What contribution can International Relations make to the evolving global health agenda?

This article presents two approaches that have dominated International Relations in their approach to the international politics of health. The statist approach, which is primarily security-focused, seeks to link health initiatives to a foreign or defence policy remit. The globalist approach, in contrast, seeks to advance health not because of its intrinsic security value but because it advances the well-being and rights of individuals. This article charts the evolution of these approaches and demonstrates why both have the potential to shape our understanding of the evolving global health agenda. It examines how the statist and globalist perspectives have helped shape contemporary initiatives in global health governance and suggests that there is evidence of an emerging convergence between the two perspectives. This convergence is particularly clear in the articulation of a number of UN initiatives in this area—especially the One World, One Health Strategic Framework and the Oslo Ministerial Declaration (2007) which inspired the first UN General Assembly resolution on global health and foreign policy in 2009 and the UN Secretary-General's note ‘Global health and foreign policy: strategic opportunities and challenges'. What remains to be seen is whether this convergence will deliver on securing states’ interest long enough to promote the interests of the individuals who require global efforts to deliver local health improvements.

Book reviews : "Biosecurity interventions: global health and security in question"

International Relations’ engagement with global health governance has proliferated in the last decade. There are a number of excellent works that seek to understand how the relationship between politics and health shapes and informs people’s lives and governments’ policies. However, the overt securitization of health by the IR field has, Biosecurity interventions argues, remained relatively unproblematized...

Law and Global Health

Law and Global Health, the sixteenth volume in the Current Legal Issues series, offers an insight into the scholarship examining the relationship between global health and the law. Covering a wide range of areas from all over the world, articles in the volume look at areas of human rights, vulnerable populations, ethical issues, legal responses and governance.

Portal-based support for mental health research

This paper describes experiences with the use of the Globus toolkit and related technologies for development of a secure portal that allows nationally-distributed Australian researchers to share data and application programs. The portal allows researchers to access infrastructure that will be used to enhance understanding of the causes of schizophrenia and advance its treatment, and aims to provide access to a resource that can expand into the world’s largest on-line collaborative mental health research facility. Since access to patient data is controlled by local ethics approvals, the portal must transparently both provide and deny access to patient data in accordance with the fine-grained access permissions afforded individual researchers. Interestingly, the access protocols are able to provide researchers with hints about currently inaccessible data that may be of interest to them, providing them the impetus to gain further access permissions.

Women's health and a framework convention on global health

This paper considers the role for a Framework Convention on Global Health in addressing key challenges in women’s health at a global level. Part I analyses the conceptualization of health in terms of human rights and the linking of women’s rights and human rights. Part II seeks to identify pressing issues for women’s health, articulating 10 key challenges for women’s health. Part III considers the proposal for a Framework Convention on Global Health to meet global health needs. Finally, Part IV asks whether international law can provide a valuable platform to support recognition and achievement of women’s health rights and identifies key elements for supporting and promoting women’s health.

Global Climate Change Impacts in the United States: a state of knowledge report from the U.S. Global Change Research Program

