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Guidance on ethical considerations in planning and reviewing research studies on sexual and reproductive health in adolescents.
Geneva, Switzerland, World Health Organization, 2018. 52 p.This document is intended to address commonly occurring situations and challenges that one faces in carrying out research with adolescents (people aged 10–19 years), the majority of whom are deemed not to have reached the recognized age of majority in their respective settings. To this end, adolescents aged 18 and 19 years are classified as adults in many settings and have the legal capacity to make autonomous decisions regarding their participation in research. In this document, the term “children” refers to people below the age of 18 years, and the term “minor adolescents” refers specifically to people aged 10-18 years.
New York, New York, UNFPA, 2016 Apr. 78 p.This training manual enables a journalist or other trainer to conduct a two- or three-day training workshop. The first part of the curriculum begins with training and group discussion about basic concepts and principles that will help participants develop a clear understanding of the meaning of the term ‘gender-based violence’. The programme continues with detailed information about the consequences of gender-based violence and the survivor support services needed. The trainer will also cover the causes and contributing factors, shining a light on prevention and how best to develop effective prevention strategies. The second part of the curriculum focuses on the ethical principles of reporting on gender-based violence, including what to do and what to avoid. It also includes tips for the journalists to consider during interviews and when to report on gender-based violence related issues.
Ethical and safety recommendations for intervention research on violence against women. Building on lessons from the WHO publication, "Putting women first: ethical and safety recommendations for research on domestic violence against women".
Geneva, Switzerland, WHO, 2016. 43 p.As the evidence base on the magnitude, context and consequences of violence against women (VAW) has grown, research efforts and attention have begun to focus on decreasing the knowledge gap on effective responses through intervention research. Demonstrating this focus, in November 2012 the WHO Department of Reproductive Health and Research convened a group of experts to discuss health sector-based research to respond to violence against women. This global network of researchers, scientists and practitioners was brought together to enhance existing research efforts and to advocate for greater funding for research on interventions to address VAW and policies and programmes related to it. With the increased interest in and attention of the global community of researchers, practitioners and policy-makers regarding rigorous intervention research for preventing and responding to VAW, a discussion of the ethical considerations specific to this type of research is warranted. These recommendations have been developed to help answer questions specific to conducting research on health-based interventions to prevent and respond to VAW. Research on strategies that use health or health care as an entry point (regardless of the implementation setting, such as a clinic or community) is the focus. However, the discussion may be relevant to research on other kinds of VAW interventions.
Geneva, Switzerland, WHO, 2017. 56 p.The WHO Guidelines on Ethical Issues in Public Health Surveillance is the first international framework of its kind, it fills an important gap. The goal of the guideline development project was to help policymakers and practitioners navigate the ethical issues presented by public health surveillance. This document outlines 17 ethical guidelines that can assist everyone involved in public health surveillance, including officials in government agencies, health workers, NGOs and the private sector. Surveillance, when conducted ethically, is the foundation for programs to promote human well-being at the population level. It can contribute to reducing inequalities: pockets of suffering that are unfair, unjust and preventable cannot be addressed if they are not first made visible. But surveillance is not without risks for participants and sometimes poses ethical dilemmas. Issues about privacy, autonomy, equity, and the common good need to be considered and balanced, and knowing how to do so can be challenging in practice.
Interpretation of World Health Organization growth charts for assessing infant malnutrition: a randomised controlled trial.
