Life Sciences, Society and Policy最新文献

Responsible Research and Innovation ('RRI') is a cross-cutting priority for scientific research in the European Union and beyond. This paper considers whether the way such research is organised and delivered lends itself to the aims of RRI. We focus particularly on international consortia, which have emerged as a common model to organise large-scale, multi-disciplinary research in contemporary biomedical science. Typically, these consortia operate through fixed-term contracts, and employ governance frameworks consisting of reasonably standard, modular components such as management committees, advisory boards, and data access committees, to co-ordinate the activities of partner institutions and align them with funding agency priorities. These have advantages for organisation and management of the research, but can actively inhibit researchers seeking to implement RRI activities. Conventional consortia governance structures pose specific problems for meaningful public and participant involvement, data sharing, transparency, and 'legacy' planning to deal with societal commitments that persist beyond the duration of the original project. In particular, the 'upstream' negotiation of contractual terms between funders and the institutions employing researchers can undermine the ability for those researchers to subsequently make decisions about data, or participant remuneration, or indeed what happens to consortia outputs after the project is finished, and can inhibit attempts to make project activities and goals responsive to input from ongoing dialogue with various stakeholders. Having explored these challenges, we make some recommendations for alternative consortia governance structures to better support RRI in future.

In 2016, the World Innovation Summit for Health (WISH) published its Forum Report on precision medicine "PRECISION MEDICINE - A GLOBAL ACTION PLAN FOR IMPACT". Healthcare is undergoing a transformation, and it is imperative to leverage new technologies to generate new data and support the advent of precision medicine (PM). Recent scientific breakthroughs and technological advancements have improved our disease knowledge and altered diagnosis and treatment approaches resulting in a more precise, predictive, preventative and personalized health care that is customized for the individual patient. Consequently, the big data revolution has provided an opportunity to apply artificial intelligence and machine learning algorithms to mine such a vast data set. Additionally, personalized medicine promises to revolutionize healthcare, with its key goal of providing the right treatment to the right patient at the right time and dose, and thus the potential of improving quality of life and helping to bring down healthcare costs.This policy briefing will look in detail at the issues surrounding continued development, sustained investment, risk factors, testing and approval of innovations for better strategy and faster process. The paper will serve as a policy bridge that is required to enhance a conscious decision among the powers-that-be in Qatar in order to find a way to harmonize multiple strands of activity and responsibility in the health arena. The end goal will be for Qatar to enhance public awareness and engagement and to integrate effectively the incredible advances in research into healthcare systems, for the benefit of all patients.The PM policy briefing provides concrete recommendations on moving forward with PM initiatives in Qatar and internationally. Equally important, integration of PM within a primary care setting, building a coalition of community champions through awareness and advocacy, finally, communicating PM value, patient engagement/empowerment and education/continued professional development programs of the healthcare workforce.Key recommendations for implementation of precision medicine inside and outside Qatar: 1. Create Community Awareness and PM Education Programs 2. Engage and Empower Patients 3. Communicate PM Value 4. Develop appropriate Infrastructure and Information Management Systems 5. Integrate PM into standard Healthcare System and Ensure Access to Care PM is no longer futuristic. It is here. Implementing PM in routine clinical care does require some investment and infrastructure development. Invariably, cost and lack of expertise are cited as barriers to PM implementation. Equally consequential, are the curriculum and professional development of medical care experts.Policymakers need to lead and coordinate effort among stakeholders and consider cultural and faith perspectives to ensure success. It is essential that policymakers integrate PM approaches into national strategies to improve health and health care for a

In the United States alone, the prevalence of AD is expected to more than double from six million people in 2019 to nearly 14 million people in 2050. Meanwhile, the track record for developing treatments for AD has been marked by decades of failure. But recent progress in genetics, neuroscience and gene editing suggest that effective treatments could be on the horizon. The arrival of such treatments would have profound implications for the way we diagnose, triage, study, and allocate resources to Alzheimer's patients. Because the disease is not rare and because it strikes late in life, the development of therapies that are expensive and efficacious but less than cures, will pose particular challenges to healthcare infrastructure. We have a window of time during which we can begin to anticipate just, equitable and salutary ways to accommodate a disease-modifying therapy Alzheimer's disease. Here we consider the implications for caregivers, clinicians, researchers, and the US healthcare system of the availability of an expensive, presymptomatic treatment for a common late-onset neurodegenerative disease for which diagnosis can be difficult.

Freezers with biospecimen deposits became biobanks and later were networked at the pan-European level in 2013 under the Biobanking and BioMolecular Resources Research Infrastructure-European Research Infrastructure Consortium (BBMRI-ERIC). Drawing on document analysis about the BBMRI-ERIC and multi-sited fieldwork with biobankers in Spain from a science and technology studies approach, we explore what biobanks are expected to do and become under the BBMRI-ERIC framework, and how infrastructural transitions promote particular transformations in biobanking practices. The primary purpose of biobanks in Europe is presented as being to become mediators in contemporary biomedical research (global sharing nodes) distribution, and distributed nodes of samples and their associated data. We argue that infrastructural transitions are complicated and heterogeneous, giving rise to unattended local concerns on adjusting their practices to fit into the BBMRI-ERIC framework, even for non-members, as the case of Spain illustrates, where "old practices" of collection and storage are questioned. In this article, we aim to encourage qualitative studies to explore the lags between pan-European policies and prospects, different contextual interpretations, and biobanking reconfigurations as an opportunity to explore what that lag is made of (e.g. tensions with "old practices," unresolved conflicts with the national agendas, reservations on a possible centralization of the biobanking practices by regional biobanks, lack of funding, etc.). Such research could enrich not only policy guidance, but also the understanding of technoscientific infrastructures' scalability.

