Reforming the legal framework for clinical trials with neonates in Ireland: a children’s rights approach

This thesis assesses the current regulatory framework regarding clinical trials with neonates in Ireland from a children’s rights perspective, as derived from the UN Convention on the Rights of the Child 1989 (UN CRC) and its supporting instruments. The focus on neonates in the thesis is due to the particular need for clinical research with this group of children, their dependency on others for their protection and the lack of attention which has been given to them in the regulatory framework. The importance of children’s rights in this area is linked to the role of human rights in the regulation of clinical research in general. A rights-based approach is of great practical relevance in reforming law, policy and practice. For example, the CRC contains a set of commonly agreed legal benchmarks which can be used to assess the current framework and shape recommendations for reform. In this way, it provides a set of binding norms under international law, which must be complied with by states and state actors in all law, policy and practice affecting children. However, the contribution which a children’s rights approach could make to the regulation of research with children has not, to date, been explored in detail. This thesis aims to address this gap by developing a set of children’s rights-based benchmarks, which are used to assess the Irish regulatory framework for clinical trials with neonates and to develop recommendations for reform. The purpose of the analysis and recommendations is to assess Ireland’s compliance with international children’s rights law in the area and to analyse the potential of children’s rights to effectively address inadequacies in the Irish framework. The recommendations ultimately aim to develop a framework which will enhance the protection of neonates’ rights in this important area of children’s lives.

Eleanor Roosevelt: supporting Zion, denying Palestine

Eleanor Roosevelt, as a renowned humanitarian, portrayed an inconsistency by supporting Zionist ambitions for a national homeland in Palestine while simultaneously ignoring the rights of the indigenous Palestinians. Because of this dichotomy, this dissertation explores her attitudes, her disposition and her position in light of the conflict in the region. It conveys how her particular character traits interplayed with the cultural influences prevalent in mid-century America and encouraged her empathy with the plight of European Jews after the Holocaust. As she evolved politically, initially under the tutelage of Franklin Roosevelt and latterly as a UN delegate, she outgrew the anti-Semitism of the period to become a committed Zionist. Judging the Palestinians as ‘primitives’ incapable of self-government and heartened by Jewish development, she supported the partition of Palestine in November 1947. After the 1948 Arab-Israeli war the 800,000 Palestinian refugees encamped in neighbouring Arab states threatened to destabilise the region. Her solution was to discourage repatriation and to re-settle them in Iraq – a plan that directly contravened the principles of the December 1948 Universal Declaration of Human Rights proclaimed by the UN committee she had chaired. No detailed work has been conducted on these aspects of Eleanor Roosevelt’s life; this dissertation reveals a complex person rather than a model of ‘humanitarianism’, and one whose activities cannot be so simply categorised. In the eight chapters that follow, her own thoughts are disclosed through her ‘My Day’ newspaper column, through letters to friends and to members of the public that petitioned her, through a scrutiny of her articles, books and autobiography. This information was attained as a result of archival research in the US and in The Netherlands and was considered against an extensive range of secondary literature. During the Cold War, to offset Soviet incursion, Eleanor Roosevelt promoted Jewish usurpation of Palestinian lands with equanimity in order that an industrious Western-style democracy would bring stability to the region. These events facilitated the exposure of a latent Orientalism and an imperialistic lien that fostered paternalism in a woman new to the nuances of international diplomacy.

