Ethics Standards (HRPP) and Public Partnership (PARTAKE) to Address Clinical Research Concerns in India: Moving Toward Ethical, Responsible, Culturally Sensitive, and Community-Engaging Clinical Research.

Like other emerging economies, India's quest for independent, evidence-based, and affordable healthcare has led to robust and promising growth in the clinical research sector, with a compound annual growth rate (CAGR) of 20.4% between 2005 and 2010. However, while the fundamental drivers and strengths are still strong, the past few years witnessed a declining trend (CAGR -16.7%) amid regulatory concerns, activist protests, and sponsor departure. And although India accounts for 17.5% of the world's population, it currently conducts only 1% of clinical trials. Indian and international experts and public stakeholders gathered for a 2-day conference in June 2013 in New Delhi to discuss the challenges facing clinical research in India and to explore solutions. The main themes discussed were ethical standards, regulatory oversight, and partnerships with public stakeholders. The meeting was a collaboration of AAHRPP (Association for the Accreditation of Human Research Protection Programs)-aimed at establishing responsible and ethical clinical research standards-and PARTAKE (Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment)-aimed at informing and engaging the public in clinical research. The present article covers recent clinical research developments in India as well as associated expectations, challenges, and suggestions for future directions. AAHRPP and PARTAKE provide etiologically based solutions to protect, inform, and engage the public and medical research sponsors.

Global value chains and agrifood standards: challenges and possibilities for smallholders in developing countries.

The rise of private food standards has brought forth an ongoing debate about whether they work as a barrier for smallholders and hinder poverty reduction in developing countries. This paper uses a global value chain approach to explain the relationship between value chain structure and agrifood safety and quality standards and to discuss the challenges and possibilities this entails for the upgrading of smallholders. It maps four potential value chain scenarios depending on the degree of concentration in the markets for agrifood supply (farmers and manufacturers) and demand (supermarkets and other food retailers) and discusses the impact of lead firms and key intermediaries on smallholders in different chain situations. Each scenario is illustrated with case examples. Theoretical and policy issues are discussed, along with proposals for future research in terms of industry structure, private governance, and sustainable value chains.

Choice and use of standards for dynamic headspace trapping and application to the analysis of the volatiles of baked potato

When attempting to quantify the volatile components of a food isolated by dynamic headspace trapping onto an adsorbent, the analyst has to select the most appropriate compounds to use as standards and at which stage of the analysis to add them. Factors to be borne in mind include the volatility of the standard, the response of the GC detector, and whether to add the standard to the sample or to the adsorbent trap. This chapter considers the issues and describes the application of one chosen method to the quantitation of the volatile components of baked potato.

Cigarette Smoke, Airway Epithelial Cells and Host Defence

In COPD inflammation driven by exposure to tobacco smoke results in impaired innate immunity in the airway and ultimately to lung injury and remodeling. To understand the biological processes involved in host interactions with cigarette derived toxins submerged epithelial cell culture is widely accepted as a model for primary human airway epithelial cell culture research. Primary nasal and bronchial epithelial cells can also be cultured in air-liquid interface (ALI) models. ALI and submerged culture models have their individual merits, and the decision to use either technique should primarily be determined primarily by the research hypothesis.

Cigarette smoke has gaseous and particulate matter, the latter constituent primarily represented in cigarette smoke extract (CSE). Although not ideal in order to facilitate our understanding of the responses of epithelial cells to cigarette smoke, CSE still has scientific merit in airway cell biology research. Using this model, it has been possible to demonstrate differences in levels of tight junction disruption after CSE exposure along with varied vulnerability to the toxic effects of CSE in cell cultures derived from COPD and control study groups.

Primary nasal epithelial cells (PNECs) have been used as an alternative to bronchial epithelial cells (PBECs). However, at least in subjects with COPD, PNECs cannot consistently substitute for PBECs. Although airway epithelial cells from patients with COPD exhibit a constitutional pro-inflammatory phenotype, these cells have a diminished inflammatory response to CSE exposure. COPD epithelial cells have an increased susceptibility to undergo apoptosis, and have reduced levels of Toll-like receptor-4 expression after CSE exposure, both of which may account for the reduced inflammatory response observed in this group.

