Michael Morrison | University of Oxford (original) (raw)
Papers by Michael Morrison
Frontiers in Political Science
Editorial on the Research Topic Regulation and governance of gene editing technologies (CRISPR, etc.
Journal of Law and the Biosciences
Biomodifying technologies—such as gene editing, induced pluripotent stem cells, and bioprinting—a... more Biomodifying technologies—such as gene editing, induced pluripotent stem cells, and bioprinting—are being developed for a wide range of applications, from pest control to lab-grown meat. In medicine, regulators have responded to the challenge of evaluating modified ‘natural’ material as a therapeutic ‘product’ by introducing more flexible assessment schemes. Attempts have also been made to engage stakeholders across the globe on the acceptable parameters for these technologies, particularly in the case of gene editing. Regulatory flexibility and stakeholder engagement are important, but a broader perspective is also needed to respond to the potential disruption of biomodification. Our case-study technologies problematize basic ideas—such as ‘nature’, ‘product’, and ‘donation’—that underpin the legal categories used to regulate biotechnology. Where such foundational concepts are rendered uncertain, a socially responsive and sustainable solution would involve exploring evolutions in t...
SSM - Qualitative Research in Health
Biomedical translational researchers aim to develop knowledge and techniques arising from researc... more Biomedical translational researchers aim to develop knowledge and techniques arising from research in the life sciences into clinical applications. Using the examples of induced pluripotent stem cells (iPSC) and gene editing, this paper examines how translational researchers identify and justify which particular conditions or patient populations make 'good targets' for translational research with particular technologies. Drawing on empirical data from qualitative interviews with academic and commercial researchers working on clinical translation of iPSC and gene editing in the UK, this study illustrates how particular combinations of technology and disease (for example iPSC-derived cells as a therapy for Parkinson's disease or gene editing for Cystic Fibrosis) were evaluated and justified as worth pursuing. The results show that translational researchers anticipate the ways in which their therapies-in-the making will be evaluated by other groups including regulators, physicians, patients, and bodies charged with health technology assessment. Each of these groups have their own understandings of what is valuable in a novel health technology and their own criteria for evaluation. As a result, translational researchers must supplement justifications that draw on scientific and industrial logics, with accounts that recognise other forms of worth, including market and civic registers of justification. These findings give an insight into the factors shaping contemporary biomedical translational research. The current regulatory and health technology adoption frameworks exert a strong influence, with elements such as 'safety' or 'unmet need' being common to most justification. However there was also sufficient flexibility to allow different competing definitions of what safety or unmet need might look like.
Science & Technology Studies
The concept of human technological enhancement originated as a tool for the moral classification ... more The concept of human technological enhancement originated as a tool for the moral classification of technologies, but has since spilled over from ethical debates to become a site for prospective technology development as part of a ‘converging technologies’ agenda. To date, enhancement and the technologies labelled as ‘enhancing’ have been underserved by STS research. While case studies do exist, there has been a dearth of co-ordinated investigation. This paper proposes a systemic programme for STS research on enhancement technologies based on five key challenges posed by dominant conceptions of enhancement as a way of understanding technological development. After setting out this agenda, a short history of the enhancement debate is provided to illustrate the changing meanings of ‘enhancement’ across different contexts. Recognising the limitations of critique alone, particular emphasis is given to the possibilities for productive engagement by STS scholars with the domain of enhance...
![Research paper thumbnail of Referee report. For: Digital Methodology to implement the ECOUTER engagement process [version 2; referees: 2 approved]](https://attachments.academia-assets.com/99361200/thumbnails/1.jpg)
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This book will present globally the main results and findings from the facts and figures collecte... more This book will present globally the main results and findings from the facts and figures collected by the different workpackages through the analysis of the literature, through the interviews and from the tools developed in the project. This material was enriched by the inputs from the external experts we have invited in the two conferences of consensus and from the comments of the various stakeholders. The chapters are based on the same presentation and are divided in two parts: a report and some recommendations either to the Commission or to stakeholders.
Stem Cell Reports, 2021
Japan's Act on the Safety of Regenerative Medicine (ASRM) created an innovative regulatory framew... more 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 endeavors to regulate SCBIs.