Justifying jihad: US politics, propaganda and the Afghan mujahedeen

Hard-line anti-communists in the United States recognised the potential for the Soviet invasion of Afghanistan in 1979 to embroil their super-power rival in a ‘Vietnam-like quagmire.’ Their covert operation to arm the mujahedeen is well documented. This dissertation argues that propaganda and public diplomacy were powerful and essential instruments of this campaign. It examines the protagonists of this strategy, their policies, initiatives and programmes offering a comprehensive analysis heretofore absent. It stretches from the dying days of the Carter administration when Zbigniew Brzezinski saw the ‘opportunity’ presented by the invasion to the Soviet’s withdrawal in 1989. The aim of these information strategies was to damage Soviet credibility and enhance that of the US, considered under threat from growing ‘moral equivalence’ amongst international publics. The conflict could help the US regain strategic advantage in South Asia undermined by the ‘loss’ of Iran. The Reagan administration used it to justify the projection of US military might that it believed was eviscerated under Carter and emasculated by the lingering legacy of Vietnam. The research engages with source material from the Reagan Presidential Library, the United States Information Agency archives and the Library of Congress as well as a number of online archives. The material is multi-archival and multi-media including documentaries, booklets, press conferences, summit programmes and news-clips as well as national security policy documents and contemporaneous media commentary. It concludes that propaganda and public diplomacy were integral to the Reagan administration and other mujahedeen supporters’ determination to challenge the USSR. It finds that the conflict was used to justify military rearmament, further strategic aims and reassert US power. These Cold War machinations had a considerable impact on the course of the conflict and undermined efforts at resolution and reconciliation with profound implications for the future stability of Afghanistan and the world.

Valuing maternity care: a comparison of stated preference methods with an application to cost-benefit analysis

This research investigates whether a reconfiguration of maternity services, which collocates consultant- and midwifery-led care, reflects demand and value for money in Ireland. Qualitative and quantitative research is undertaken to investigate demand and an economic evaluation is performed to evaluate the costs and benefits of the different models of care. Qualitative research is undertaken to identify women’s motivations when choosing place of delivery. These data are further used to inform two stated preference techniques: a discrete choice experiment (DCE) and contingent valuation method (CVM). These are employed to identify women’s strengths of preferences for different features of care (DCE) and estimate women’s willingness to pay for maternity care (CVM), which is used to inform a cost-benefit analysis (CBA) on consultant- and midwifery-led care. The qualitative research suggests women do not have a clear preference for consultant or midwifery-led care, but rather a hybrid model of care which closely resembles the Domiciliary Care In and Out of Hospital (DOMINO) scheme. Women’s primary concern during care is safety, meaning women would only utilise midwifery-led care when co-located with consultant-led care. The DCE also finds women’s preferred package of care closely mirrors the DOMINO scheme with 39% of women expected to utilise this service. Consultant- and midwifery-led care would then be utilised by 34% and 27% of women, respectively. The CVM supports this hierarchy of preferences where consultant-led care is consistently valued more than midwifery-led care – women are willing to pay €956.03 for consultant-led care and €808.33 for midwifery-led care. A package of care for a woman availing of consultant- and midwifery-led care is estimated to cost €1,102.72 and €682.49, respectively. The CBA suggests both models of care are cost-beneficial and should be pursued in Ireland. This reconfiguration of maternity services would maximise women’s utility, while fulfilling important objectives of key government policy.

Policy impacts on Vietnam stock markets: a case of anomalies and disequilibria 2000-2006

Vietnam launched its first-ever stock market, named as Ho Chi Minh City Securities Trading Center (HSTC) on July 20, 2000. This is one of pioneering works on HSTC, which finds empirical evidences for the following: Anomalies of the HSTC stock returns through clusters of limit-hits, limit-hit sequences; Strong herd effect toward extreme positive returns of the market portfolio;The specification of ARMA-GARCH helps capture fairly well issues such as serial correlations and fat-tailed for the stabilized period. By using further information and policy dummy variables, it is justifiable that policy decisions on technicalities of trading can have influential impacts on the move of risk level, through conditional variance behaviors of HSTC stock returns. Policies on trading and disclosure practices have had profound impacts on Vietnam Stock Market (VSM). The over-using of policy tools can harm the market and investing mentality. Price limits become increasingly irrelevant and prevent the market from self-adjusting to equilibrium. These results on VSM have not been reported before in the literature on Vietnam’s financial markets. Given the policy implications, we suggest that the Vietnamese authorities re-think the use of price limit and give more freedom to market participants.

A Note on Studies of Monetary Policy and Implementation in Vietnam

In this short paper, we have gone through some key results of monetary policy research applied for the Vietnamese economy, over the past 20 years after Doi Moi, together with a few caveats when putting these results in use. We look at different research themes, and suggest that future research make better and more diverse choice of analytic framework, and also put macro and micro-setting connection at work, which appear to likely bring about better and more insightful results for the monetary economics literature in Vietnam.