Executive Summary: Observations show that warming of the climate is unequivocal. The global warming observed over the past 50 years is due primarily to human-induced emissions of heat-trapping gases. These emissions come mainly from the burning of fossil fuels (coal, oil, and gas), with important contributions from the clearing of forests, agricultural practices, and other activities. Warming over this century is projected to be considerably greater than over the last century. The global average temperature since 1900 has risen by about 1.5ºF. By 2100, it is projected to rise another 2 to 11.5ºF. The U.S. average temperature has risen by a comparable amount and is very likely to rise more than the global average over this century, with some variation from place to place. Several factors will determine future temperature increases. Increases at the lower end of this range are more likely if global heat-trapping gas emissions are cut substantially. If emissions continue to rise at or near current rates, temperature increases are more likely to be near the upper end of the range. Volcanic eruptions or other natural variations could temporarily counteract some of the human-induced warming, slowing the rise in global temperature, but these effects would only last a few years. Reducing emissions of carbon dioxide would lessen warming over this century and beyond. Sizable early cuts in emissions would significantly reduce the pace and the overall amount of climate change. Earlier cuts in emissions would have a greater effect in reducing climate change than comparable reductions made later. In addition, reducing emissions of some shorter-lived heat-trapping gases, such as methane, and some types of particles, such as soot, would begin to reduce warming within weeks to decades. Climate-related changes have already been observed globally and in the United States. These include increases in air and water temperatures, reduced frost days, increased frequency and intensity of heavy downpours, a rise in sea level, and reduced snow cover, glaciers, permafrost, and sea ice. A longer ice-free period on lakes and rivers, lengthening of the growing season, and increased water vapor in the atmosphere have also been observed. Over the past 30 years, temperatures have risen faster in winter than in any other season, with average winter temperatures in the Midwest and northern Great Plains increasing more than 7ºF. Some of the changes have been faster than previous assessments had suggested. These climate-related changes are expected to continue while new ones develop. Likely future changes for the United States and surrounding coastal waters include more intense hurricanes with related increases in wind, rain, and storm surges (but not necessarily an increase in the number of these storms that make landfall), as well as drier conditions in the Southwest and Caribbean. These changes will affect human health, water supply, agriculture, coastal areas, and many other aspects of society and the natural environment. This report synthesizes information from a wide variety of scientific assessments (see page 7) and recently published research to summarize what is known about the observed and projected consequences of climate change on the United States. It combines analysis of impacts on various sectors such as energy, water, and transportation at the national level with an assessment of key impacts on specific regions of the United States. For example, sea-level rise will increase risks of erosion, storm surge damage, and flooding for coastal communities, especially in the Southeast and parts of Alaska. Reduced snowpack and earlier snow melt will alter the timing and amount of water supplies, posing significant challenges for water resource management in the West. (PDF contains 196 pages)

Access to medical records for research purposes:Varying perceptions across research ethics boards

Introduction: Variation across research ethics boards (REBs) in conditions placed on access to medical records for research purposes raises concerns around negative impacts on research quality and on human subject protection, including privacy. Aim: To study variation in REB consent requirements for retrospective chart review and who may have access to the medical record for data abstraction. Methods: Thirty 90-min face-to-face interviews were conducted with REB chairs and administrators affiliated with faculties of medicine in Canadian universities, using structured questions around a case study with open-ended responses. Interviews were recorded, transcribed and coded manually. Results: Fourteen sites (47%) required individual patient consent for the study to proceed as proposed. Three (10%) indicated that their response would depend on how potentially identifying variables would be managed. Eleven sites (38%) did not require consent. Two (7%) suggested a notification and opt-out process. Most stated that consent would be required if identifiable information was being abstracted from the record. Among those not requiring consent, there was substantial variation in recognising that the abstracted information could potentially indirectly re-identify individuals. Concern over access to medical records by an outside individual was also associated with requirement for consent. Eighteen sites (60%) required full committee review. Sixteen (53%) allowed an external research assistant to abstract information from the health record. Conclusions: Large variation was found across sites in the requirement for consent for research involving access to medical records. REBs need training in best practices for protecting privacy and confidentiality in health research. A forum for REB chairs to confidentially share concerns and decisions about specific studies could also reduce variation in decisions.

Who's minding the shop?:the role of Canadian research ethics boards in the creation and uses of registries and biobanks

Abstract. Background. The amount of research utilizing health information has increased dramatically over the last ten years. Many institutions have extensive biobank holdings collected over a number of years for clinical and teaching purposes, but are uncertain as to the proper circumstances in which to permit research uses of these samples. Research Ethics Boards (REBs) in Canada and elsewhere in the world are grappling with these issues, but lack clear guidance regarding their role in the creation of and access to registries and biobanks. Methods. Chairs of 34 REBS and/or REB Administrators affiliated with Faculties of Medicine in Canadian universities were interviewed. Interviews consisted of structured questions dealing with diabetes-related scenarios, with open-ended responses and probing for rationales. The two scenarios involved the development of a diabetes registry using clinical encounter data across several physicians' practices, and the addition of biological samples to the registry to create a biobank. Results. There was a wide range of responses given for the questions raised in the scenarios, indicating a lack of clarity about the role of REBs in registries and biobanks. With respect to the creation of a registry, a minority of sites felt that consent was not required for the information to be entered into the registry. Whether patient consent was required for information to be entered into the registry and the duration for which the consent would be operative differed across sites. With respect to the creation of a biobank linked to the registry, a majority of sites viewed biobank information as qualitatively different from other types of personal health information. All respondents agreed that patient consent was needed for blood samples to be placed in the biobank but the duration of consent again varied. Conclusion. Participants were more attuned to issues surrounding biobanks as compared to registries and demonstrated a higher level of concern regarding biobanks. As registries and biobanks expand, there is a need for critical analysis of suitable roles for REBs and subsequent guidance on these topics. The authors conclude by recommending REB participation in the creation of registries and biobanks and the eventual drafting of comprehensive legislation.

