Monitoring of the human microbiome is an emerging area of diagnostics for personalized medicine. Here, the potential of different nanomaterials and nanobiosensing technologies is reviewed for the development of novel diagnostic devices for the detection and measurement of microbiome‐related biomarkers. Moreover, the current and future landscape of microbiome‐based diagnostics is defined by exploring the advantages and disadvantages of current nanotechnology‐based approaches, especially in the context of developing point‐of‐care (PoC) devices that would meet the international guidelines known as REASSURED (Real‐time connectivity; Ease of specimen collection; Affordability; Sensitivity; Specificity; User‐friendliness; Rapid & robust operation; Equipment‐free; and Deliverability). Finally, the strategies of the latest international scientific consortia working in this field are analyzed, the current microbiome diagnostics market are reported and the principal ethical, legal, and societal issues related to microbiome R&D and innovation are discussed.
The current model for reviewing research with human beings basically depends on decision-making processes within research ethics committees. These committees must be aware of the importance of the new digital paradigm based on the large-scale exploitation of datasets, including personal data on health. This article offers guidelines, with the application of the EU's General Data Protection Regulation, for the appropriate evaluation of projects that are based on the use of big data analytics in healthcare. The processes for gathering and using this data constitute a niche where current research is developed. In this context, the existing protocols for obtaining informed consent from participants are outdated, as they are based not only on the assumption that personal data are anonymized, but that they will continue to be so in the future. As a result, it is essential that research ethics committees take on new capabilities and revisit values such as privacy and freedom, updating protocols, methodologies and working procedures. This change in the work culture will provide legal security to the personnel involved in research, will make it possible to guarantee the protection of the privacy of the subjects of the data, and will permit orienting the exploitation of data to avoid the commodification of personal data in this era of deidentification, so that research meets actual social needs and not spurious or opportunistic interests disguised as research.
Personal health-related data in the context of the European Union is being increasingly used for big data projects under diverse schemes. There, public and private sectors participate distinctively or jointly, pursuing very different goals which may conflict with individual rights, notably privacy. Given that, this paper advocates for stopping the unjustified accumulation and commercialisation of personal data, protecting the interests of citizens and building appropriate frameworks to govern big data projects for health. A core tool for achieving such goals is to develop consent mechanisms which allow truly informed but adaptable consent, conjugated with the engagement of donors, participants and society.
. The World Conferences were established as global forums for discussion of ideas, policies and empirical findings related to the responsible conduct of research. The Conferences aim to galvanise the global effort to strengthen the trustworthiness and reliability of research and encourage researchers worldwide to be accountable for their findings. Earlier conferences were held in Lisbon (2007), Singapore (2010) and Montréal (2010). The Rio conference attracted over 470 delegates from 42 countries, including leaders of research institutions and funding agencies, policy makers, editors and publishers, legal experts, researchers and graduate students. The theme of the conference was Research Rewards and Integrity: Improving Systems to Promote Responsible Research. These Proceedings contain the abstracts of the presentations given at the 4th World Conference in concurrent sessions, partner symposia, and poster sessions. Also included are summaries of the discussions in three focus tracks, which allowed delegates to consider and work on questions about the roles of funders, institutions, and countries in improving research systems and strengthening research integrity. Videos of the plenary presentations are available at the conference website (www.wcri2015.org). The 5 th World Conference will be held in Amsterdam, The Netherlands, May 28-31, 2017 (www.wcri2017.org). The University of Queensland (UQ) is one of the leading research-intensive universities in Australia. UQ first developed formal policy and procedure relating to responsible conduct of research in 2011. The ongoing practical application of the first iteration of these policies identified lack of clarity in procedure with challenges arising from unintended consequences. A significant case of research misconduct in 2013 was a catalyst to commission a comprehensive external review of policy, procedure and practice relevant to research integrity, ethics and compliance in line with the Australian Code for Responsible Conduct of Research (2007). This presentation will describe the comprehensive strategy arising from this review to improve our policies, our resources, our systems and to ensure the practice of responsible conduct of research sits at the heart of UQ. Additional funds have enabled us to increase the number and seniority of staff in the Research Integrity Office, to purchase a purpose built complaints management system and the Epigeum online Research Integrity training tool. With a team of experienced research leaders and other key staff we are revising our responsible research policies and developing an education and communication plan to ensure senior staff such as Executive Deans and Heads of Schools are confident in working collaboratively with the Research Integrity Office and that all staff understand their responsibilities under the Australian Code and university policy. We have appointed a team of 16 senior researchers to the roles of Research Integrity Advisors embedded within each Faculty and Institute as a first triage point for people wi...
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