New technologies allow accurate modification of DNA, transformation of skin or hair cells into stem cells, and printing of 3D structures made of cells. These deliberate modifications of living tissue and can be used to improve human health and treat disease.
These new, disruptive technologies present novel risks and challenge existing regulatory systems. This project will therefore investigate the laws, regulations and guidelines which apply to these technologies; how this regulatory framework influences their development, and the options for improving governance of biodmodifying technologies in the future.
The project will focus on three case-study technologies:
- Gene editing, which allows scientists to make changes to the structure and function of DNA in living tissues and cells,
- Induced pluripotent stem cell (iPSC) technology that can convert any ordinary skin or hair cell into a potent stem cell, and
- 3D printing of biological material, which aims to create novel structures for bodily repair and renewal.
Each of the three are ‘gateway’ technologies; being relatively easy to use, having a wide range of clinical applications, and attracting significant commercial engagement. Furthermore, each technology interacts with the others: gene-edited iPSC lines are already being developed as research tools and 3D printing is being designed to create bio-structures from differentiated iPSC.
The project will focus on the development of biomodifying technologies in the UK, ultimately aiming to provide an evidence base to inform the development of appropriate, flexible and responsive governance models for converging biodmodifying technologies. This will be attempted through analysis of existing regulations, statutes, guidelines, scientific and ‘grey’ literature, as well as qualitative interviews with key stakeholders in the field.
The BIOGOV project team is led by Professor Jane Kaye (HeLEX), and includes Professor Alex Faulkner (University of Sussex), Dr Phoebe Li (University of Sussex), Professor Andrew Webster (University of York), Miranda Mourby and Dr Michael Morrison (HeLEX).
Read article in Impact: Biomodifying technologies and experimental space: Organisational and regulatory implications for the translation and valuation of health research
The project is funded by the Leverhulme Trust through grant number RPG-2017-330.
Outputs
Umemura, M and Morrison, M. (2021) Comparative lessons in regenerative medicine readiness: learning from the UK and Japanese experience. Regenerative Medicine 16(3): 269-282.
Stephens, N., Hogle, L., Morrison, M. and Martin, P. (2021) Spatiotemporal readiness is key to preparing regenerative medicine for the clinic. Regenerative Medicine 16(3): 229-235.
Takashima, K., Morrison, M., and Minari J. (2021). Reflection on the enactment and impact of safety laws for regenerative medicine in Japan. Stem Cell Reviews and Reports (forthcoming).
Aurélie Mahalatchimy, Pin Lean Lau, Phoebe Li, Mark Flear (2021) ‘Framing and legitimating EU legal regulation of human gene-editing technologies: key facets and functions of an imagery’ Journal of Law and the Biosciences (forthcoming).
Webster, A. and Terzic, A. (2021) Regenerative readiness: innovation meets sociology. Regenerative Medicine 16(3): 189–195.
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
Edison Bicudo , Alex Faulkner & Phoebe Li (2020): Software, risks, and
liabilities: ongoing and emergent issues in 3D bioprinting, Journal of Risk Research, DOI:
10.1080/13669877.2020.1848904
Bicudo E, Faulkner A, Li P. Digital readiness in 3D bioprinting: software, governance and hospitals’ proto-clinical interfaces. Regenerative Medicine 16(3): 237-252
Phoebe Li, Alex Faulkner & Nicholas Medcalf (2020) 3D bioprinting in a 2D regulatory landscape: gaps, uncertainties, and problems, Law, Innovation and Technology, 12:1, 1-29, DOI: 10.1080/17579961.2020.1727054
Mourby, M. (2020) Anonymity in EU Healthcare Law: Not an Alternative to Information Governance, Medical Law Review, https://doi.org/10.1093/medlaw/fwaa010
Mourby, M. and Morrison, M. (2020) Gene therapy regulation: could in-body editing fall through the net? Eur J Hum Genet 28, 979–981. https://doi.org/10.1038/s41431-020-0607-y
Morrison, M. (2020) Commentary: Research using free text data in medical records could benefit from dynamic consent and other tools for responsible governance. J. Med Ethics 46:380-381
Bicudo, E.; Faulkner, A. and Li, P. (2020) Patents and the experimental space: social, legal and geographical dimensions of 3D bioprinting. International Review of Law, Computers & Technology. https://doi.org/10.1080/13600869.2020.1785066
Morrison, M., Coy, S., Mourby, M., Gowans ,H., Bell, J. and Kaye, J. ‘Governance of Research in Consortia.’ Life Sciences Society and Policy (under review).
