target’ in each of the areas studied: gene editing, induced pluripotent stem cells (iPSCs) and 3D bioprinting.

Other (6)

M Morrison, 'Research using free text data in medical records could benefit from dynamic consent and other tools for responsible governance' (2020) Journal of Medical Ethics 367
DOI: http:// dx. doi. org/ 10. 1136/m edethics-2 019- 105472
As the capacity to generate, store, aggregate and combine ever greater volumes and types of data about individuals, behaviours and interactions continues to expand apace, so too does the challenge of ensuring suitable and appropriate governance of that data. In broad terms, the challenge is simple; how to ensure the (public) benefits of data, such as improvements in service delivery or individual and collective well-being, while avoiding harms such as discrimination, injustice or placing undue burdens on individuals and groups. The difficulty, as ever, lies in the details. As Nicol et al observe, informed consent is important but does not replace the need for an appropriate governance framework that covers the wider ecosystem of data generation, use and reuse. Moreover, there is no one universal oversight mechanism for data sharing, but what counts as ‘appropriate’ must take into account the context and purpose of data use. In this regard, the study by Ford et al is an important and valuable contribution to our understanding of the specificities involved in sharing data contained within Electronic Health Records (EHRs) for clinical, quality improvement and comparative effectiveness research in healthcare. The paper provides empirical evidence, from a citizen’s jury, to support the intuition that transferring free text data from a clinical care setting to that of research, especially research conducted outside the National Health Service by academic researchers who are unlikely to have any direct relationship with the data providers-cum-research participants, is at risk of transgressing the contextual integrity of the initial data generation.
M Morrison, J Bell and R Isasi, 'Chapter 2: stem cell use' (2018) Genotoul Societal Governing Stem cells Regenerative medicine in Europe: the vision and recommendations from the EU CelLEX project

Chapter (2)

M Morrison, HJA Teare and G Bertier and others, 'Implications of secondary findings for clinical contexts' in M Langanke| P Erdmann| K Brothers (ed), Secondary Findings in Genomic Research (Elsevier 2020)

Report (1)

Research programmes

Research projects

Research Interests

Michael’s primary research interest and expertise lies in the application of insights and perspectives from Science and Technology Studies (STS) and medical sociology to the study of novel and emerging biotechnologies. More specifically, he is concerned with understanding the ways in which these technologies are shaped by a variety of social factors – including institutional and regulatory cultures as well as the perspectives of developers and prospective users – throughout the course of their development and deployment into practice; and how, in turn, new biomedical technologies shape and reconfigure our understandings of disease, health, and the ‘sorts’ of people we are or can be. He is also working with Jane Kaye and other HeLEX members to develop novel consent procedures for large-scale biobanking projects.

Research projects