The Microbiome Meets Nanotechnology: Opportunities and Challenges in Developing New Diagnostic Devices.

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).

European perspectives on big data applied to health: The case of biobanks and human databases.

Introduction: The paradigm shift to a knowledge-based economy has incremented the use of personal information applied to health-related activities, such as biomedical research, innovation, and commercial initiatives. The convergence of science, technology, communication and data technologies has given rise to the application of big data to health; for example through eHealth, human databases and biobanks.

Methods: In light of these changes, we enquire about the value of personal data and its appropriate use.

[Review of the methodological, ethical, legal and social issues of research projects in healthcare with big data].

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.

Gene Editing in Humans: Towards a Global and Inclusive Debate for Responsible Research.

In December 2016, the Opinion Group of the Bioethics and Law Observatory (OBD) of the University of Barcelona launched a Declaration on Bioethics and Gene Editing in Humans analyzing the use of genome editing techniques and their social, ethical, and legal implications through a multidisciplinary approach. It focuses on CRISPR/Cas9, a genome modification technique that enables researchers to edit specific sections of the DNA sequence of humans and other living beings. This technique has generated expectations and worries that deserve an interdisciplinary analysis and an informed social debate.

[Unresolved issues in the evaluation of research projects involving induced pluripotent stem cells (iPS)].

This paper identifies problems and analyzes those conflicts posed by the evaluation of research projects involving the collection and use of human induced pluripotent stem cells (iPS) in Spain. Current legislation is causing problems of interpretation, circular and unnecessary referrals, legal uncertainty and undue delays. Actually, this situation may cause a lack of control and monitoring, and even some paralysis in regenerative medicine and cell therapy research, that is a priority nowadays.

[International regulation of ethics committees on biomedical research as protection mechanisms for people: analysis of the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research of the Council of Europe].

The article explores and analyses the content of the Council of Europe's Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research regarding the standard legal instrument in biomedical research, issued by an international organization with leadership in bioethics. This implies ethics committees are mechanisms of protection of humans in biomedical research and not mere bureaucratic agencies and that a sound inescapable international regulatory framework exists for States to regulate biomedical research. The methodology used focuses on the analysis of the background, the context in which it is made and the nature and scope of the Protocol.