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[eng] Research involving human subjects must be performed with standards that promote protection of their rights. Several codes were developed and all are unanimous in the following ethic principles: respect for persons, beneficence and justice. The fulfilment of these principles will assure that the dignity, rights, safety and well-being of the participants in a biomedical research are guaranteed.The need of a special protection to those with diminished autonomy is a common requirement to all codes. Pregnant women are defined as a vulnerable population because of the potential risk of harm of the foetus. Apart from the foetal risk, pregnant women in developing countries have additional potential for vulnerability, as in most of the cases they are economically or/and educationally disadvantaged individuals. Their generally low level of education may put them in a difficult situation to fully understand consent forms and the risk-benefit assessment provided by the researchers.In recent years, the evidence-based medicine has been an important international goal. Mechanisms to support the use of research-based evidence in developing health policy are being promoted. The research must be sensitive to the potential for vulnerability when designing evidence-based trials and they have to assure that the vulnerable population is being protected.With the intention to protect the vulnerable population, some groups such as pregnant women have being traditionally excluded from clinical trials. As a result of this exclusion, pregnant women are being exposed to medicines in situations where no evidence-based information is available on efficacy and safety. They are deprived of the benefits of treatment in order to be protected themselves and their offspring from an unknown risk. Although is very clear that protection of a vulnerable population, particularly the pregnant women, is mandatory in the design of any trial, the challenges of the implementation of this principle should be taken into account in order to not increase the gap between the introduction of a pharmaceutical product in the market and the availability of safety information for its use in pregnancy.In developing countries maternal mortality is an important public health problem. Most maternal deaths occur in the poorest countries particularly in Sub-Saharan Africa. In Mozambique the rate could be between 408-1000 per 100 000 live births according to the source of information. Several studies have addressed different causes of maternal mortality in Africa, eclampsia and malaria being part of the five most reported.There is strong evidence of the effectiveness of magnesium sulphate (MGSO4) in women with pre-eclampsia and eclampsia but the drug is not available in some countries. The example of MgSO4 has being used to describe failure in translating results of research into policy and/or practice.For malaria treatment few drugs were considered effective and safe for use during pregnancy including chloroquine, sulphadoxine-pyrimethamine and quinine. The information on safety comes from a long experience of use. The emergency of resistance of P. falciparum to these drugs is limiting its use in most of endemic areas. The artemisinin derivatives are being strongly recommended to be used in combination with other antimalarial drugs. Preclinical studies have consistently shown that artemisinin and its derivatives are embryolethal and teratogenic in animals. Current available information is not adequate to extrapolate the results in animals to humans.Limited data on the safety profile of antimalarial drugs during pregnancy is a challenge. Nowadays these drugs are used in pregnant women based on retrospective cumulative risk-benefit assessment. Mechanisms of prospectively monitoring the drugs use are required to protect pregnant women from the potential risk.The aim of this thesis is to describe the (un)availability of drugs and their reasons, as well as, the (un)availability of safety information on drugs needed to be used during pregnancy in Southern Africa, and to propose mechanisms to effectively monitor drug safety in pregnancy in developing countries.In order to achieve this objective four studies were performed. In the first study a qualitative case-study based on interviews and bibliographic review was performed in Mozambique and Zimbabwe. Factors affecting the (un)availability of MgSO4 were assessed. This study showed that research evidence regarding the effectiveness of MgSO4 for the treatment of eclampsia and pre-eclampsia, was widely known in the study countries. However, the registration, approval, acquisition and distribution of