Gaining ethical approvals to undertake sexual health research with young people in the UK: Applying a 'Children's Rights Based Approach'

This paper (co-written with Dr Maria Lohan, Dr Carmel Kelly & Professor Laura Lundy) will describe the ethical review process to undertake health research in the UK, and explain an approach that can help researchers deal with ethical and methodological dilemmas in their research. Ethical review is necessary to ensure researchers and participants are protected, yet the requirement to ‘pass’ numerous committees may be challenging particularly for health researchers who work with vulnerable groups and sensitive topics. The inclusion of these groups/topics is crucial if health researchers are to understand health disparities and implement appropriate interventions with health benefits for vulnerable populations. It is proposed that to overcome ethical and methodological challenges and pitfalls, researchers must implement strategies that advocate for, and increase the participation of, vulnerable populations in health research. A ‘children’s rights based approach’ using participatory methodology will be described that draws on the jurisprudence of international law, (United Nations Convention on the Rights of the Child, 1989) and provides a framework that may empower ethics committees to carry out their function confidently. The role of the researcher, framed within the context of doctoral level study, will be reviewed in terms of the investment required and benefits of utilising this approach. It will be argued that adopting this approach with vulnerable groups, not only guarantees their meaningful participation in the research process and permits their voices to be heard, but also offers ethics committees an internationally agreed upon legal framework, ratified by their governing States, from which to fulfil their obligations and resolve their ethical dilemmas. Increasing the representation and participation of vulnerable groups in health research can inform the development of health policy and practice based on ‘insider knowledge’ that better engages with and more adequately reflects their specific needs. This is likely to yield numerous health, social and economic benefits for all of society through the delivery of more equitable, effective and sustainable services.

Extent of non-publication in cohorts of studies approved by research ethics committees or included in trial registries

BACKGROUND: The synthesis of published research in systematic reviews is essential when providing evidence to inform clinical and health policy decision-making. However, the validity of systematic reviews is threatened if journal publications represent a biased selection of all studies that have been conducted (dissemination bias). To investigate the extent of dissemination bias we conducted a systematic review that determined the proportion of studies published as peer-reviewed journal articles and investigated factors associated with full publication in cohorts of studies (i) approved by research ethics committees (RECs) or (ii) included in trial registries. METHODS AND FINDINGS: Four bibliographic databases were searched for methodological research projects (MRPs) without limitations for publication year, language or study location. The searches were supplemented by handsearching the references of included MRPs. We estimated the proportion of studies published using prediction intervals (PI) and a random effects meta-analysis. Pooled odds ratios (OR) were used to express associations between study characteristics and journal publication. Seventeen MRPs (23 publications) evaluated cohorts of studies approved by RECs; the proportion of published studies had a PI between 22% and 72% and the weighted pooled proportion when combining estimates would be 46.2% (95% CI 40.2%-52.4%, I2 = 94.4%). Twenty-two MRPs (22 publications) evaluated cohorts of studies included in trial registries; the PI of the proportion published ranged from 13% to 90% and the weighted pooled proportion would be 54.2% (95% CI 42.0%-65.9%, I2 = 98.9%). REC-approved studies with statistically significant results (compared with those without statistically significant results) were more likely to be published (pooled OR 2.8; 95% CI 2.2-3.5). Phase-III trials were also more likely to be published than phase II trials (pooled OR 2.0; 95% CI 1.6-2.5). The probability of publication within two years after study completion ranged from 7% to 30%. CONCLUSIONS: A substantial part of the studies approved by RECs or included in trial registries remains unpublished. Due to the large heterogeneity a prediction of the publication probability for a future study is very uncertain. Non-publication of research is not a random process, e.g., it is associated with the direction of study findings. Our findings suggest that the dissemination of research findings is biased.