Journal of Paediatrics and Child Health. 2014 Jan; 50(1):32-9.AIMS: The study aims to assess the effects of switching from National Center for Health Statistics (NCHS) growth references to World Health Organization (WHO) growth standards on health-care workers' decisions about malnutrition in infants aged <6 months. METHODS: We conducted a single blind randomised crossover trial involving 78 health-care workers (doctors, clinical officers, health service assistants) in Southern Malawi. Participants were offered hypothetical clinical scenarios with the same infant plotted on NCHS-based weight-for-age charts and again on WHO-based charts. Additional scenarios compared growth charts with a single final weight against charts with the same final weight plus a preceding growth trend. Reported (i) level of concern, (ii) referral suggestions and (iii) feeding advice were elicited with a questionnaire. RESULTS: Even after adjusting for health-care worker type and experience, using WHO rather than NCHS charts increased: (i) concern: aOR 4.4 (95% CI 2.4-8.1); (ii) odds of referral: aOR 5.1 (95% CI 2.4-10.8); and (iii) odds of feeding advice which would interrupt exclusive breastfeeding (aOR 2.4, 95% CI 1.2-4.9). A preceding steady growth trend line did not affect concern, referral or feeding advice. CONCLUSIONS: Health-care workers take insufficient account of linear growth trend, clinical and feeding status when interpreting a low weight-for-age plot. Because more infants <6 months fall below low centile lines on WHO growth charts, their use may increase inappropriate referrals and risks undermining already low rates of exclusive breastfeeding. To avoid their being misinterpreted in this way, WHO charts need accompanying guidelines and training materials that recognise and address this possible adverse effect. (c) 2013 The Authors. Journal of Paediatrics and Child Health (c) 2013 Paediatrics and Child Health Division (Royal Australasian College of Physicians).
Making fair choices on the path to universal health coverage. Final report of the WHO Consultative Group on Equity and Universal Health Coverage.
Geneva, Switzerland, WHO, 2014.  p.Universal health coverage (UHC) is at the center of current efforts to strengthen health systems and improve the level and distribution of health and health services. This document is the final report of the WHO Consultative Group on Equity and Universal Health Coverage. The report addresses the key issues of fairness and equity that arise on the path to UHC. As such, the report is relevant for every actor that affects that path and governments in particular, as they are in charge of overseeing and guiding the progress toward UHC.
The ghosts of user fees past: Exploring accountability for victims of a 30-year economic policy mistake.
Health and Human Rights. 2013 Jun; 15(1):175-185.Today, there is an unmistakable shift in international consensus away from private health financing, including the use of user fees toward public financing mechanisms (notably tax financing), to achieve universal health coverage (UHC). This is, however, much the same as an earlier consensus reached at the WHO's World Health Assembly at Alma-Ata in 1978. When considering the full circle journey from Alma-Ata in 1978 to today’s re-emerging support for UHC, it is worth taking stock and reflecting on how and why the international health community took this nearly three decade detour and how such misguided policies as user fees came to be so widely implemented during the intervening period. It is important for the international health community to ensure that steps are taken to compensate victims and determine accountability for those responsible. Victims of user fees suffered violations of their human right to health as enshrined in Universal Declaration, ICESCR, and a number of other human rights treaties, and yet still cannot avail themselves of remedies, such as those provided by international and regional human rights fora or the various United Nations treaty-monitoring bodies, and the responsible institutions and individuals have thus far remained unaccountable. This lack of accountability suggests a degree of impunity for international organizations and health economists dispensing with health policy advice. Such a lack of accountability should be noted with concern by the international health community as it increasingly relies on the advice and direction of health economists. Steps must be taken to provide survivors of user fees with compensation and hold those responsible to account.
London, United Kingdom, IPPF, 2011 Mar.  p.Confidentiality is crucial in the provision of youth friendly services. Privacy and confidentiality are distinct concepts. Confidentiality ensures privacy. The promotion of young people's sexual and reproductive health can only be achieved through providing confidential services that encourage them to seek preventative care and counselling.
Geneva, Switzerland, World Health Organization [WHO], 2012.  p. (Global Observatory for eHealth Series Vol. 5)Given that privacy of the doctor-patient relationship is at the heart of good health care, and that the electronic health record (EHR) is at the heart of good eHealth practice, the question arises: Is privacy legislation at the heart of the EHR? The second global survey on eHealth conducted by the Global Observatory for eHealth (GOe) set out to answer that question by investigating the extent to which the legal frameworks in the Member States of the World Health Organization (WHO) address the need to protect patient privacy in EHRs as health care systems move towards leveraging the power of EHRs to deliver safer, more efficient, and more accessible health care. (Excerpt)
[Ethic evaluation of sexual health programs on adolescence]. Valoracion Etica de los Programas de Salud Sexual en la Adolescencia.
