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J Korean Med Sci
J Korean Med Sci
JKMS
Journal of Korean Medical Science
1011-8934
1598-6357
The Korean Academy of Medical Sciences

10.3346/jkms.2024.39.e262
Opinion
Humanities & Basic Medical Science
The Government Should Play a Role Greater Than That of Construction Supervisor in the National Bio-Big Data Infrastructure
http://orcid.org/0000-0001-8345-7150
Shin Youjung 1
http://orcid.org/0000-0001-6889-5478
Kim Claire Junga 2
1 Department of Science Studies/Science Culture Research Center, Jeonbuk National University, Jeonju, Korea.
2 Department of Medical Humanities, College of Medicine, Dong-A University, Busan, Korea.
Address for Correspondence: Claire Junga Kim, MD, PhD. Department of Medical Humanities, College of Medicine, Dong-A University, 32 Daesingongwon-ro, Seo-gu, Busan 49201, Republic of Korea. clairejungakim@gmail.com
23 9 2024
06 8 2024
39 36 e26230 4 2024
29 7 2024
© 2024 The Korean Academy of Medical Sciences.
2024
The Korean Academy of Medical Sciences
https://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Dong-A University https://doi.org/10.13039/501100002468
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pmcOn November 30, 2023, the Korean Society for Bioinformatics and Korea Genome Organization issued a petition to reconsider the governance of the Korea Bioinformation Center (KOBIC). The KOBIC was selected as the central institute for managing various biodata, especially multiomics data, in South Korea, which will be collected in the next five years through the National Integrated Bio-Big Data Construction Project (2024–2028). The petition stressed that “as KOBIC’s role in the management and operation of biodata becomes more significant, it is necessary to reconsider its autonomy and governance accordingly.”1 For example, by making the KOBIC an independent institute at the Korea Research Institute of Bioscience and Biotechnology, the petition argued for preparing appropriate governance for the new national big biodata infrastructure. However, reestablishing the KOBIC’s autonomy would be just a first step and would not be enough to prepare the overall governance structure for the national big biodata infrastructure. The establishment of appropriate governance, not after but before the construction of the biodata infrastructure, is key to its success, as many historical cases have shown, which requires an active and accountable role of the government beforehand.

This paper aimed to highlight an issue that must be considered for a national big data project to succeed as a data infrastructure but does not seem to have received much attention to date. The issue is establishing a proper governance for the new national bio-big data infrastructure and clarifying the role and responsibility of the government. By highlighting the distinctive features and nature of data infrastructure compared with traditional infrastructure, this study emphasizes the role that the government should play, when, and how. The significance of proper governance cannot be overstated, particularly at this critical juncture characterized by the announcement of the project’s target population number and timeframe at its official launch, but marred by the conspicuous absence of a trustworthy governance system. We argued for the government to change its attitude toward the National Integrated Bio-Big Data Construction Project by realizing the way biodata flows and creates value. Thereby, the government should take the active lead of creating short- and long-term governance systems to manage social and technical care work, thus creating a trustful and dynamic venue for diverse biodata workers to grow, interact, and create value in South Korea.

We would like to begin this study with observations from the government that raise our concerns. Currently, the Korean government seems to regard the national bio-big data project as one of its many infrastructure-building projects. The project aimed to collect biodata from around 772,000 people initially and plans to gather data from a total of 1 million people by 2032. It is often depicted as a "health information highway" or biodata dam.2 By doing so, the government stressed that its aim is to achieve “the complete construction [of infrastructure] without defect.” Similar to the construction of a highway within a certain period of time, the government hopes to “complete” the construction of data infrastructure within a specific timeframe. To prevent its “poor construction,” in this context, the government further announced that it would focus on “setting [construction] processes and managing performances.”3 These expressions vividly illustrate how the government is seeing the building of biodata infrastructure: one of construction projects that could be completely constructed with a certain end-point, like a highway. Therefore, its attention is mostly geared towards acting as a technical supervisor with the aim of completing its construction.