The Swiss regulatory framework for pædiatric health research

Medical research on minors entails both risks and benefits. Under Swiss law, clinical trials on children, including nontherapeutic drug trials, are permissible. However, ethics committees must systematically verify that all clinical studies have a favorable risk-benefit profile. Additional safeguards are designed to ensure that children are not unnecessarily involved in research and that proper consent is always obtained. Federal Swiss law is undergoing revision to extend these protections beyond clinical trials to a broad array of health research. The Swiss drug agency also seeks to improve the incentives for pharmaceutical firms to develop new paediatric drugs and relevant paediatric drug labels.

Variance in Bioethics Services: Challenges and Opportunities in Canada with a Focus on In-house vs. Outsourced Health Care Ethics Consultations

Étude de cas / Case study

Committees for ethics in research involving human subjects

In Brazil since October 1996 there have been guidelines for research involving human subjects. Now human subjects know when their treatment is part of research. Deceit is no longer tolerated. But is not enough to say we offer an explanation to the potential subject and we offer a choice before he or she is confronted with an informed consent form. As in all professional activity, scientific investigation needs social controls. In Brazil, the ultimate responsibility of an investigation lies on the investigator, but in every institution where research is carried out there is a Committee for Ethics in Research. All Committees are subordinated to the National Commission of Ethics in Research, which is submitted to the Brazilian Institute of Health. During 2005 around 17,000 protocols involving 700,000 human subjects were revised by 475 Committees distributed all over the country. Approximately 7,000 people are now working in these Committees.

Evaluating the U.S. Global Health Policy Initiative

In understanding that the efforts made in improving global health affects the health of U.S. citizens, a policy analysis of President Barak Obama's Global Health Initiative was conducted. Using materials gathered from experts in the field of health and their findings and recommendations, paired with the current policies of other G8 countries that pledged to support the efforts of improving global health, the analysis was conducted using four specifically defined criteria. The set criteria determine the appropriateness, responsiveness, effectiveness and equity of Obama's GHI in comparison to other G8 country health policies and overall global health priorities. G8 countries without a specific global health policy, or with a policy that was not in English were excluded from this study and Switzerland, headquarters of the World Health Organization, was added due to its membership in the OECD, and the fact that it has a specific foreign health policy. In evaluating the U.S. Global Health Initiative it is clear that in terms of implementing foreign policy specific to health, the United States is on the forefront alongside the United Kingdom and Switzerland. Other G8 Countries have pledged monies and in order to Millennium Development Health Goals by 2015. The U.S. Global Health Policy does not address issues necessary to meet Millennium Development Goals in Health. Instead the Global Health Initiative is focused narrowly on Fighting and rolling back the HIV/Aids Epidemic based on President Bush's PEPFAR policy. Policy recommendations for a more effective and efficient Global Health Initiative include building upon the PEPFAR policy foundation in order to strengthen health systems worldwide, allowing individuals and communities to combat unnecessary death and disease through research, education, and other preventative methods.^

Access to death certificates: What should research ethics committees require for approval?

PURPOSE: To present and discuss the reactions of research ethics committees (RECs) in a number of countries when asked for approval Of a study requiring access to death certificates to identify the physicians signing the certificates and to send them a four-page questionnaire about medical decisions made at the patient's end-of-life that could possibly have hastened death. METHODS: A simple questionnaire were sent to the responsible national investigator in an international study (Australia, Belgium, Denmark, Italy, the Netherlands, Sweden, Switzerland) asking about the interactions between the national research group and the national/regional REC(s). RESULTS: Different laws or guidelines were used by the RECs. Denmark, the Netherlands, and Switzerland did not require an application to a REC. In Australia and Sweden, the RECs wanted changes in the research protocol, and one national research group had to refrain from publishing its results because the attrition rate became too high, probably due to the required changes in the protocol. RECOMMENDATIONS: Generally, similar demands from all RECs in relation to one project are strongly desirable. In epidemiological research, in which Voluntary completion of an anonymous questionnaire demonstrates consent, additional prior informed consent about being approached should not be required.