MgSO4, and hence its availability to clinicians, was affected by market and systems failures. With this study we concluded that the low cost of magnesium sulphate, as well as the mechanisms through which it is procured, means that market forces alone cannot be relied upon to ensure its availability. Governments and international organizations must be prepared to intervene to ensure the wide availability of low cost, effective drugs critical to improving public health in Africa.The second and the third studies shown that antimalarial drugs are being used in pregnant women even without information on its safety profile in this particular group. Robust safety monitoring systems are clearly needed in developing countries to accompany the deployment of new drugs, especially those with a potential teratogenic risk.The fourth study showed that spontaneous reporting system may be a tool for drug safety monitoring. This system could be used to increase health care providers' and patients' awareness of possible ADRs, and to develop a culture to report these reactions. Spontaneous reporting and pregnancy registries were presented as examples of mechanisms that could and should be in place.Recommendations on how these systems could be effectively implemented in resource constrained countries were also presented.All these studies suggest that the definition of vulnerability of pregnant women in developing countries should not be restricted to the potential risk of harm of the foetus (harm-based definition) or to the difficulty of fully understanding consent forms (consent-based definitions). Women are also vulnerable because of the high risk of dying from any cause related to or aggravated by the pregnancy. The implementation of these ethic principles need to take into account the urgent need to implement effective and safe drugs targeted to reduce the burden of maternal morbidity and mortality. ; [spa] La investigación relativa a los seres humanos debe realizarse dentro de unos estándares que promuevan la protección de sus derechos. Varios códigos han sido desarrollados y todos ellos coinciden unánimemente en los siguientes principios éticos: el respeto por las personas, la beneficencia y la justicia. La realización de estos principios debe asegurar la dignidad, los derechos, la seguridad y el bienestar de los participantes en una investigación biomédica sean preservados.La necesidad de una protección especial hacia aquellos seres cuya autonomía sea limitada es un requerimiento común para todos los códigos. Las mujeres embarazadas están definidas como un grupo de población vulnerable dado el riesgo potencial de causar daño al feto. Además del riesgo para el feto, las mujeres embarazadas en los países en desarrollo son potencialmente más vulnerables, y suelen contar con desventajas a nivel económico y/o educativo. Su nivel de educación, por lo general bajo, les pone en una situación difícil, dificultando la comprensión de los formularios de consentimiento y la evaluación del riesgo-beneficio que prestan los investigadores.En los últimos años, la medicina basada en la evidencia ha sido una meta muy importante a nivel internacional. Se están promoviendo mecanismos para respaldar el uso de la evidencia científica para la definición de política de desarrollo de la salud. La investigación debe ser sensible a la vulnerabilidad potencial cuando se diseñan ensayos basados en la evidencia. Además, se debe asegurar que la población vulnerable esté siendo protegida.Con la intención de proteger a esa población vulnerable, algunos grupos como los de mujeres embarazadas han sido tradicionalmente excluidos de los ensayos clínicos. Como resultado de esta exención, algunas mujeres embarazadas están siendo expuestas a medicamentos de los que no hay información basada en la evidencia en cuanto a su eficacia y seguridad. Este hecho las priva de los beneficios del tratamiento que debería protegerlas, a ellas y sus hijos, de un riesgo desconocido. Aunque está muy claro que proteger a una población vulnerable, particularmente a las mujeres embarazadas, es obligatorio en el diseño de un ensayo clínico, los retos de la implementación de este principio no deberían aumentar el vacío entre la introducción de un producto farmacéutico en el mercado y la disponibilidad de información sobre su seguridad para uso en el embarazo.En los países en vías de desarrollo la mortalidad materna es un problema importante de salud pública. La mayoría de muertes maternas ocurren en los países más pobres, particularmente en África Subsahariana. En Mozambique el índice puede ser entre 408-1000 por 100000 nacidos vivos, dependiendo de la fuente de información. Diferentes estudios han señalado