Research Article: Considerations for ethics review of big data health research: A scoping review

Date Published: October 11, 2018

Publisher: Public Library of Science

Author(s): Marcello Ienca, Agata Ferretti, Samia Hurst, Milo Puhan, Christian Lovis, Effy Vayena, Godfrey Biemba.


Big data trends in biomedical and health research enable large-scale and multi-dimensional aggregation and analysis of heterogeneous data sources, which could ultimately result in preventive, diagnostic and therapeutic benefit. The methodological novelty and computational complexity of big data health research raises novel challenges for ethics review. In this study, we conducted a scoping review of the literature using five databases to identify and map the major challenges of health-related big data for Ethics Review Committees (ERCs) or analogous institutional review boards. A total of 1093 publications were initially identified, 263 of which were included in the final synthesis after abstract and full-text screening performed independently by two researchers. Both a descriptive numerical summary and a thematic analysis were performed on the full-texts of all articles included in the synthesis. Our findings suggest that while big data trends in biomedicine hold the potential for advancing clinical research, improving prevention and optimizing healthcare delivery, yet several epistemic, scientific and normative challenges need careful consideration. These challenges have relevance for both the composition of ERCs and the evaluation criteria that should be employed by ERC members when assessing the methodological and ethical viability of health-related big data studies. Based on this analysis, we provide some preliminary recommendations on how ERCs could adaptively respond to those challenges. This exploration is designed to synthesize useful information for researchers, ERCs and relevant institutional bodies involved in the conduction and/or assessment of health-related big data research.

Partial Text

The generation of digital data has drastically increased in the last years due to the ubiquitous deployment of digital technology as well as advanced computational analytics techniques [1, 2]. The term big data is still vaguely defined. In general terms, big data involves large sets of data with diverse levels of analysable structuration, coming from heterogeneous sources (online data, social media profiles, financial records, self-tracked parameters, etc.), produced with high frequency and which can be further processed and analysed using computational techniques. While the term big data has become nearly ubiquitous, there is controversy over what data volumes are sufficiently large to obtain the big data label. Dumbill, for example, suggested that data should be considered big when they cross the threshold of the conventional databases systems’ capacity in processing information [3].

On the 18thof September 2018 we conducted a scoping review of the scientific literature and searched five databases (EMBASE, Web of Science, Pubmed, IEEE Xplore, and Scopus) to retrieve eligible publications. We searched title, abstract, and keywords for the terms: (“big data” OR “Artificial Intelligence” OR “data science” OR “digital data”) AND (“medical” OR “healthcare” OR “clinical” OR “personalised medicine”) AND (“policy” OR “ethics” OR “governance” OR “ethics committee” OR “IRB” OR “review board” OR “assessment”). Query logic was modified to adapt to the language used by each engine or database. Screening identified 1093 entries. All entries were imported into the Endnote literature manager software. Three phases of filtering were performed independently by two researchers to minimize subjective bias.

Our results reveal a large, diverse and rapidly growing body of literature on the impact of big data in the biomedical domain. Data show that the overall number of articles published in the time period 2012–2017 is 131 times higher compared to the period 2001–2005 as represented in Fig 2.

This study presents four main limitations. First, a selection bias might be present since the search retrieved only articles written in languages known by the researchers (English, French, German and Italian), excluding articles written in other languages. A similar limitation affects database selection as searching other databases may have possibly identified additional relevant studies. While this risk of selection bias applies to any review since the number of databases that can be feasibly searched is always finite, we attempted to minimize selection bias by exploring both domain-general and domain-specific databases, including the major databases in biomedical research and computer science, which represent the primary interdisciplinary intersection when it comes to biomedical big data. Second, as it was often observed in relation to scoping reviews, the explorative nature and broad focus of our search methodology makes it ‘unrealistic to retrieve and screen all the relevant literature’ [39]. However, one advantage of the scoping methodology is the opportunity to explore also the grey literature and the secondary sources (e.g. bibliographies of retrieved papers), which is likely to increase comprehensiveness. The breadth of the research focus might have inevitably affected the depth of the analysis. The reason for that stems from the fact that the outcomes of a scoping review, compared to systematic review methods, are “more narrative in nature” [40] and usually not presented through descriptive statistical analysis. Finally, our review included very heterogeneous studies and did not assess the study quality. The reason for that stems from the fact that our main goal was to explore the entire range of challenges that have relevance for ERCs, regardless of how those challenges were originally addressed and discussed. While these four limitations might prevent generalization, we believe that the scoping methodology was best suited to reflect the explorative nature and broad focus of our research question. In fact, it has often been noted, that scoping reviews are not intended to be exhaustive [41, 42] or to provide detailed statistical analyses [40] but to map an heterogeneous body of literature related to a broad and novel topic [35]. As scoping reviews are usually considered a “richly informed starting point for further investigations” [40], future studies should consider this work as a preliminary step to a systematic review and associated statistical data analysis. Furthermore, they could use this general mapping of the health-related big data topic to generate empirically testable research hypotheses.

The drastic increase over the past 5 years in the number of studies discussing the implications of health-related big data confirms the research community’s increasing attention to the applicability of big data approaches into the healthcare domain. As the application of big data in healthcare [43] and the market size forecasts for big data hardware, software and professional services investments in the healthcare and pharmaceutical industry are growing steadily [44], there will be a parallel need to assess the impact of this expanding sociotechnical trend. This expansion can be seen as a sign of what has been defined the “inevitable application of big data to healthcare”[10] induced by the widespread uptake of electronic health records (EHRs), and the large-scale storing and sharing of genomic, proteomics, imaging and many other biomedical data.




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