Cuadernos De Bioetica. 2011 Jan-Apr; 22(74):77-91.In public health services, the interest in sexuality seems to turning from traditional topics such as potential treatments for male erectile dysfunction, psychosomatic disorders, the control of premature ejaculation and contraception. Instead, an increasingly prominent role is being given to prevention strategies carried out by means of campaigns or through sexual health programme sin schools. The different teaching strategies that underlie these programmes, which in many cases lack social consensus but are often promoted by international organizations such as WHO or UNESCO, reveal not only divergent ethical conceptions and worldviews on the meaning of sexuality, but also conflicting starting points, means and goals, focusing either on barrier-contraceptive methods or on sexual abstinence and personal responsibility. There is therefore a pressing need to understand the scientific evidence underlying each educational approach and the ethical postulates of each pedagogical proposal. This paper presents an outline of a six-point adolescent sexuality education program, which is respectful of individuals' ethical convictions. Given that few works on preventive medicine issues include an ethical evaluation of the steps followed in their development, this article also proposes a systematic evaluation of strategies for sexual health in the community that is developed through four steps verifying the following aspects: 1) the accuracy of information, 2) the level of evidence, 3) efficiency and 4) non-maleficence about the target population of each health program. The methodology used in these sexual health programs is another aspect that will verify their ethical consistence or, conversely, their absence of ethical values. We emphasize the duty of designers of programme for children not to carry then out against the will of their parents or tutors, and not conceal sensitive and relevant information.
Anthropology and Medicine. 2010 Aug; 17(2):201-214.This paper explores the issue of compliance by focusing on the control of tuberculosis. In the last ten years, patient compliance in tuberculosis control has discursively shifted from 'direct observation' of therapy to more patient-centred focus and support drawing on rights-based approaches in dealing with health care provision. At the same time, there has been an increased international concern with the rise of drug resistant forms of tuberculosis, and how to manage this. This paper looks at these issues and the tensions between them, by discussing the shift in discourses around the two and how they relate. Drawing on experience from work in Nepal, and its successful tuberculosis control programme, it looks at debates around this and how these two arenas have been addressed. The rise of increasingly drug resistant forms of tuberculosis has stimulated the development of new WHO and other guidelines addressing how to deal with this problem. The links between public health, ethics and legal mandate are presented, and the implications of this for controlling transmission of drug resistant disease, on the one hand, and the drive for greater patient support mechanisms on the other. Looking forwards to uncertain ethical and public health futures, these issues will be mediated by emergent WHO and international frameworks.
African Journal of Reproductive Health. 2008 Apr; 12(1):7-11.Add to my documents.
Indian Journal of Medical Ethics. 2007 Jul-Sep; 4(3):109-10; discussion 111-2.In the last several months, there have been discussions in the media, including in this journal (1), about issues related to how AIDS vaccine trials are conducted in India. The International AIDS Vaccine Initiative (IAVI) has partnered with the ministry of health and family welfare in India through the National AIDS Control Organisation (NACO) and the Indian Council of Medical Research (ICMR) since 2002 to implement the AIDS vaccine research and development programme. With our partners, we strongly support transparency and the highest ethical standards in our joint efforts to find and deliver an AIDS vaccine that the world so desperately needs. In fact, IAVI's intellectual property agreements are also used as a mechanism to avoid any delay in the introduction of vaccines to developing countries (delays of more than 10 years or so in the past) by insisting that any vaccine will be made simultaneously available in developed and developing countries (2). (excerpt)
Safe, voluntary, informed male circumcision and comprehensive HIV prevention programming. Guidance for decision-makers on human rights, ethical and legal considerations. Pre-publication.