However, if the government only functions as a technical construction supervisor, the development of sustainable biodata infrastructure would be impossible. According to the principles of Health Data Research UK, it is crucial to “demonstrate active and ongoing engagement with patients and public in the design, development, and governance of [biodata infrastructure] to provide assurance that these activities are in the public interest.”4 To this end, the UK Health Data Research Alliance, convened by Health Data Research UK has worked to develop a technical and social apparatus to harmoniously bring various stakeholders to biodata infrastructure. The Alliance, which has more than seventy organization members, developed, for example, transparency standards and a contract template for data access to ensure wider participation from various stakeholders. They also conducted a study on best-practice standards for public involvement and engagement while launching a pilot public engagement campaign for bio and health data infrastructure.5 In this context, it was no accident that the UK Biobank Ethics and Governance Framework comprises three parts: relationships with patients, research users, and society.6 This demonstrates that these organizations recognize the importance of not only building legal norms but also developing and nurturing various relationships with various stakeholders. This is because data infrastructure is, by nature, different from traditional physical infrastructure such as dams and highways. Two points should be noted in this regard.

First, data do not—and cannot—flow by itself. In traditional infrastructure, for example, in the case of a highway, a car or various vehicles move here and there with the power of an engine. In the case of a dam, water flows from the top to the bottom with the power of gravity. Data, regardless of where it is produced, without special efforts or power to make it move, cannot be flowed across various areas. Furthermore, data should be moved in a usable form, which means that extensive curation and management works are required. If data flows without any detail or metadata, it becomes rather useless for many stakeholders. However, without being used by other stakeholders, the data have little values in terms of a value creation. It should be emphasized that the data being stored, no matter how large they are, do not have much value. This is different from traditional infrastructure. Data have a relational value, which means that only when they make a relation with other data or stakeholders do they generate new values, ranging from scientific to economic and social values.7 Thus, the most important task of a biodata infrastructure is to enable and promote various relationships among diverse stakeholders and generate value from them.8 To this end, more than computing power is needed in the biodata infrastructure. Without the endeavor and power to make data move while shaping relations, what is left after the construction would be a bunch of data being stored without proper arrangement.

Second, there are numerous people involved in biodata infrastructure, especially bio-“big” data infrastructure. In the case of railroads, for example, people are users who come after the construction and take advantage of it; though they contribute to its making by paying taxes. However, in the case of a biodata infrastructure, people are not only users but also important providers who generate and deliver their biodata to an infrastructure. In the case of a national bio-big data infrastructure, 7,720,000 people, including patients, should contribute to its development from an early stage. In other words, unlike a highway where the involvement of a small number of construction experts is important, biodata infrastructure requires continuous engagement not only from data scientists but also from data producers, data users, and data managers.9 To grasp a wide range of stakeholders in a data ecology, Beaulieu and Leonelli addressed the term “data workers,” which consists of “data scientists,” “data producers,” “data users,” and “data managers” as major stakeholders in data ecology.10 Without extensive work from those stakeholders, i.e., works of providing their data from data producers, works of giving feedback from data users and so on, data infrastructure cannot be developed and sustained.

Despite these distinctive characteristics of biodata infrastructure, the Korean government seems to have overlooked them. Biodata infrastructure can be defined as an array of technical and social arrangements that enable and facilitate various flows of biodata from laboratories to hospitals in biological, life science, and biomedical fields. Although the government currently emphasizes the collection of large amounts of data through nationwide whole-genome sequencing, it is not the amount of data per se that is important, but the type of networks among diverse data workers. Therefore, attention should be paid not only to data but also data workers, and not only to the amount of data but also the value of data. And this attention would have no end-point. Actually, it is not difficult to find previous instances of biodata infrastructures that were developed but not widely used, experienced social crises and financial challenges or ultimately ceased operations.11 We should not be misled by the notion that whole-genome sequencing data are unprecedented because of the perceived novelty of this technology. Instead, we must acknowledge that these projects are situated within a broader history of bioinfrastructure. This recognition presents an opportunity to draw insights from past experiences; the first protein data bank was launched in the 1970s.12 Thus, along with historical learning from historical experiences, it is necessary to understand the characteristics of biodata infrastructure projects and develop proper governance at the right time and place.