diversas causas de mortalidad materna en África, encontrándose la eclampsia y la malaria entre las cinco primeras.Existe una gran evidencia de la eficacia del sulfato de magnesio (MGSO4) en mujeres con pre-eclampsia y eclampsia, sin embargo el fármaco no está disponible en algunos países. El ejemplo del sulfato de magnesio se ha utilizado para describir el fracaso en el traslado de los resultados de la investigación a la práctica y/o política.Para el tratamiento de la malaria, se consideró seguro el uso durante el embarazo de algunos fármacos incluyendo cloroquina, sulfadoxinapirimetamina y quinina. La información sobre seguridad responde a una gran experiencia de uso. El aumento de resistencia de P. falciparum a estos fármacos está limitando su uso en la mayoría de las zonas endémicas. Actualmente se está recomendando el uso de los derivados de la artemisinina en combinación con otros fármacos antimaláricos. Los estudios preclínicos han mostrado sistemáticamente que la artemisina y sus derivados son embrioletales y teratogénicos en animales. La información disponible hasta la fecha no es adecuada para extrapolar los resultados de los animales a los humanos.Los datos limitados en el perfil de seguridad de los fármacos antimaláricos durante el embarazo constituyen un desafío. Hoy en día, estos fármacos se usan en mujeres embarazadas basándose en una valoración retrospectiva acumulativa de riesgo-beneficio. Se necesitarían mecanismos de monitorización prospectiva del uso de los fármacos para proteger a las mujeres de su riesgo potencial.El objetivo de esta tesis es el de describir la disponibilidad o no disponibilidad de los fármacos y sus razones; describir la disponibilidad o no disponibilidad de información sobre la seguridad de estos fármacos que son de uso necesario en el sureste de África. Se pretende también proponer mecanismos efectivos para monitorizar la seguridad de los fármacos en el embarazo en los países en desarrollo.Para alcanzar estos objetivos se llevaron a cabo cuatro estudios. El primero consistía en un estudio cualitativo de casos basados en entrevistas y en una revisión bibliográfica en Mozambique y Zimbawe. Se evaluaron los factores que afectaban a la disponibilidad o no disponibilidad del sulfato de magnesio. El estudio mostró que la evidencia científica respecto a la eficacia del sulfato de magnesio para el tratamiento de la eclampsia y la pre-eclampsia fue ampliamente conocida en los países del estudio. Sin embargo, el registro, aprobación, adquisición y distribución del sulfato de magnesio y como consecuencia, su disponibilidad para los médicos se vio afectada por fallos de mercado y de sistema. Este estudio concluye que el bajo coste del sulfato de magnesio, así como el mecanismo a través del cual se obtiene, significa que las fuerzas del mercado por si solas no pueden asegurar su disponibilidad. Los gobiernos y las organizaciones internacionales deben estar preparados para intervenir y para asegurar una amplia disponibilidad de fármacos efectivos de bajo coste, críticos para mejorar la salud pública en África.El segundo y tercer estudio mostraron que los fármacos antimaláricos se están usando en mujeres embarazadas sin contar con información sobre su perfil de seguridad en este grupo particular. Se necesita claramente una monitorización fuerte y segura en los países en vías de desarrollo para acompañar el despliegue de los nuevos fármacos, especialmente aquellos que conllevan un potencial riesgo teratogénico.El cuarto estudio mostró que el sistema de notificación espontánea puede ser una herramienta para la monitorización de la seguridad de los fármacos. Este sistema se podrá usar para incrementar la consciencia en proveedores de salud y en enfermos sobre las posibles reacciones adversas de fármacos. Ello permitirá desarrollar una cultura de notificación de estas reacciones. La notificación espontánea y los registros de embarazo se presentaron como ejemplos de mecanismos que podrían y deberían ser implementados. Las recomendaciones de cómo estos sistemas podrían ser implementados de forma efectiva en países con recursos limitados también fueron presentadas.Todos estos estudios sugieren que la definición de vulnerabilidad de las mujeres embarazas en los países en desarrollo no se puede restringir a causa del riesgo potencial de daño al feto, o debido a la dificultad de entender por completo los formularios de consentimiento. También son vulnerables por el riesgo elevado de morir por alguna causa relacionada o agravada por el embarazo. La implementación de estos principios éticos necesita tener en cuenta la necesidad de implementar fármacos diana efectivos y seguros para reducir la mortalidad y morbilidad materna.