The use of CSE in both submerged and ALI epithelial cultures has extended our understanding of the cellular mechanisms that are important in COPD, and helped to unravel important pathways which may be of relevance in its pathogenesis.

Financial Information Mediation: A Case Study of Standards Integration for Electronic Bill Presentment and Payment Using the COIN Mediation Technology

Each player in the financial industry, each bank, stock exchange, government agency, or insurance company operates its own financial information system or systems. By its very nature, financial information, like the money that it represents, changes hands. Therefore the interoperation of financial information systems is the cornerstone of the financial services they support. E-services frameworks such as web services are an unprecedented opportunity for the flexible interoperation of financial systems. Naturally the critical economic role and the complexity of financial information led to the development of various standards. Yet standards alone are not the panacea: different groups of players use different standards or different interpretations of the same standard. We believe that the solution lies in the convergence of flexible E-services such as web-services and semantically rich meta-data as promised by the semantic Web; then a mediation architecture can be used for the documentation, identification, and resolution of semantic conflicts arising from the interoperation of heterogeneous financial services. In this paper we illustrate the nature of the problem in the Electronic Bill Presentment and Payment (EBPP) industry and the viability of the solution we propose. We describe and analyze the integration of services using four different formats: the IFX, OFX and SWIFT standards, and an example proprietary format. To accomplish this integration we use the COntext INterchange (COIN) framework. The COIN architecture leverages a model of sources and receivers’ contexts in reference to a rich domain model or ontology for the description and resolution of semantic heterogeneity.

Sistema multimodal para la planificación de viajes en transportes públicos de código abierto y basado en estándares 'de facto' = A multimodal journey planner based on open source software and 'de facto' standards

Este artículo muestra cómo con bajo coste y riesgo se puede desarrollar un sistema de planificación de viaje multimodal, basado en un enfoque de código abierto y estándares ‘de facto’. Se ha desarrollado completamente una solución de código abierto para un sistema de información de transporte público puerta a puerta basado en estándares ‘de facto’. El cálculo de rutas se realiza mediante Graphserver, mientras que la cartografía se basa en OpenStreetMap. También se ha demostrado cómo exportar una base de datos real de horarios de transporte público como la del operador ETM (Empresa de Transporte Metropolitano de València) a la especificación de Google Transit, para permitir el cálculo de rutas, tanto desde nuestro prototipo como desde Google Transit

Changing Standards? Children's awareness and knowledge of features of written standard English at ages 10-11

This paper reports the findings of a small-scale research project, which investigated the levels of awareness and knowledge of written standard English of 10- and 11-year-old children in two English primary schools over a six-year period, coinciding with the implementation in the schools of the National Literacy Strategy (NLS). A questionnaire was used to provide quantitative and qualitative data relating to: features of writing which were recognised as standard or non-standard; children's understanding of technical terminology; variations between boys' and girls' performance; and the impact of the NLS over time. The findings reveal variations in levels of recognition of different non-standard features, differences between girls' and boys' recognition, possible examples of language change, but no evidence of a positive impact of the NLS. The implications of these findings are discussed both in terms of changes in educational standards and changes to standard English.

Planning for the reuse of redundant defence estate: disposal processes, policy frameworks and development impacts

This paper reviews recent research and other literature concerning the planning and development of redundant defence estate. It concentrates on UK sources but includes reference to material from Europe and the North America were it is relevant for comparative purposes. It introduces the topic by providing a brief review of the recent restructuring of the UK defence estate and then proceeds to examine the various planning policy issues generated by this process; the policy frameworks used to guide it; comparable approaches to surplus land disposal and the appraisal of impacts; and ending the main body of the review with an analyse of the economic, social and environmental impacts of military base closure and redevelopment. It concludes that there is a significant body of work focusing on the reuse and redevelopment of redundant defence estate in the UK and abroad, but that much of this work is based on limited research or on personal experience. One particular weakness of the current literature is that it does not fully reflect the institutional difficulties posed by the disposal process and the day-to-day pressures which MOD personnel have to deal with. In doing this, it also under-emphasises the embedded cultures of individuals and professional groups who are required to operationalise the policies, procedures and practices for planning and redeveloping redundant defence estate.

