Browsing by Subject "Research Personnel"

Now showing 1 - 6 of 6
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    Barriers to clinical research in Africa, a quantitative and qualitative survey of 27 African countries
    (2019) Conradie, Aletta; Duys, Rowan; Biccard, Bruce M
    Background There is a need for high quality research to improve perioperative patient care in Africa. The aim of this study was to understand the particular barriers to clinical research in this environment. Methods Electronic survey of African Surgical Outcomes Study (ASOS) investigators, including 29 quantitative Likert scale questions and eight qualitative questions with subsequent thematic analysis. Protocol compliant and non-compliant countries were compared according to the WHO statistics for research and development, health workforce data and world internet statistics. Results Responses were received from 134/418 invited researchers in 24/25 (96%) participating countries, and three non-participating countries. Barriers included the lack of a dedicated research team (47.7%), reliable internet access (32.6%), staff skilled in research (31.8%) and team commitment (23.8%). Protocol compliant countries had significantly more physicians per 1000 population (4 vs 0.9 p<0.01), internet penetration (38% vs 28% p=0.01) and published clinical trials (1461 vs 208 p<0.01) compared to non-compliant countries. Facilitators of research included establishing a research culture (86.9%), simple data collection tools (80%) and ASOS team interaction (77.9%). Most participants are interested in future research (93.8%). Qualitative data reiterated human resource, financial resource, and regulatory barriers. However, the desire to contribute to an African collaboration producing relevant data to improve patient outcomes, was expressed strongly by the ASOS investigators. Conclusions: Barriers to successful participation in ASOS related to resource limitations and not the motivation of clinician investigators. Practical solutions to individual barriers may increase the success of multi-centre perioperative research in Africa.
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    Is it ethical to prevent secondary use of stored biological samples and data derived from consenting research participants? The case of Malawi
    (2015) Mungwira, Randy G; Nyangulu, Wongani; Misiri, James; Iphani, Steven; Ng’ong’ola, Ruby; Chirambo, Chawanangwa M; Masiye, Francis; Mfutso-Bengo, Joseph
    BackgroundThis paper discusses the contentious issue of reuse of stored biological samples and data obtained from research participants in past clinical research to answer future ethical and scientifically valid research questions. Many countries have regulations and guidelines that guide the use and exportation of stored biological samples and data. However, there are variations in regulations and guidelines governing the reuse of stored biological samples and data in Sub-Saharan Africa including Malawi.DiscussionThe current research ethics regulations and guidelines in Malawi do not allow indefinite storage and reuse of biological samples and data for future unspecified research. This comes even though the country has managed to answer pertinent research questions using stored biological samples and data. We acknowledge the limited technical expertise and equipment unavailable in Malawi that necessitates exportation of biological samples and data and the genuine concern raised by the regulatory authorities about the possible exploitation of biological samples and data by researchers. We also acknowledge that Malawi does not have bio-banks for storing biological samples and data for future research purposes. This creates room for possible exploitation of biological samples and data collected from research participants in primary research projects in Malawi. However, research ethics committees require completion and approval of material transfer agreements and data transfer agreements for biological samples and data collected for research purposes respectively and this requirement may partly address the concern raised by the regulatory authorities. Our concern though is that there is no such requirement for biological samples and data collected from patients for clinical or diagnostic purposes.SummaryIn conclusion, we propose developing a medical data and material transfer agreement for biological samples and data collected from patients for clinical or diagnostic purposes in both public and private health facilities that may end up in research centers outside Malawi. We also propose revision of the current research ethics regulations and guidelines in Malawi in order to allow secondary use of biological samples and data collected from primary research projects as a way of maximizing the use of collected samples and data. Finally, we call for consultation of all stakeholders within the Malawi research community when regulatory authorities are developing policies that govern research in Malawi.
