Ethical Considerations for Including Women as Research Participants

Pediatrics
January 2016, VOLUME 137 / ISSUE 1
http://pediatrics.aappublications.org/content/137/1?current-issue=y

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Ethics Rounds
Ethical Considerations for Including Women as Research Participants
Pediatrics Jan 2016, 137 (1) 1; DOI: 10.1542/peds.2015-3990
In November 2015, the American Academy of Pediatrics endorsed the following publication: American College of Obstetricians and Gynecologists. Committee Opinion No. 646. Ethical considerations for including women as research participants. Washington, DC: American College of Obstetricians and Gynecologists; November 2015. Available at: http://www.acog.org/-/media/Committee-Opinions/Committee-on-Ethics/co646.pdf?dmc=1&ts=20151028T1411564748
Abstract
Inclusion of women in research studies is necessary for valid inference about health and disease in women. The generalization of results from trials conducted in men may yield erroneous conclusions that fail to account for the biological differences between men and women. Although significant changes in research design and practice have led to an increase in the proportion of women in research trials, knowledge gaps remain because of a continued lack of inclusion of women, especially those who are pregnant, in in premarketing research trials. This document provides a historical overview of issues surrounding women as participants in research trials, followed by an ethical framework and discussion of the issues of informed consent, contraception requirements, intimate partner consent, and the appropriate inclusion of pregnant women in research studies.

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Immigrant Families, Children With Special Health Care Needs, and the Medical Home
Kristin Kan, Hwajung Choi, Matthew Davis
Pediatrics Jan 2016, 137 (1) 1-8; DOI: 10.1542/peds.2015-3221

PLoS Medicine (Accessed 9 January 2016)

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 9 January 2016)

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Data Sharing as Part of the Normal Scientific Process: A View from the Pharmaceutical Industry
Patrick Vallance, Andrew Freeman, Murray Stewart
Perspective | published 05 Jan 2016 | PLOS Medicine
10.1371/journal.pmed.1001936

In this week’s PLOS Medicine, Modjarrad and colleagues report the outcome of a World Health Organisation (WHO) consultation on developing global norms for sharing data and results during public health emergencies, with a focus on clinical, epidemiologic, and genetic features of emerging infectious diseases as well as experimental diagnostics, therapeutics, and vaccines [1]. There can be little doubt that the need to find effective health care solutions as quickly as possible to prevent or stop the spread of infectious disease in an emergency makes rapid data sharing the right thing to do for patients and society. Many of the barriers to data sharing in public health emergencies identified in the paper by Modjarrad et al. have been highlighted as areas for change to enable data sharing more generally [2,3]. We are perpetually in the midst of several health care crises, including those of neglected tropical diseases and other chronic diseases, for which data sharing has the potential to lead to faster and better solutions. As a matter of principle, we should be willing to share data without regards to which disease is being studied. So, which data and when?…

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Developing Global Norms for Sharing Data and Results during Public Health Emergencies
Kayvon Modjarrad, Vasee S. Moorthy, Piers Millett, Pierre-Stéphane Gsell, Cathy Roth, Marie-Paule Kieny
Policy Forum | published 05 Jan 2016 | PLOS Medicine
10.1371/journal.pmed.1001935
Summary Points
:: Leading stakeholders from around the world convened at a WHO consultation in September 2015, where they affirmed that timely and transparent sharing of data and results during public health emergencies must become the global norm.
:: Representatives from major biomedical journals who attended the meeting agreed that public disclosure of information of relevance to public health emergencies should not be delayed by publication timelines and that early disclosure should not and will not prejudice later journal publication.
:: Researchers should be responsible for the accuracy of shared preliminary results, ensuring that they have been subjected to sufficient quality control before public dissemination.
:: Opting in to data sharing should be the default practice, and the onus should be placed on data generators and stewards at the local, national, and international level to explain any decision to opt out from sharing data and results during public health emergencies.
:: Incentives for sharing data should be created and tailored for each type of data generator and steward, while data management and analysis expertise is enhanced in under-resourced settings.

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Advancing Medical Professionalism in US Military Detainee Treatment
Leonard S. Rubenstein, Scott A. Allen, Phyllis A. Guze
Essay | published 05 Jan 2016 | PLOS Medicine
10.1371/journal.pmed.1001930
Summary Points
:: The United States Department of Defense and Central Intelligence Agency (CIA) promulgated policies and requirements that required health professionals to participate in the mistreatment of counter-terrorism detainees through participation in such practices as abusive interrogation and force-feeding of detainees, in violation of ethical standards established by associations representing the health professions.
:: A report of the Defense Health Board to the Secretary of Defense on military medical ethics released in 2015 found that the Department of Defense “does not have an enterprise-wide, formal, integrated infrastructure to systematically build, support, sustain, and promote an evolving ethical culture within the military health care environment.”
:: The Board also found that ethical codes promulgated by the health professions, including the duty to avoid harm, provide a sound basis for military medical practice, even taking into account the unique challenges often faced by military health professionals in reconciling the military mission with patient needs.
:: The health professional community should urge the Secretary of Defense to adopt and implement the recommendations of the Defense Health Board, rescind directives authorizing participation of health professionals in interrogation and force-feeding because they are inconsistent with professional ethics, and provide ongoing advice and support for the reform process.