‘Historical ‘lessons’ and discourse on defence in France, Germany, 1945-1990’,

This article demonstrates how experiences of the same historical events (especially wars), but experienced from different angles, have led France and Germany to draw diametrically opposed lessons from them, which play key roles in the articulation of their defence postures and strategies.

Nurse practitioner competency standards: findings from collaborative Australian and New Zealand research

Background: The title, Nurse Practitioner, is protected in most jurisdictions in Australia and New Zealand and the number of nurse practitioners is increasing in health services in both countries. Despite this expansion of the role, there is scant national or international research to inform development of nurse practitioner competency standards.

Objectives: The aim of this study was to research nurse practitioner practice to inform development of generic standards that could be applied for the education, authorisation and practice of nurse practitioners in both countries.

Design: The research used a multi-methods approach to capture a range of data sources including research of policies and curricula, and interviews with clinicians. Data were collected from relevant sources in Australia and New Zealand.

Settings: The research was conducted in New Zealand and the five states and territories in Australia where, at the time of the research, the title of nurse practitioner was legally protected.

Participants: The research was conducted with a purposeful sample of nurse practitioners from diverse clinical settings in both countries. Interviews and material data were collected from a range of sources and data were analysed within and across these data modalities.

Results: Findings included identification of three generic standards for nurse practitioner practice: namely, Dynamic Practice, Professional Efficacy and Clinical Leadership. Each of these standards has a number of practice competencies, each of these competencies with its own performance indicators.

Conclusions: Generic standards for nurse practitioner practice will support a standardised approach and mutual recognition of nurse practitioner authorisation across the two countries. Additionally, these research outcomes can more generally inform education providers, authorising bodies and clinicians on the standards of practice for the nurse practitioner whilst also contributing to the current international debate on nurse practitioner standards and scope of practice.

Nurse practitioner standards : an Australian and New Zealand research collaboration

This paper will report the findings from research conducted in Australia and New Zealand to inform development of standards for nurse practitioner education and practice competencies. In New Zealand and Australia the nurse practitioner is a new and unique level of health-care provider. The shifting boundaries caused by health-care reform have created impetus and demand for development of new models of health-care, but have also created some uncertainty regarding nurse practitioner standards, education and models of care. The title, Nurse Practitioner, is now legislated in New Zealand and most jurisdictions in Australia but there is scant research to inform development of nurse practitioner standards. This research, sponsored by the Australian Nursing Council and the Nursing Council of New Zealand, was conducted to develop generic standards that could be applied for the education, authorisation and practice of nurse practitioners in both countries. The study involved collection and triangulation of data from a range of sources across Australia and New Zealand including: in-depth interviews with 15 nurse practitioners from different geographical and clinical contexts; curriculum survey of all nurse practitioner courses in the two countries and interview with convenors of these courses; collation of the authorisation/registration processes and policies from states and territories in Australia, New Zealand and internationally. These data were analysed within and across the data modalities to provide information on standards for nurse practitioner practice and education. Findings from the study included identification of the core role of the nurse practitioner as it is expressed in New Zealand and Australia and generic standards for nurse practitioner competencies, education and authorisation. These findings will standardise expectations, support mutual recognition of nurse practitioner authorisation across the two countries and make an important contribution to the current international debate on nurse practitioner standards and scope of practice.