Regenerative Medicine, 2021
This paper explores how ‘regenerative readiness’ varies between different national research and h... more 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.
Regenerative Medicine, 2021
Tweetable abstract Successful translation of regenerative medicine projects to the clinic require... more Tweetable abstract Successful translation of regenerative medicine projects to the clinic requires attention to the complex interaction of spatial and timing issues from manufacturing to clinical use.
New Genetics and Society, 2020
Genome editing enables very accurate alterations to DNA. It promises profound and potentially dis... more 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.
BioSocieties, 2020
The concept of bio-objectification describes how the 'raw materials' of living cells and tissues ... more 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.
Life Sciences, Society and Policy, 2020
Responsible Research and Innovation (‘RRI’) is a cross-cutting priority for scientific research i... more 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 ...
Journal of Medical Ethics, 2020
As the capacity to generate, store, aggregate and combine ever greater volumes and types of data ... more 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 1 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 …
European Journal of Human Genetics, 2020
Somatic gene therapies may be authorised for marketing in the EU under the advanced therapy medic... more Somatic gene therapies may be authorised for marketing in the EU under the advanced therapy medicinal product regulation. These therapeutic compounds are sufficiently novel and complex in their potential effects to require specialist evaluation. However, the current definition of gene therapy medicinal products ('GTMP') risks excluding molecules which are not manufactured through techniques involving recombination. We consider the way, in which the 'recombinant nucleic acid' aspect of the GTMP definition is challenged by developments in gene-editing technology, and why a broader scope of GTMP regulation may be desirable.
Palgrave Communications, 2019
Following the birth in 2018 of two babies from embryos altered using CRISPR-Cas9, human germline ... more Following the birth in 2018 of two babies from embryos altered using CRISPR-Cas9, human germline gene editing (GGE) moved from abstract concern to reality. He Jiankui, the scientist responsible, has been roundly condemned by most scientific, legal and ethical commentators. However, opinions remain divided on whether GGE could be acceptably used in the future, and how, or if it should be prohibited entirely. The many reviews, summits, positions statements and high-level meetings that have accompanied the emergence of CRISPR technology acknowledge this, calling for greater public engagement to help reach a consensus on how to proceed. These calls are laudable but far from unproblematic. Consensus is not only hugely challenging to reach, but difficult to measure and to know when it might be achieved. Engagement is clearly desirable, but engagement strategies need to avoid the limitations of previous encounters between publics and biotechnology. Here we set CRISPR in the context of the ...
The American Journal of Bioethics, 2019
The American Journal of Bioethics, 2018
In 2012, a new and promising gene manipulation technique, CRISPR-Cas9, was announced which seems ... more In 2012, a new and promising gene manipulation technique, CRISPR-Cas9, was announced which seems likely to be a foundational technique in healthcare and agriculture. However, patents have been granted. As with other technological developments, there are concerns of social justice regarding inequalities in access. Given the technologies' 'foundational' nature and societal impact, it is vital for such concerns to be translated into workable recommendations for policymakers and legislators. Colin Farrelly has proposed a moral justification for the use of patents to speed up the arrival of technology by encouraging innovation and investment. While sympathetic to his argument, this paper highlights a number of problems. By examining the role of patents in CRISPR and in two previous foundational technologies, we make some recommendations for realistic and workable guidelines for patenting and licensing.
Sociology of Health & Illness, 2018
This paper proposes a 'valuographic' approach to diagnosis, exploring how values and valuation pr... more This paper proposes a 'valuographic' approach to diagnosis, exploring how values and valuation practices are implicated in the contested diagnostic category of idiopathic short stature (ISS). ISS describes children who are 'abnormally' short but do not have any other detectable pathology. In the USA growth-promoting hormone therapy has been approved for ISS children, since 2003. However, no other jurisdiction has approved this treatment and the value of ISS as a diagnostic category remains disputed among healthcare professionals. Drawing on qualitative interviews with paediatric endocrinologists in the UK and the US, this study presents a historical snapshot illustrating how the problematisation of ISS as a diagnosis involved multiple registers of value including epistemic, economic and moral calculations of worth. Contestation of the diagnosis was not just about what counts but about what ought to be counted, as respondents' accounts of ISS gave differential weight to a range of types of evidence and methods of assessment. Ultimately what was at stake was not just the value of increased height for short patients, but what it meant to properly practice paediatric endocrinology. Consideration is then given to how a valuographic approach can be applied to sociological studies of diagnosis more broadly.
