Beatrice Loff

Moving beyond 'rates, roads and rubbish' : how do local governments make choices about healthy public policy to prevent obesity?

While the causes of obesity are well known traditional education and treatment strategies do not appear to be making an impact. One solution as part of a broader complimentary set of strategies may be regulatory intervention at local government level to create environments for healthy nutrition and increased physical activity. Semi structured interviews were conducted with representatives of local government in Australia. Factors most likely to facilitate policy change were those supported by external funding, developed from an evidence base and sensitive to community and market forces. Barriers to change included a perceived or real lack of power to make change and the complexity of the legislative framework. The development of a systematic evidence base to provide clear feedback on the size and scope of the obesity epidemic at a local level, coupled with cost benefit analysis for any potential regulatory intervention, are crucial to developing a regulatory environment which creates the physical and social environment required to prevent obesity.

Distortions and difficulties in data for trafficking.

Research into issues related to trafficking is hampered by a lack of clarity in they way we think about and act with respect to trafficked people. Work in the area is made even more difficult by the paucity of accurate data on the topic. Despite the definition given to trafficking in international law the term and issues surrounding it remain confused both conceptually and in government policy and practice. Several issues contribute to this confusion. First researchers law enforcement agencies and nongovernmental organisations usually focus on a subset of trafficked people—women and children in sex work. Second trafficking is rarely discussed without mention of coercion. But what constitutes coercion in the trafficking context? There is no universal or even readily arrived at position which creates difficulties in contextualising and responding to many dilemmas raised by trafficking. Third the definition of trafficking is complicated by a frequent failure to differentiate between women and children. Issues pertinent to children are sometimes incorrectly applied to adults. Even the Palermo Protocol adopts the indiscriminate phrase “especially women and children” (panel). Further trafficking is sometimes confused with people smuggling and illegal immigration. (excerpt)

The possibility of regulating for obesity prevention - understanding regulation in the Commonwealth Government

A complex regulatory package is likely to be necessary to effectively reduce obesity prevalence in developed countries. This study investigated the barriers and facilitators to implementing regulatory interventions to prevent obesity within the executive arm of the Australian Commonwealth Government. Policy reviews were conducted on nine government departments to understand their roles and interests in obesity. From this process we identified regulatory review carried out by the Office of Best Practice Regulation as possibly posing a barrier to law reform for obesity prevention, along with the complexity of the food policymaking structures. The policy reviews informed subsequent in‐depth semi‐structured interviews with senior Commonwealth government officers (n = 13) focused on refining our understanding of the barriers to enacting obesity prevention policy. In addition to the two barriers already identified, interviewees identified a lack of evidence for interventions, which would reduce obesity prevalence, and the influence of politicians on executive decisions as posing obstacles. Most interviewees believed that the barriers to regulating to prevent obesity were strong and that intervention by elected politicians would be the most likely method of implementing obesity prevention policy.

Exploitation and community engagement: can community advisory boards successfully assume a role minimising exploitation in international research?

It has been suggested that community advisory boards (CABs) can play a role in minimising exploitation in international research. To get a better idea of what this requires and whether it might be achievable, the paper first describes core elements that we suggest must be in place for a CAB to reduce the potential for exploitation. The paper then examines a CAB established by the Shoklo Malaria Research Unit under conditions common in resource-poor settings - namely, where individuals join with a very limited understanding of disease and medical research and where an existing organisational structure is not relied upon to serve as the CAB. Using the Tak Province Border Community Ethics Advisory Board (T-CAB) as a case study, we assess the extent to which it might be able to take on a role minimising exploitation were it to decide to do so. We investigate whether, after two years in operation, T-CAB is capable of assessing clinical trials for exploitative features and addressing those found to have them. The findings show that, although T-CAB members have gained knowledge and developed capacities that are foundational for one-day taking on a role to reduce exploitation, their ability to critically evaluate studies for the presence of exploitative elements has not yet been strongly demonstrated. In light of this example, we argue that CABs may not be able to perform such a role for a number of years after initial formation, making it an unsuitable responsibility for many short-term CABs.

Evaluating the Capacity of Theories of Justice to Serve as a Justice Framework for International Clinical Research

This article investigates whether or not theories of justice from political philosophy, first, support the position that health research should contribute to justice in global health, and second, provide guidance about what is owed by international clinical research (ICR) actors to parties in low- and middle-income countries. Four theories—John Rawlss theory of justice, the rights-based cosmopolitan theories of Thomas Pogge and Henry Shue, and Jennifer Rugers health capability paradigm—are evaluated. The article shows that three of the four theories require the conduct of health research for justice in global health. The theories help identify the ends of justice to which ICR is to contribute, but they cannot tell us how to organize ICR to promote these ends. Aside from Rugers health capability paradigm, the theories also lack an allocative principle for assigning specific duties to specific actors. This creates difficulties for establishing obligations for certain types of ICR actors.

