Project Outputs

The project is led by the University of Oxford in collaboration with colleagues at the University of Sussex and the University of York, and funded by the UK Economic and Social Research Council. The project is aims to investigate the likely impact of such technology on human health, healthcare and medicine in the UK. Michael Morrison and Jane Kaye from our Faculty are both part of the project. 

This is the second of four policy briefings. In this briefing, the team discuss the challenges of time and timing in translating biomodifying therapy research into enabling technologies. In this new briefing, Michael 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.

 

Poilcy Briefing Paper I

 

Policy Briefing Paper II

Michael Morrison, who leads the Biomodifying Technologies project, has recently published a second policy briefing titled "Accelerating Innovation: Speed and Timing in Translational Research". The policy briefing can be viewed on the Regenerative Medicine Journal. 

 

 

Publications :

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 

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)

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

J Bell, S Aidinlis, H Smith and J Kaye, 'Balancing data subjects' rights and public interest research: Examining the interplay between UK Law, EU Human Rights Law and the GDPR' (2019) 5 European Data Protection Law Review 43

M Morrison, M Mourby and A Bartlett, 'Biomodifying technologies and experimental space: organisational and regulatory implications for the translation and valuation of health research' (2019) ESRC 63

D Nicol, L Eckstein, HB Bentzen and J Kaye and others, 'Consent insufficient for data release' (2019) 364 Science 445

M Morrison and S de Saille, 'CRISPR in context: towards a socially responsible debate on embryo editing.' (2019) 5 Palgrave Communications

J Kaye, A Phillips, H Gowans and N Shah, 'International Direct-to-Participant (DTP) Genomic Research: The United Kingdom Responses (Country Reports)' (2019) 47 The Journal of Law, Medicine & Ethics 683

J Bell, S E Wallace, M Mourby and J Kaye, 'Lawful disclosure of administrative data for research purposes in the UK' (2019) 2 Journal of Data Protection & Privacy

N Shah, V Coathup, H Teare and J Kaye and others, 'Motivations for data sharing - views of research participants from four European countries: a DIRECT study' (2019) 27 European Journal of Human Genetics 721

M Mourby, E Mackey, M Elliot and J Kaye and others, 'Are 'pseudonymised' data always personal data? Implications of the GDPR for administrative data research in the UK' (2018) 34 Computer Law & Security Review: The International Journal of Technology Law and Practice 222

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

M Prictor, H Teare, J Bell and J Kaye, 'Consent for data processing under the General Data Protection Regulation: Could ‘dynamic consent’ be a useful tool for researchers?' (2018) 3 SSRN Electronic Journal

S Coy, H Teare, S Aidinlis and J Kaye, Data Policy Models for Funding Bodies (Wellcome Trust 2018)

J Kaye, SF Terry, E Jeungst and M Morrison and others, 'Including all voices in international data-sharing governance' (2018) 12 Human Genomics 13

J Kaye, SF Terry and E Jeungst and others, 'Including all voices in international data-sharing governance' (2018) 12 Human Genomics

M Morrison, 'Making Cells Worthwhile: Calculations of Value in a European Consortium for Induced Pluripotent Stem Cell Banking' (2018) Science as Culture 46

O Feeney, J Cockbain and M Morrison, 'Patenting Foundational Technologies: Lessons From CRISPR and Other Core Biotechnologies' (2018) The American Journal of Bioethics 36

J Minari, K Brothers and M Morrison, 'Tensions in ethics and policy created by National Precision Medicine Programs' (2018) Human Genomics

M Morrison, 'Valuing height: diagnosis, valuation and the case of idiopathic short stature' (2018) 41 Sociology of Health & Illness 502

M Morrison, 'A good collaboration is based on unique contributions from each side: assessing the dynamics of collaboration in stem cell science' (2017) 13 Life Sciences, Society and Policy 7

Budin-Ljosne, H Teare, J Kaye and J Kaye and others, 'Dynamic Consent: a potential solution to some of the challenges of modern biomedical research' (2017) 18 BMC Medical Ethics 4

C Mitchell, C Ploem, V Chico and J Kaye and others, 'Exploring the potential duty of care in clinical genomics under UK law' (2017) 17 Med Law Int 158

M Morrison, 'Infrastructural expectations: exploring the promise of international large-scale induced pluripotent stem cell banks' (2017) New Genetics and Society 66

