Harm, hype and evidence: ELSI research and policy guidance.

There has been much investment in research on the ethical, legal and social issues (ELSI) associated with genetic and genomic research. This research should inform the development of the relevant policy. So far, much of the relevant policy - such as in the areas of patents, genetic testing and genetic discrimination - seems to be informed more by speculation of harm and anecdote than by available evidence. Although a quest for evidence cannot always be allowed to delay policy choice, it seems axiomatic to us that policy options are improved by the incorporation of evidence.

An Economic Analysis of Global Policy Proposals to Prohibit Compensation of Blood Plasma Donors

© 2016 International Journal of the Economics of Business.Human blood plasma and its derivative therapies have been used therapeutically for more than 50 years, after first being widely used to treat injuries during World War II. In certain countries, manufacturers of these therapies – known as plasma-derived medicinal products (PDMPs) – compensate plasma donors, raising healthcare and ethical concerns among some parties. In particular, the World Health Organization has taken a strong advocacy position that compensation for blood donations should be eliminated worldwide. This review evaluates the key economic factors underlying the supply and demand for PDMPs and the evidence pointing to the policy options that are most likely to maintain a reliable supply of life-sustaining therapies. It concludes that compensated plasma donation is important for maintaining adequate and consistent supplies of plasma and limits the risk of under-treatment for the foreseeable future.

A strategy to advance the evidence base in palliative medicine: formation of a palliative care research cooperative group.

BACKGROUND: Palliative medicine has made rapid progress in establishing its scientific and clinical legitimacy, yet the evidence base to support clinical practice remains deficient in both the quantity and quality of published studies. Historically, the conduct of research in palliative care populations has been impeded by multiple barriers including health care system fragmentation, small number and size of potential sites for recruitment, vulnerability of the population, perceptions of inappropriateness, ethical concerns, and gate-keeping. METHODS: A group of experienced investigators with backgrounds in palliative care research convened to consider developing a research cooperative group as a mechanism for generating high-quality evidence on prioritized, clinically relevant topics in palliative care. RESULTS: The resulting Palliative Care Research Cooperative (PCRC) agreed on a set of core principles: active, interdisciplinary membership; commitment to shared research purposes; heterogeneity of participating sites; development of research capacity in participating sites; standardization of methodologies, such as consenting and data collection/management; agile response to research requests from government, industry, and investigators; focus on translation; education and training of future palliative care researchers; actionable results that can inform clinical practice and policy. Consensus was achieved on a first collaborative study, a randomized clinical trial of statin discontinuation versus continuation in patients with a prognosis of less than 6 months who are taking statins for primary or secondary prevention. This article describes the formation of the PCRC, highlighting processes and decisions taken to optimize the cooperative group's success.

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.

Multiple Response System: Evaluation of Policy Change in North Carolina's Child Welfare System.

Systemic challenges within child welfare have prompted many states to explore new strategies aimed at protecting children while meeting the needs of families, but doing so within the confines of shrinking budgets. Differential Response has emerged as a promising practice for low or moderate risk cases of child maltreatment. This mixed methods evaluation explored various aspects of North Carolina's differential response system, known as the Multiple Response System (MRS), including: child safety, timeliness of response and case decision, frontloading of services, case distribution, implementation of Child and Family Teams, collaboration with community-based service providers and Shared Parenting. Utilizing Child Protective Services (CPS) administrative data, researchers found that compared to matched control counties, MRS: had a positive impact on child safety evidenced by a decline in the rates of substantiations and re-assessments; temporarily disrupted timeliness of response in pilot counties but had no effect on time to case decision; and increased the number of upfront services provided to families during assessment. Qualitative data collected through focus groups with providers and phone interviews with families provided important information on key MRS strategies, highlighting aspects that families and social workers like as well as identifying areas for improvement. This information is useful for continuous quality improvement efforts, particularly related to the development of training and technical assistance programs at the state and local level.

The Justice Gap in Global Forest Governance

Claims of injustice in global forest governance are prolific: assertions of colonization, marginalization and disenfranchisement of forest-dependent people, and privatization of common resources are some of the most severe allegations of injustice resulting from globally-driven forest conservation initiatives. At its core, the debate over the future of the world's forests is fraught with ethical concerns. Policy makers are not only deciding how forests should be governed, but also who will be winners, losers, and who should have a voice in the decision-making processes. For 30 years, policy makers have sought to redress the concerns of the world's 1.6 billion forest-dependent poor by introducing rights-based and participatory approaches to conservation. Despite these efforts, however, claims of injustice persist. This research examines possible explanations for continued claims of injustice by asking: What are the barriers to delivering justice to forest-dependent communities? Using data collected through surveys, interviews, and collaborative event ethnography in Laos and at the Tenth Conference of Parties to the Convention on Biological Diversity, this dissertation examines the pursuit of justice in global forest governance across multiple scales of governance. The findings reveal that particular conceptualizations of justice have become a central part of the metanormative fabric of global environmental governance, inhibiting institutional evolution and therewith perpetuating the justice gap in global forest governance.

Policy-induced technology adoption: Evidence from the U.S. lead phasedown

Theory suggests that economic instruments, such as pollution taxes or tradable permits, can provide more efficient technology adoption incentives than conventional regulatory standards. We explore this issue for an important industry undergoing dramatic decreases in allowed pollution - the U.S. petroleum industry's phasedown of lead in gasoline. Using a duration model applied to a panel of refineries from 1971-1995, we find that the pattern of technology adoption is consistent with an economic response to market incentives, plant characteristics, and alternative policies. Importantly, evidence suggests that the tradable permit system used during the phasedown provided incentives for more efficient technology adoption decisions.