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With the rise of systems biology as an approach in biochemistry research, using high throughput techniques such as mass spectrometry to generate metabolic profiles of cancer metabolism is becoming increasingly popular. There are examples of cancer metabolic profiling studies in the academic literature; however they are often only in journals specific to the metabolomics community. This book will be particularly useful for post-graduate students and post-doctoral researchers using this pioneering technique of network-based correlation analysis. The approach can be adapted to the analysis of any large scale metabolic profiling experiment to answer a range of biological questions in a range of species or for a range of diseases.

Background: Governments, funding bodies, institutions, and publishers have developed a number of strategies to encourage researchers to facilitate access to datasets. The rationale behind this approach is that this will bring a number of benefits and enable advances in healthcare and medicine by allowing the maximum returns from the investment in research, as well as reducing waste and promoting transparency. As this approach gains momentum, these data-sharing practices have implications for many kinds of research as they become standard practice across the world. Main text: The governance frameworks that have been developed to support biomedical research are not well equipped to deal with the complexities of international data sharing. This system is nationally based and is dependent upon expert committees for oversight and compliance, which has often led to piece-meal decisionmaking. This system tends to perpetuate inequalities by obscuring the contributions and the important role of different data providers along the data stream, whether they be low- or middle-income country researchers, patients, research participants, groups, or communities. As research and data-sharing activities are largely publicly funded, there is a strong moral argument for including the people who provide the data in decision-making and to develop governance systems for their continued participation. Conclusions: We recommend that governance of science becomes more transparent, representative, and responsive to the voices of many constituencies by conducting public consultations about data-sharing addressing issues of access and use; including all data providers in decision-making about the use and sharing of data along the whole of the data stream; and using digital technologies to encourage accessibility, transparency, and accountability. We anticipate that this approach could enhance the legitimacy of the research process, generate insights that may otherwise be overlooked or ignored, and help to bring valuable perspectives into ...

Much is known about patient attitudes to ethical and legal questions in the context of biobanking, particularly regarding privacy protection and consent. However, little is known about the attitudes of medical researchers who use biobanks for research to these issues. Four focus groups with medical researchers in the UK were conducted in 2010–2011. The study highlights a range of issues associated with the research oversight and consent process (including obtaining ethical approval to use biobank samples and particular concerns for international studies), the benefits and limitations of broad consent and the possibilities of revoking consent. Many of these issues originate in the relatively static consent processes that currently govern the biobanking process. However, it is now possible to develop reliable, dynamic processes using information technology that can resolve many of these ethical and legal concerns. The 'dynamic consent' approach therefore offers the opportunity to fundamentally transform the process of medical research in a manner that addresses the concerns of both patients and medical researchers.

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.

The protection of identity of participants in medical research has traditionally been guaranteed by the maintenance of the confidentiality of health information through mechanisms such as only releasing data in an aggregated form or after identifying variables have been removed. This protection of privacy is regarded as a fundamental principle of research ethics, through which the support of research participants and the public is maintained. Whilst this traditional model was adopted for genetics and genomics research, and was generally considered broadly fit for purpose, we argue that this approach is increasingly untenable in genomics. Privacy risk assessments need to have regard to the whole data environment, not merely the quality of the dataset to be released in isolation. As sources of data proliferate, issues of privacy protection are increasingly problematic in relation to the release of genomic data. However, we conclude that, by paying careful attention to potential pitfalls, scientific funders and researchers can take an important part in attempts to safeguard the public and ensure the continuation of potentially important scientific research.

Background The limited availability of maternal and child health data has limited progress in reducing mortality and morbidity among pregnant women and children. Global health agencies, leaders, and funders are prioritizing strategies that focus on acquiring high quality health data. Electronic maternal and child health registries (eRegistries) offer a systematic data collection and management approach that can serve as an entry point for preventive, curative and promotive health services. Due to the highly sensitive nature of reproductive health information, careful consideration must be accorded to privacy, access, and data security. In the third paper of the eRegistries Series, we report on the current landscape of ethical and legal governance for maternal and child health registries in developing countries. Methods This research utilizes findings from two web-based surveys, completed in 2015 that targeted public health officials and health care providers in 76 countries with high global maternal and child mortality burden. A sample of 298 public health officials from 64 countries and 490 health care providers from 59 countries completed the online survey. Based on formative research in the development of the eRegistries Governance Guidance Toolkit, the surveys were designed to investigate topics related to maternal and child health registries including ethical and legal issues. Results According to survey respondents, the prevailing legal landscape is characterized by inadequate data security safeguards and weak support for core privacy principles. Respondents from the majority of countries indicated that health information from medical records is typically protected by legislation although legislation dealing specifically or comprehensively with data privacy may not be in place. Health care provider trust in the privacy of health data at their own facilities is associated with the presence of security safeguards. Conclusion Addressing legal requirements and ensuring that privacy and data security of women's ...

Currently, researchers have to apply separately to individual biobanks if they want to carry out studies that use samples and data from multiple biobanks. This article analyzes the access governance arrangements of the original five biobank members of the Biobank Standardisation and Harmonisation for Research Excellence in the European Union (BioSHaRE-EU) project in Finland, Germany, the Netherlands, Norway, and the United Kingdom to identify similarities and differences in policies and procedures, and consider the potential for internal policy "harmonization." Our analysis found differences in the range of researchers and organizations eligible to access biobanks; application processes; requirements for Research Ethics Committee approval; and terms of Material Transfer Agreements relating to ownership and commercialization. However, the main elements of access are the same across biobanks; access will be granted to bona fide researchers conducting research in the public interest, and all biobanks will consider the scientific merit of the proposed use and it's compatibility with the biobank's objectives. These findings suggest potential areas for harmonization across biobanks. This could be achieved through a single centralized application to a number of biobanks or a system of mutual recognition that places a presumption in favor of access to one biobank if already approved by another member of the same consortium. Biobanking and Biomolecular Resources Research Infrastructure-European Research Infrastructure Consortia (BBMRI-ERIC), a European consortium of biobanks and bioresources with its own ethical, legal, and social implications (ELSI) common service, could provide a platform by developing guidelines for harmonized internal processes.

With the advent of fast, high efficiency and low cost DNA sequencing techniques, the ability to study the human genome by reading the sequence of its DNA is growing exponentially, with a resulting tremendous impact on many fields of scientific research. The application of genomics inside routine healthcare is boosting preventive medicine practices and can lead to personalised treatments that can highly improve the healthcare services and patients' health, and in the same time provide a wealth of data for medical research. In parallel, this has also led to the spread of commercial opportunities to provide consumers with the possibility of sequencing their genomes in a way which is both appealing and affordable. These commercial offers, however, do not always ensure the security of the generated data. In addition, the accuracy and reliability of the offered findings are not homogenous, as there are no standards to guarantee that the quality of the outputs satisfies minimum requirements - in fact, no agreements yet exist on the definition of these requirements. In this frame, a comprehensive knowledge of what is present at the legislative level in the member states of the European Union (plus Switzerland, Iceland and Norway) regarding the regulatory oversight of genomics technologies is of fundamental importance to frame the status of existing European norms, to understand whether possible incompatibilities might arise between frameworks and to highlight eventual gaps.