GDPR: Governance implications for regimes outside the EU

It is estimated that as of 2017 around 120 nations around the globe had legislation to protect personal data with at least another 30 in train. Many of the early regimes (dating back to the 1980s and 90s) reflect the OECD Guidelines on the Protection of Privacy and Transborder Flows of Personal Data (1980, updated 2013). However, there are also increasing concerns that these guidelines may no longer be fit for purpose with recent issues regarding breaches of data security and privacy. The EU's General Data Protection Regulation (GDPR) (2016) implements a reformed data privacy regime. Tellingly, some of the new and pending privacy regulations elsewhere reflect the GDPR, a characteristic that suggests much about the impact of international trade. Two questions arise: first, how is the GDPR likely to affect and influence governance of organisations, not only those domiciled in the EU, but also those trading with the Union or having a presence there? Second, compared to the GDPR, what gaps are there in other existing privacy regimes and what are the implications for the governance of those organisations and their risk management strategies? This paper compares the GDPR with privacy regimes in place in New Zealand and Australia (the first of which has GDPR “approved country status” for receipt of data) and attempts to answer the questions above, thus providing a focus for empirical research. As such, the paper provides insight into the impact of the data privacy and security legislative reform, on corporate governance, strategy and risk management beyond the EU in its reach to far distant regions. © The Authors, 2018. All Rights Reserved.Proceedings of the 14th European Conference on Management, Leadership and Governance, ECMLG 201

Independent Directors: The Contrasting Cases of Australia and Bangladesh

The Bangladesh corporate governance regime is framed by legal rules and requirements, in comparison to those prevailing in such jurisdictions as Australia. However, it is arguable that such legal rules have not necessarily led to major modernisation of structures or to such significant changes to the profile of company boards that would maximise their effectiveness. This study involves analysis and comparison of some of the important characteristics of Bangladeshi and Australian company boards, with a particular focus on independent directors. To provide context for this study, the regulatory framework for corporate governance in Bangladesh is compared and contrasted with that of Australia as an example of a developed country, while the study itself explores directors with reference to diversity, age, remuneration, expertise and experience and governance involvement. The results demonstrate that as well as differences, particularly around diversity, there are surprising similarities as well, principally around age and expertise. What is most marked is the lack of an independent skill development or recruitment facility for Bangladeshi directors such as operates in Australia, a lack that potentially limits the extent to which an open, competitive market for director skills can develop

Scoping and targeted reviews to support development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: protocol

Introduction Using a surrogate endpoint as a substitute for a primary patient-relevant outcome enables randomised controlled trials (RCTs) to be conducted more efficiently, that is, with shorter time, smaller sample size and lower cost. However, there is currently no consensus-driven guideline for the reporting of RCTs using a surrogate endpoint as a primary outcome; therefore, we seek to develop SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) extensions to improve the design and reporting of these trials. As an initial step, scoping and targeted reviews will identify potential items for inclusion in the extensions and participants to contribute to a Delphi consensus process. Methods and analysis The scoping review will search and include literature reporting on the current understanding, limitations and guidance on using surrogate endpoints in trials. Relevant literature will be identified through: (1) bibliographic databases; (2) grey literature; (3) handsearching of reference lists and (4) solicitation from experts. Data from eligible records will be thematically analysed into potential items for inclusion in extensions. The targeted review will search for RCT reports and protocols published from 2017 to 2021 in six high impact general medical journals. Trial corresponding author contacts will be listed as potential participants for the Delphi exercise. Ethics and dissemination Ethical approval is not required. The reviews will support the development of SPIRIT and CONSORT extensions for reporting surrogate primary endpoints (surrogate endpoint as the primary outcome). The findings will be published in open-access publications. This review has been prospectively registered in the OSF Registration DOI: 10.17605/OSF.IO/WP3QH

Creating and implementing a biodiversity recording app for teaching and research in environmental studies

This case study reports on the development of a bespoke mobile recording app for collating records of biodiversity sightings on a University campus. This innovative project was achieved through a multi-disciplinary partnership of staff and students. It is hoped that the app itself will benefit lecturers by streamlining data collection during teaching and learning activities, whilst engaging students and highlighting the wealth of diversity available on campu