Relevance of Non-communicable Comorbidities for the Development of the Severe Forms of Dengue: A Systematic Literature Review

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 9 January 2016)

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Relevance of Non-communicable Comorbidities for the Development of the Severe Forms of Dengue: A Systematic Literature Review
Joao Toledo, Leyanna George, Eric Martinez, Adhara Lazaro, Wai Wai Han, Giovanini E. Coelho, Silvia Runge Ranzinger, Olaf Horstick
Research Article | published 04 Jan 2016 | PLOS Neglected Tropical Diseases
10.1371/journal.pntd.0004284

PLoS One [Accessed 9 January 2016]

PLoS One
http://www.plosone.org/
[Accessed 9 January 2016]

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Social Factors Influencing Child Health in Ghana
Emmanuel Quansah, Lilian Akorfa Ohene, Linda Norman, Michael Osei Mireku, Thomas K. Karikari
Research Article | published 08 Jan 2016 | PLOS ONE
10.1371/journal.pone.0145401
Abstract
Objectives
Social factors have profound effects on health. Children are especially vulnerable to social influences, particularly in their early years. Adverse social exposures in childhood can lead to chronic disorders later in life. Here, we sought to identify and evaluate the impact of social factors on child health in Ghana. As Ghana is unlikely to achieve the Millennium Development Goals’ target of reducing child mortality by two-thirds between 1990 and 2015, we deemed it necessary to identify social determinants that might have contributed to the non-realisation of this goal.
Methods
ScienceDirect, PubMed, MEDLINE via EBSCO and Google Scholar were searched for published articles reporting on the influence of social factors on child health in Ghana. After screening the 98 articles identified, 34 of them that met our inclusion criteria were selected for qualitative review.
Results
Major social factors influencing child health in the country include maternal education, rural-urban disparities (place of residence), family income (wealth/poverty) and high dependency (multiparousity). These factors are associated with child mortality, nutritional status of children, completion of immunisation programmes, health-seeking behaviour and hygiene practices.
Conclusions
Several social factors influence child health outcomes in Ghana. Developing more effective responses to these social determinants would require sustainable efforts from all stakeholders including the Government, healthcare providers and families. We recommend the development of interventions that would support families through direct social support initiatives aimed at alleviating poverty and inequality, and indirect approaches targeted at eliminating the dependence of poor health outcomes on social factors. Importantly, the expansion of quality free education interventions to improve would-be-mother’s health knowledge is emphasised.

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Exploring the Potential Health Impact and Cost-Effectiveness of AIDS Vaccine within a Comprehensive HIV/AIDS Response in Low- and Middle-Income Countries
Thomas M. Harmon, Kevin A. Fisher, Margaret G. McGlynn, John Stover, Mitchell J. Warren, Yu Teng, Arne Näveke
Research Article | published 05 Jan 2016 | PLOS ONE
10.1371/journal.pone.0146387
Abstract
Background
The Investment Framework Enhanced (IFE) proposed in 2013 by the Joint United Nations Programme on HIV/AIDS (UNAIDS) explored how maximizing existing interventions and adding emerging prevention options, including a vaccine, could further reduce new HIV infections and AIDS-related deaths in low- and middle-income countries (LMICs). This article describes additional modeling which looks more closely at the potential health impact and cost-effectiveness of AIDS vaccination in LMICs as part of UNAIDS IFE.
Methods
An epidemiological model was used to explore the potential impact of AIDS vaccination in LMICs in combination with other interventions through 2070. Assumptions were based on perspectives from research, vaccination and public health experts, as well as observations from other HIV/AIDS interventions and vaccination programs. Sensitivity analyses varied vaccine efficacy, duration of protection, coverage, and cost.
Results
If UNAIDS IFE goals were fully achieved, new annual HIV infections in LMICs would decline from 2.0 million in 2014 to 550,000 in 2070. A 70% efficacious vaccine introduced in 2027 with three doses, strong uptake and five years of protection would reduce annual new infections by 44% over the first decade, by 65% the first 25 years and by 78% to 122,000 in 2070. Vaccine impact would be much greater if the assumptions in UNAIDS IFE were not fully achieved. An AIDS vaccine would be cost-effective within a wide range of scenarios.
Interpretation
Even a modestly effective vaccine could contribute strongly to a sustainable response to HIV/AIDS and be cost-effective, even with optimistic assumptions about other interventions. Higher efficacy would provide even greater impact and cost-effectiveness, and would support broader access. Vaccine efficacy and cost per regimen are critical in achieving cost-effectiveness, with cost per regimen being particularly critical in low-income countries and at lower efficacy levels.

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Impact of Contextual Factors on the Effect of Interventions to Improve Health Worker Performance in Sub-Saharan Africa: Review of Randomised Clinical Trials
Claire Blacklock, Daniela C. Gonçalves Bradley, Sharon Mickan, Merlin Willcox, Nia Roberts, Anna Bergström, David Mant
Research Article | published 05 Jan 2016 | PLOS ONE
10.1371/journal.pone.0145206

Social relationships and physiological determinants of longevity across the human life span

PNAS – Proceedings of the National Academy of Sciences of the United States
of America
http://www.pnas.org/content/early/
(Accessed 9 January 2016)

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Social Sciences – Social Sciences – Biological Sciences – Physiology
Social relationships and physiological determinants of longevity across the human life span
Yang Claire Yang, Courtney Boen, Karen Gerken, Ting Li, Kristen Schorpp, and Kathleen Mullan Harris
PNAS 2016 ; published ahead of print January 4, 2016, doi:10.1073/pnas.1511085112
Significance
Although much evidence has accrued in research over the past 20 years on the strong causal associations between social relationships and health and longevity, important gaps remain in our understanding of the mechanisms, timing, and duration of these associations. This study integrates social and biological disciplinary perspectives and research to examine how social relationships “get under the skin” to affect physiological well-being as individuals age. By combining data from and harmonizing measurement across four large nationally representative, population-based, contemporary surveys using an innovative longitudinal life course design, this study provides previously unidentified evidence on the biological and life course mechanisms linking social relationship patterns with health. As such, our findings advance explanations of the emergence and progression of diseases across the human life span.