In order to devise an appropriate government approach for this project, it is essential to consider the characteristics discussed above. To create a dynamic flow of bio-data among those wide range of data workers, continuous technical and social care works are required. Care works refer to continuous and deliberate engagements with infrastructure so that it works properly. It is not about making a new thing, a new research paper, patent, etc., but about maintaining a trustworthy infrastructure at the social and technical levels, so that people continue to rely upon it. Building social trust among stakeholders is deceptively simple but proves arduous. However, without trust in data scientists, who would deal with private data very carefully, people would not hand over their private data. Without trust in data managers, who would curate data to make it usable, data users or data scientists would not utilize the collected data. Likewise, caring for social as well as technical arrangements in biodata infrastructure is key in determining its active usage and success, and it is governance which provides a continuous space for considering the kind of care works that are needed.

Therefore, someone should keep paying attention to it. This is not something that can be ignored or disregarded, even after the construction of infrastructure is complete. Thus, from a way before and even after the construction of the data infrastructure, continuous technical and social care work would be needed. In the name of building a public data infrastructure, it is the government who could and should play this role. Without such a role and endeavor from the government in caring for the flow of data, the life of the data infrastructure would be at risk.

Furthermore, such care work requires specific strategies. According to Gottweis and Lauss, shaping governance in data infrastructure meant conceiving a “strategy [or a system that enables such strategy] for patterning a network of interaction that unfolds within and across a number of different fields”; a number of different fields range from scientific/technological to medical/health, industrial/economic, legal/ethical, and social/political.13 For example, to secure trust among biodata workers, not only a trustworthy standard for data format at a technical sense, but also a trustful legal guideline of data handling as well as a trustful venue for the interaction of diverse data workers at a social level would be needed. Only then data could flow without friction. In that sense, it should be noted that shaping governance, as a way of conceiving strategy for various care works, meant more than building some legal frameworks. For example, authoritative interpretations of the Personal Information Protection Act and/or the Bioethics and Safety Act may be required to ensure a seamless return of results. However, this may be insufficient. A mutual understanding among various data workers regarding the necessity of data circulation, awareness of the balance between risks and benefits, and trust in the government’s competence as the main actor are also required, and appropriate incentives and responsibilities must be allocated.14 These points underscore the necessity of governance strategies. Harmon et al.15 alarmed how “the absence of any sound governance framework,” which should have brought a wide range of stakeholders into the biodata infrastructure at an early stage, has posed serious challenges and difficulties for the Taiwan Biobank. By continuously conceiving a strategy in line with the changing environment around a data ecology and caring for technical and social arrangements properly, governance provides grounds for biodata to flow and create value.

In this context, if the government only focuses on the construction itself, there is a danger that it would focus only on its completion while overlooking the various care work that needs to be addressed.

Some may believe that we can address governance after the construction. However, this should be done before and not after the construction of the biodata infrastructure. Timing does matter. Depending on what governance is implemented, which stakeholders participate in creating the data infrastructure, and which do not, the way of designing and developing the infrastructure is different. As we have emphasized, some previous biodata infrastructures ultimately became unsustainable and eventually shut down because of their failure to effectively engage essential stakeholders in enabling the flow of biodata. These failures are costly to society and should be avoided as much as possible through well-thought-out planning. Notably, the UK Biobank launched its independent Ethics and Governance Council at an early stage.1617 When benchmarking a series of other countries’ cases, it is necessary to look at not only their technical aspects but also their ways of governing and caring for a particular biodata infrastructure.

Therefore, the Korean government should change its attitude toward the national biodata infrastructure, as it differs from that of a dam or highway. Considering the distinctive features of creating value in biodata infrastructure, the government should move forward and take a responsibility for developing a strategy to generate dynamic relations among various biodata workers in South Korea. To this end, the government should first put an effort in realizing the current status of biodata workers in South Korea. For example, who, and how many biodata workers—data scientists, data producers, data users, and data managers—are there in Korean biodata ecology; where are they? who is lacking? what are their relationships? Based on this, the government should arrange a sociotechnical space for those biodata workers to come in the name of shaping governance for public infrastructure in the early stages. Without a trustworthy and resourceful space that only the government can provide, various biodata workers would not come to meet other data workers—be they data scientists or data users. With this space in hand, the government should also develop a system for governance that can continuously monitor the various types of care work required for the evolution of biodata infrastructure. Many biodata infrastructure projects have experienced crises because of a lack of technical and social care work to address their flows. Now is the time for the government to take further steps, instead of acting as a mere construction supervisor, and take the active lead of shaping a trustful and dynamic governance for the new biodata infrastructure, which would not end even with its construction.

