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Towards Principles–Based Approaches to Governance of Health–Related Research Using Personal Data

Published online by Cambridge University Press:  20 January 2017

Graeme Laurie
University of Edinburgh – School of Law
Nayha Sethi
The Mason Institute, University of Edinburgh – School of Law


Technological advances in the quality, availability and linkage potential of health data for research make the need to develop robust and effective information governance mechanisms more pressing than ever before; they also lead us to question the utility of governance devices used hitherto such as consent and anonymisation. This article assesses and advocates a principles–based approach, contrasting this with traditional rule–based approaches, and proposes a model of principled proportionate governance. It is suggested that the approach not only serves as the basis for good governance in contemporary data linkage but also that it provides a platform to assess legal reforms such as the draft Data Protection Regulation.

Copyright © Cambridge University Press 2013

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4 The House of Lords Report on Genomic Medicine offers an account of the regulatory hurdles which must be surpassed by researchers in order to gain approval. See House of Lords Science and Technology Committee, Genomic Medicine, Volume 1: Report, (HL Paper 17-I 2009).

5 For example, in contrast to the Privacy Advisory Committee for Scotland, which advises on health data linkages despite a lack of statutory authority, in England and Wales, by virtue of section 251 of the NHS Act 2006,the Ethics and Confidentiality Committee (under the auspices of the National Information Governance Board) enjoys the statutory authority to take such decisions. Additional decision makers charged with overseeing the appropriate sharing of health data include Caldicott Guardians and Research Ethics Committees. This is all in addition to the legal responsibilities to which Data Controllers are subject under the European Data Protection Directive.

6 The Academy of Medical Science, Personal data for public good: using health information in medical research, (2006), at p. 3.

7 For further discussion, Laurie and Sethi, Information Governance of Use of Health–Related Data, supra note 3

8 The Academy of Medical Sciences, Personal data for public good:supra note 6, at p. 29.

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44 UK Data Protection Act Part 1 s4(4).

45 Section 55(A) Data Protection Act 1998.

46 UK Data Protection Act Schedule 1 – The Data Protection Principles.

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50 It is important to remember, and often forgotten, that consent is but one lawful basis for processing, even when data are sensitive and require both schedule 2 and schedule 3 of the Data Protection Act (1998) must be satisfied.

51 Proposal for a new Regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation) Brussels, 25.1.2012 COM(2012) 11 final.

52 Draft Recital 7, supra note 46.

53 In fact, proportionality is emerging as a key concept within the regulatory landscape and features in the proposal for a new EU Data Protection Regulation, supra note 46. Note mention of proportionality also appears in draft recitals 133 and 139 and also draft Article 22(4).

54 See draft Recitals 22, 53, 123, 125 and 126.

55 Pursuant to Article 290 TFEU.

56 The following publications offer examples of the research which SHIP has facilitated: Logue, Jennifer et al, “Do men develop type 2 diabetes at lower body mass indices than women?54 Diabetologia (2011), pp. 30033006; CrossRefGoogle ScholarPubMed Walker, Jeremy et al, “Effect of Socioeconomic Status on Mortality Among People with Type 2 Diabetes; A study from the Scottish Diabetes Research Network Epidemiology Group”, 34 Diabetes Care (2011), pp. 11271132.CrossRefGoogle ScholarPubMed

57 SHIP, “A Blueprint for Health Records Research in Scotland”, December 2011, available on the Internet at: <> (last accessed on 04 January 2013).

58 Graeme Laurie and Nayha Sethi, ‘SHIP Working Paper 1: Information governance of use of health-related data in medical research in Scotland: current practices and future scenarios’, 26 U. of Edinburgh School of Law Working Paper (2011), available via SSRN at <> (last accessed on 04 January 2013). Graeme Laurie and Nayha Sethi, ‘SHIP Working Paper 2: Information governance of use of health-related data in medical research in Scotland: Towards a Good Governance Framework’, 13 Edinburgh School of Law Research Paper (2012), available via SSRN at <> (last accessed on 04 January 2013).

59 See all, supra note 42.

60 SHIP demonstrates how it complies with the Data Protection “Principles” in its Privacy Impact Assessment. See SHIP, “SHIP Privacy Impact Assessment”, January 2012, available on the Internet at : <> (last accessed on 04 January 2013).

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