Geneva, Switzerland, UNAIDS, 2008 Mar. 28 p. (UNAIDS/08.19E / JC1552E)Throughout the world, HIV prevalence is generally lower in populations that practise male circumcision than in populations where most men are uncircumcised. This has been observed over the years of the HIV epidemic and has now been confirmed through three randomized controlled trials concluded in 2005-2006. The trials showed that male circumcision reduces by 60% the transmission of HIV from women to circumcised men. The results have led to the conclusion that male circumcision is an effective risk-reduction measure for men, and should be used in addition to other known strategies for the prevention of heterosexually acquired HIV infection in men. (excerpt)
WHO ethical and safety recommendations for researching, documenting and monitoring sexual violence in emergencies.
Geneva, Switzerland, WHO, 2007.  p.Sexual violence in humanitarian emergencies, such as armed conflict and natural disasters, is a serious, even life-threatening, public health and human rights issue. Growing concern about the scale of the problem has led to increased efforts to learn more about the contexts in which this particular form of violence occurs, its prevalence, risk factors, its links to HIV infection, and also how best to prevent and respond to it. Recent years have thus seen an increase in the number of information gathering activities that deal with sexual violence in emergencies. These activities often involve interviewing women about their experiences of sexual violence. It is generally accepted that the prevalence of sexual violence is underreported almost everywhere in the world. This is an inevitable result of survivors' well-founded anxiety about the potentially harmful social, physical, psychological and/or legal consequences of disclosing their experience of sexual violence. In emergency situations, which arecharacterized by instability, insecurity, fear, dependence and loss of autonomy, as well as a breakdown of law and order, and widespread disruption of community and family support systems, victims of sexual violence may be even less likely to disclose incidents. (excerpt)
Lancet. 2007 Dec 1; 370(9602):1808-1809.Important questions about implementation of the new guidance by WHO and UNAIDS on provider-initiated HIV testing and counselling were raised by Daniel Tarantola and Sofia Gruskin. Their comments and those by other critics centre on individuals' rights to confidentiality, to refuse testing, and to not disclose their status if they fear negative consequences. We are concerned that a singular focus on the individual's rights of refusal overlooks the rights of the individual's sexual partners to protect themselves from HIV. Human rights and public health will be best served by an ethical framework which recognises that both persons in a sexual relationship or exchange have equal rights and responsibilities for their mutual pleasure and protection. Further, these individual rights are meaningless unless each partner respects the rights of the other. Protection of the human rights of both partners needs more commitment from health systems, and from societies, than simply ensuring informed consent and confidentiality. (excerpt)
Epidemiology and clinical features of pneumonia according to radiographic findings in Gambian children.
Tropical Medicine and International Health. 2007 Nov; 12(11):1377-1385.The objective was to assess the effect of vaccines against pneumonia in Gambian children. Data from a randomized, controlled trial of a 9-valent pneumococcal conjugate vaccine (PCV) were used. Radiographic findings, interpreted using WHO definitions, were classified as primary end point pneumonia, 'other infiltrates / abnormalities' pneumonia and pneumonia with no abnormality. We calculated the incidence of the different types of radiological pneumonia, and compared clinical and laboratory features between these groups. Among children who did not receive PCV, the incidence of pneumonia with no radiographic abnormality was about twice that of 'other infiltrates' pneumonia and three times that of primary endpoint pneumonia. Most respiratory symptoms, reduced feeding and vomiting occurred most frequently in children with primary endpoint pneumonia. These children were more likely to be malnourished, to have bronchial breath sounds or invasive bacterial diseases, and to die within 28 days of consultation than children in the other groups. Conversely, a history of convulsion, diarrhoea or fast breathing, malaria parasitaemia and isolation of salmonellae were commoner in children with pneumonia with no radiographic abnormality. Lower chest wall indrawing and rhonchi on auscultation were seen most frequently in children with 'other infiltrates / abnormalities' pneumonia. Primary endpoint pneumonia is strongly associated with bacterial aetiology and severe pneumonia. Since this category of pneumonia is significantly reduced after vaccination with Hib and pneumococcal vaccines, the risk-benefit of antimicrobial prescription for clinical pneumonia for children with increased respiratory rate may warrant re-examination once these vaccines are in widespread use. (author's)