JUSTICE IN INTERNATIONAL CLINICAL RESEARCH

Debates about justice in international clinical research problematically conflate two quite different forms of obligation. International research ethics guidelines were intended to describe how to conduct biomedical research in a just manner at the micro or clinical level (within the researcher-participant interaction) but have come to include requirements that are clearly intended to promote justice at the global level. Ethicists have also made a variety of claims regarding what international research should contribute to global justice. This paper argues that the conflation of debates about justice at the micro and macro-levels has not only resulted in the placement of obligations upon the wrong actors but has also served to exclude relevant actors from the ethical picture. Suggestions for who should properly bear macro-level obligations of justice in international clinical research are offered. The paper further contends that, unlike researchers who violate informed consent requirements, no similar type of accountability exists for obligations of global justice, even for those obligation-bearers (incorrectly) identified by current ethics guidelines.

Ancillary Care: From Theory to Practice in International Clinical Research

How international research might contribute to justice in global health has not been substantively addressed by bioethics. This article describes how the provision of ancillary care can link international clinical research to the reduction of global health disparities. It identifies the ancillary care obligations supported by a theory of global justice, showing that Jennifer Ruger’s health capability paradigm requires the delivery of ancillary care to trial participants for a limited subset of conditions that cause severe morbidity and mortality. Empirical research on the Shoklo Malaria Research Unit’s (SMRU) vivax malaria treatment trial was then undertaken to demonstrate whether and how these obligations might be upheld in a resource-poor setting. Our findings show that fulfilment of the ancillary care obligations is feasible where there is commitment from chief investigators and funders and is strongly facilitated by SMRU’s dual role as a research unit and medical non-governmental organization.

Why Do People Participate in Epidemiological Research

Many assumptions are made about public willingness to participate in epidemiological research, yet few empirical studies have been conducted to ascertain whether such assumptions are correct. Our qualitative study of the public and of expert stakeholders leads us to suggest that people are generally prepared to participate in epidemiological research, particularly if it is conducted by a trusted public institution such as a government health department, charity, or university. However, there is widespread community distrust of research conducted or sponsored by pharmaceutical companies. Individuals are prompted to take part if the study concerns an illness they or a family member or friend have personally experienced or if they believe the research will confer a widespread public benefit. Preferences vary about the mode of contact for the research to be conducted. Willingness to participate in telephone surveys has decreased in recent years, and this may be a consequence of an increase in calls to homes by telemarketers and market researchers. Participants also stressed the importance of knowing where their names and contact details were sourced and suggested that this information be available to prospective study participants as a matter of course in the first approach or letter. We provide valuable information to epidemiologists in designing studies.

Linking international clinical research with stateless populations to justice in global health

BackgroundIn response to calls to expand the scope of research ethics to address justice in global health, recent scholarship has sought to clarify how external research actors from high-income countries might discharge their obligation to reduce health disparities between and within countries. An ethical framework—‘research for health justice’—was derived from a theory of justice (the health capability paradigm) and specifies how international clinical research might contribute to improved health and research capacity in host communities. This paper examines whether and how external funders, sponsors, and researchers can fulfill their obligations under the framework.MethodsCase study research was undertaken on the Shoklo Malaria Research Unit’s (SMRU) vivax malaria treatment trial, which was performed on the Thai-Myanmar border with Karen and Myanmar refugees and migrants. We conducted nineteen in-depth interviews with trial stakeholders, including investigators, trial participants, community advisory board members, and funder representatives; directly observed at trial sites over a five-week period; and collected trial-related documents for analysis.ResultsThe vivax malaria treatment trial drew attention to contextual features that, when present, rendered the ‘research for health justice’ framework’s guidance partially incomplete. These insights allowed us to extend the framework to consider external research actors’ obligations to stateless populations. Data analysis then showed that framework requirements are largely fulfilled in relation to the vivax malaria treatment trial by Wellcome Trust (funder), Oxford University (sponsor), and investigators. At the same time, this study demonstrates that it may be difficult for long-term collaborations to shift the focus of their research agendas in accordance with the changing burden of illness in their host communities and to build the independent research capacity of host populations when working with refugees and migrants. Obstructive factors included the research funding environment and staff turnover due to resettlement or migration.ConclusionsOur findings show that obligations for selecting research targets, research capacity strengthening, and post-trial benefits that link clinical trials to justice in global health can be upheld by external research actors from high-income countries when working with stateless populations in LMICs. However, meeting certain framework requirements for long-term collaborations may not be entirely feasible.

No agreement reached in talks on access to cheap drugs

At a meeting on Nov 25–27 in Geneva Switzerland the Council for the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs) was expected to finalise a plan that would enable generic drug manufacturers in countries such as Brazil India and China to export drugs still under patent under certain circumstances to countries with little or no manufacturing industry. Instead the TRIPs Council meeting which followed a “miniministerial” meeting held earlier in November (see Lancet 2002; 360: 1670) ended without any prospect of reaching agreement. (excerpt)