A Call for Evaluation of Restorative Justice Programs.

Restorative justice as a response to sexual violence continues to be subject to significant criticism. To assess the evidence, we sought to appraise and synthesize evaluations of restorative justice programs for sexual and family violence offences by conducting a systematic review of peer-reviewed literature. However, our rigorous search identified only one eligible study. This dearth of evidence leaves us unable to identify how best to achieve the aims for which programs were established and poses difficulties for policy makers determining whether it is justified to introduce restorative justice programs for sexual and family violence. We recommend that evaluations of restorative justice programs that accept sexual and family violence cases be conducted as a matter of urgency.

Was an epidemic of gonorrhoea among heterosexuals attending an Adelaide sexual health services associated with variations in sex work policing policy?

BACKGROUND: A review of historical trends in gonococcal diagnoses made at the Adelaide Sexual Health Clinic (ASHC), South Australia, identified a substantial rise in diagnoses among heterosexuals between 2006 and 2010. Sex work is illegal in South Australia, regulated in Victoria and legal in New South Wales. This and other factors that could have influenced the epidemic were explored in this analysis. METHODS: Retrospective analyses of gonorrhoea diagnoses made by sexual health services between 1990 and 2012 in three Australian state capitals, Melbourne (Victoria) and Sydney (New South Wales) were undertaken. RESULTS: At the ASHC the proportion of gonorrhoea diagnoses was higher between 2006 and 2010 among heterosexual men (5.34% vs 0.84%, p<0.001), non-sex worker women (0.64% vs 0.28%, p<0.001) and female sex workers (FSWs) (1.75% vs 0.24%, p<0.001) compared with other years. This relationship was not seen at the Melbourne Sexual Health Clinic and corresponding data from the Sydney Sexual Health Centre showed that FSWs were less likely to have gonorrhoea between 2006 and 2010 than the other groups (p=0.746, p=0.522, p=0.024, respectively). At ASHC FSWs were significantly more likely to be diagnosed between 2006 and 2010 (OR 2.8, 95% CI 1.48 to 5.27, p=0.002). Charges against sex workers peaked in 2007/2008. CONCLUSIONS: A substantial, self-limiting rise in diagnoses of heterosexual gonorrhoea was seen in Adelaide FSWs between 2006 and 2010. Removing barriers to condom use is vital to the prevention of HIV and STI transmission.

A cross-sectional survey to investigate community understanding of medical research ethics committees.

Study explanatory forms often state that an ethics committee has approved a research project. To determine whether the lay community understand the roles of ethics committees in research, we took a cross-sectional national sample from three sampling frames: the general population (n=1532); cohort study participants (n=397); and case-control study participants (n=151). About half (51.3%) of the participants had heard of ethics committees. Those who had were more likely to be those who had participated in previous surveys, older participants, those born in Australia and those with higher education. Almost all participants agreed that the roles of an ethics committee were to protect participants' privacy and ensure no harm came to study participants and most agreed that the committee's role was to ensure that the research was capable of providing answers. Case-control and cohort participants were more likely than the general population to consider that the role of an ethics committee was to design the research and obtain research funding. Overall, we found that about half of the population are aware of ethics committees and that most could correctly identify that ethics committees are there to protect the welfare and rights of research participants, although a substantial minority had some incorrect beliefs about the committees' roles. Increased education, particularly for migrants and older people, might improve understanding of the role of ethics committees in research.

A comparison of justice frameworks for international research.

Justice frameworks have been developed for international research that provide guidance on the selection of research targets, ancillary care, research capacity strengthening, and post-trial benefits. Yet there has been limited comparison of the different frameworks. This paper examines the underlying aims and theoretical bases of three such frameworks--the fair benefits framework, the human development approach and research for health justice--and considers how their aims impact their guidance on the aforementioned four ethical issues. It shows that the frameworks' underlying objectives vary across two dimensions. First, whether they seek to prevent harmful or exploitative international research or to promote international research with health benefits for low and middle-income countries. Second, whether they address justice at the micro level or the macro level. The fair benefits framework focuses on reforming contractual elements in individual international research collaborations to ensure fairness, whereas the other two frameworks aim to connect international research with the reduction of global health inequities. The paper then highlights where there is overlap between the frameworks' requirements and where differences in the strength and content of the obligations they identify arise as a result of their varying objectives and theoretical bases. In doing so, it does not offer a critical comparison of the frameworks but rather seeks to add clarity to current debates on justice and international research by showing how they are positioned relative to one another.