Participants' understanding of key elements of a research protocol is essential to their ethical enrollment in the study. Ongoing participation should be based on continued comprehension and consent, which presumes a high degree of recall. Many obstacles can prevent full understanding of information about the research protocol. This study's aim was to evaluate the comprehension and 1-day recall of the elements of informed consent by the parents/guardians of children enrolled in a clinical study in Mozambique. We developed a 10-question test based on the study's informed consent document. We asked participants to answer questions shortly after being read the informed consent document and again the following day. Participants who did not demonstrate good or reasonable understanding at enrollment were provided the information again as a refresher. Overall high rates of initial comprehension demonstrate that attention to the informed consent process can result in Mozambicans' informed, voluntary participation in clinical trials.

Mozambique has one of the highest rates of maternal mortality in sub-Saharan Africa. The main influences on maternal health encompass social, economic, political, environmental and cultural determinants of health. To effectively address maternal mortality in the post-2015 agenda, interventions need to consider the determinants of health so that their delivery is not limited to the health sector. The objective of this exploratory qualitative study was to identify key community groups' perspectives on the perceived determinants of maternal health in rural areas of southern Mozambique.

Background: Mozambique has one of the highest rates of maternal mortality in sub-Saharan Africa. The main influences on maternal health encompass social, economic, political, environmental and cultural determinants of health. To effectively address maternal mortality in the post-2015 agenda, interventions need to consider the determinants of health so that their delivery is not limited to the health sector. The objective of this exploratory qualitative study was to identify key community groups' perspectives on the perceived determinants of maternal health in rural areas of southern Mozambique. Methods: Eleven focus group discussions were conducted with women of reproductive age, pregnant women, matrons, male partners, community leaders and health workers. Participants were recruited using sampling techniques of convenience and snow balling. Focus groups had an average of nine participants each. The heads of 12 administrative posts were also interviewed to understand the local context. Data were coded and analysed thematically using NVivo software. Results: A broad range of political, economic, socio-cultural and environmental determinants of maternal health were identified by community representatives. It was perceived that the civil war has resulted in local unemployment and poverty that had a number of downstream effects including lack of funds for accessing medical care and transport, and influence on socio-cultural determinants, particularly gender relations that disadvantaged women. Socio-cultural determinants included intimate partner violence toward women, and strained relationships with in-laws and co-spouses. Social relationships were complex as there were both negative and positive impacts on maternal health. Environmental determinants included natural disasters and poor access to roads and transport exacerbated by the wet season and subsequent flooding. Conclusions: In rural southern Mozambique, community perceptions of the determinants of maternal health included political, economic, socio-cultural and environmental factors. These determinants were closely linked with one another and highlight the importance of including the local history, context, culture and geography in the design of maternal health programs. ; Medicine, Faculty of ; Other UBC ; Non UBC ; Medicine, Department of ; Obstetrics and Gynaecology, Department of ; Reviewed ; Faculty

INTRODUCTION: Indoor residual spraying (IRS) and insecticide-treated nets (ITNs), two principal malaria control strategies, are similar in cost and efficacy. We aimed to describe recent policy development regarding their use in Mozambique, South Africa and Zimbabwe. METHODS: Using a qualitative case study methodology, we undertook semi-structured interviews of key informants from May 2004 to March 2005, carried out document reviews and developed timelines of key events. We used an analytical framework that distinguished three broad categories: interests, ideas and events. RESULTS: A disparate mix of interests and ideas slowed the uptake of ITNs in Mozambique and Zimbabwe and prevented uptake in South Africa. Most respondents strongly favoured one strategy over the other. In all three countries, national policy makers favoured IRS, and only in Mozambique did national researchers support ITNs. Outside interests in favour of IRS included manufacturers who supplied the insecticides and groups opposing environmental regulation. International research networks, multilateral organizations, bilateral donors and international NGOs supported ITNs. Research evidence, local conditions, logistic feasibility, past experience, reaction to outside ideas, community acceptability, the role of government and NGOs, and harm from insecticides used in spraying influenced the choice of strategy. The end of apartheid permitted a strongly pro-IRS South Africa to influence the region, and in Mozambique and Zimbabwe, floods provided conditions conducive to ITN distribution. CONCLUSIONS: Both IRS and ITNs have a place in integrated malaria vector management, but pro-IRS interests and ideas slowed or prevented the uptake of ITNs. Policy makers needed more than evidence from trials to change from the time-honoured IRS strategy that they perceived was working. Those intending to promote new policies such as ITNs should examine the interests and ideas motivating key stakeholders and their own institutions, and identify where shifts in thinking or coalitions among the like-minded may be possible.