Making marine life count: a new baseline for policy.

The Census of Marine Life aids practical work of the Convention on Biological Diversity, discovers and tracks ocean biodiversity, and supports marine environmental planning.

Application description and policy model in collaborative environment for sharing of information on epidemiological and clinical research data sets.

BACKGROUND: Sharing of epidemiological and clinical data sets among researchers is poor at best, in detriment of science and community at large. The purpose of this paper is therefore to (1) describe a novel Web application designed to share information on study data sets focusing on epidemiological clinical research in a collaborative environment and (2) create a policy model placing this collaborative environment into the current scientific social context. METHODOLOGY: The Database of Databases application was developed based on feedback from epidemiologists and clinical researchers requiring a Web-based platform that would allow for sharing of information about epidemiological and clinical study data sets in a collaborative environment. This platform should ensure that researchers can modify the information. A Model-based predictions of number of publications and funding resulting from combinations of different policy implementation strategies (for metadata and data sharing) were generated using System Dynamics modeling. PRINCIPAL FINDINGS: The application allows researchers to easily upload information about clinical study data sets, which is searchable and modifiable by other users in a wiki environment. All modifications are filtered by the database principal investigator in order to maintain quality control. The application has been extensively tested and currently contains 130 clinical study data sets from the United States, Australia, China and Singapore. Model results indicated that any policy implementation would be better than the current strategy, that metadata sharing is better than data-sharing, and that combined policies achieve the best results in terms of publications. CONCLUSIONS: Based on our empirical observations and resulting model, the social network environment surrounding the application can assist epidemiologists and clinical researchers contribute and search for metadata in a collaborative environment, thus potentially facilitating collaboration efforts among research communities distributed around the globe.

So different, yet so similar: meta-analysis and policy modeling of willingness to participate in clinical trials among Brazilians and Indians.

BACKGROUND: With the global expansion of clinical trials and the expectations of the rise of the emerging economies known as BRICs (Brazil, Russia, India and China), the understanding of factors that affect the willingness to participate in clinical trials of patients from those countries assumes a central role in the future of health research. METHODS: We conducted a systematic review and meta-analysis (SRMA) of willingness to participate in clinical trials among Brazilian patients and then we compared it with Indian patients (with results of another SRMA previously conducted by our group) through a system dynamics model. RESULTS: Five studies were included in the SRMA of Brazilian patients. Our main findings are 1) the major motivation for Brazilian patients to participate in clinical trials is altruism, 2) monetary reimbursement is the least important factor motivating Brazilian patients, 3) the major barrier for Brazilian patients to not participate in clinical trials is the fear of side effects, and 4) Brazilian patients are more likely willing to participate in clinical trials than Indians. CONCLUSION: Our study provides important insights for investigators and sponsors for planning trials in Brazil (and India) in the future. Ignoring these results may lead to unnecessary fund/time spending. More studies are needed to validate our results and for better understanding of this poorly studied theme.

Modeling endogenous technological change for climate policy analysis

The approach used to model technological change in a climate policy model is a critical determinant of its results in terms of the time path of CO2 prices and costs required to achieve various emission reduction goals. We provide an overview of the different approaches used in the literature, with an emphasis on recent developments regarding endogenous technological change, research and development, and learning. Detailed examination sheds light on the salient features of each approach, including strengths, limitations, and policy implications. Key issues include proper accounting for the opportunity costs of climate-related knowledge generation, treatment of knowledge spillovers and appropriability, and the empirical basis for parameterizing technological relationships. No single approach appears to dominate on all these dimensions, and different approaches may be preferred depending on the purpose of the analysis, be it positive or normative. © 2008 Elsevier B.V. All rights reserved.