Human genomics, Apr 17, 2018
Precision medicine promises to use genomics and other data-intensive approaches to improve diagno... more Precision medicine promises to use genomics and other data-intensive approaches to improve diagnosis and develop new treatments for major diseases, but also raises a range of ethical and governance challenges. Implementation of precision medicine in "real world" healthcare systems blurs the boundary between research and care. This has implications for the meaning and validity of consent, and increased potential for discrimination, among other challenges. Increased sharing of personal information raises concerns about privacy, commercialization, and public trust. This paper considers national precision medicine schemes from the USA, the UK, and Japan, comparing how these challenges manifest in each national context and examining the range of approaches deployed to mitigate the potential undesirable social consequences. There is rarely a "one size" fits all solution to these complex problems, but the most viable approaches are those which take account of cultural p...
Human genomics, Mar 7, 2018
Governments, funding bodies, institutions, and publishers have developed a number of strategies t... more Governments, funding bodies, institutions, and publishers have developed a number of strategies to encourage researchers to facilitate access to datasets. The rationale behind this approach is that this will bring a number of benefits and enable advances in healthcare and medicine by allowing the maximum returns from the investment in research, as well as reducing waste and promoting transparency. As this approach gains momentum, these data-sharing practices have implications for many kinds of research as they become standard practice across the world. The governance frameworks that have been developed to support biomedical research are not well equipped to deal with the complexities of international data sharing. This system is nationally based and is dependent upon expert committees for oversight and compliance, which has often led to piece-meal decision-making. This system tends to perpetuate inequalities by obscuring the contributions and the important role of different data pro...
Frontiers in Political Science
Editorial on the Research Topic Regulation and governance of gene editing technologies (CRISPR, etc.
Journal of Law and the Biosciences
Biomodifying technologies—such as gene editing, induced pluripotent stem cells, and bioprinting—a... more Biomodifying technologies—such as gene editing, induced pluripotent stem cells, and bioprinting—are being developed for a wide range of applications, from pest control to lab-grown meat. In medicine, regulators have responded to the challenge of evaluating modified ‘natural’ material as a therapeutic ‘product’ by introducing more flexible assessment schemes. Attempts have also been made to engage stakeholders across the globe on the acceptable parameters for these technologies, particularly in the case of gene editing. Regulatory flexibility and stakeholder engagement are important, but a broader perspective is also needed to respond to the potential disruption of biomodification. Our case-study technologies problematize basic ideas—such as ‘nature’, ‘product’, and ‘donation’—that underpin the legal categories used to regulate biotechnology. Where such foundational concepts are rendered uncertain, a socially responsive and sustainable solution would involve exploring evolutions in t...
SSM - Qualitative Research in Health
Biomedical translational researchers aim to develop knowledge and techniques arising from researc... more Biomedical translational researchers aim to develop knowledge and techniques arising from research in the life sciences into clinical applications. Using the examples of induced pluripotent stem cells (iPSC) and gene editing, this paper examines how translational researchers identify and justify which particular conditions or patient populations make 'good targets' for translational research with particular technologies. Drawing on empirical data from qualitative interviews with academic and commercial researchers working on clinical translation of iPSC and gene editing in the UK, this study illustrates how particular combinations of technology and disease (for example iPSC-derived cells as a therapy for Parkinson's disease or gene editing for Cystic Fibrosis) were evaluated and justified as worth pursuing. The results show that translational researchers anticipate the ways in which their therapies-in-the making will be evaluated by other groups including regulators, physicians, patients, and bodies charged with health technology assessment. Each of these groups have their own understandings of what is valuable in a novel health technology and their own criteria for evaluation. As a result, translational researchers must supplement justifications that draw on scientific and industrial logics, with accounts that recognise other forms of worth, including market and civic registers of justification. These findings give an insight into the factors shaping contemporary biomedical translational research. The current regulatory and health technology adoption frameworks exert a strong influence, with elements such as 'safety' or 'unmet need' being common to most justification. However there was also sufficient flexibility to allow different competing definitions of what safety or unmet need might look like.