D Nicol, L Eckstein and M Morrison and others, 'Key challenges in bringing CRISPR-mediated somatic cell therapy into the clinic' (2017) 9 Genomic Medicine 85

D Sipp, Tcaulfield, J Kaye and J Kaye, 'Marketing of unproven stem cell-based interventions: A call to action' (2017) Science Translational Medicine 1

V Coathup, N Hamakawa, T Finlay and J Kaye, 'Participant-centric initiatives and medical research: Scoping review protocol' (2017) 6 JMIR Res Protoc

NAA Giesbertz, K Melham, J Kaye and J Kaye, 'Personalized assent for pediatric biobanks' (2017) 12 BMC Medical Ethics 59

M F. Bin Abdul Azi, M Morrison and J Kaye, 'Regulating human stem cell research and therapy in low- and middle-income countries: Malaysian perspectives' (2017) New Genetics and Society 43862

M Morrison, J Bell and C George, 'The European General Data Protection Regulation: Challenges and considerations for iPSC researchers and biobanks' (2017) 12 Regenerative Medicine 693

M Morrison, J Bell, C George and J Kaye, 'The European General Data Protection Regulation: Challenges and considerations for iPSC researchers and biobanks' (2017) 12 Regenerative Medicine

H Teare, J Hogg and J Kaye and others, 'The RUDY study: using digital technologies to enable a research partnership' (2017) 25 European Journal of Human Genetics 816

Kaye, J Bell and M Prictor, 'Trends and challenges in biobanking, tensions and and traumas in health law' in I Freckelton and K Petersen (eds), Tensions and Traumas in Health Law (The Federation Press 2017)

C Johnston, J Kaye and J Bell, 'Who owns your DNA?' (2017) Pursuit (Melbourne University) Legal Affairs

J Kaye, L Briceño Moraia, C Mitchell and J Bell, 'Access governance for biobanks: The case of the BioSHaRE-EU cohorts' (2016) 14 Biopreservation and Biobank 201

L Bezuidenhout and M Morrison, 'Between Scylla and Charybdis: reconciling competing data management demands in the life sciences' (2016) 17 BMC Medical Ethics 74

J Kaye, J Bell and L Briceño Moraia, 'Biobank Report: United Kingdom' (2016) 44 J Law Med Ethics 96

J Bell, M Ancillotti, V Coathup and J Kaye and others, 'Challenges and opportunities for ELSI Early Career Researchers' (2016) 17 BMC Medical Ethics

P Woolley, ML McGowan, H Teare and J Kaye and others, 'Citizen science or scientific citizenship? Disentangling the uses of public engagement rhetoric in national research initiatives' (2016) 17 BMC Medical Ethics 33

J Kaye, L Briceño Moraia, L Curren and J Bell, 'Consent for biobanking: The legal frameworks of countries in the BioSHaRE-EU project' (2016) 14 Biopreserv ation and Biobank 195

D Chalmers, D Nicol, J Kaye and J Bell, 'Has the biobank bubble burst? Withstanding the challenges for sustainable biobanking in the digital era' (2016) 17 BMC Medical Ethics 39

M Morrison, D Dickenson and SS_J Lee, 'Introduction to the article collection 'Translation in healthcare: Ethical, legal, and social implications' (2016) 17 BMC Medical Ethics 29

M Morrison, 'Overdiagnosis, medicalisation and social justice: commentary on Carter et al (2016) ‘A definition and ethical evaluation of overdiagnosis’' (2016) 42 Journal of Medical Ethics

Kaye and The 1000 Genome Project Consortium, 'A global reference for human gentic variation' (2015) 526 Nature

J Kaye and The UK10K Consortium, 'Improved imputation of low-frequency and rare variants using the UK10K haplotype reference panel' (2015) 6 Nature Communications

J Kaye, D Muddyman, C Smee and J Bell, 'Pop-up' governance: Developing internal governance frameworks for consortia: The example of UK10K' (2015) Life Sciences, Society and Policy 10

M Morrison, C Klein and N Clemann and others, 'StemBANCC: Governing access to material and data in a large stem cell research consortium' (2015) 11 Stem Cell Reviews and Reports 681

M Morrison, 'STS and enhancement technologies: A programme for future research' (2015) 28 Science and Technology Studies

J Kaye and The UK10K Consortium, 'The UK10K project identifies rare variants in health and disease' (2015) 526 Nature