Funding: This work was supported by the Dong-A University research fund (2024).

Disclosure: The authors have no potential conflicts of interest to disclose.

Author Contributions: Conceptualization: Shin Y, Kim CJ.

Formal analysis: Shin Y.

Funding: Kim CJ.

Investigation: Shin Y.

Validation: Kim CJ.

Writing - original draft: Shin Y.

Writing - review & editing: Kim CJ.
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1 Korean Society for Bioinformatics Korea Genome Organization A Petition for Reconsidering the Governance of the Korea Bioinformation Center. Forwarded to the Ministry of Science and ICT Seoul, Korea Korean Society for Bioinformatics, Korea Genome Organization 2023
2 Ministry of Health and Welfare (KR) Ministry of Science and ICT (KR) Ministry of Trade, Industry, and Energy (KR) Korea Disease Control and Prevention Agency The Presentation of the Result of the Preliminary Feasibility Study on the National Integrated Bio-Big Data Construction Project. Presentation Slide Sejong, Korea Ministry of Health and Welfare 2023
3 Ministry of Health and Welfare (KR) Ministry of Science and ICT (KR) Ministry of Trade, Industry, and Energy (KR) Korea Disease Control and Prevention Agency Advance Notice of Call for [the National Integrated Bio-Big Data Construction] Project. Presentation Slide Sejong, Korea Ministry of Health and Welfare 2023
4 Health Data Research UK Digital Innovation hub programme prospectus appendix: principles for participation Updated 2020 Accessed July 4, 2024 https://www.hdruk.ac.uk/wp-content/uploads/2019/07/Digital-Innovation-Hub-Programme-Prospectus-Appendix-Principles-for-Participation.pdf
5 UK Health Data Research Alliance An introduction to the UK Health Data Research Alliance. Presentation slide Updated 2022 Accessed July 4, 2024 https://ukhealthdata.org/wp-content/uploads/2022/07/HDRUK_ALLIANCE_BROCHURE.pdf
6 UK Biobank UK Biobank ethics and governance framework version 3.0 (October 2007) Updated 2007 Accessed July 4, 2024 https://www.ukbiobank.ac.uk/media/0xsbmfmw/egf.pdf
7 Leonelli S Data-centric Biology: A Philosophical Study Chicago, IL, USA University of Chicago Press 2019
8 Pinel C Prainsack B McKevitt C Caring for data: value creation in a data-intensive research laboratory Soc Stud Sci 2020 50 2 175 197 32053062
9 Edwards PN Jackson SJ Bowker GC Knoble CP Understanding Infrastructure: Dynamics, Tensions, and Design. NSF Grant 0630263 Alexandria, VA, USA National Science Foundation 2007
10 Beaulieu A Leonelli S Data and Society: A Critical Introduction London, UK SAGE Publications Ltd. 2022
11 Hawkins AK O’Doherty K Biobank governance: a lesson in trust New Genet Soc 2010 29 3 311 327
12 Strasser B Collecting Experiments: Making Big Data Biology Chicago, IL, USA The University of Chicago Press 2019
13 Gottweis H Lauss G Biobank governance: heterogeneous modes of ordering and democratization J Community Genet 2012 3 2 61 72 22147279
14 Yang JH Kim JE Lee I Ethical considerations for return of results in genomic research J Korean Bioethics Assoc 2023 24 2 69 86
15 Harmon SHE Yen SY Tang SM Biobank governance: the cautionary tale of Taiwan biobank Scripted 2018 15 1 123
16 Levitt M UK Biobank: a model for public engagement? Genom Soc Policy 2005 1 3 78 81
17 Papaioannou T Democratic governance of genomics: the case of UK Biobank New Genet Soc 2012 31 2 111 133
