- Open Access
Introduction to the article collection ‘Translation in healthcare: ethical, legal, and social implications’
© The Author(s). 2016
- Received: 25 October 2016
- Accepted: 28 October 2016
- Published: 14 November 2016
New technologies are transforming and reconfiguring the boundaries between patients, research participants and consumers, between research and clinical practice, and between public and private domains. From personalised medicine to big data and social media, these platforms facilitate new kinds of interactions, challenge longstanding understandings of privacy and consent, and raise fundamental questions about how the translational patient pathway should be organised.
This editorial introduces the cross-journal article collection "Translation in healthcare: ethical, legal, and social implications", briefly outlining the genesis of the collection in the 2015 Translation in healthcare conference in Oxford, UK and providing an introduction to the contemporary ethical challenges of translational research in biology and medicine accompanied by a summary of the papers included in this collection.
In June 2015 some 130 delegates from 20 countries including the USA, Japan, Taiwan, Israel, and Canada, converged on Oxford for the Translation in Healthcare conference, hosted by the Centre for Health, Law and Emerging Technologies (HeLEX) at the University of Oxford. The conference, subtitled ‘exploring the impact of emerging technologies’, provided a forum for a range of voices from different national and disciplinary perspectives to discuss the ethical, legal and social challenges raised by novel healthcare technologies. Hosted in the spacious, contemporary environs of the recently-opened Andrew Wiles building, the event deployed a number of innovative features, including works by artist in residence Miranda Creswell and an interactive Écouter session for conference attendees (about which more below). The intention was to foster the kinds of lively, productive discussions that are otherwise often restricted to the intervals between scheduled presentations. The conference was also part of the international ELSI 2.0 collaboratory  with webcasts of key plenaries and a live Twitter feed connecting the debates with a global audience. Some of the papers in this special issue were presented in an early form at the Translation in Healthcare conference, while others germinated from the interdisciplinary exchanges and discussions stimulated by the event. Each paper in this special issue addresses a particular technology and brings a particular disciplinary and methodological approach, but together they reveal the broad array of ethical issues emerging from the work of translation.
In recent years the notion of ‘translation’ has been ever-present in discussions about healthcare technology and biomedical research, becoming something of a mantra for policymakers and funders to rank alongside ‘innovation’ and, indeed, ‘choice’. As with other concepts that have achieved near-ubiquity, ‘translation’ appears to mean different things to different people in different contexts [2, 3]. However, it is most commonly understood to refer to the application of novel scientific discoveries to improve health outcomes, benefit patients, produce new products and services, and promote economic growth and prosperity. This meaning of translation is reflected in the oft-stated goal of helping innovative discoveries move ‘from bench to bedside’. The translational ideal encompasses both a hopeful optimism about the potential of technology to transform health and alleviate suffering and a concern that the benefits of science are in danger of failing to be realised. These hopes and fears for the future are employed to stimulate and organise action in the present . This mixture of hope and concern as a stimulus for widespread change in the organisation of research is clearly illustrated by the field of genomics.
On the one hand, the sequencing of the complete human genome has been hailed as a landmark scientific achievement with the potential to “revolutionise the diagnosis, prevention and treatment of most, if not all, human diseases” . On the other, some have questioned whether those anticipated benefits have so far been adequately demonstrated, especially in terms of returns for patients with chronic and incurable conditions . When, in 2003 the US National Institutes of Health (NIH) launched its ‘roadmap’ for future research, the sequencing of the human genome was presented as both an opportunity and a challenge; realizing the benefits of this and other scientific discoveries would not happen automatically, but required work, effort and transformation of existing systems of clinical research to drive the translation of discoveries into clinical benefits . In fact, nothing less than the ‘reengineering of the clinical enterprise’ was prescribed (, p64). The changes, which have resulted from the roadmap and from similar endeavours elsewhere, in effect constitute the translational enterprise.
These changes have been, and continue to be, substantial and extend to many domains of health-related science and technology beyond genomics. Many of the initiatives put in place to support translational research have been ‘top down’ changes fostered by state governments and major organisations with significant financial and institutional resources. In the USA the NIH Clinical and Translational Science Awards (CTSA) Program has established 50 regional hubs to support translational research and had a budget in 2016 of USD 685 million to provide training, engage under-served populations, and develop bioinformatics and other tools to improve translational efficiency. The Innovative Medicines Initiative is a joint venture between the European Commission and the European Federation of Pharmaceutical Industries and Associations (Efpia) with a Euro 3.3 billion budget to support public- private consortia working on novel health technologies and platforms for drug discovery.