Background: Pre-eclampsia is one of the leading causes of maternal death in Mozambique. Limited access to health care facilities and a lack of skilled health professionals contribute to the high maternal morbidity and mortality rates in Mozambique and indicate a need for community-level interventions. The aim of this review was to identify and characterise health policies related to the role of CHWs in the management of pre-eclampsia and eclampsia in Mozambique. Methods: The policy review was based on three methods: a desk review of relevant documents from the Mozambique Ministry of Health (n = 7), contact with 28 key informants in the field of health policy in Mozambique (n = 5) and literature review (n = 699). Policy documents obtained included peer-reviewed articles, government and institutional policies, reports and action plans. Seven hundred and eleven full-text documents were assessed for eligibility and included based on pre-defined criteria. Qualitative analysis was done to identify main themes using content analysis. Results: A total of 56 papers informed the timeline of key events. Three main themes were identified from the qualitative review: establishment of the community health worker programme and early challenges, revitalization of the CHW programme and the integration of maternal health in the community health tasks. In 1978, following the Alma Alta Declaration, the Mozambique government brought in legislation establishing primary health care and the CHW programme. Between the late 1980s and early 1990s, this programme was scaled down due to several factors including a prolonged civil war; however, the decision to revitalise the programme was made in 1995. In 2010, a revitalised programme was re-launched and expanded to include the management of common childhood illnesses, detection of warning signs of pregnancy complications, referrals for maternal health and basic health promotion. To date, their role has not included management of emergency conditions of pregnancy including pre-eclampsia and eclampsia. Conclusion: The role of CHWs has evolved over the last 40 years to include care of childhood diseases and basic maternal health counselling. Studies to assess the impact of CHWs in providing services to reduce maternal morbidity and mortality are recommended. ; Medicine, Faculty of ; Non UBC ; Obstetrics and Gynaecology, Department of ; Reviewed ; Faculty

Background: In 2017, a North-South partnership was created, to strengthen Bioethics Committees in African Lusophone African countries (LAC), by joining the forces of National and Institutional Research Ethics Committees (REC) and Universities in Angola, Cape Verde, Mozambique and Portugal. This study is part of an EDCTP2-funded project and aims to describe key RECs operating in LAC, its establishment dates and further characteristics. Methods: Document analysis and interviews with REC representatives of five LAC were conducted in April 2018. Legal documents were obtained through official national sources. Results: We identified four National Ethics Committees, created between 2000 and 2008 by ministerial or governmental decree; only S. Tomé e Principe does not have an established REC. In Angola, the National REC was created in 2000, and since 2007, seven Institutional Committees were implemented at faculty level. National REC in Cape Verde and Guinee-Bissau (CNES) are unique and were founded in 2007 and 2009 respectively. In Mozambique, National REC (CNBS) dates to 2002, and since 2011, 8 Institutional Committees were formed; they functioned as a network under the umbrella of CNBS. Most National REC have representatives from health professional associations, lawyers, civil society and religious communities and have regular meetings (usually monthly). The number of members ranges between 6 (CNES) and 13 (CNBS). In 2007, around 200 protocols were reviewed by CNBS and 29 by CNES. Most of the National REC members attended training activities in bioethics but at different levels. Conclusion: Few publications described REC operating in LAC; this study fills this gap by reporting historical and functional characteristics of RECs in five Lusophone African countries. Additional tools based on quantitative and qualitative approaches are being developed to assess more in-depth REC operational characteristics and to identify their needs in order to target training and capacity building initiatives underlying our project. ; publishersversion ; published