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Business School, The University of Edinburgh

Business School Auditorium

29 Buccleuch Place

Edinburgh EH8 9JS

Edinburgh EH

United Kingdom

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Abstract

Health research ethics has a long history of adapting itself to contemporary challenges. The current paradigm reflects concerns, exposed by the Nuremberg trials and codified in the Declaration of Helsinki, to protect against the abuse of research 'subjects' through unacceptable experimentation in the name of societal and scientific interests. Some of the assumptions underpinning this framework now seem anomalous. The separation of the roles of researcher and subject is blurring, as participants are increasingly co-designing projects. Managing the immediate risks of research interventions is reducing in significance compared to the need for governance of data moving forward. Health research is no longer the sole prerogative of health professionals and the legitimacy of the traditional norms and processes may no longer be recognized by everyone concerned. Research and clinical care are more closely connected than the current paradigm of research ethics suggests. The limitations of the evidence-base for current care are becoming more apparent. The need to make research trustworthy reaches beyond the challenge of misconduct. In different ways these developments pull research ethics in new directions. Perhaps the anomalies are sufficient to suggest that we need a new paradigm, based on social contract rather than principalism.

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Jonathan Montgomery is Professor of Health Care Law at University College London and Chair of the Health Research Authority (which oversees research ethics committees for England). He chaired the UK’s Human Genetics Commission from 2009-2012 and the Nuffield Council on Bioethics (the UK’s national bioethics committee) from 2012-17. He was a panel member on the Morecambe Bay Investigation into maternal and neonatal deaths (2013-5) and of the expert advisory group on the establishment of the Healthcare Safety Investigation Branch (which becomes operational in 2017). Between 1998 and 2013 he served as chair of a number of NHS organisations in Hampshire and the Isle of Wight, including providers, commissioners and a Strategic Health Authority. His current programme of work includes examining bioethics as a governance practice.

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Business School, The University of Edinburgh

Business School Auditorium

29 Buccleuch Place

Edinburgh EH8 9JS

Edinburgh EH

United Kingdom

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