The 14 Day Rule and Human Embryo Research: A Sociology of Biological Translation
By Professor Sarah Franklin and Professor Emily Jackson
Published by Routledge
ISBN-10: 1032277890, ISBN-13: 978-1032277899
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This book is a testament to the power of interdisciplinarity. The authors, Professors Emily Jackson and Sarah Franklin, leaders in their respective fields of law and sociology, present an engaging account of the history, legacy and future of the 14-day rule, the 'signature component' of the Human Fertilisation and Embryology (HFE) Act 1990 (as amended), showing how effective regulation and scientific progress depends on fostering trust through sociological examination, engagement, and science communication.
Described by Professor Peter Braude, emeritus professor of obstetrics and gynaecology at King's College London, in his foreword as 'one of the most important legal issues in assisted human reproductive technology', the 14-day rule stipulates that no human embryos may be lawfully kept for research beyond 14 days from creation. It communicates the principle that human embryo research is permitted only on a strictly limited and highly regulated basis. A clear 'red line', the authors point out, that helped establish trust and confidence in regulatory governance and laid the foundations for a successful biomedical industry in the UK.
The 14-day limit is a simple rule ('everyone can count to 14 days on a calendar'), yet Professors Franklin and Jackson demonstrate how surprisingly complex it is – an 'amalgam' and 'enigma', they write. Amid moral concerns at the time around social issues such as abortion, the rule needed to be clear, reassuring, and facilitative if consequential health benefits from research were to be realised – 'principled but pragmatic', 'strict but permissive', 'cautious but progressive'. The book documents how drawing the line was 'one of the most challenging and complex hurdles' faced by the Warnock Committee who conceived the limit.
Baroness Mary Warnock, chair of the committee, recognised that the rule would operate as the 'cornerstone' for the licensing regime and needed to be based on the scientific facts of embryonic development (which were not altogether fixed) yet precise enough for application in every clinic and research centre in the UK. Professors Franklin and Jackson document the strategic chairing by Baroness Warnock to achieve this outcome. Baroness Warnock 'ran her committees much like a classroom', presenting briefing papers and expert testimony from a huge range of interested parties in clear agendas, diagrams, and objectives for every meeting.
Crucially, Baroness Warnock also appreciated the importance of sociological engagement. Professors Franklin and Jackson explain how the 14-day rule 'embodies the social contract or exchange model' of scientific research, which involved exploring and listening to the public's view to instil trust between the public and science. Baroness Warnock judged that public acceptance of a new technology depended not only on what people knew about the technologies but how they 'felt about them', the authors write. She also realised that she needed to translate IVF and embryo research into the 'public consciousness as valued innovations'.
Working with Professor Anne McLaren, scientific advisor to the Committee, Baroness Warnock engaged directly with their audience, presented evidence, and making arguments. They gained the trust of professionals, legislators, the media and the public, and persuaded people to support their proposals for well-regulated research, the authors explain. This approach to regulation helped produce great strides in scientific research, enabling the future expansion of rules to support developments in stem cell research, cell nuclear replacement, and the creation of human admixed embryos. It proved to become a 'symbolic anchor and most widely emulated feature worldwide', Professors Franklin and Jackson write.
The authors argue that a sociological examination of the 14-day rule is made pertinent by recent developments that arguably necessitate a review of the limit. It is now possible to culture human embryos for more than 14 days and the creation of embryo models has also challenged legal definitions of the embryo. The Human Fertilisation and Embryology Authority has conducted a consultation on recommendations for changes to the HFE Act 1990 (as amended) and the International Society for Stem Cell Research has recognised that reform is needed (see BioNews 1097). This book is therefore an important and timely intervention.
Professors Franklin and Jackson make a robust case for engaging with the question of extension and outline the potential benefits of extending the 14-day limit, but they make clear it is necessary to do so in a way that can sustain effective regulation. They acknowledge the risks of reopening up the 14-day rule and 'how much is at stake' in potentially changing it, referring to the GM food debate as an example of poor public engagement.
Understanding how the rule came about and its purpose is therefore crucial to inform current debates. As the authors put it, 'taking a broad sociological look at the effects on public perceptions of bioscience of the normalisation of human fertility technology… is both overdue and essential'.
Overall, this book immerses the reader in complex sociological themes with a clear lesson on how such approaches contribute to effective and sustainable regulation. The book is a vital reminder of the need for, in the authors words, 'robust social processes for biogovernance'. This is clearly highly relevant to all those working in the field and involved in the regulatory governance, but the book also would also be of great interest to those interested in contemporary history and political processes. Not least, underneath all this lies a fascinating story of how Baroness Warnock and Dame McLaren spearheaded a revolutionary approach to establishing a consensus on a diverse and intractable moral issue.
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