To what are we opening science? Reform of the publishing system is only a step in a much broader re-evaluation.

Openness is being invoked as a silver bullet to increase the productivity and cost-effectiveness of academic research. Sabina Leonelli and Barbara Prainsack argue that openness is more than just a blanket strategy to reduce costs. The failure to recognise neoliberal commodificaton and the false premise that open science will necessarily save money are two major misconceptions. Openness in science is not an end in itself, but it should always be in the service of something good

Sticks AND Carrots: encouraging open science at its source

publication-status: Acceptedtypes: ArticleThe Open Science (OS) movement has been seen as an important facilitator for public participation in science. This has been underpinned by the assumption that widespread and free access to research outputs leads to (i) better and more efficient science, (ii) economic growth, in particular for small and medium-sized enterprises wishing to capitalise on research findings and (iii) increased transparency of knowledge production and its outcomes. The latter in particular could function as a catalyst for public participation and engagement. Whether OS is likely to help realise these benefits, however, will depend on the emergence of systemic incentives for scientists to utilise OS in a meaningful manner. While some areas, the environmental sciences have a long tradition of open ethos, citizen inclusion and global collaborations, such activities need to be more systematically supported and promoted by funders and learned societies in order to improve scientific research and public participation.European Research Council under the European Union's Seventh Framework Programme (FP7/2007-2013)ERC grant agreement n° 335925Economic and Social Research Council (ESRCESRC grant number ES/F028180/1L T grant number RPG-2013-15

Responsible personalised medicine: Exploring the ethical, legal, social, political and economic issues of manufacturing, distribution, access and reimbursement. A Report of the Responsible Personalised Medicine Project, UCL Future Targeted Manufacturing in Healthcare Hub

This report provides an overview of the ethical, legal, social, political and economic (ELSPE) issues underpinning the “manufacturing, business and regulatory challenges” that confront the development and delivery of affordable and accessible new targeted biological medicines. We specifically focus on the evolving definitions and its implication for the public understanding of personalised medicine (section 1), issues of manufacturing and distribution of Personalised Therapies (section 2) and institutional readiness (section 3) specifically focusing on emerging regulatory and reimbursement pathways (section 3.2) and how these are shaping or being shaped by ‘real world evidence’ (section 3.3). This is followed by our reflection on the implications of and for the entangled, complex and contingent interrelationships between personalised medicine, society and responsibility (section 4). Finally we conclude with discussion of the gaps and priorities for future ELSPE research on manufacturing of advanced biotherapeutics in terms of access, reimbursement, skills and infrastructure, regulation, responsible research and innovation (RRI) and the international political economy of emerging personalised medicine markets (section 5). This is a necessarily narrower review of the spectrum of ELSPE issues that attend personalised medicine activities and reflects this report’s aims to focus on those aspects of personalised medicine addressed by the UCL’s Future Targeted Manufacturing in Healthcare Hub

Genomic sequencing capacity, data retention, and personal access to raw data in Europe

Whole genome/exome sequencing (WGS/WES) has become widely adopted in research and, more recently, in clinical settings. Many hope that the information obtained from the interpretation of these data will have medical benefits for patients and—in some cases—also their biological relatives. Because of the manifold possibilities to reuse genomic data, enabling sequenced individuals to access their own raw (uninterpreted) genomic data is a highly debated issue. This paper reports some of the first empirical findings on personal genome access policies and practices. We interviewed 39 respondents, working at 33 institutions in 21 countries across Europe. These sequencing institutions generate massive amounts of WGS/WES data and represent varying organisational structures and operational models. Taken together, in total, these institutions have sequenced ∼317,259 genomes and exomes to date. Most of the sequencing institutions reported that they are able to store raw genomic data in compliance with various national regulations, although there was a lack of standardisation of storage formats. Interviewees from 12 of the 33 institutions included in our study reported that they had received requests for personal access to raw genomic data from sequenced individuals. In the absence of policies on how to process such requests, these were decided on an ad hoc basis; in the end, at least 28 requests were granted, while there were no reports of requests being rejected. Given the rights, interests, and liabilities at stake, it is essential that sequencing institutions adopt clear policies and processes for raw genomic data retention and personal access

The best Open Access policies put researchers in charge, and recent EU Horizon 2020 and COST policies support this.

COST (European Cooperation in Science and Technology) – an intergovernmental framework supporting cooperation among scientists and researchers across Europe – recently supported an independent Strategic Initiative to better understand issues pertaining to open access publishing across a range of disciplines. Here COST Domain Committee members Marc Caball, Soulla Louca and Roland Pochet, Policy Officer for Open Access at the European Commission, Daniel Spichtinger, and Chair of the COST Strategic Initiative on Open Access, Barbara Prainsack emphasise here that the best pathways to the goal of open access vary across disciplines and across countries and institutions. The individuals best placed to decide what is right for them are the researchers themselves. The European Commission also encourages this position through the adoption of the Horizon 2020 open access regulation which will present researchers with a range of OA options, rather than prescribing one narrow format

Is there a duty to participate in digital epidemiology?

This paper poses the question of whether people have a duty to participate in digital epidemiology. While an implied duty to participate has been argued for in relation to biomedical research in general, digital epidemiology involves processing of non-medical, granular and proprietary data types that pose different risks to participants. We first describe traditional justifications for epidemiology that imply a duty to participate for the general public, which take account of the immediacy and plausibility of threats, and the identifiability of data. We then consider how these justifications translate to digital epidemiology, understood as an evolution of traditional epidemiology that includes personal and proprietary digital data alongside formal medical datasets. We consider the risks imposed by re-purposing such data for digital epidemiology and propose eight justificatory conditions that should be met in justifying a duty to participate for specific digital epidemiological studies. The conditions are then applied to three hypothetical cases involving usage of social media data for epidemiological purposes. We conclude with a list of questions to be considered in public negotiations of digital epidemiology, including the application of a duty to participate to third-party data controllers, and the important distinction between moral and legal obligations to participate in research