Translational research also requires large data sets and large cohorts of research participants. In the UK, Genomics England has been set up to sequence the genomes of 100,000 volunteers. China’s Kadoorie Biobank already has half a million registered participants, while in the USA President Obama’s Precision Medicine Initiative has started recruiting the first of an envisioned 1 million patients and healthy volunteers who will contribute biological, environmental, lifestyle and other data. It is not only states that are instituting large-scale collections of health and biomedical data; AstraZeneca recently announced a collaborative venture with the Wellcome Trust Sanger Institute and Craig Venter’s San Diego-based biotech Human Longevity to collate genome sequence data and health records from 2 million people to help identify rare genetic variations with significant effects for health . In addition to generating large swathes of new data, translational efforts have also focused on improving access to existing data.
Much of the impetus behind the open access and open data movements is driven by a belief that increased availability of scientific data will lead to new knowledge and new applications . New infrastructures and networks have also been developed to facilitate the sharing of scientific data and expertise such as the Biobanking and Biomolecular resources Research Infrastructure (BBMRI-ERIC) for international biobanking (, the Human Heredity and Health in Africa (H3Africa) network and the Global Alliance for Genomics and Health (GA4GH) for genomic and clinical data . Another example is the increasing use of large consortia as an organisational form of science intended to foster collaboration between disciplines, and between industrial and academic researchers, to tackle major translational tasks [12, 13].
Considered broadly, the transformations brought about by the desire to accelerate the translation of research into new treatments also have a ‘bottom up’ component, driven by the efforts of patients and citizens motivated to secure improvements in healthcare. One element of this participatory turn in translation is reflected in the rise of novel digital platforms where patients can share experiences and data, including genomic data, on their conditions, such as PatientsLikeMe and the Platform for Engaging Everyone Responsibly (PEER) developed by the Genetic Alliance patient group. Many common translational aims are also shared by advocates of Citizen Science movements, such as the Mark2Cure initiative which teaches lay members to scan and interpret biomedical literature, or do-it-yourself biology and bioinformatics entrants in the International Genetically Engineered Machine (IGEM) competition, even if they do not necessarily use the term ‘translational research’. The power of distributed data contributed by patients and citizens chimes with the demand for large data sets in translational research, and the drive to engage wider publics in data generation efforts has attracted interest from academic, government, and commercial organisations alike. This is evident in the rise of patient-centred initiatives in biomedical research , but also in the business models of companies like 23andMe, which employed a model of active customer participation in data production in order to generate their proprietary databases of genomic and lifestyle information [15, 16]. Indeed, the push for greater engagement and participation is forging novel and unexpected alliances and forms of interaction such as the European Patients’ Academy on Therapeutic Innovation (EUPATI) a combined venture of European patient groups, universities and pharmaceutical companies, funded through the IMI program .
We would like to thank Clare Partridge, Editor, and Ted Dove, former Section Editor, at BMC Medical Ethics for all their enthusiasm, hard work and support in realising this article collection and also to the editorial staff at BMC Medical Ethics and BMC Medical Genomics who contributed their time and labour to reviewing manuscripts submitted to this collection.
The Translation in Healthcare conference was supported by the Nuffield Department of Population Health at the University of Oxford; ISIS Innovation at the University of Oxford; the BioShare.EU consortium; The Wellcome Trust; The Public Population Project in Genomics and Society (P3G) consortium; Oxford Biotech; and the Centre for Law and Genetics at the University of Tasmania. The funders were not involved in the writing of this manuscript or in the selection or review of papers for the special collection.
MM, DD and SL did not receive any funding or other compensation for writing this manuscript.
Availability of data and materials
All three authors were guest editors on this BMC thematic collection. All of the authors (MM, DD, SL) contributed to writing this paper. All authors read and approved the final manuscript.
Consent for publication
In addition to being a Guest Editor for this article collection, MM is a co- author on one of the articles in the collection  and shares an institutional affiliation to the Centre for Health, Law and Emerging Technologies at the University of Oxford in common with a number of a number of other authors of articles featured in this collection. All of the papers included in this collection were subject to independent peer review in line with BMC editorial policy and none of the Guest Editors were involved in overseeing the review of papers written by their colleagues. MM, DD, and SL therefore declare no competing interests.
Ethics approval and consent to participate
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