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    Public/community engagement in health research with men who have sex with men in sub-Saharan Africa: challenges and opportunities
    (2016) Molyneux, Sassy; Sariola, Salla; Allman, Dan; Dijkstra, Maartje; Gichuru, Evans; Graham, Susan; Kamuya, Dorcas; Gakii, Gloria; Kayemba, Brian; Kombo, Bernadette; Maleche, Allan; Mbwambo, Jessie; Marsh, Vicki; Micheni, Murugi; Mumba, Noni; Parker, Michael; Shio, Jasmine; Yah, Clarence; van der Elst, Elise; Sanders, Eduard
    Abstract Background Community engagement, incorporating elements of the broader concepts of public and stakeholder engagement, is increasingly promoted globally, including for health research conducted in developing countries. In sub-Saharan Africa, community engagement needs and challenges are arguably intensified for studies involving gay, bisexual and other men who have sex with men, where male same-sex sexual interactions are often highly stigmatised and even illegal. This paper contextualises, describes and interprets the discussions and outcomes of an international meeting held at the Kenya Medical Research Institute-Wellcome Trust in Kilifi, Kenya, in November 2013, to critically examine the experiences with community engagement for studies involving men who have sex with men. Discussion We discuss the ethically charged nature of the language used for men who have sex with men, and of working with ‘representatives’ of these communities, as well as the complementarity and tensions between a broadly public health approach to community engagement, and a more rights based approach. We highlight the importance of researchers carefully considering which communities to engage with, and the goals, activities, and indicators of success and potential challenges for each. We suggest that, given the unintended harms that can emerge from community engagement (including through labelling, breaches in confidentiality, increased visibility and stigma, and threats to safety), representatives of same-sex populations should be consulted from the earliest possible stage, and that engagement activities should be continuously revised in response to unfolding realities. Engagement should also include less vocal and visible men who have sex with men, and members of other communities with influence on the research, and on research participants and their families and friends. Broader ethics support, advice and research into studies involving men who have sex with men is needed to ensure that ethical challenges – including but not limited to those related to community engagement – are identified and addressed. Summary Underlying challenges and dilemmas linked to stigma and discrimination of men who have sex with men in Africa raise special responsibilities for researchers. Community engagement is an important way of identifying responses to these challenges and responsibilities but itself presents important ethical challenges.
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    Regulation of genomic and biobanking research in Africa: a content analysis of ethics guidelines, policies and procedures from 22 African countries
    (2017) de Vries, Jantina; Munung, Syntia Nchangwi; Matimba, Alice; McCurdy, Sheryl; Ouwe Missi Oukem-Boyer, Odile; Staunton, Ciara; Yakubu, Aminu; Tindana, Paulina
    Abstract Background The introduction of genomics and biobanking methodologies to the African research context has also introduced novel ways of doing science, based on values of sharing and reuse of data and samples. This shift raises ethical challenges that need to be considered when research is reviewed by ethics committees, relating for instance to broad consent, the feedback of individual genetic findings, and regulation of secondary sample access and use. Yet existing ethics guidelines and regulations in Africa do not successfully regulate research based on sharing, causing confusion about what is allowed, where and when. Methods In order to understand better the ethics regulatory landscape around genomic research and biobanking, we conducted a comprehensive analysis of existing ethics guidelines, policies and other similar sources. We sourced 30 ethics regulatory documents from 22 African countries. We used software that assists with qualitative data analysis to conduct a thematic analysis of these documents. Results Surprisingly considering how contentious broad consent is in Africa, we found that most countries allow the use of this consent model, with its use banned in only three of the countries we investigated. In a likely response to fears about exploitation, the export of samples outside of the continent is strictly regulated, sometimes in conjunction with regulations around international collaboration. We also found that whilst an essential and critical component of ensuring ethical best practice in genomics research relates to the governance framework that accompanies sample and data sharing, this was most sparingly covered in the guidelines. Conclusions There is a need for ethics guidelines in African countries to be adapted to the changing science policy landscape, which increasingly supports principles of openness, storage, sharing and secondary use. Current guidelines are not pertinent to the ethical challenges that such a new orientation raises, and therefore fail to provide accurate guidance to ethics committees and researchers.
