The capacity to collect and analyse data is growing exponentially. Referred to as ‘Big Data’, this scientific, social and technological trend has helped create destabilising amounts of information, which can challenge accepted social and ethical norms. Big Data remains a fuzzy idea, emerging across social, scientific, and business contexts sometimes seemingly related only by the gigantic size of the datasets being considered. As is often the case with the cutting edge of scientific and technological progress, understanding of the ethical implications (...) of Big Data lags behind. In order to bridge such a gap, this article systematically and comprehensively analyses academic literature concerning the ethical implications of Big Data, providing a watershed for future ethical investigations and regulations. Particular attention is paid to biomedical Big Data due to the inherent sensitivity of medical information. By means of a meta-analysis of the literature, a thematic narrative is provided to guide ethicists, data scientists, regulators and other stakeholders through what is already known or hypothesised about the ethical risks of this emerging and innovative phenomenon. Five key areas of concern are identified: informed consent, privacy, ownership, epistemology and objectivity, and ‘Big Data Divides’ created between those who have or lack the necessary resources to analyse increasingly large datasets. Critical gaps in the treatment of these themes are identified with suggestions for future research. Six additional areas of concern are then suggested which, although related have not yet attracted extensive debate in the existing literature. It is argued that they will require much closer scrutiny in the immediate future: the dangers of ignoring group-level ethical harms; the importance of epistemology in assessing the ethics of Big Data; the changing nature of fiduciary relationships that become increasingly data saturated; the need to distinguish between ‘academic’ and ‘commercial’ Big Data practices in terms of potential harm to data subjects; future problems with ownership of intellectual property generated from analysis of aggregated datasets; and the difficulty of providing meaningful access rights to individual data subjects that lack necessary resources. Considered together, these eleven themes provide a thorough critical framework to guide ethical assessment and governance of emerging Big Data practices. (shrink)

Recent developments in biotechnology allow for the generation of increasingly complex products out of human tissues, for example, human stem cell lines, synthetic embryo-like structures and organoids. These developments are coupled with growing commercial interests. Although commercialisation can spark the scientific and clinical promises, profit-making out of human tissues is ethically contentious and known to raise public concern. The traditional bioethical frames of gift versus market are inapt to capture the resulting practical and ethical complexities. Therefore, we propose an alternative (...) approach to identify, evaluate and deal with the ethical challenges that are raised by the increasing commercialisation of the exchange of sophisticated human tissue products. We use organoid technology, a cutting-edge stem cell technology that enables the cultivation of ‘mini-organs’ in a dish, as an example. First, we examine the moral value of organoids and recognise them as hybrids that relate to persons and their bodies as well as to technologies and markets in ambiguous ways. Second, we show that commercialisation of organoids is legitimised by a detachment of the instrumental and commercial value of organoids from their associations with persons and their bodies. This detachment is enacted in steps of disentanglement, among which consent and commodification. Third, we contend that far-reaching disentanglement is ethically challenging: (1) Societal interests could be put under pressure, because the rationale for commercialising organoid technology, that is, to stimulate biomedical innovation for the good of society, may not be fulfilled; (2) The interests of donors are made subordinate to those of third parties and the relational moral value of organoids may be insufficiently recognised. Fourth, we propose a ‘consent for governance’ model that contributes to responsible innovation and clinical translation in this exciting field. (shrink)

This article argues that personal medical data should be made available for scientific research, by enabling and encouraging individuals to donate their medical records once deceased, similar to the way in which they can already donate organs or bodies. This research is part of a project on posthumous medical data donation developed by the Digital Ethics Lab at the Oxford Internet Institute at the University of Oxford. Ten arguments are provided to support the need to foster posthumous medical data donation. (...) Two major risks are also identified—harm to others, and lack of control over the use of data—which could follow from unregulated donation of medical data. The argument that record-based medical research should proceed without the need to secure informed consent is rejected, and instead a voluntary and participatory approach to using personal medical data should be followed. The analysis concludes by stressing the need to develop an ethical code for data donation to minimise the risks, and offers five foundational principles for ethical medical data donation suggested as a draft code. (shrink)

There has been extensive discussion in research ethics literature surrounding the appropriate form of informed consent for biobanking, whether with adapted content, or adapted forms such as broad or tiered consent. These discussions presuppose that it is possible to disclose adequate information at the outset to facilitate an informed choice to donate to a biobank. I will argue that informed consent cannot be achieved because in the biobanking context, we are either consenting to an enterprise that is not research or (...) to future research. Nor is the solution to abandon the idea that informed consent ethically requires the disclosure of a certain minimal amount of information to make an informed choice by misleadingly identifying broad, blanket or even tiered consent as forms of ‘informed’ consent. Rather, we should abandon the idea that informed consent for research can be adapted to the type of endeavor that biobanking is, and understand the goal as to develop alternatives not as alternative forms of informed consent, but rather alternatives to informed consent. (shrink)

