Suchergebnisse

9TH Annual ethics conference. Theme : Bioethics medical, legal, environmental and cultural aspects in healthcare ethics at STRATHMORE UNIVERSITY, 25-26 OCTOBER 2012. ; Ethical Principles on Human Subject Protection in Clinical Research revolves around Autonomy, Beneficence and Justice. Beneficence requires that the benefits to research participants are maximized as you minimize the risk There's need to enhance health, healthcare and general well being of communities participating in research Background well being of communities participating in research. Many local communities in developing countries have limited access to basic healthcare making them vulnerable and open to undue influence. Without collaborative partnership, strong interest and investment by government, research results may not influence policy making decisions and allocation of scarce healthcare resources. The KEMRI/Walter Reed Project a collaborative research program has conducted clinical trials for over 20 years in Kenya. During this period its objectives have included working with partners to maximize research benefits in the community in which it works by effectively utilizing the available resources to address local health needs.

OBJECTIVES: Vaccine clinical trials in low‐resource settings have unique challenges due to structural and financial inequities. Specifically, protecting participant and caregiver autonomy to participate in the research study can be a major challenge, so understanding the setting and contextual factors which influence the decision process is necessary. This study investigates the experience of caregivers consenting on behalf of paediatric participants in a malaria vaccine clinical trial where participation enables access to free, high‐quality medical care. METHODS: We interviewed a total of 78 caregivers of paediatric participants previously enrolled in a phase II or III malaria vaccine clinical trial in Uganda, Tanzania and Kenya. Interviews were qualitative and analysed using a thematic framework analysis focusing on the embodied caregiver in the political, economic and social reality. RESULTS: Caregivers of participants in this study made the decision to enrol their child based on economic, social and political factors that extended beyond the trial into the community and the home. The provision of health care was the dominant reason for participation. Respondents reported how social networks, rumours, hierarchal structures, financial constraints and family dynamics affected their experience with research. CONCLUSIONS: The provision of medical care was a powerful motivator for participation. Caregiver choice was limited by structural constraints and scarce financial resources. The decision to participate in research extended beyond individual consent and was embedded in community and domestic hierarchies. Future research should assess other contexts to determine how the choice to participate in research is affected when free medical care is offered.

When clinical trials enter human communities, two complex systems merge—creating challenges for the clinical trial team and the local human community. This is of particular relevance for clinical trials in low-resource settings where the resource scarcity can intensify existing inequities. Here we present a case study of a phase III malaria vaccine clinical trial. Through qualitative interviews with researchers and caregivers of pediatric participants we elucidate themes that shape the clinical trial system. These themes can be a useful complementary planning tool to existing research guidelines for clinical trial researchers. Respondents from both groups reported financial and social contextual realities to be major drivers in the system. We found a strong historical path dependency in the community that was closely tied to the relationships with researchers and indicative of the structural inequities. We elaborate on these findings and offer recommendations to improve trial design.

Abstract Background Repeat household surveys are useful to assess change in prevalence over time, but there have been no repeat surveys of common mental disorder (CMD) in Kenya, or indeed sub-Saharan Africa. Therefore a repeat household survey of CMD and its associated risk factors was conducted in Maseno area, Kisumu county in Kenya, using a demographic surveillance site as the sample frame, in order to test the hypotheses that (a) the prevalence of CMD would increase between 2004 and 2013 due to the intervening political, social and economic pressures; (b) as in 2004, there would be no gender difference in prevalence of CMD. Methods One thousand one hundred ninety households were selected, and 1158 adult participants consented to be interviewed with a structured epidemiological assessment while 32 refused to participate in the study interviews, giving a response rate of 97.3 %. Results The study found that the overall prevalence of CMD in 2013 was 10.3 %. However, there were significantly higher rates of having any CMD in 2013 if one was female (OR 6.2, p < 0.001), divorced/widowed (OR 2.5, p < 0.003), aged over 60 (OR 2.3, p = 0.052), either self-employed (OR 3.3 p < 0.001) or employed (OR 3.3, p < 0.001), or belonged to the lowest asset quintile (OR 2.5, p = .0.004) after adjusting for other variables significant at the bivariate level. The overall prevalence in 2013 was consistent with that found in 2004, despite intervening political and community turbulence. However, this apparent consistency masks the development of a striking difference in prevalence between the genders. Over the decade 2004–13, the prevalence for men dropped from 10.9 to 3.8 % ( P = 0.001) and the prevalence for women increased from 10.8 to 17.5 % ( p = 0.001). Conclusion Common mental disorders continue to pose a significant public health burden in Kenya, and gender related vulnerability merits further research and is relevant for health worker training.

Abstract Background The opportunities for developing new drugs and vaccines for malaria control look brighter now than ten years ago. However, there are few places in sub-Saharan Africa with the necessary infrastructure and expertise to support such research in compliance to international standards of clinical research (ICH-GCP). The Clinical Research Unit of Nanoro (CRUN) was founded in 2008 to provide a much-needed GCP-compliant clinical trial platform for an imminent large-scale Phase 3 malaria vaccine trial. A dynamic approach was used that entailed developing the required infrastructure and human resources, while engaging local communities in the process as key stakeholders. This provided a better understanding and ownership of the research activities by the local population. Case description Within five years (2008–2013), the CRUN set up a fully and well-equipped GCP-compliant clinical trial research facility, which enabled to attract 25 grants. The research team grew from ten health workers prior to 2008 to 254 in 2013. A Health and Demographic Surveillance System (HDSS), which covers a total population of about 60,000 people in 24 villages was set up in the district. The local community contributed to the development of the facility through the leadership of the king and the mayor of Nanoro. As a result of their active advocacy, the government extended the national electrical grid to the new research center, and later to the entire village. This produced a positive impact on the community's quality of life. The quality of health care improved substantially, due to the creation of more elaborate clinical laboratory services and the acquisition of state-of-the-art equipment. Conclusion Involving the community in the key steps of establishing the centre provided the foundation for what was to become the CRUN success story. This experience demonstrates that when clinical trials research sites are carefully developed and implemented, they can have a positive and powerful impact on local communities in resource-poor settings, well beyond the task of generating expected study data.