Science & Technology Studies
The concept of human technological enhancement originated as a tool for the moral classification ... more The concept of human technological enhancement originated as a tool for the moral classification of technologies, but has since spilled over from ethical debates to become a site for prospective technology development as part of a ‘converging technologies’ agenda. To date, enhancement and the technologies labelled as ‘enhancing’ have been underserved by STS research. While case studies do exist, there has been a dearth of co-ordinated investigation. This paper proposes a systemic programme for STS research on enhancement technologies based on five key challenges posed by dominant conceptions of enhancement as a way of understanding technological development. After setting out this agenda, a short history of the enhancement debate is provided to illustrate the changing meanings of ‘enhancement’ across different contexts. Recognising the limitations of critique alone, particular emphasis is given to the possibilities for productive engagement by STS scholars with the domain of enhance...
This book will present globally the main results and findings from the facts and figures collecte... more This book will present globally the main results and findings from the facts and figures collected by the different workpackages through the analysis of the literature, through the interviews and from the tools developed in the project. This material was enriched by the inputs from the external experts we have invited in the two conferences of consensus and from the comments of the various stakeholders. The chapters are based on the same presentation and are divided in two parts: a report and some recommendations either to the Commission or to stakeholders.
Stem Cell Reports, 2021
Japan's Act on the Safety of Regenerative Medicine (ASRM) created an innovative regulatory framew... more 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 endeavors to regulate SCBIs.
Regenerative Medicine, 2021
This paper explores how ‘regenerative readiness’ varies between different national research and h... more 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.
Regenerative Medicine, 2021
Tweetable abstract Successful translation of regenerative medicine projects to the clinic require... more Tweetable abstract Successful translation of regenerative medicine projects to the clinic requires attention to the complex interaction of spatial and timing issues from manufacturing to clinical use.
New Genetics and Society, 2020
Genome editing enables very accurate alterations to DNA. It promises profound and potentially dis... more 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.
BioSocieties, 2020
The concept of bio-objectification describes how the 'raw materials' of living cells and tissues ... more 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.
Life Sciences, Society and Policy, 2020
Responsible Research and Innovation (‘RRI’) is a cross-cutting priority for scientific research i... more 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 ...
Journal of Medical Ethics, 2020
As the capacity to generate, store, aggregate and combine ever greater volumes and types of data ... more 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 1 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 …
European Journal of Human Genetics, 2020
Somatic gene therapies may be authorised for marketing in the EU under the advanced therapy medic... more Somatic gene therapies may be authorised for marketing in the EU under the advanced therapy medicinal product regulation. These therapeutic compounds are sufficiently novel and complex in their potential effects to require specialist evaluation. However, the current definition of gene therapy medicinal products ('GTMP') risks excluding molecules which are not manufactured through techniques involving recombination. We consider the way, in which the 'recombinant nucleic acid' aspect of the GTMP definition is challenged by developments in gene-editing technology, and why a broader scope of GTMP regulation may be desirable.
Palgrave Communications, 2019
Following the birth in 2018 of two babies from embryos altered using CRISPR-Cas9, human germline ... more Following the birth in 2018 of two babies from embryos altered using CRISPR-Cas9, human germline gene editing (GGE) moved from abstract concern to reality. He Jiankui, the scientist responsible, has been roundly condemned by most scientific, legal and ethical commentators. However, opinions remain divided on whether GGE could be acceptably used in the future, and how, or if it should be prohibited entirely. The many reviews, summits, positions statements and high-level meetings that have accompanied the emergence of CRISPR technology acknowledge this, calling for greater public engagement to help reach a consensus on how to proceed. These calls are laudable but far from unproblematic. Consensus is not only hugely challenging to reach, but difficult to measure and to know when it might be achieved. Engagement is clearly desirable, but engagement strategies need to avoid the limitations of previous encounters between publics and biotechnology. Here we set CRISPR in the context of the ...