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    Synergies, tensions and challenges in HIV prevention, treatment and cure research: exploratory conversations with HIV experts in South Africa
    (2016) Moodley, Keymanthri; Rossouw, Theresa; Staunton, Ciara; Colvin, Christopher J
    Abstract Background The ethical concerns associated with HIV prevention and treatment research have been widely explored in South Africa over the past 3 decades. However, HIV cure research is relatively new to the region and significant ethical and social challenges are anticipated. There has been no published empirical enquiry in Africa into key informant perspectives on HIV cure research. Consequently, this study was conducted to gain preliminary data from South African HIV clinicians, researchers and activists. Methods In-depth interviews were conducted on a purposive sample of fourteen key informants in South Africa. Audiotaped interviews were transcribed verbatim with concurrent thematic analysis. The perspectives of HIV clinicians, researchers and activists were captured. Analyst triangulation occurred as the data were analysed by three authors independently. Results The rapid evolution of HIV cure research agendas was prominent with participants expressing some concern that the global North was driving the cure agenda. Participants described a symbiotic relationship between cure, treatment and prevention research necessitating collaboration. Assessing and managing knowledge and expectations around HIV cure research emerged as a central theme related to challenges to constructing ‘cure’ - how patients understand the idea of cure is important in explaining the complexity of cure research especially in the South African context where understanding of science is often challenging. Managing expectations and avoiding curative misconception will have implications for consent processes. Unique strategies in cure research could include treatment interruption, which has the potential to create therapeutic and ethical conflict and will be perceived as a significant risk. Ethical challenges in cure research will impact on informed consent and community engagement. Conclusions It was encouraging to note the desire for synergy amongst researchers and clinicians working in the fields of prevention, treatment and cure. Translation of complex HIV cure science into lay language is critical. Moving forward, RECs must be adequately constituted with scientific expertise and community representation when reviewing cure protocols. It is hoped that knowledge and resource sharing in the context of collaboration between research scientists working in cure and those working in treatment and prevention will accelerate progress towards cure.
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    The challenge of bridging the gap between researchers and policy makers: experiences of a Health Policy Research Group in engaging policy makers to support evidence informed policy making in Nigeria
    (2016) Uzochukwu, Benjamin; Onwujekwe, Obinna; Mbachu, Chinyere; Okwuosa, Chinenye; Etiaba, Enyi; Nyström, Monica E; Gilson, Lucy
    Abstract Background Getting research into policy and practice (GRIPP) is a process of going from research evidence to decisions and action. To integrate research findings into the policy making process and to communicate research findings to policymakers is a key challenge world-wide. This paper reports the experiences of a research group in a Nigerian university when seeking to ‘do’ GRIPP, and the important features and challenges of this process within the African context. Methods In-depth interviews were conducted with nine purposively selected policy makers in various organizations and six researchers from the universities and research institute in a Nigerian who had been involved in 15 selected joint studies/projects with Health Policy Research Group (HPRG). The interviews explored their understanding and experience of the methods and processes used by the HPRG to generate research questions and research results; their involvement in the process and whether the methods were perceived as effective in relation to influencing policy and practice and factors that influenced the uptake of research results. Results The results are represented in a model with the four GRIPP strategies found: i) stakeholders’ request for evidence to support the use of certain strategies or to scale up health interventions; ii) policymakers and stakeholders seeking evidence from researchers; iii) involving stakeholders in designing research objectives and throughout the research process; and iv) facilitating policy maker-researcher engagement in finding best ways of using research findings to influence policy and practice and to actively disseminate research findings to relevant stakeholders and policymakers. The challenges to research utilization in health policy found were to address the capacity of policy makers to demand and to uptake research, the communication gap between researchers, donors and policymakers, the management of the political process of GRIPP, the lack of willingness of some policy makers to use research, the limited research funding and the resistance to change. Conclusions Country based Health Policy and Systems Research groups can influence domestic policy makers if appropriate strategies are employed. The model presented gives some direction to potential strategies for getting research into policy and practice in the health care sector in Nigeria and elsewhere.