Lancet. 2007 Sep 22; 370(9592):1007.This week, The Lancet publishes two papers of critical interest to child survival. Unfortunately, both have stirred concerns about misuse of data by UN agencies. Here, we review the allegations and try to draw lessons about the place of independent scientific inquiry in the arena of global health policymaking. Greg Fegan and colleagues report the success of an expanded insecticide-treated bednet programme in Kenya. The full paper reveals the strengths and limitations of the study, and provides important estimates of uncertainty. No such statistical caution was expressed in the WHO statement about these data, released on Aug 16. Indeed, WHO claimed that this finding "ends the debate about how to deliver long-lasting insecticidal nets". Yet communications between the Kenyan research team and WHO suggest an ill-considered rush by WHO against the advice of wiser scientific minds. (excerpt)
International Migration. 2006; 44(1):13-19.The Global Commission on International Migration (GCIM) was established as a means of moving beyond the political deadlock which had effectively paralyzed international discussion on migration for more than a decade. Its mandate was to provide the framework within which a "coherent, comprehensive and global" response to the issue of international migration could be developed. It would, it was hoped, succeed in identifying the issues in such a way that United Nations (UN) member states would agree to talk about a subject which had proved too sensitive for formal discussion. It is sometimes the case that texts which are drafted in general terms, and with the object of finding a consensus between conflicting interests, disappoint specialists. But the fact that the Commission's report is modest in some of its findings is not a reason to criticize it. Seen within its international context, the report succeeds as a general analysis of the issues, and in setting out broad -- and positive -- policy principles, and recommendations for action. (excerpt)
Exploring disparities between global HIV / AIDS funding and recent tsunami relief efforts: an ethical analysis.
Developing World Bioethics. 2007; 7(1):1-7.The objective was to contrast relief efforts for the 26 December 2004 tsunami with current global HIV/AIDS relief efforts and analyse possible reasons for the disparity. Methods: Literature review and ethical analysis. Just over 273,000 people died in the tsunami, resulting in relief efforts of more than US$10 bn, which is sufficient to achieve the United Nation's long-term recovery plan for South East Asia. In contrast, 14 times more people died from HIV/AIDS in 2004, with UNAIDS predicting a US$8 bn funding gap for HIV/AIDS in developing nations between now and 2007. This disparity raises two important ethical questions. First, what is it that motivates a more empathic response to the victims of the tsunami than to those affected by HIV/AIDS? Second, is there a morally relevant difference between the two tragedies that justifies the difference in the international response? The principle of justice requires that two cases similarly situated be treated similarly. For the difference in the international response to the tsunami and HIV/AIDS to be justified, the tragedies have to be shown to be dissimilar in some relevant respect. Are the tragedies of the tsunami disaster and the HIV/AIDS pandemic sufficiently different, in relevant respects, to justify the difference in scope of the response by the international community? We detected no morally relevant distinction between the tsunami and the HIV/AIDS pandemic that justifies the disparity. Therefore, we must conclude that the international response to HIV/ AIDS violates the fundamental principles of justice and fairness. (author's)
Lancet Infectious Diseases. 2006 Dec; 6(12):760.It has been 21 years since the test that detects antibodies to HIV was developed, and in the ensuing decades, many millions of people have learned that they are infected with the virus that causes AIDS. But many, many more have not. Today, with almost 40 million HIV-infected people worldwide, UNAIDS estimates that globally, fewer than one in every ten people with HIV in developing countries knows their status. Those who do not miss out on treatment services, which are slowly expanding in even the poorest countries. In November, WHO/UNAIDS issued a draft of operational recommendations for an approach to HIV testing that is designed to redress this yawning gap. The approach is known as provider-initiated testing and counselling (PITC), and it suggests that health-care workers in countries with generalised epidemics, such as those in sub-Saharan Africa should encourage their patients in wards and clinics of all stripes to be tested for HIV even if they do not present with symptoms. The current standard for delivering HIV tests is client-initiated, meaning that individuals who wish to learn their status ask for the test. (excerpt)
The dilemma of intellectual property rights for pharmaceuticals: the tension between ensuring access of the poor to medicines and committing to international agreements.