Abstract
Two decades of research indicate causal associations between social relationships and mortality, but important questions remain as to how social relationships affect health, when effects emerge, and how long they last. Drawing on data from four nationally representative longitudinal samples of the US population, we implemented an innovative life course design to assess the prospective association of both structural and functional dimensions of social relationships (social integration, social support, and social strain) with objectively measured biomarkers of physical health (C-reactive protein, systolic and diastolic blood pressure, waist circumference, and body mass index) within each life stage, including adolescence and young, middle, and late adulthood, and compare such associations across life stages. We found that a higher degree of social integration was associated with lower risk of physiological dysregulation in a dose–response manner in both early and later life. Conversely, lack of social connections was associated with vastly elevated risk in specific life stages. For example, social isolation increased the risk of inflammation by the same magnitude as physical inactivity in adolescence, and the effect of social isolation on hypertension exceeded that of clinical risk factors such as diabetes in old age. Analyses of multiple dimensions of social relationships within multiple samples across the life course produced consistent and robust associations with health. Physiological impacts of structural and functional dimensions of social relationships emerge uniquely in adolescence and midlife and persist into old age.

Post-nuclear disaster evacuation and survival amongst elderly people in Fukushima: A comparative analysis between evacuees and non-evacuees

Preventive Medicine
Volume 82, Pages 1-118 (January 2016)
http://www.sciencedirect.com/science/journal/00917435/82
Original Research Article
Post-nuclear disaster evacuation and survival amongst elderly people in Fukushima: A comparative analysis between evacuees and non-evacuees
Pages 77-82
Shuhei Nomura, Marta Blangiardo, Masaharu Tsubokura, Yoshitaka Nishikawa, Stuart Gilmour, Masahiro Kami, Susan Hodgson
Abstract
Background
Considering the health impacts of evacuation is fundamental to disaster planning especially for vulnerable elderly populations; however, evacuation-related mortality risks have not been well-investigated. We conducted an analysis to compare survival of evacuated and non-evacuated residents of elderly care facilities, following the Great East Japan Earthquake and subsequent Fukushima Dai-ichi nuclear power plant incident on 11th March 2011.
Objective
To assess associations between evacuation and mortality after the Fukushima nuclear incident; and to present discussion points on disaster planning, with reference to vulnerable elderly populations.
Methods
The study population comprised 1,215 residents admitted to seven elderly care facilities located 20–40 km from the nuclear plant in the five years before the incident. Demographic and clinical characteristics were obtained from medical records. Evacuation histories were tracked until mid 2013. Main outcome measures are hazard ratios in evacuees versus non-evacuees using random-effects Cox proportional hazards models, and pre- and post-disaster survival probabilities and relative mortality incidence.
Results
Experiencing the disasters did not have a significant influence on mortality (hazard ratio 1.10, 95% confidence interval: 0.84–1.43). Evacuation was associated with 1.82 times higher mortality (95% confidence interval: 1.22–2.70) after adjusting for confounders, with the initial evacuation from the original facility associated with 3.37 times higher mortality risk (95% confidence interval: 1.66–6.81) than non evacuation.
Conclusions
The government should consider updating its requirements for emergency planning for elderly facilities and ensure that, in a disaster setting, these facilities have the capacity and support to shelter in place for at least sufficient time to adequately prepare initial evacuation.

Photovoice – Assessing the Long-Term Impact of a Disaster on a Community’s Quality of Life

Qualitative Health Research
January 2016; 26 (2)
http://qhr.sagepub.com/content/current

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Photovoice – Assessing the Long-Term Impact of a Disaster on a Community’s Quality of Life
Lucy Annang1, Sacoby Wilson2, Chiwoneso Tinago1, Louisiana Wright Sanders3, Tina Bevington3, Bethany Carlos4, Evangeline Cornelius5, Erik Svendsen6
1University of South Carolina, Columbia, South Carolina, USA
2University of Maryland, College Park, Maryland, USA
3GRACE Study Center, Graniteville, South Carolina, USA
4Medical University of South Carolina, Charleston, South Carolina, USA
5PASOs, Columbia, South Carolina, USA
6Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana, USA
Abstract
Photovoice is a qualitative method of inquiry whereby individuals can document their lived experiences, particularly individuals whose voices are not typically heard in regard to promoting social change and policy development. We used photovoice to elicit major themes regarding community members’ perceptions of the long-term impact on their quality of life as a deadly technological disaster hit a small, rural town in South Carolina. Overall, participants photographed more negative images than positive. Overarching themes included residential and business vacancies, economic decline, the need for clean-up and modernization, attention to wellness or rehabilitation, and concerns for safety. Emergency response agencies should consider the themes elicited from these community residents to help identify where to focus disaster response efforts both in the immediate aftermath and during the long-term recovery period of technological disasters, particularly in underserved, rural communities.

Reproductive Health [Accessed 9 January 2016]

Reproductive Health
http://www.reproductive-health-journal.com/content
[Accessed 9 January 2016]

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Research
Balancing workload, motivation and job satisfaction in Rwanda: assessing the effect of adding family planning service provision to community health worker duties
Dawn Chin-Quee, Cathy Mugeni, Denis Nkunda, Marie Uwizeye, Laurie Stockton, Jennifer Wesson Reproductive Health 2016, 13:2 (6 January 2016)

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Research
Mobile Technology for Improved Family Planning (MOTIF): the development of a mobile phone-based (mHealth) intervention to support post-abortion family planning (PAFP) in Cambodia
Chris Smith, Uk Vannak, Ly Sokhey, Thoai Ngo, Judy Gold, Caroline Free Reproductive Health 2016, 13:1 (5 January 2016)

Public Perception of Climate Change: The Importance of Knowledge and Cultural Worldviews

