Analysis and data sharing

Increasing attention has been paid in recent years to efforts to strengthen the impact of research on policy in low- and middle-income countries. However, the processes by which such research might have policy impact remain a subject of debate. This paper presents an analysis of the research/policy interface, drawing on the experiences of two South African health policy and systems research (HPSR) units and one specific study which traced the development and implementation of three areas of health care financing policy change and debate between 1994 and 1999. The analysis is based primarily on the authors’ own experiences and has been developed through a deliberate process of reflection. It suggests, first, that it is important to acknowledge the conceptual and symbolic uses and impacts of research – perhaps, particularly in relation to the system-oriented work of HPSR groups. These uses may not be verifiable by specific changes in policy and practice but are important contributions to the policy environment and do filter into policy-makers’ understandings and actions. Second, achieving any form of impact on policy is linked to the attention researchers pay to the context in which the research is undertaken, the nature and credibility of the research; and the importance of nesting any single project in a broader programme of engagement with the policy environment that builds trust in the researchers.

Gilson L. and McIntyre D. (2008) The interface between research and policy: Experience from South Africa, Social Science & Medicine, Volume 67, Issue 5, September 2008, Pages 748-759

This study draws on interviews with forty-nine members of a biomedical research community in the UK that is involved in negotiating data sharing and access. During an interview, an interviewee used the words ‘‘ethical moment’’ to describe a confrontation between collaborators in relation to data sharing. In this article, I use this as a lens for thinking about relations between ‘‘the conceptual and the empirical’’ in a way that allows both analyst and actor to challenge the status quo and consider other ethical possibilities. Drawing on actor network theory (ANT), I approach ‘‘the empirical’’ using the concepts of controversy and ontological uncertainty as methodological tools to tackle the problem of ethics. I suggest that these concepts also provide a bridge for understanding the ontological structure of the virtual and the actual, as described in Deleuze’s Difference and Repetition. While other science and technology studies scholars have sought to draw on Deleuze, this article addresses the integration of ethics and empirical research. It arises as a critical reaction to existing treatments of this problem as found in empirical ethics, especially in the sociology of bioethics, and indirectly in ANT texts.

Heeney C (2017) An ‘‘Ethical Moment’’ in Data Sharing, Science, Technology, & Human Values 2017, Vol. 42(1) 3-28

Sharing individual-level data from clinical and public health research is increasingly being seen as a core requirement for effective and efficient biomedical research. This article discusses the results of a systematic review and multisite qualitative study of key stakeholders’ perspectives on best practices in ethical data sharing in low- and middle-income settings. Our research suggests that for data sharing to be effective and sustainable, multiple social and ethical requirements need to be met. An effective model of data sharing will be one in which considered judgments will need to be made about how best to achieve scientific progress, minimize risks of harm, promote fairness and reciprocity, and build and sustain trust.

Bull S, Cheah PY, Denny S, Jao I, Marsh V, Merson L, Shah More N, Nhan LNT, Osrin D, Tangseefa D, Wassenaar D, and Parker M (2015) Best Practices for Ethical Sharing of Individual-Level Health Research Data From Low- and Middle-Income Settings, Journal of Empirical Research on Human Research Ethics, 2015, Vol. 10(3) 302–313

The movement for research transparency has gained irresistible momentum over the past decade. Although qualitative research is rarely published in the high-impact journals that have adopted, or are most likely to adopt, data sharing policies, qualitative researchers who publish work in these and similar venues will likely encounter questions about data sharing within the next few years. The fundamental ways in which qualitative and quantitative data differ should be considered when assessing the extent to which qualitative and mixed methods researchers should be expected to adhere to data sharing policies developed with quantitative studies in mind. We outline several of the most critical concerns below, while also suggesting possible modifications that may help to reduce the probability of unintended adverse consequences and to ensure that the sharing of qualitative data is consistent with ethical standards in research.

Tsai AC, Kohrt BA, Matthews LT, Betancourt TS, Lee JK, Papachristos AV, Weiser SD and Dworkin SL (2016) Promises and pitfalls of data sharing in qualitative research, Social Science & Medicine, Volume 169, November 2016, Pages 191-198

There is increasing recognition of the importance of sharing research data within the international scientific community, but also of the ethical and social challenges this presents, particularly in the context of structural inequities and varied capacity in international research. Public involvement is essential to building locally responsive research policies, including on data sharing, but little research has involved stakeholders from low-to-middle income countries. Between January and June 2014, a qualitative study was conducted in Kenya involving sixty stakeholders with varying experiences of research in a deliberative process to explore views on benefits and challenges in research data sharing. In-depth interviews and extended small group discussions based on information sharing and facilitated debate were used to collect data. Data were analysed using Framework Analysis, and charting flow and dynamics in debates. The findings highlight both the opportunities and challenges of communicating about this complex and relatively novel topic for many stakeholders. For more and less research-experienced stakeholders, ethical research data sharing is likely to rest on the development and implementation of appropriate trust-building processes, linked to local perceptions of benefits and challenges. The central nature of trust is underpinned by uncertainties around who might request what data, for what purpose and when. Key benefits perceived in this consultation were concerned with the promotion of public health through science, with legitimate beneficiaries defined differently by different groups. Important challenges were risks to the interests of study participants, communities and originating researchers through stigmatisation, loss of privacy, impacting autonomy and unfair competition, including through forms of intentional and unintentional ‘misuse’ of data. Risks were also seen for science. Given background structural inequities in much international research, building trust in this low-to-middle income setting includes ensuring that the interests of study participants, primary communities and originating researchers will be promoted as far as possible, as well as protected. Important ways of building trust in data sharing include involving the public in policy development and implementation, promoting scientific collaborations around data sharing and building close partnerships between researchers and government health authorities to provide checks and balances on data sharing, and promote near and long-term translational benefits.

Jao I., Kombe F., Mwalukore S., Bull S., Parker M., Kamuya D., Molyneux S. and Marsh V. (2015) Research Stakeholders’ Views on Benefits and Challenges for Public Health Research Data Sharing in Kenya: The Importance of Trust and Social Relations, PLoS One, 2015, Sep 2;10(9):e0135545

Increased global sharing of public health research data has potential to advance scientific progress but may present challenges to the interests of research stakeholders, particularly in low-to-middle income countries. Policies for data sharing should be responsive to public views, but there is little evidence of the systematic study of these from low-income countries. This qualitative study explored views on fair data-sharing processes among 60 stakeholders in Kenya with varying research experience, using a deliberative approach. Stakeholders’ attitudes were informed by perceptions of benefit and concerns for research data sharing, including risks of stigmatization, loss of privacy, and undermining scientific careers and validity, reported in detail elsewhere. In this article, we discuss institutional trust-building processes seen as central to perceptions of fairness in sharing research data in this setting, including forms of community involvement, individual prior awareness and agreement to data sharing, independence and accountability of governance mechanisms, and operating under a national framework.

Jao et al. (2015) Involving Research Stakeholders in Developing Policy on Sharing Public Health Research Data in Kenya Views on Fair Process for Informed Consent, Access Oversight, and Community Engagement, J Empir Res Hum Res Ethics, 2015, Jul; 10(3): 264–277