The issue of globalization of research is receiving considerable attention due to the increasing number of offshored R&D activities from the United States, Europe, and Japan. This paper explores this phenomenon and provides a model to analyze the factors that will likely contribute to a global transformation of clinical trials. By identifying the main characteristics of clinical trials, I aim to clarify the main driver of the relocation process of clinical research. I reviewed the relevant published articles to address the research questions. The results of this study challenge the traditional thinking of cost-related factors as the major reason for offshoring cilinical trials and show the importance of the recruitment of human subjects in trials. Consequently, this paper suggests that "recruitment crisis" in home country as the main contribution and a key driver to offshore R&D activities, has been underestimated by previous studies. In particular, this study provides policy-decision makers with a new insight into the development issue surrounding the pharmaceutical industry.

In European research and innovation policy, Responsible Research and Innovation (RRI) and Open Science (OS) encompass two co-existing sets of ambitions concerning systemic change in the practice of research and innovation. This paper is an exploratory attempt to uncover synergies and differences between RRI and OS, by interrogating what motivates their respective transformative agendas. We offer two storylines that account for the specific contexts and dynamics from which RRI and OS have emerged, which in turn offer entrance points to further unpacking what 'opening up' to society means with respect to the transformative change agendas that are implicit in the two agendas. We compare differences regarding the 'how' of opening up in light of the 'why' to explore common areas of emphasis in both OS and RRI. We argue that while both agendas align with mission-oriented narratives around grand societal challenges, OS tends to emphasize efficiency and technical optimisation over RRI's emphasis on normative concerns and democracy deficits, and that the two agendas thus contrast in their relative legitimate emphasis on doable outcomes versus desirable outcomes. In our conclusion, we reflect on the future outlook for RRI and OS' co-existence and uptake, and on what their respective ambitions for transformation might mean for science-society scholars and scholarship.

This paper argues that data-driven medicine gives rise to a particular normative challenge. Against the backdrop of a distinction between the good and the right, harnessing personal health data towards the development and refinement of data-driven medicine is to be welcomed from the perspective of the good. Enacting solidarity drives progress in research and clinical practice. At the same time, such acts of sharing could-especially considering current developments in big data and artificial intelligence-compromise the right by leading to injustices and affecting concrete modes of individual self-determination. In order to address this potential tension, two key elements for ethical reflection on data-driven medicine are proposed: the controllability of information flows, including technical infrastructures that are conducive towards controllability, and a paradigm shift towards output-orientation in governance and policy.

In this paper, I will argue that making it mandatory to report research misconduct is too demanding, as this kind of intervention can at times be self-destructive for the researcher reporting the misconduct. I will also argue that posing the question as a binary dilemma masks important ethical aspects of such situations. In situations that are too demanding for individual researchers to rectify through reporting, there can be other forms of social control available. I will argue that researchers should explore these. Finally, framing the issue as a question about the responsibilities of individual researchers masks the responsibilities of research institutions. Until institutions introduce measures that make this safe and effective, we should not consider reporting research misconduct mandatory. I will discuss this in light of both quantitative and qualitative data gathered as part of a survey in the PRINTEGER-project.

This paper offers the Eastern Mediterranean Region (EMR) viewpoint with Qatar as a case for lasting transformation of health systems. The Qatar case study illustrates the importance of research in the development of health policy. It provides description of a series of projects that have been undertaken in relevant national areas such as autism, dementia, genomics, palliative care and patient safety. The paper discourse draws attention to investment requirement in health research systems to respond to country national health priorities and to strengthen public health policies for improving health and social outcomes by narrowing the gap between research and politics. In short, the discussion highlights the following: i) health is a human right marching towards universal health care, with research underpinning every advance in health care and quality medical services; ii) evidence-based research is emerging as a critical tool to aid policy- and decision-makers; iii) investment necessity in healthcare research/systems to enable responding to a country's national health priorities and to strengthen public health policies; and iv) need for multi-sectoral involvement of stakeholders to bridge the gap between research and politics. Finally, atypical stakeholders' engagement and bond to politics is a prerequisite to achieve healthcare objectives and policy success so as to reap the benefits of public health results.

Ideally, guidelines reflect an accepted position with respect to matters of concern, ranging from clinical practices to researcher behaviour. Upon close reading, authorship guidelines reserve authorship attribution to individuals fully or almost fully embedded in particular studies, including design or execution as well as significant involvement in the writing process. These requirements prescribe an organisation of scientific work in which this embedding is specifically enabled. Drawing from interviews with nutrition scientists at universities and in the food industry, we demonstrate that the organisation of research labour can deviate significantly from such prescriptions. The organisation of labour, regardless of its content, then, has consequences for who qualifies as an author. The fact that fewer food industry employees qualify is actively used by the food industry to manage the credibility and ownership of their knowledge claims as allonymous science: the attribution of science assisted by authorship guidelines blind to all but one organisational frame.