Dissecting Policy Designs: An Application of the Institutional Grammar Tool

An enduring challenge for the policy and political sciences is valid and reliable depiction of policy designs. One emerging approach for dissecting policy designs is the application of Sue Crawford and Elinor Ostrom's institutional grammar tool. The grammar tool offers a method to identify, systematically, the core elements that comprise policies, including target audiences, expected patterns of behavior, and formal modes of sanctioning for noncompliance. This article provides three contributions to the study of policy designs by developing and applying the institutional grammar tool. First, we provide revised guidelines for applying the institutional grammar tool to the study of policy design. Second, an additional component to the grammar, called the oBject, is introduced. Third, we apply the modified grammar tool to four policies that shape Colorado State Aquaculture to demonstrate its effectiveness and utility in illuminating institutional linkages across levels of analysis. The conclusion summarizes the contributions of the article as well as points to future research and applications of the institutional grammar tool. © 2011 Policy Studies Organization.

Using decision analysis to improve malaria control policy making.

Malaria and other vector-borne diseases represent a significant and growing burden in many tropical countries. Successfully addressing these threats will require policies that expand access to and use of existing control methods, such as insecticide-treated bed nets (ITNs) and artemesinin combination therapies (ACTs) for malaria, while weighing the costs and benefits of alternative approaches over time. This paper argues that decision analysis provides a valuable framework for formulating such policies and combating the emergence and re-emergence of malaria and other diseases. We outline five challenges that policy makers and practitioners face in the struggle against malaria, and demonstrate how decision analysis can help to address and overcome these challenges. A prototype decision analysis framework for malaria control in Tanzania is presented, highlighting the key components that a decision support tool should include. Developing and applying such a framework can promote stronger and more effective linkages between research and policy, ultimately helping to reduce the burden of malaria and other vector-borne diseases.

Integrated vector management for malaria control in Uganda: knowledge, perceptions and policy development.

BACKGROUND: Integrated vector management (IVM) is increasingly being recommended as an option for sustainable malaria control. However, many malaria-endemic countries lack a policy framework to guide and promote the approach. The objective of the study was to assess knowledge and perceptions in relation to current malaria vector control policy and IVM in Uganda, and to make recommendations for consideration during future development of a specific IVM policy. METHODS: The study used a structured questionnaire to interview 34 individuals working at technical or policy-making levels in health, environment, agriculture and fisheries sectors. Specific questions on IVM focused on the following key elements of the approach: integration of chemical and non-chemical interventions of vector control; evidence-based decision making; inter-sectoral collaboration; capacity building; legislation; advocacy and community mobilization. RESULTS: All participants were familiar with the term IVM and knew various conventional malaria vector control (MVC) methods. Only 75% thought that Uganda had a MVC policy. Eighty percent (80%) felt there was inter-sectoral collaboration towards IVM, but that it was poor due to financial constraints, difficulties in involving all possible sectors and political differences. The health, environment and agricultural sectors were cited as key areas requiring cooperation in order for IVM to succeed. Sixty-seven percent (67%) of participants responded that communities were actively being involved in MVC, while 48% felt that the use of research results for evidence-based decision making was inadequate or poor. A majority of the participants felt that malaria research in Uganda was rarely used to facilitate policy changes. Suggestions by participants for formulation of specific and effective IVM policy included: revising the MVC policy and IVM-related policies in other sectors into a single, unified IVM policy and, using legislation to enforce IVM in development projects. CONCLUSION: Integrated management of malaria vectors in Uganda remains an underdeveloped component of malaria control policy. Cooperation between the health and other sectors needs strengthening and funding for MVC increased in order to develop and effectively implement an appropriate IVM policy. Continuous engagement of communities by government as well as monitoring and evaluation of vector control programmes will be crucial for sustaining IVM in the country.

Designing Climate Mitigation Policy

This paper provides an exhaustive review of critical issues in the design of climate mitigation policy by pulling together key findings and controversies from diverse literatures on mitigation costs, damage valuation, policy instrument choice, technological innovation, and international climate policy. We begin with the broadest issue of how high assessments suggest the near and medium term price on greenhouse gases would need to be, both under cost-effective stabilization of global climate and under net benefit maximization or Pigouvian emissions pricing. The remainder of the paper focuses on the appropriate scope of regulation, issues in policy instrument choice, complementary technology policy, and international policy architectures.