Developing World Bioethics. 2003 May; 3(1):27-48.In this paper, we provide an overview of how the outcomes of the Uruguay Round affected the application of pharmaceutical intellectual property rights globally. Second, we explain how specific pharmaceutical policy tools can help developing states mitigate the worst effects of the TRIPS Agreement. Third, we put forward solutions that could be implemented by the World Bank to help overcome the divide between creating private incentives for research and development of innovative medicines and ensuring access of the poor to medicine. Fourth, we evaluate these solutions on the basis of utilitarian considerations and urge that equitable pricing is morally preferable to the other solutions. (author's)
Oceans of need in the desert: ethical issues identified while researching humanitarian agency response in Afghanistan.
Developing World Bioethics. 2002 Dec; 2(2):109-130.This paper describes the interventions by the International Committee of the Red Cross to support a hospital in Afghanistan during the mid-1990s. We present elements of the interventions introduced in Ghazni, Afghanistan, and consider a number of ethical issues stimulated by this analysis. Ethical challenges arise wherever humanitarian interventions to deal with complex political emergencies are undertaken: among those related to the case study presented are questions concerning: a) whether humanitarian support runs the risk of propping up repressive and irresponsible governments; b) whether humanitarian relief activities can legitimately focus on a narrow range of interventions, or need to broaden to address the range of challenges facing the health system; and c) whether sustainability and quality of care should be routinely considered in such settings. The paper concludes by highlighting the value of case studies, suggesting mechanisms for extending transparency and accountability in humanitarian health interventions, and highlighting the need for contextualising humanitarian work if the interventions are to be successful. (author's)
Developing World Bioethics. 2001 Nov; 1(2):153-155.The UNAIDS' Ethical Considerations in HIV Preventive Vaccine Research guidance document transposes to the field of clinical research on the HIV/AIDS vaccine the most recent ethical thinking on research with human beings, particularly that prompted by the process of review of the Declaration of Helsinki. The document sets out to be an ethical and political guide on issues where moral mediation is difficult, such as the use of placebos, the inclusion of women of reproductive age and children in clinical trials, or even on the world distribution of the risks inherent in clinical research. In this brief commentary, I shall centre my remarks on Guidance Points 6, 7 and 8 of the document, as these bear most directly on the issues of social inequality and vulnerability. (excerpt)
Developing World Bioethics. 2001 Nov; 1(2):148-152.The UNAIDS guidance document Ethical Considerations in HIV Preventive Vaccine Research, as its title implies, contextualizes the ethical concerns in the arena of vaccine development in HIV. It seems that UNAIDS decided to develop a rather comprehensive list of guidance points independent of the revisions to the Helsinki declaration. Confronted with a particular problem of the developing world i.e., the rapid spread of HIV and the related issue of the need to carry out candidate vaccine trials in developing countries, this UNAIDS publication is very timely. Ethical guidelines in the UNAIDS document are thus expected to speed up the process of vaccine development by providing more specific guidance that could eventually assist the developing countries to contain the spread of AIDS following successful deployment of vaccination programs by sharing the burdens and benefits of such trials. This paper attempts to answer two questions: Do we need to do more about the vulnerabilities of research subjects in the developing world? Are these guidelines enough to enhance the ethical practice in vaccine trials? (excerpt)