The American Journal of Bioethics, 2019
The American Journal of Bioethics, 2018
In 2012, a new and promising gene manipulation technique, CRISPR-Cas9, was announced which seems ... more In 2012, a new and promising gene manipulation technique, CRISPR-Cas9, was announced which seems likely to be a foundational technique in healthcare and agriculture. However, patents have been granted. As with other technological developments, there are concerns of social justice regarding inequalities in access. Given the technologies' 'foundational' nature and societal impact, it is vital for such concerns to be translated into workable recommendations for policymakers and legislators. Colin Farrelly has proposed a moral justification for the use of patents to speed up the arrival of technology by encouraging innovation and investment. While sympathetic to his argument, this paper highlights a number of problems. By examining the role of patents in CRISPR and in two previous foundational technologies, we make some recommendations for realistic and workable guidelines for patenting and licensing.
Sociology of Health & Illness, 2018
This paper proposes a 'valuographic' approach to diagnosis, exploring how values and valuation pr... more This paper proposes a 'valuographic' approach to diagnosis, exploring how values and valuation practices are implicated in the contested diagnostic category of idiopathic short stature (ISS). ISS describes children who are 'abnormally' short but do not have any other detectable pathology. In the USA growth-promoting hormone therapy has been approved for ISS children, since 2003. However, no other jurisdiction has approved this treatment and the value of ISS as a diagnostic category remains disputed among healthcare professionals. Drawing on qualitative interviews with paediatric endocrinologists in the UK and the US, this study presents a historical snapshot illustrating how the problematisation of ISS as a diagnosis involved multiple registers of value including epistemic, economic and moral calculations of worth. Contestation of the diagnosis was not just about what counts but about what ought to be counted, as respondents' accounts of ISS gave differential weight to a range of types of evidence and methods of assessment. Ultimately what was at stake was not just the value of increased height for short patients, but what it meant to properly practice paediatric endocrinology. Consideration is then given to how a valuographic approach can be applied to sociological studies of diagnosis more broadly.
Human genomics, Apr 17, 2018
Precision medicine promises to use genomics and other data-intensive approaches to improve diagno... more Precision medicine promises to use genomics and other data-intensive approaches to improve diagnosis and develop new treatments for major diseases, but also raises a range of ethical and governance challenges. Implementation of precision medicine in "real world" healthcare systems blurs the boundary between research and care. This has implications for the meaning and validity of consent, and increased potential for discrimination, among other challenges. Increased sharing of personal information raises concerns about privacy, commercialization, and public trust. This paper considers national precision medicine schemes from the USA, the UK, and Japan, comparing how these challenges manifest in each national context and examining the range of approaches deployed to mitigate the potential undesirable social consequences. There is rarely a "one size" fits all solution to these complex problems, but the most viable approaches are those which take account of cultural p...
Human genomics, Mar 7, 2018
Governments, funding bodies, institutions, and publishers have developed a number of strategies t... more Governments, funding bodies, institutions, and publishers have developed a number of strategies to encourage researchers to facilitate access to datasets. The rationale behind this approach is that this will bring a number of benefits and enable advances in healthcare and medicine by allowing the maximum returns from the investment in research, as well as reducing waste and promoting transparency. As this approach gains momentum, these data-sharing practices have implications for many kinds of research as they become standard practice across the world. The governance frameworks that have been developed to support biomedical research are not well equipped to deal with the complexities of international data sharing. This system is nationally based and is dependent upon expert committees for oversight and compliance, which has often led to piece-meal decision-making. This system tends to perpetuate inequalities by obscuring the contributions and the important role of different data pro...