It is common practice for biobanks and biobank researchers to seek funding from agencies that are independent of the biobank that often stipulate conditions requiring researchers to grant access and share biomaterials and data as part of the agreement, in particular, in international collaborative health research. As yet, to the author’s knowledge, there has been no study conducted to examine whether these conditions could result in the commercialization of biomaterials and data and whether such practice is considered ethical. This paper (...) therefore seeks to answer the question of whether such sharing of biomaterials and data for biobank research in exchange for funding from sponsors and funders in collaborative health research is ethically justified. The central idea of this paper is based on an argument against commodification of the body and its parts, which includes biomaterials and data and holds that it is ethically wrong to commodify humans and their body parts. The arguments against commodification of biomaterials and data explored are the Kantian approach argument as it relates to interference of commodification with human dignity which is linked to a diminished sense of personhood, an argument against commodification that is based on a dilution of altruism and lastly the communitarian approach anti-commodification argument which emphasizes a social responsibility to the common good. Arguments in support of commodification based on liberal individualism and consequentialism are also discussed. (shrink)

The establishment of MyCohort in 2005 showed that there is a growing interest on the part of the Malaysian government in the creation of biobanks in the country. This project can be considered as the biggest and most comprehensive cohort study in Malaysia, where hundreds of thousands of human samples are stored for epidemiological and biomedical research. However, little is known about the current issues or the situation related to biobank research in Malaysia. There are pressing issues that need answers (...) such as the governance of the national biobank as well as other privately owned biobanks in the nation, the public perspectives and perceptions regarding biobanks, and other matters such as the ethical, legal, and social issues related to biobank research. This article will highlight the status and issues related to biobank research in Malaysia and provide suggestions on future research practices that we feel need to be seriously considered. These suggestions are designed to advance and enlighten researchers’ knowledge, as well as provide the public with information on issues associated to biobanking. Good governance increases public knowledge and trust, and religious acceptance of biobank research and accountability can lead to increased participation in biobank research. The direct implications of the discussion about the ethical, legal, and social issues of biobanks are pertinent for the foundation of knowledge relating to biobanks, as well as the forward gestures for future medicine for mankind. (shrink)

BackgroundLarge-scale, centralized data repositories are playing a critical and unprecedented role in fostering innovative health research, leading to new opportunities as well as dilemmas for the medical sciences. Uncovering the reasons as to why citizens do or do not contribute to such repositories, for example, to population-based biobanks, is therefore crucial. We investigated and compared the views of existing participants and non-participants on contributing to large-scale, centralized health research data repositories with those of ex-participants regarding the decision to end their (...) participation. This comparison could yield new insights into motives of participation and non-participation, in particular the behavioural change of withdrawal.MethodsWe conducted 36 in-depth interviews with ex-participants, participants, and non-participants of a three-generation, population-based biobank in the Netherlands. The interviews focused on the respondents’ decision-making processes relating to their participation in a large-scale, centralized repository for health research data.ResultsThe decision of participants and non-participants to contribute to the biobank was motivated by a desire to help others. Whereas participants perceived only benefits relating to their participation and were unconcerned about potential risks, non-participants and ex-participants raised concerns about the threat of large-scale, centralized public data repositories and public institutes, such as social exclusion or commercialization. Our analysis of ex-participants’ perceptions suggests that intrapersonal characteristics, such as levels of trust in society, participation conceived as a social norm, and basic societal values account for differences between participants and non-participants.ConclusionsOur findings indicate the fluidity of motives centring on helping others in decisions to participate in large-scale, centralized health research data repositories. Efforts to improve participation should focus on enhancing the trustworthiness of such data repositories and developing layered strategies for communication with participants and with the public. Accordingly, personalized approaches for recruiting participants and transmitting information along with appropriate regulatory frameworks are required, which have important implications for current data management and informed consent procedures. (shrink)

Globally active companies are involved in the discursive construction of moral legitimacy. Establishing normative conformance is problematic given the plurality of norms and values worldwide, and is particularly difficult for companies operating in morally controversial industries. In this paper, we investigate how organizations publicly legitimize the trade of human tissue for private profit when this practice runs counter to deep-seated and widespread moral beliefs. To do so, we use inductive, qualitative methods to analyze the website discourse of three types of (...) organizations that trade in human tissue and are associated with different degrees of moral controversy with respect to tissue procurement and use. Our analysis reveals an object-oriented approach to moral legitimizing centered on the human tissue as a morally disputed good. We find that the website discourse translates human tissue into technology, constructs normative meaning around a dominant instrumental value associated with human-tissue-as-technology, and reproduces and stabilizes this meaning by six discursive mechanisms that amplify and anchor it. Moreover, the use of amplifying and anchoring discourse was greater in organizations associated with greater controversy. The results are consistent with an object-oriented sociality. (shrink)

The economic aspects of biobanking are intertwined with the social and scientific aspects. We describe two problems that structure the discussion about the economics of biobanking and which illustrate this intertwining. First, there is a ‘sustainability problem’ about how to maintain biobanks in the long term. Second, and representing a partial response to the first problem, there is a ‘commercialisation problem’ about how to deal with the voluntary altruistic relationship between participants and biobanks, and the potential commercial relationships that a (...) biobank may form. Social scientists have argued that the commercialisation problem is inadequate as a way to construct the multiple tensions that biobanks must negotiate. We agree that the commercialisation problem is an inadequate framework; turning to alternative accounts of bioeconomy, we suggest that contemporary consideration of the economics of biobanking primarily in terms of participants and their bodily tissue may reproduce the very commodification of science that these scholars critique. We suggest that an alternative conception of the economics of biobanking beyond the logics of commodification, which may thereby allow broader questions about the social and economic conditions and consequences of biobanks to be posed. (shrink)