A framework to link international clinical research to the promotion of justice in global health.

How international research might contribute to justice in global health has not been substantively addressed by bioethics. Theories of justice from political philosophy establish obligations for parties from high-income countries owed to parties from low and middle-income countries. We have developed a new framework that is based on Jennifer Ruger's health capability paradigm to strengthen the link between international clinical research and justice in global health. The 'research for health justice' framework provides direction on three aspects of international clinical research: the research target, research capacity strengthening, and post-trial benefits. It identifies the obligations of justice owed by national governments, research funders, research sponsors, and investigators to trial participants and host communities. These obligations vary from those currently articulated in international research ethics guidelines. Ethical requirements of a different kind are needed if international clinical research is to advance global health equity.

Linking research to global health equity: the contribution of product development partnerships to access to medicines and research capacity building.

Certain product development partnerships (PDPs) recognize that to promote the reduction of global health disparities they must create access to their products and strengthen research capacity in developing countries. We evaluated the contribution of 3 PDPs--Medicines for Malaria Venture, Drugs for Neglected Diseases Initiative, and Institute for One World Health--according to Frost and Reich's access framework. We also evaluated PDPs' capacity building in low- and middle-income countries at the individual, institutional, and system levels. We found that these PDPs advance public health by ensuring their products' registration, distribution, and adoption into national treatment policies in disease-endemic countries. Nonetheless, ensuring broad, equitable access for these populations--high distribution coverage; affordability, particularly for the poor; and adoption at provider and end-user levels--remains a challenge.

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.

Linking international research to global health equity: the limited contribution of bioethics.

Health research has been identified as a vehicle for advancing global justice in health. However, in bioethics, issues of global justice are mainly discussed within an ongoing debate on the conditions under which international clinical research is permissible. As a result, current ethical guidance predominantly links one type of international research (biomedical) to advancing one aspect of health equity (access to new treatments). International guidelines largely fail to connect international research to promoting broader aspects of health equity - namely, healthier social environments and stronger health systems. Bioethical frameworks such as the human development approach do consider how international clinical research is connected to the social determinants of health but, again, do so to address the question of when international clinical research is permissible. It is suggested that the narrow focus of this debate is shaped by high-income countries' economic strategies. The article further argues that the debate's focus obscures a stronger imperative to consider how other types of international research might advance justice in global health. Bioethics should consider the need for non-clinical health research and its contribution to advancing global justice.

Toward a legal framework that promotes and protects sex workers' health and human rights.

Complex combinations of law, policy, and enforcement practices determine sex workers vulnerability to HIV and rights abuses. We identify "lack of recognition as a person before the law" as an important but undocumented barrier to accessing services and conclude that multi-faceted, setting-specific reform is needed-rather than a singular focus on decriminalization-if the health and human rights of sex workers are to be realized.

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 Rawls's theory of justice, the rights-based cosmopolitan theories of Thomas Pogge and Henry Shue, and Jennifer Ruger's 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 Ruger's 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.

Closing the translation gap for justice requirements in international research.

Bioethicists have long debated the content of sponsors and researchers' obligations of justice in international clinical research. However, there has been little empirical investigation as to whether and how obligations of responsiveness, ancillary care, post-trial benefits and research capacity strengthening are upheld in low- and middle-income country settings. In this paper, the authors argue that research ethics guidelines need to be more informed by international research practice. Practical guidance on how to fulfil these obligations is needed if research groups and other actors are to successfully translate them into practice because doing so is often a complicated, context-specific process. Case study research methods offer one avenue for collecting data to develop this guidance. The authors describe how such methods have been used in relation to the Shoklo Malaria Research Unit's vivax malaria treatment (VHX) trial (NCT01074905). Relying on the VHX trial example, the paper shows how information can be gathered from not only international clinical researchers but also trial participants, community advisory board members and research funder representatives in order to: (1) measure evidence of responsiveness, provision of ancillary care, access to post-trial benefits and research capacity strengthening in international clinical research; and (2) identify the contextual factors and roles and responsibilities that were instrumental in the fulfilment of these ethical obligations. Such empirical work is necessary to inform the articulation of obligations of justice in international research and to develop guidance on how to fulfil them in order to facilitate better adherence to guidelines' requirements.