Small amounts of foetal DNA present in circulating maternal blood were first reported by Professo... more Small amounts of foetal DNA present in circulating maternal blood were first reported by Professor Dennis Lo in 1997. This discovery suggested a potential method for assessing the genetic status of the foetus without the limitations of current prenatal genetic testing techniques, such as amniocentesis, which carry a relatively high risk of miscarriage. Novel technologies based on this free foetal DNA and promising easier, less invasive, safer and earlier detection of single gene disorders and chromosomal abnormalities are currently poised to move from research into routine clinical practice for the first time. One of the first widespread medical applications of this technology to be rolled out in the UK is likely to be the detection of Trisomy 21 (Down Syndrome). While non-invasive prenatal diagnostic (NIPD) technologies for T21 are being framed in familiar rhetorics of improved choice and safety for pregnant women, they also raise significant ethical questions about genetic discrimination and the systemic undervaluing of ‘disabled’ lives. Critical assessment of both the promises and problems of NIPD in T21 require understanding of a range of elements from public attitudes on prenatal genetic testing to healthcare professionals’ expectations about the utility and implementation of how any new testing regime will be implemented in practice. In this seminar I will present details of ongoing work on NIPD (particularly in relation to T21), including key findings to date, being carried out by the Healthcare Technology and Society research group at the University of Exeter.
This presentation considers how the production of 'severe growth hormone deficiency', the first d... more This presentation considers how the production of 'severe growth hormone deficiency', the first diagnostic category for the legitimate use of human Growth Hormone as a growth-promoting agent in short statured children, influenced
the medicalisation of growth and stature and how it continues to affect the treatment decisions of contemporary physicians
In this presentation I will introduce my current work on the Regenerative Medicine in Europe (REM... more In this presentation I will introduce my current work on the Regenerative Medicine in Europe (REMEDiE) project. I aim to describe how we have set about trying to measure and assess European commercial activity in regenerative medicine - including stem cells, gene therapy and tissue engineering. I will discuss some of the difficulties we faced in finding ways to appropriately measure this activity in line with the goals of the work package and provide some details of the different approaches we have employed so far. Much of what I discuss is work in progress so I hope to get some useful and stimulating feedback.
Europe constitutes both an important market and a significant industry sector for commercial rege... more Europe constitutes both an important market and a significant industry sector for commercial regenerative medicine (RM). As part of the REMEDiE project, a ‘universe’ of European companies working in the RM field has been mapped out. This data can be used to assess the positioning of European regenerative medicine firms on key strategic issues such as the source of cells for products (non-stem cell vs. stem cell; adult/foetal or embryonic stem cells), selection of therapeutic targets, and autologous vs. allogenic cell products. The data also allows for an analysis of the number and type of regenerative medicine products on the market and in development at European firms and an
evaluation of the level of uptake and investment by the commercial sector in emergent technologies including induced pluripotent stem (iPS) cells and cell-based toxicity and target screening in conventional drug development. At a broader level, the European RM sector can be characterised with regards to some of the major promissory trajectories associated with regenerative medicine, notably the transition from a tissue engineering model to a more globalised, translation-orientated regenerative medicine (see Mason,
2007) and the promise of regenerative medicine products to address the problems of an ageing population.
RegMedNet, 2021
This briefing looks at the potential for ‘customization’ and ‘personalization’ in the clinical tr... more 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.
RegMedNet, 2020
This briefing examines issues of time and timing in the clinical translation of therapies based o... more This briefing examines issues of time and timing in the clinical translation of therapies based on gene editing, induced pluripotent stem cells (iPSCs) 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.
RegMedNet, 2020
Viable clinical applications for biomodifying technologies need to fit the available technologica... more Viable clinical applications for biomodifying technologies need to fit the available technological capacity for scale of production and delivery, to target a well-defined patient population where they can outcompete existing care regimens in cost-benefit assessment, and to align with regulatory requirements. It is necessary to evaluate whether we can support multiple advanced therapies aiming at an initially limited set of conditions (for example both cell and gene therapies are in development for eye diseases like Advanced Macular Degeneration), and how we might do this. These initial product niches require support in ways that avoid ‘lock-in’ to one way of doing things, to enable the industry to evolve and expand over time. We draw on multiple research methods, including analysis of papers and IP filings, literature reviews, and interviews with stakeholders from scientists and clinicians to representatives of SMEs and regulatory agencies. This provided up to date information on the current thinking and the contemporary challenges faced by different groups involved in the translational research pathway, which allows us to build on and extend previous social science work on regenerative medicine and 3D printing, including prior work by members of the project team. There is also input from the parallel ‘Governing biomodification’ project, led by Jane Kaye, on legal and regulatory aspects of gene editing, bioprinting, and iPSC.