Risk Analysis
December 2015 Volume 35, Issue 12 Pages 2121–2228
http://onlinelibrary.wiley.com/doi/10.1111/risa.2015.35.issue-12/issuetoc

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Original Research Articles
Public Perception of Climate Change: The Importance of Knowledge and Cultural Worldviews (pages 2183–2201)
Jing Shi, Vivianne H. M. Visschers and Michael Siegrist
Article first published online: 29 MAY 2015 | DOI: 10.1111/risa.12406
Abstract
The importance of knowledge for lay people’s climate change concerns has been questioned in recent years, as it had been suggested that cultural values are stronger predictors of concern about climate change than knowledge. Studies that simultaneously measured knowledge related to climate change and cultural values have, however, been missing. We conducted a mail survey in the German-speaking part of Switzerland (N = 1,065). Results suggested that cultural worldviews and climate-related knowledge were significantly related with people’s concern about climate change. Also, cultural worldviews and climate-relevant knowledge appeared important for people’s willingness to change behaviors and to accept climate change policies. In addition, different types of knowledge were found to have different impacts on people’s concern about climate change, their willingness to change behaviors, and their acceptance of policies about climate change. Specifically, causal knowledge significantly increased concern about climate change and willingness to support climate-friendly policies. We therefore concluded that risk communication should focus on causal knowledge, provided this knowledge does not threaten cultural values.

Science – 8 January 2016

Science
8 January 2016 vol 351, issue 6269, pages 101-200
http://www.sciencemag.org/current.dtl

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Editorial
Biggest opportunity of our age
Sir David King
Sir David King is the United Kingdom Foreign Secretary’s Special Representative for Climate Change.
The importance of the agreement reached at the Paris climate Conference of Parties (COP21) last month cannot be overstated. It is a major step toward preventing some of the worst risks that climate change presents to the global economy and security. Now is the time to seize the opportunity that this moment represents. We must transform world economies away from fossil fuels toward a more sustainable low-carbon future.

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Policy Forum
Development and Environment
Balancing hydropower and biodiversity in the Amazon, Congo, and Mekong
K. O. Winemiller, P. B. McIntyre, L. Castello, E. Fluet-Chouinard, T. Giarrizzo, S. Nam, I. G. Baird, W. Darwall, N. K. Lujan, I. Harrison, M. L. J. Stiassny, R. A. M. Silvano, D. B. Fitzgerald, F. M. Pelicice, A. A. Agostinho, L. C. Gomes, J. S. Albert, E. Baran, M. Petrere Jr., C. Zarfl, M. Mulligan, J. P. Sullivan, C. C. Arantes, L. M. Sousa, A. A. Koning, D. J. Hoeinghaus, M. Sabaj, J. G. Lundberg, J. Armbruster, M. L. Thieme, P. Petry, J. Zuanon, G. Torrente Vilara, J. Snoeks,
C. Ou, W. Rainboth, C. S. Pavanelli, A. Akama, A. van Soesbergen, and L. Sáenz
Science 8 January 2016: 128-129.
The world’s most biodiverse river basins—the Amazon, Congo, and Mekong—are experiencing an unprecedented boom in construction of hydropower dams. These projects address important energy needs, but advocates often overestimate economic benefits and underestimate far-reaching effects on biodiversity and critically important fisheries. Powerful new analytical tools and high-resolution environmental data can clarify trade-offs between engineering and environmental goals and can enable governments and funding institutions to compare alternative sites for dam building. Current site-specific assessment protocols largely ignore cumulative impacts on hydrology and ecosystem services as ever more dams are constructed within a watershed (1). To achieve true sustainability, assessments of new projects must go beyond local impacts by accounting for synergies with existing dams, as well as land cover changes and likely climatic shifts (2, 3). We call for more sophisticated and holistic hydropower planning, including validation of technologies intended to mitigate environmental impacts. Should anything less be required when tampering with the world’s great river ecosystems?

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The Anthropocene is functionally and stratigraphically distinct from the Holocene
Review
Colin N. Waters, et al

Social Science & Medicine (January 2016)

Social Science & Medicine
Volume 148, Pages 1-172 (January 2016)
http://www.sciencedirect.com/science/journal/02779536/148

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Commentaries
Taking the bull by the horns: Ethical considerations in the design and implementation of an Ebola virus therapy trial
Pages 163-170
Francis Kombe, Morenike O. Folayan, Jennyfer Ambe, Adaora Igonoh, Akin Abayomi, GET members
Abstract
Ebola virus is categorized as one of the most dangerous pathogens in the world. Although there is no known cure for Ebola virus, there is some evidence that the severity of the disease can be curtailed using plasma from survivors. Although there is a general consensus on the importance of research, methodological and ethical challenges for conducting research in an emergency situation have been identified. Performing clinical trials is important, especially for health conditions that are of public health significance (including rare epidemics) to develop new therapies as well as to test the efficacy and effectiveness of new interventions. However, routine clinical trial procedures can be difficult to apply in emergency public health crises hence require a consideration of alternative approaches on how therapies in these situations are tested and brought to the market. This paper examines some of the ethical issues that arise when conducting clinical trials during a highly dangerous pathogen outbreak, with a special focus on the Ebola virus outbreak in West Africa. The issues presented here come from a review of a protocol that was submitted to the Global Emerging Pathogens Treatment Consortium (GET). In reviewing the proposal, which was about conducting a clinical trial to evaluate the safety and efficacy of using convalescent plasma in the management of Ebola virus disease, the authors deliberated on various issues, which were documented as minutes and later used as a basis for this paper. The experiences and reflections shared by the authors, who came from different regions and disciplines across Africa, present wide-ranging perspectives on the conduct of clinical trials during a dangerous disease outbreak in a resource-poor setting.

