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The strikethrough: an approach to regulatory writing and professional discipline*

Published online by Cambridge University Press:  02 January 2018

Marie-Andrée Jacob
Marie-Andrée Jacob*
Affiliation:
Keele University
*
Marie-Andrée Jacob, School of Law, Chancellor's Building, Keele University, Keele, Staffordshire ST5 5BG, UK. Email: [email protected]
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Abstract

This paper attends to writing practices by way of examining how a professional regulator engages with research activities conducted by doctors. In order to explore regulatory responses to alleged research misconduct, I use a specific calligraphic practice shared by researchers and regulators. The paper shows that taking this calligraphic practice as an analytical focus can offer surprising dividends to the study of regulation across fields. Via the practice of strikethrough, the General Medical Council effectuates three gestures as it engages with research activities: display, authentication and isolation. Understanding them requires asking what literal and metaphorical meanings travel in the strikethrough.

Type
Research Article
Information
Legal Studies , Volume 37 , Issue 1 , March 2017 , pp. 137 - 161
Copyright
Copyright © Society of Legal Scholars 2017

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Footnotes

*

This paper is based on research funded by an Arts and Humanities Research Council Fellowship, grant number AH/J008338/1. For feedback on earlier drafts, I thank audiences at the universities of Birmingham, Lancaster, Edinburgh, Kent, Leeds and Keele; and for their helpful comments at different stages of this project, I wish to thank particularly Paula Case, Stella Coyle, Aleksandra Jordanoska, Tsachi Keren-Paz, Jean McHale, Deirdre McKay, Anna Macdonald, Helen Parr, Simon Stern, Michael Thomson, Steve Wilkinson, Peter Wilmshurst and the Legal Studies peer reviewers and editors.

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39. See eg the AMS report: Academy of Medical Sciences A New Pathway for the Regulation and Governance of Health Research (London: AMS, 2011).

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50. The Medical Act 1983, as amended; GMC Rules Order of Council 2004.

51. Smith 2004, above n 3; GMC, above n 46, pp 25–50.

52. Council for Healthcare Regulatory Excellence (CHRE) v NMC and Grant [2011] EWHC 927 (Admin), [71], [74], [76] (referring to a decision from the Nursing and Midwifery Council); General Medical Council v Meadow [2006] EWCA Civ 1390. I will return to this forward-looking approach below.

53. Cohen v GMC [2008] EWHC 581 (Admin); Davies, above n 3; J Glynn and D Gomez The Regulation of Healthcare Professionals: Law, Principle and Process (London: Sweet & Maxwell, 2012).

54. ‘110. Research misconduct is a further example. The term is used to describe a range of misconduct from presenting misleading information in publications to dishonesty in clinical drugs trials. Such behaviour undermines the trust that both the public and the profession have in medicine as a science, regardless of whether this leads to direct harm to patients. Because it has the potential to have far reaching consequences, this type of dishonesty is particularly serious’: GMC Indicative Sanctions Guidance for the Fitness to Practise Panel, April 2009 (with 7 August 2009 revisions, March 2012 revisions and March 2013 revisions) para 110, at p 29.

55. The GMC's Good Medical Practice states that ‘You must act with honesty and integrity when designing, organising or carrying out research, and follow national research governance guidelines and our guidance’: GMC Good Medical Practice (London: GMC, updated March 2013) para 67. The GMC thus refers explicitly to additional norms that govern the conduct of those who do scientific research: the rules of scientific community, formal and informal, produced and distributed by employers (research institutions), research funders and sponsors, and academic journals. Research guidance outlines principles governing research and their applications into practice: GMC Good Practice in Research and Consent to Research (London: GMC, 2010); GMC Research: The Role and Responsibilities of Doctors (London: GMC, 2005). The areas covered by the guidance are: law and governance; good research design and practice; protecting participants from harm; honesty and integrity; avoiding conflicts of interest; consent to research; and respecting confidentiality. The 2005 version of the guidance included two additional areas: funding and payments, and teaching, supervision and managerial responsibilities for research.

56. Smith, above n 3, as cited in Glynn and Gomez, above n 53, at 1-078. Scholars have picked up on how such stylised aspirational publications get crafted mainly for outside consumption: Riles, A Collateral Knowledge: Legal Reasoning in the Global Financial Markets (Chicago: University of Chicago Press, 2011) p 13 CrossRefGoogle Scholar. Indeed, we should not overrate the influence of these statements on practitioners, since they most often do not have time to read through them: Chisholm, A, Cairncross, L and Askham, J Setting Standards. Final Report: The Views of Members of the Public and of Doctors on the Standard of Care and Practice They Expect of Doctors (London: Picker Institute, 2006)Google Scholar.

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59. That same year, Pearce published in the same journal a Randomised Controlled Trial involving 191 women with recurring miscarriages, a trial that never took place.

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61. In generic terms, the PPC said that ‘the responsibility for published work rests on every participant – the main author, any co-authors, all others involved in the research, assessors, referees and the editorial board’. PCC, 7 June 1995.

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63. My research in the GMC Minutes and secondary material indicates that the prior to Pearce, 13 research misconduct cases had been dealt with by the PCC, all to do with falsification and/or fabrication of data. Twelve cases took place between 1990 and 1995, and Lock identifies one additional PCC decision on research misconduct from 1975. See Lock, above n 27, p 17.

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69. What is known as the ‘Wakefield decision’ is in fact a trilogy (Wakefield, Walker-Smith and another), and the three decisions are not discussing fraudulent research processes strictly speaking. The determination on Andrew Wakefield catalogues the numerous breaches in detail: carrying out a programme of investigations of research on 12 children without REC approval; misleading and dishonest description of the patient population; the irresponsible and misleading description of the project and of the referral process in correspondence with journal and funders, contrary to the duty to ensure that information in the paper is accurate; a dishonest statement about REC approval; breach of ‘fundamental principles of research medicine’; and the use of invasive procedures when not clinically indicated. The FtPP carefully describes the funding arrangements in relation to the research, indicating how the misconduct also included the non-disclosure of conflicts of interests.

70. Dyer, above n 65. Graham Stringer MP confirmed this point during evidence-gathering meetings of the House of Commons Science and Technology Committee: ‘the General Medical Council did not deal with whether his research was fraudulent or not’: House of Commons Science and Technology Committee, above n 2, at Q275; but see Kirkland, A ‘The legitimacy of vaccine critics: what is left after the autism hypothesis?’ (2012) 37 J Health Pol, Pol'y & L 69–97 Google ScholarPubMed.

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72. Walker-Smith v GMC [2012] EWHC 503 (Admin).

73. Personal communication with the author, 2013.

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103. PCC, 6 July 2001.

104. For a more detailed discussion of such customs in hospitals see Jacob, above n 9.

105. PCC, 6 July 2001.

106. FtPP, 13 January 2012.

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108. Ibid, at 17.

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114. The FtP Panel determination described numerous breaches: examination of research material (organs of infants) carried without the authority of the person legally in possession of the body by reason of the Human Tissue Act 1961, and examination carried in breach of the limited consent obtained (for a ‘small incision’), and having ‘knowingly disregarded parents’ wishes and expectations’; failure to complete post-mortem reports within proper and reasonable time; and misleading or false post-mortem reports with respect to weight and sections of organs.

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119. Idem.

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126. Note that for Derrida, the strikethrough is thought to mark both ‘untenability’ and ‘for-the-moment-at-least necessity’: Orton, F Figuring Jasper Johns (London: Reaktion, 1994) p 227 Google Scholar.

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