Health research systems: promoting health equity or economic competitiveness?

International collaborative health research is justifiably expected to help reduce global health inequities. Investment in health policy and systems research in developing countries is essential to this process but, currently, funding for international research is mainly channelled towards the development of new medical interventions. This imbalance is largely due to research legislation and policies used in high-income countries. These policies have increasingly led these countries to invest in health research aimed at boosting national economic competitiveness rather than reducing health inequities. In the United States of America and the United Kingdom of Great Britain and Northern Ireland, the regulation of research has encouraged a model that: leads to products that can be commercialized; targets health needs that can be met by profitable, high-technology products; has the licensing of new products as its endpoint; and does not entail significant research capacity strengthening in other countries. Accordingly, investment in international research is directed towards pharmaceutical trials and product development public-private partnerships for neglected diseases. This diverts funding away from research that is needed to implement existing interventions and to strengthen health systems, i.e. health policy and systems research. Governments must restructure their research laws and policies to increase this essential research in developing countries.

An analysis of potential barriers and enablers to regulating the television marketing of unhealthy foods to children at the state government level in Australia.

BACKGROUND: In Australia there have been many calls for government action to halt the effects of unhealthy food marketing on children's health, yet implementation has not occurred. The attitudes of those involved in the policy-making process towards regulatory intervention governing unhealthy food marketing are not well understood. The objective of this research was to understand the perceptions of senior representatives from Australian state and territory governments, statutory authorities and non-government organisations regarding the feasibility of state-level government regulation of television marketing of unhealthy food to children in Australia. METHOD: Data from in-depth semi-structured interviews with senior representatives from state and territory government departments, statutory authorities and non-government organisations (n=22) were analysed to determine participants' views about regulation of television marketing of unhealthy food to children at the state government level. Data were analysed using content and thematic analyses. RESULTS: Regulation of television marketing of unhealthy food to children was supported as a strategy for obesity prevention. Barriers to implementing regulation at the state level were: the perception that regulation of television advertising is a Commonwealth, not state/territory, responsibility; the power of the food industry and; the need for clear evidence that demonstrates the effectiveness of regulation. Evidence of community support for regulation was also cited as an important factor in determining feasibility. CONCLUSIONS: The regulation of unhealthy food marketing to children is perceived to be a feasible strategy for obesity prevention however barriers to implementation at the state level exist. Those involved in state-level policy making generally indicated a preference for Commonwealth-led regulation. This research suggests that implementation of regulation of the television marketing of unhealthy food to children should ideally occur under the direction of the Commonwealth government. However, given that regulation is technically feasible at the state level, in the absence of Commonwealth action, states/territories could act independently. The relevance of our findings is likely to extend beyond Australia as unhealthy food marketing to children is a global issue.

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.

Taxing junk food: applying the logic of the Henry tax review to food.

The recent review of taxation in Australia - the Henry tax review - has recommended that the federal government increase the taxes already levied on tobacco and alcohol. Tobacco and alcohol taxes are put forward as the best way of reducing the social harms caused by the use and misuse of these substances. Junk foods have the same pattern of misuse and the same social costs as tobacco and alcohol. The Henry tax review rejects the idea of taxing fatty foods, and to date the government has not implemented a tax on junk food. We propose that a tax on junk food be implemented as a tool to reduce consumption and address the obesity epidemic.

Returning to history: the ethics of researching asylum seeker health in Australia.

Australia's policy of mandatory indefinite detention of those seeking asylum and arriving without valid documents has led to terrible human rights abuses and cumulative deterioration in health for those incarcerated. We argue that there is an imperative to research and document the plight of those who have suffered at the hands of the Australian government and its agents. However, the normal tools available to those engaged in health research may further erode the rights and well being of this population, requiring a rethink of existing research ethics paradigms to approaches that foster advocacy research and drawing on the voices of those directly affected, including those bestowed with duty of care for this population.