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“I was on the way to the hospital but delivered in the bush”: Maternal health in Ghana’s Upper West Region in the context of a traditional birth attendants’ ban
Original Research Article
Pages 8-17
Andrea Rishworth, Jenna Dixon, Isaac Luginaah, Paul Mkandawire, Caesar Tampah Prince
Abstract
This study examines perceptions and experiences of mothers, traditional birth attendants (TBA), and skilled birth attendants (SBA) regarding Ghana’s recent policy that forbids TBAs from undertaking deliveries and restricts their role to referrals. In the larger context of Ghana’s highly underdeveloped and geographically uneven health care system, this study draws on the political ecology of health framework to explore the ways global safe motherhood policy discourses intersect with local socio-cultural and political environments of Ghana’s Upper West Region (UWR). This study reveals that futile improvements in maternal health and the continued reliance on TBAs illustrate the government’s inability to understand local realities marked by poor access to SBAs or modern health care services. Using focus group discussions (FGDs) (n = 10) and in-depth interviews (IDIs) (n = 48) conducted in Ghana’s UWR, the findings suggest that mothers generally perceive TBAs as better placed to conduct deliveries in rural isolated communities, where in most cases no SBAs are present or easily accessible. The results indicate that by adhering to the World Health Organization’s guidelines, the local government may be imposing detrimental, unintended consequences on maternal and child health in remote rural locations. In addition, the findings suggest that the new policy has resulted in considerable confusion among TBAs, many of whom remain oblivious or have not been officially notified about the new policy. Furthermore, participant accounts suggest that the new policy is seen as contributing to worsening relations and tensions between TBAs and SBAs, a situation that undermines the delivery of maternal health services in the region. The study concludes by suggesting relevant policy recommendations.

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Quality of qualitative research in the health sciences: Analysis of the common criteria present in 58 assessment guidelines by expert users
Original Research Article
Pages 142-151
M. Santiago-Delefosse, A. Gavin, C. Bruchez, P. Roux, S.L. Stephen
Abstract
The number of qualitative research methods has grown substantially over the last thirty years, both in social sciences and, more recently, in health sciences. This growth came with questions on the quality criteria needed to evaluate this work, and numerous guidelines were published. These guidelines, however, include many discrepancies, both in terms of vocabulary and structure. Many expert evaluators also decry the absence of consensual and reliable evaluation tools. To address this gap, we present the results of an evaluation of 58 existing guidelines in four major health science fields (medicine and epidemiology; nursing and health education; social sciences and public health; psychology/psychiatry, research methods and organization) by expert (n = 16) and peer (n = 40) users (e.g., article reviewers, experts allocating funds, editors). This research was conducted between 2011 and 2014 at the University of Lausanne in Switzerland. Experts met during three workshops spread over this period. A series of 12 consensual essential criteria, along with definitions, stemmed from a question in a semi-qualitative evaluation questionnaire that we developed. Although there is consensus on the name of the criteria, we highlight limitations on the ability to compare specific definitions of criteria across health science fields. We conclude that each criterion must be explained to come to broader consensus and identify definitions that are easily operational and consensual to all fields examined.

Quality of antenatal and childbirth care in rural health facilities in Burkina Faso, Ghana and Tanzania: an intervention study

Tropical Medicine & International Health
January 2016 Volume 21, Issue 1 Pages 1–156
http://onlinelibrary.wiley.com/doi/10.1111/tmi.2016.21.issue-1/issuetoc

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Original Research Papers
Quality of antenatal and childbirth care in rural health facilities in Burkina Faso, Ghana and Tanzania: an intervention study (pages 70–83)
Els Duysburgh, Marleen Temmerman, Maurice Yé, Afua Williams, Siriel Massawe, John Williams, Rose Mpembeni, Svetla Loukanova, Walter E. Haefeli and Antje Blank
Article first published online: 18 NOV 2015 | DOI: 10.1111/tmi.12627

The Sentinel

Human Rights Action :: Humanitarian Response :: Health ::
Holistic Development :: Sustainable Resilience
__________________________________________________
Two weeks ending 2 January 2016

This weekly digest is intended to aggregate and distill key content from a broad spectrum of practice domains and organization types including key agencies/IGOs, NGOs, governments, academic and research institutions, consortia and collaborations, foundations, and commercial organizations. We also monitor a spectrum of peer-reviewed journals and general media channels. The Sentinel’s geographic scope is global/regional but selected country-level content is included. We recognize that this spectrum/scope yields an indicative and not an exhaustive product. Comments and suggestions should be directed to:

David R. Curry
Editor &
Founding Managing Director
GE2P2 – Center for Governance, Evidence, Ethics, Policy, Practice
david.r.curry@ge2p2center.net

pdf version: The Sentinel_ week ending 2 January 2016

blog edition: comprised of the 35+ entries  posted below on 3-10 January 2016

Security Council Renews Authorization for Passage of Humanitarian Aid into Syria

Unanimously Adopting Resolution 2258 (2015), Security Council Renews Authorization for Passage of Humanitarian Aid into Syria
22 December 2015
SC/12179
In efforts to ensure that humanitarian assistance reached people in need throughout Syria by the most direct routes, the Security Council today unanimously adopted resolution 2258 (2015), thus renewing for a period of 12 months two decisions taken in its resolution 2165 (2014) that authorized passage of aid into that country.

According to those stipulations, which were renewed until 10 January 2017, the 15-nation body decided that the United Nations humanitarian agencies and their implementing partners were authorized to use routes across conflict lines in Syria and the border crossings of Bab al-Salam, Bab al-Hawa, Al Yarubiyah and Al-Ramtha, in addition to those already in use, with notification to the Syrian authorities. (See Press Release SC/11708 of 17 December 2014.)