Implementing FATF standards in developing countries and financial inclusion : findings and guidelines

This report, emanating from a project commissioned by the FIRST Initiative, considers the impact of the implementation of Anti-Money Laundering (AML) and Combating the Financing of Terrorism (CFT) controls on financial inclusion in five countries (Indonesia, Kenya, Mexico, Pakistan and South Africa). Based on these findings, it develops a set of guidelines to assist the authorities in developing countries to design effective AML/CFT regimes that are compliant with Financial Action Task Force (FATF) standards and supports financial inclusion.
The report and guidelines will be of benefit to countries striving towards the dual goals of protecting their institutions against money laundering and the financing of terrorism as well as extending financial inclusion, irrespective of whether protective measures are being considered in the process of implementing or amending AML/CFT controls to meet the Forty Nine Recommendations of the FATF or in order to meet other, related international requirements, such as those set out in the 2000 United Nations Convention on Transnational Organised Crime or the 2003 United Nations Convention Against Corruption.
The project was supervised and guided by a steering committee consisting of representatives from the FIRST Management Unit, World Bank, International Monetary Fund (IMF), the UK’s Department for International Development (DFID), the Consultative Group to Assist the Poor (CGAP), the South African National Treasury, the FinMark Trust and Professor Nikos Passas, an acknowledged world expert on AML/CFT standards and implementation.

Social moderation, assessment and assuring standards for accounting graduates

Evidencing student achievement of standards is a growing imperative worldwide. Key stakeholders (including current and prospective students, government, regulators and employers) want confidence that threshold learning standards in an accounting degree have been assured. Australia’s new higher education regulatory environment requires that student achievements are benchmarked against intended programme learning outcomes, guided by published disciplinary standards and a national qualifications framework, and against other higher education providers. Here, we report on a process involving academics from 10 universities, aided by professional practitioners, to establish and equip assessors to reliably assure threshold learning standards in accounting that are nationally comparable. Importantly, we are learning more about how standards are interpreted. Based on the premise that meaning is constructed from tacit experiences, social interactions and intentional reflection on explicit information, we report outcomes of three multi-part calibration interventions, situated around judgements of the quality of the written communication skills exhibited in student work and their related assessment tasks. Qualitative data from 30 participants in the calibration process suggest that they perceive that the process both assists them both in developing a shared understanding of the accounting threshold learning standards and in the redesign of assessment tasks to more validly assess the threshold learning standards.

The application of universal design legislation and standards in Malaysia and Australia

Legislation and standards are alleged to be one of the key solutions for improving accessibility and Universal Design implementation in Malaysia including its implementation in housing design. In response to this concern, the government of Malaysia has taken considerable steps in articulating professional practice obligations as demonstrated in continual improvements in relevant new laws and standards (Malaysian Standard (MS)). The findings from a preliminary study have however evidenced a clear gap between having laws and standards and ensuring their implementation in the construction industry. This paper reviews the issues faced by the existing Malaysian enforcement and practices to Universal Design. The findings emphasise awareness, understanding and practice implications for the legislation and its standards in Malaysia, and problems and assumptions perceived. Findings indicate that there is lack of understanding and awareness of the current legislation and standards in the construction industry, in addition to the insufficiency of comprehensive guidelines to regulate Universal Design in Malaysia.

Professional knowledge and standards-based reforms: Learning from the experiences of early career teachers

This article explores the paradoxical situation of early career teachers in this era of standards-based reforms, beginning with the experiences of an English teacher working in a state school in Queensland, Australia and expanding to consider the viewpoints of her colleagues. Our goal is to trace the ways she and the other early career teachers at this particular school negotiate the tensions between the current emphases on standardisation of curricula, testing regimes and teaching standards and their burgeoning sense of their identities as teachers. We shall raise questions about the status of the professional knowledge that these early career teachers bring to their work, showing examples of how this knowledge puts them at odds with standards-based reforms, including the professional standards recently introduced by the Australian Institute for Teaching and School Leadership (AITSL) and the National Assessment Program – Literacy and Numeracy (NAPLAN).