Scoping and targeted reviews to support development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: protocol

Introduction: Using a surrogate endpoint as a substitute for a primary patient-relevant outcome enables randomised controlled trials (RCTs) to be conducted more efficiently, that is, with shorter time, smaller sample size and lower cost. However, there is currently no consensus-driven guideline for the reporting of RCTs using a surrogate endpoint as a primary outcome; therefore, we seek to develop SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) extensions to improve the design and reporting of these trials. As an initial step, scoping and targeted reviews will identify potential items for inclusion in the extensions and participants to contribute to a Delphi consensus process. Methods and analysis: The scoping review will search and include literature reporting on the current understanding, limitations and guidance on using surrogate endpoints in trials. Relevant literature will be identified through: (1) bibliographic databases; (2) grey literature; (3) handsearching of reference lists and (4) solicitation from experts. Data from eligible records will be thematically analysed into potential items for inclusion in extensions. The targeted review will search for RCT reports and protocols published from 2017 to 2021 in six high impact general medical journals. Trial corresponding author contacts will be listed as potential participants for the Delphi exercise. Ethics and dissemination: Ethical approval is not required. The reviews will support the development of SPIRIT and CONSORT extensions for reporting surrogate primary endpoints (surrogate endpoint as the primary outcome). The findings will be published in open-access publications

Genome-wide scan identifies novel genetic loci regulating salivary metabolite levels.

Saliva, as a biofluid, is inexpensive and non-invasive to obtain, and provides a vital tool to investigate oral health and its interaction with systemic health conditions. There is growing interest in salivary biomarkers for systemic diseases, notably cardiovascular disease. Whereas hundreds of genetic loci have been shown to be involved in the regulation of blood metabolites, leading to significant insights into the pathogenesis of complex human diseases, little is known about the impact of host genetics on salivary metabolites. Here we report the first genome-wide association study exploring 476 salivary metabolites in 1419 subjects from the TwinsUK cohort (discovery phase), followed by replication in the Study of Health in Pomerania (SHIP-2) cohort. A total of 14 distinct locus-metabolite associations were identified in the discovery phase, most of which were replicated in SHIP-2. While only a limited number of the loci that are known to regulate blood metabolites were also associated with salivary metabolites in our study, we identified several novel saliva-specific locus-metabolite associations, including associations for the AGMAT (with the metabolites 4-guanidinobutanoate and beta-guanidinopropanoate), ATP13A5 (with the metabolite creatinine) and DPYS (with the metabolites 3-ureidopropionate and 3-ureidoisobutyrate) loci. Our study suggests that there may be regulatory pathways of particular relevance to the salivary metabolome. In addition, some of our findings may have clinical significance, such as the utility of the pyrimidine (uracil) degradation metabolites in predicting 5-fluorouracil toxicity and the role of the agmatine pathway metabolites as biomarkers of oral health

Concordance for clonal hematopoiesis is limited in elderly twins.

Although acquisition of leukemia-associated somatic mutations by 1 or more hematopoietic stem cells is inevitable with advancing age, its consequences are highly variable, ranging from clinically silent clonal hematopoiesis (CH) to leukemic progression. To investigate the influence of heritable factors on CH, we performed deep targeted sequencing of blood DNA from 52 monozygotic (MZ) and 27 dizygotic (DZ) twin pairs (aged 70-99 years). Using this highly sensitive approach, we identified CH (variant allele frequency ≥0.5%) in 62% of individuals. We did not observe higher concordance for CH within MZ twin pairs as compared with that within DZ twin pairs, or to that expected by chance. However, we did identify 2 MZ pairs in which both twins harbored identical rare somatic mutations, suggesting a shared cell of origin. Finally, in 3 MZ twin pairs harboring mutations in the same driver genes, serial blood samples taken 4 to 5 years apart showed substantial twin-to-twin variability in clonal trajectories. Our findings propose that the inherited genome does not exert a dominant influence on the behavior of adult CH and provide evidence that CH mutations may be acquired in utero