It further decided to establish a monitoring mechanism, under the authority of the United Nations Secretary-General, to monitor, with the consent of the relevant neighbouring countries of Syria, the loading of all humanitarian relief consignments of the United Nations humanitarian agencies and their implementing partners at the relevant United Nations facilities, also with notification to the Syrian authorities.

By the terms of the text, the Council — expressing grave concern at the continuing and growing impediments to the delivery of humanitarian assistance across conflict lines — demanded that all parties, in particular the Syrian authorities, immediately comply with their obligations under international law, including international humanitarian law and international human rights law, as well as with all relevant Security Council resolutions, and recalled that some of the violations and abuses committed in Syria might amount to war crimes and crimes against humanity.

The Council further requested the Syrian authorities to expeditiously respond to all requests for cross-line deliveries submitted by the United Nations and their implementing partners, and to give such requests positive consideration.
Full Resolution text integrated into press release

Ethical principles for protecting health workers during armed conflict and other emergencies

Ethical principles for protecting health workers during armed conflict and other emergencies
WHO welcomes the publication “Ethical Principles of Health Care in Times of Armed Conflict and Other Emergencies” and encourages all health practitioners to apply these principles in all contexts, with particular attention to their importance in complex emergency settings where they can serve to highlight the impartiality of health care workers and help to protect health care from violence. This issue is of extreme importance to WHO and to the entire health community worldwide. This document provides additional strength to the first progress report to the SG and UNGA from WHO’s Director General in relation to UNGA Res/69/132, and to the draft Global Strategy on Human Resources for Health that will be presented to WHO’s Executive Board in January 2016. WHO takes every opportunity to repeat the importance of upholding the ethical principles of health care.

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ETHICAL PRINCIPLES OF HEALTH CARE IN TIMES OF ARMED CONFLICT AND OTHER EMERGENCIES
Read the full document on principles of Health Care pdf, 1.67Mb
Within the framework of the Health Care in Danger project, the World Medical Association (WMA), the International Committee of Military Medicine (ICMM), the International Council of Nurses (ICN) and the International Pharmaceutical Federation (FIP) were consulted by the ICRC with the aim of these organizations agreeing on a common denominator of ethical principles of health care applicable in times of armed conflict and other emergencies. The following document, which is the result of these consultations, is without prejudice to existing policy documents adopted by these organizations.

Civilian and military health-care organizations share the common goal of improving the safety of their personnel and other health assets and the delivery of impartial and efficient health care in armed conflicts and other emergencies,

Referring to the principles of humanity, whereby human suffering shall be prevented and alleviated wherever it may be found and impartiality, whereby health care shall be provided with no discrimination;

Bearing in mind the standards of international humanitarian law, in particular the 1949 Geneva Conventions and their 1977 Additional Protocols, and of international human rights law, specifically the Universal Declaration of Human Rights (1948) and the International Covenants on Civil and Political Rights and on Economic, Social and Cultural Rights (1966);

Considering the principles of professional ethics adopted by health-care professional associations, including the WMA Regulations in Times of Armed Conflict and Other Situations of Violence;

Endorse the following ethical principles of health care:

GENERAL PRINCIPLES
1. Ethical principles of health care do not change in times of armed conflict and other emergencies and are the same as the ethical principles of health care in times of peace.
2. Health-care personnel shall at all times act in accordance with relevant international and national law, ethical principles of health care and their conscience. In providing the best available care, they shall take into consideration the equitable use of resources.
3. The primary task of health-care personnel is to preserve human physical and mental health and to alleviate suffering. They shall provide the necessary care with humanity, while respecting the dignity of the person concerned, with no discrimination of any kind, whether in times of peace or of armed conflict or other emergencies.
4. Privileges and facilities afforded to health-care personnel in times of armed conflict and other emergencies are never to be used for purposes other than for health-care needs.
5. No matter what arguments may be put forward, health-care personnel never accept acts of torture or any other form of cruel, inhuman or degrading treatment under any circumstances, including armed conflict or other emergencies. They must never be present at and may never take part in such acts.

RELATIONS WITH PATIENTS
6. Health-care personnel act in the best interest of their patients and whenever possible with their explicit consent. If, in performing their professional duties, they have conflicting loyalties, their primary obligation, in terms of their ethical principles, is to their patients.
7. In armed conflict or other emergencies, health-care personnel are required to render immediate attention and requisite care to the best of their ability. No distinction is made between patients, except in respect of decisions based upon clinical need and available resources.
8. Health-care personnel respect patients’ right to confidentiality. It is ethical for health-care personnel to disclose confidential information only with the patient’s consent or when there is a real and imminent threat of harm to the patient or to others
9. Health-care personnel make their best efforts to ensure respect for the privacy of the wounded, sick and deceased, including avoiding the use of health care for the wounded and sick, whether civilian or military, for publicity or political purposes.

PROTECTION OF HEALTH-CARE PERSONNEL
10. Health-care personnel, as well as health-care facilities and medical transports, whether military or civilian, must be respected by all. They are protected while performing their duties and the safest possible working environment shall be provided to them.
11. Safe access by health-care personnel to patients, health-care facilities and equipment shall not be unduly impeded, nor shall patients’ access to health-care facilities and health-care personnel be unduly impeded.
12. In fulfilling their duties and where they have the legal right, health-care personnel are identified by internationally recognized symbols such as the Red Cross, Red Crescent or Red Crystal as a visible manifestation of their protection under applicable international law.
13. Health-care personnel shall never be punished for executing their duties in compliance with legal and ethical norms.

FINAL
14. By endorsing these ethical principles of health care, the signatory organizations commit themselves to work for the promotion and implementation thereof wherever possible, including by appropriate dissemination amongst their members.

