Call for Papers: Interdisciplinary Perspectives on the Regulation of Diagnostic Technologies

Call for Papers: Interdisciplinary Perspectives on the Regulation of Diagnostic Technologies

Call for papers for special issue of Social Science & Medicine
Special issue: Interdisciplinary perspectives on the regulation of diagnostic technologies
Guest editors: Stuart Hogarth, University of Cambridge; Fiona Miller, University of Toronto; Steve Sturdy, University of Edinburgh.

Aims and scope of the special issue

There is a burgeoning interdisciplinary literature devoted to the regulation of pharmaceuticals, with contributions from the fields of sociology, STS, medical anthropology, socio-legal studies, political science, and social history of medicine. In contrast, the regulation of diagnostic tests has received relatively little attention. This special issue seeks to redress that balance – an aim that has compelling timeliness for a number of reasons.

Firstly, recent years have seen accelerating innovation in diagnostic technologies, as well as rapid commercialisation, often accompanied by ambitious claims for the potential impact of new diagnostics. For instance, advocates of personalised/precision medicine promise that omics-based diagnostic tools will redefine disease taxonomies and transform clinical practice. However, these heady expectations are often accompanied by concerns about the need for robust clinical evidence on the diagnostic accuracy and clinical effectiveness of new tests, and by calls for expanded regulatory mechanisms to evaluate such evidence.

Secondly, there is evidence that diagnostic innovation is being met with increased, and increasingly multi-faceted (or polycentric), regulatory action. This includes not just statutory regulation, but also a range of activities conducted under the auspices of Health Technology Assessment and Evidence-Based Medicine (EBM). Such initiatives are also being extended to low- and middle-income countries, where the World Health Organization, in particular is playing an increasingly important role in supporting the development of regulatory structures in countries that have none, and in standard setting and test evaluation. Such developments exemplify a broader process of regulatory expansion and diffusion in the regimes governing healthcare technology adoption, including growing demand for evidence of comparative and cost-effectiveness by HTA agencies, and a greater role for clinical guidelines.

Thirdly, there are good reasons to suppose that this is not so much about a previously unregulated innovation space becoming subject to regulation, as about a shift of regulatory regime. Diagnostic innovation has often occurred through diffuse networks of actors operating at the interface of the clinic and the laboratory in what Hopkins (2006) has termed a ‘hidden innovation system’. In recent years, this has been intensified by enhanced funding for translational science programmes that encourage novel forms of clinical research and novel interactions with basic bioscience. Hopkins has noted that while the hidden innovation system has generally escaped the attention of formal oversight mechanisms, it is not a regulation-free space. Informal regulatory practices, for instance processes of technical standardization, have long been a feature of this hidden innovation system. Recent moves to implement formal regulatory regimes thus mark a significant adjustment in the diagnostic innovation system more generally, and in the means by which it is organised and sustained.

All of this suggest that there is a need to take stock of just what is happening in relation to the regulation of diagnostics: what the drivers of change are and what implications these changes have for the diagnostics industry, for healthcare providers and patients, and for the organisation and effects of regulatory regimes. We therefore invite contributions to a special issue of Social Science & Medicine, which will examine these issues from a range of social scientific perspectives including sociology, STS, medical anthropology, and social history of medicine. Papers that consider the regulation of diagnostics in global or low-income contexts will be particularly welcome.

Submission instructions

Manuscripts are invited between 01 May 2018 and 31 August 2018, with the goal of publishing the Special Issue in May of 2019. All submissions will undergo normal peer review. Please ensure to select the appropriate article type ‘SI: Regulation of Diagnostic’ when submitting your paper.

Important dates

First submission expected: 01 July 2018
Submission deadline: 31 August 2018
Acceptance deadline: 28 February 2019
Publication: 01 May 2019

For questions regarding this special issue, please contact Stuart Hogarth: sh339@cam.ac.uk; Fiona Miller: fiona.miller@utoronto.ca, or Steve Sturdy: s.sturdy@ed.ac.uk

For general questions or inquiries about the journal SSM, please contact Stefan Timmermans, stefan@soc.ucla.edu

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