When thinking about how to responsibly develop technologies, it is important to remember that tec... more When thinking about how to responsibly develop technologies, it is important to remember that technologies, including potential enhancement technologies, do not simply appear fully formed to present dilemmas about their application.
In order to think about the potential social consequences of enhancement, we therefore have to think about how enhanced humans might interact with unenhanced people, with each other, and with the world around them. In short, how might the enhanced behave and what strategies might be available to manage this behaviour?
Comics provide a ready-made treasure trove of ideas about what it might be like to live in a world where enhanced humans exist. Comics allow us to imagine different scenarios from codes of conduct for enhanced people to formal legal rules, from treating the enhanced as a new and specialized profession to offering incentives for good behaviour, and to think about which approaches would be suitably fair, flexible and enforceable.
There is a strong case to be made that superheroes are a quintessentially American phenomenon. Th... more There is a strong case to be made that superheroes are a quintessentially American phenomenon. The Costumed Visions initiative invites us to consider these representations of enhanced human (or indeed post-human) states as a way to reflect on contemporary debates about potential (bio)technological modification of human capabilities. As the debates on enhancement have expanded, so too the arena of discussion has shifted beyond the US and beyond the confines of academic bioethics and moral philosophy. The Costumed Visions initiative is itself evidence of this wider approach. If we consider that the debate is enriched by the kind of novel perspectives offered by the Costumed Visions approach, might we also consider alternative visions of enhanced bodies beyond those offered by American superheroes?
New Genetics and Society, 2022
Review of "The matrix of stem cell research: an approach to rethinking science in society" Edited... more Review of "The matrix of stem cell research: an approach to
rethinking science in society"
Edited by C. Hauskeller, A. Manzeschke, and A. Pichl. Published by Routledge, 2020, 213 pp., £36.99 (pbk), ISBN 13: 978-0-367-72683-6
Petersen, A., Munsie, M., Tanner, C., MacGregor, C. and Brophy, J. Stem Cell Tourism and the Poli... more Petersen, A., Munsie, M., Tanner, C., MacGregor, C.
and Brophy, J. Stem Cell Tourism and the Political
Economy of Hope. London: Palgrave Macmillan.
2017. 218pp £79.99 (hbk) ISBN
978-1-137-47042-3 £63.99 (ebk) ISBN 978-1-137-
47043-0
This book provides a timely, sociologically informed account of the phenomenon of ‘stem cell tourism,’ where patients, often accompanied by parents, family members and carers travel overseas to access stem cell treatments not available in their home country. Many of these stem cell products are not approved by any regulatory authority, nor
is their use generally part of a recognised clinical trial. Often, the likelihood of any therapeutic effect and the mechanisms by which such an effect might occur are equally uncertain. This situation is commonly portrayed as one of desperate patients exploited by unscrupulous providers. From the outset, Petersen and colleagues state that their
intention is to challenge this over-simplistic framing.
We are living in multiple bio-political potentialities, futures resonating ideas of life-as-it-co... more We are living in multiple bio-political potentialities, futures resonating ideas of life-as-it-could-be. Life and bodies seem to have become the materialization of various biotechnological utopias. For fifty years, assorted technologies for human genome editing and DNA repair/recombination have been used. Particular techniques such as CRISPR-Cas9, TALENs, and zinc finger nucleases have been employed significantly in human genome editing and DNA repair in recent years. The current applications of genome editing and DNA repair technology have provoked significant attention and raised a number of ethical and legal questions. We analyze various economies of hope, hype, expectations, politics, and poetics of promises and better or worse predictions or moral panic from the point of view of sociology, anthropology, and science and technology (STS) studies. Miscellaneous futurities, as material-semiotic reconfigurations, are present in the topics of the current genome editing technologies. We will discuss concrete research cases, fieldwork, projects, and analyses.
PROGRAMME: https://lasst.uni-frankfurt.de/files/2019/09/WE_NEW_UTOPIANS_workshop_2019_agenda-1.pdf