Call for Participation -New Research: “Stay and Deliver: Good practice for humanitarians in complex security environments”

Call for Participation -New Research: “Stay and Deliver: Good practice for humanitarians in complex security environments”
22 Dec 2015
OCHA
In 2011, the Organization for the Coordination of Humanitarian Affairs (OCHA) published the landmark study “To Stay and Deliver: Good practice for humanitarians in complex security environments”.

The study identified and documented humanitarian organizations’ strategies and practices to maintain effective operations in insecure environments. It provided guidance on critical areas such as risk management, responsible partnerships, adherence to humanitarian principles, acceptance approaches and communication and negotiations with relevant actors.

Nearly five years on, OCHA, the Norwegian Refugee Council (NRC) and the Jindal School of International Affairs in India have decided to launch a follow-up study, to be conducted again by Humanitarian Outcomes. This review aims to assess the extent of implementation of the 2011 study’s recommendations, to examine changes that have occurred since its publication, and to evaluate how improvements in “staying” over the past years have led to improvements in our ability to “deliver” in volatile environments.

To support the research, OCHA has launched an online survey aimed at members of Humanitarian Country Teams, personnel from UN agencies, international organizations, and international, national and local non-governmental organizations (NGOs).

We would like to invite humanitarian partners working in the Middle East and North Africa to contribute to the study by completing the survey. In particular, we encourage NGO representatives and national humanitarian workers to participate.

The survey is available in English, French and Arabic, and all responses are anonymous.
:: English Survey: https://www.surveymonkey.com/r/BG7LJVH
:: French Survey: https://www.surveymonkey.com/r/XNFBK23
:: Arabic Survey: https://www.surveymonkey.com/r/DB7VJZ5

Ebola Situation Report – 30 December 2015

Ebola Situation Report – 30 December 2015
SUMMARY
:: No confirmed cases of Ebola virus disease (EVD) were reported in the week to 27 December. On 29 December, WHO declared that human-to-human transmission of Ebola virus has ended in Guinea, after the completion of 42 days with zero cases since the last person confirmed to have EVD received a second consecutive negative blood test for Ebola virus RNA. Guinea has now entered a 90-day period of heightened surveillance.

:: The 8th meeting of the Emergency Committee convened by the WHO Director-General under the International Health Regulations (2005) regarding the EVD outbreak in West Africa took place by teleconference on 15 December 2015. Based on the advice of the Committee, the Director-General declared that the 2014–15 Ebola outbreak continues to constitute a Public Health Emergency of International Concern….
Editor’s Note:
Two important vaccine milestones were reached over the last few weeks with regulatory approval of a dengue vaccine – Dengvaxia [Sanofi Pasteur] – by Brazil, representing the third successful licensure following approval by Mexico and the Philippines earlier this month. Separately, an inactivated oral cholera vaccine – Euvichol [Eubiologics, Republic of Korea] – received WHO pre-qualification on 23 December 2015.

United Nations – Secretary General, Security Council, General Assembly [to 2 January 2016]

United Nations – Secretary General, Security Council, General Assembly  [to 2 January 2016]
http://www.un.org/en/unpress/
Selected Press Releases/Meetings Coverage

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31 December 2015
SC/12188-AFR/3296-L/3249
Security Council Press Statement on Closure of International Criminal Tribunal for Rwanda
The members of the Security Council mark the closure on 31 December 2015 of the International Criminal Tribunal for Rwanda (ICTR) established by its resolution 955 (1994) of 8 November 1994.

The members of the Security Council acknowledge the substantial contribution of the ICTR to the process of national reconciliation and the restoration of peace and security, and to the fight against impunity and the development of international criminal justice, especially in relation to the crime of genocide.

The members of the Security Council emphasize that the establishment of the International Residual Mechanism for Criminal Tribunals pursuant to resolution 1966 (2010) was essential to ensure that the closure of the ICTR does not leave the door open to impunity for the remaining fugitives.

The members of the Security Council call upon all States to cooperate with the International Residual Mechanism for Criminal Tribunals and the Government of Rwanda in the arrest and prosecution of the eight remaining ICTR-indicted fugitives, and further call upon States to investigate, arrest, prosecute or extradite, in accordance with applicable international obligations, all other fugitives accused of genocide residing on their territories.

The members of the Security Council reaffirm their strong commitment to justice and the fight against impunity.

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23 December 2015
SC/12184
Security Council Press Statement on Situation in Yemen
[Excerpt]
The members of the Security Council expressed deep concern about the dire humanitarian situation in Yemen, which continues to worsen. The members of the Security Council recognized that over 80 per cent of the population — 21 million people — require some form of humanitarian assistance and emphasized that the civilian impact of the conflict has been devastating, particularly for children and the 2.5 million internally displaced persons. The members of the Security Council expressed particular concern at the food security situation, with over 7 million people suffering severe food insecurity and a doubling in the number of children under five who are acutely malnourished. They recognized that functioning markets inside Yemen are essential to address the situation, as humanitarian assistance alone cannot overcome a humanitarian crisis of this scale.

The members of the Security Council noted that the humanitarian appeal for 2015 has been 52 per cent funded and urged the international community to contribute to the humanitarian appeal for 2016.

