"Obviously It's for the Victim to Decide": Restorative Justice for Sexual and Family Violence From the Perspective of Second-Wave Anti-Rape Activists.

While the appropriateness of restorative justice for sexual and family violence continues to experience worldwide feminist debate, these programs already exist. We thematically analyzed the transcripts of former members of a second-wave feminist antirape organization in Australia to ascertain their perspectives on a victim-centered conferencing model. They provided informed and valuable insights drawn from their decades of advocacy. Participants supported restorative justice in principle, stressing respect for victims' agency and independence in all policies and program designs. Their reservations, consistent with concerns in the literature, related to meeting victims' needs within a constrained system rather than principled opposition to the concept.

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.

Teaching Vulnerability in Research: A Study of Approaches Utilized by a Sample of Research Ethics Training Programs.

This article reports the outcomes of qualitative research on the teaching of "vulnerability in research" undertaken with principal investigators of international bioethics training programs funded by the Fogarty International Center of the National Institutes of Health (NIH) of the United States. To properly contextualize this research, we begin with an overview of the various ways in which vulnerability has been conceptualized both by writers and by ethical guidance from low-, middle-, and high-income countries. We conclude with some preliminary suggestions for best practice and recommendations for further research. To the best of our knowledge, this is the first time research of this kind has been carried out.

Work environment risks for health care workers with cystic fibrosis.

In Australia and New Zealand, >50% of people with cystic fibrosis (CF) are adults and many of these people are pursuing vocational training and undertaking paid employment. More than 6% of adults with CF are working in health care. There is limited guidance in literature to support health care workers with CF (HCWcf) in training and in employment to support safe practice and to provide protection for themselves and their patients from the acquisition of health care associated infection. A multidisciplinary team of CF and Infectious Disease Clinicians, Infection Prevention and Control Practitioners, HCWcf, academic experts in medical ethics and representatives from universities, appraised the available evidence on the risk posed to and by HCWcf. Specific recommendations were made for HCWcf, CF health care teams, hospitals and universities to support the safe practice and appropriate support for HCWcf.

A Hospital-based Patient Legal Clinic.

The HeLP Patient Legal Clinic has provided free legal advice to public hospital patients with health-related problems since March 2014. This article reports on the findings of a study of the first six months of HeLP's operation. The study adopted qualitative methods informed by grounded theory and sought to understand patient and social worker experiences of HeLP. Interviews were conducted with 13 patients and 10 next of kin. Focus group discussions were carried out with 19 social workers who referred patients to HeLP. Locating the legal service in the hospital's social work department enabled and expedited access to legal advice; a team-based approach to patient problems emerged that enhanced patient outcomes; and provision of legal advice relieved the anxiety experienced by patients, allowing them to focus better on their health concern.

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.

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.

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.

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.

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

BACKGROUND: In 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. METHODS: Case 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. RESULTS: The 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. CONCLUSIONS: Our 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.

Perspectives from South and East Asia on clinical and research ethics: a literature review.

A review was conducted of English-language peer-reviewed and gray literature on health and ethics written by authors from Bangladesh, China, India, and Pakistan. This was supplemented by the knowledge of co-authors who are involved in bioethics capacity building in these countries. Of the identified literature that focused on the application of Western principles, it largely discussed informed consent and revealed norms in clinical decision-making that include physician paternalism, family involvement in decision-making, and reluctance to provide information that might upset patients. It appears that Western ethical principles may be interpreted and applied in unexpected ways. The literature further indicates that, although there is some consistency with Western ideas, Islamic, Confucian, and Indian religious and philosophical traditions contain concepts not reflected in international guidance. Findings suggest scholars from these countries seek to enter into a bioethics dialogue with the potential to enrich and inform "international" frameworks.

Fogarty research ethics training programs in the Asia-Pacific: the merging of cultures.

In-depth interviews were undertaken with nine principal investigators and 16 former trainees from eight FIC programs recruiting trainees from the Asia-Pacific to assess the impact of training. Incorporation of new knowledge into teaching, research, and medical practice; advanced training; and ethics committee participation were the most common outcomes identified. When attempting to implement ethics activities posttraining, trainees often had to contend with opposition from more senior staff. Approaches that enhanced the cultural relevance of program content were identified as necessary, including comparing/contrasting non-Western principles and religions with Western bioethics, using region-specific case studies, and integrating clinical and research ethics. Best practices associated with program and trainee success included selecting more senior trainees clustered within Asia-Pacific institutions, offering a variety of degree and nondegree options, and post-training mentorship and networking support. This paper is part of a collection of papers analyzing the Fogarty International Center's International Research Ethics Education and Curriculum Development program.

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.

The tide cannot be turned without us: sex workers and the global response to HIV.

Improved knowledge, better programmes and policies, effective treatment and other scientific developments have reduced levels of new HIV infections globally. Evidence shows that programmes that prevent HIV among sex workers and their clients are most successful when all aspects of vulnerability are addressed and when they are underpinned by policy that advances human rights. This is particularly important in the context of the introduction of antiretroviral-based HIV prevention, which could have harmful consequences if not well planned. In this context, law and policy on sex work should not be limited to aiming to deliver medicine and services to sex workers in dangerous working conditions. A high-priority aim should be to ensure that the law enables commercial sex to take place in the safest possible conditions. To achieve this, the meaningful involvement of sex workers at all levels of the response is crucial. However, although that has been recognized in theory, it has not been achieved in practice.

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.

Access to the Commonwealth electoral roll for medical research.

In the 2010-11 financial 2013, there was a dramatic reduction in the approvals granted by the Australian Electoral Commission for access to samples of the adult population derived from the electoral roll for the purposes of public health research. Much time and effort has been expended in making applications without success. Researchers refused access to electoral roll samples must rely on sampling methods that are not as robust and that may produce less reliable data. We outline a set of recommendations that, if adopted, will result in a fairer system for obtaining access to the electoral roll for public health research.