The members of the Security Council urged all parties to fulfil their commitments to facilitate the delivery of commercial goods, humanitarian assistance and fuel for civilian purposes to all parts of Yemen, as well as urgent measures to further ensure rapid, safe and unhindered humanitarian access. They also stressed the urgent need for commercially shipped food, medicine, fuel and other vital supplies to continue to enter Yemen through all of Yemen’s ports without delay as a humanitarian imperative because of the heavy dependence of Yemen and its people on imported food and fuel. In that regard, they urged all parties to work with the new United Nations Verification and Inspection Mechanism. The members of the Security Council called upon all sides to comply with international humanitarian law, including to take all feasible precautions to minimize harm to civilians and civilian objects, to end the recruitment and use of children in violation of applicable international law, and to urgently work with the United Nations and humanitarian aid organizations to bring assistance to those in need throughout the country…

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22 December 2015
SC/12180
Amid Worsening Humanitarian Situation, Latest Peace Talks Provide ‘Solid’ Basis for Renewed, Stronger Ceasefire in Yemen, Security Council Told
Despite deep remaining divisions, the latest round of peace negotiations between parties to the conflict in Yemen had provided a solid foundation for resumed talks in January and a renewed, strengthened cessation of hostilities, the Secretary-General’s Special Envoy told the Security Council in today.

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22 December 2015
SC/12179
Unanimously Adopting Resolution 2258 (2015), Security Council Renews Authorization for Passage of Humanitarian Aid into Syria
In efforts to ensure that humanitarian assistance reached people in need throughout Syria by the most direct routes, the Security Council today unanimously adopted resolution 2258 (2015), thus renewing for a period of 12 months two decisions taken in its resolution 2165 (2014) that authorized passage of aid into that country.

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21 December 2015
SC/12176
Syria Sinking Deeper into Violence, Top Officials Warn Security Council, Calling for Increased Humanitarian Aid Funding, Access to War-Torn Country
With 2015 drawing to a close, Syria continued to sink “deeper and deeper into violence and brutality”, top United Nations officials told the Security Council today, urging parties to the conflict to allow humanitarian aid to enter and the international community to fund a $3.2 billion appeal for 2016.

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21 December 2015
DC/3597
Joint Investigative Mechanism Panel Visits Syria
NEW YORK, 21 December 2015 (Joint Investigative Mechanism) — The three-member leadership panel of the Organization for the Prohibition of Chemical Weapons-United Nations Joint Investigative Mechanism, led by its Head, Virginia Gamba, was in Damascus on 17 December for meetings with the Government of the Syrian Arab Republic

UN OHCHR Office of the United Nations High Commissioner for Human Rights [to 2 January 2016]

UN OHCHR Office of the United Nations High Commissioner for Human Rights [to 2 January 2016]
http://www.ohchr.org/EN/NewsEvents/Pages/media.aspx?IsMediaPage=true

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UN expert calls for fundamental rethink of global trading system
Press Releases
GENEVA (22 December 2015) – The Independent Expert on the promotion of a democratic and equitable international order, Alfred de Zayas, deplores that developed countries evaded their Doha development commitments at the World Trade Organization’s 10th ministerial conference, held in Nairobi from 15 to 19 December 2015. Although a majority of States meeting in Nairobi wanted to have a clear reaffirmation of the Doha Framework, the opposition of some developed countries prevented the adoption of a consensus on this important point. Instead, he says, developed countries tried to pressure the developing world into agreements that undermine the promotion of the right to development and many provisions of human rights treaties…

UN OCHA [to 2 January 2016]

UN OCHA [to 2 January 2016]
http://www.unocha.org/media-resources/press-releases

31 Dec 2015
World: CERF: Celebrating 10 years of success and envisioning the future
Source: UN Office for the Coordination of Humanitarian Affairs Country: World Background CERF’s annual High-Level Pledging Conference, which also marked the kick-off of its 10-year anniversary campaign, took place on 17 December in New York. Member States and Observers, UN officials, and representatives of the humanitarian community attended the event during which they took stock of the Funds’ achievements, discussed its future and pledged their renewed support for the Fund for 2016.

23 Dec 2015
World: El Niño impact in Eastern Africa continues to require highest level of investment in preparedness and response
Source: Intergovernmental Authority on Development, UN Office for the Coordination of Humanitarian Affairs Country: Eritrea, Ethiopia, Kenya, Somalia, South Sudan, Uganda, World (Nairobi, 23 December 2015): The El Nino global climatic event has since May been the major driver of new humanitarian needs in the Horn of Africa region. Enhanced rainfall continues in parts of Ethiopia, Kenya, Somalia and Uganda, and persistent drought has been reported in parts of Eritrea, Ethiopia, South Sudan,…

22 Dec 2015
Yemen: Assistant Secretary- General for Humanitarian Affairs and Deputy Emergency Relief Coordinator, Ms. Kyung-Wha Kang – Statement to the Security Council on the Humanitarian Situation in Yemen, New York, 22 December 2015
Source: UN Office for the Coordination of Humanitarian Affairs Country: Yemen Madam President, Distinguished members of the Security Council, I thank you for this opportunity to brief the Council on the latest developments in Yemen on behalf of the Emergency Relief Coordinator, Mr. Stephen O’Brien. The conditions today for the people inside Yemen are appalling. Around 7.6 million people now require emergency food assistance to survive. At least two million people are malnourished,…

22 Dec 2015
World: To Stay and Deliver: Good practice for humanitarians in complex security environments [EN/AR]
Source: UN Office for the Coordination of Humanitarian Affairs Country: World Dear Partners, In 2011, the Organization for the Coordination of Humanitarian Affairs (OCHA) published the landmark study “To Stay and Deliver: Good practice for humanitarians in complex security environments”. The study identified and documented humanitarian organizations’ strategies and practices to maintain effective operations in insecure environments.

21 Dec 2015
Syrian Arab Republic: Assistant Secretary-General for Humanitarian Affairs and Deputy Emergency Relief Coordinator Kyung-Wha Kang: Security Council briefing on Syria

21 Dec 2015
South Sudan: CERF: Innovation and impact: Building on the past and moving to the future – Statement by the Humanitarian Coordinator for South Sudan, Mr. Eugene Owusu 17 december 2015