Browsing by Subject "Biomedical Research"

Now showing 1 - 7 of 7
  • Thumbnail Image
    Item
    Open Access
    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.
  • Thumbnail Image
    Item
    Open Access
    The ethics of human volunteer studies involving experimental exposure to pesticides: unanswered dilemmas
    (BioMed Central Ltd, 2010) London, Leslie; Coggon, David; Moretto, Angelo; Westerholm, Peter; Wilks, Martin; Colosio, Claudio
    The controversy about the use of data from human volunteer studies involving experimental exposure to pesticides as part of regulatory risk assessment has been widely discussed, but the complex and interrelated scientific and ethical issues remain largely unresolved. This discussion paper, generated by authors who comprised a workgroup of the ICOH Scientific Committee on Rural Health, reviews the use of human experimental studies in regulatory risk assessment for pesticides with a view to advancing the debate as to when, if ever, such studies might be ethically justifiable. The discussion is based on three elements: (a) a review of discussion papers on the topic of human testing of pesticides and the positions adopted by regulatory agencies in developed countries; (b) an analysis of published and unpublished studies involving human testing with pesticides, both in the peer-reviewed literature and in the JMPR database; and (c) application of an ethical analysis to the problem. The paper identifies areas of agreement which include general principles that may provide a starting point on which to base criteria for judgements as to the ethical acceptability of such studies. However, the paper also highlights ongoing unresolved differences of opinion inherent in ethical analysis of contentious issues, which we propose should form a starting point for further debate and the development of guidelines to achieve better resolution of this matter.
  • Thumbnail Image
    Item
    Open Access
    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.
  • Thumbnail Image
    Item
    Open Access
    Maternal participant experience in a South African birth cohort study enrolling healthy pregnant women and their infants
    (2016) Barnett, Whitney; Brittain, Kirsty; Sorsdahl, Katherine; Zar, Heather J; Stein, Dan J
    Abstract Background Critical to conducting high quality research is the ability to attract and retain participants, especially for longitudinal studies. Understanding participant experiences and motivators or barriers to participating in clinical research is crucial. There are limited data on healthy participant experiences in longitudinal research, particularly in low- and middle-income countries. This study aims to investigate quantitatively participant experiences in a South African birth cohort study. Methods Maternal participant experience was evaluated by a self-administered survey in the Drakenstein Child Health Study, a longitudinal birth cohort study investigating the early life determinants of child health. Pregnant mothers, enrolled during the second trimester, were followed through childbirth and the early childhood years. Satisfaction scores were derived from the participant experience survey and quantitatively analyzed; associations between satisfaction scores and sociodemographic variables were then investigated using a linear regression model. Results Data were included from 585 pregnant mothers (median age 26.6 years), who had participated in the study for a median time of 16 months. Overall participant satisfaction was high (median score 51/60) and associated with increased attendance of study visits. Reasons for participating were a belief that involvement would improve their health, their child’s health or the health of family and friends. Potential reasons for leaving the study were inconvenience, not receiving clinical or study results, and unexpected changes in study visits or procedures. Variables associated with higher overall satisfaction scores were no prior participation in research, higher socioeconomic status, less intensive follow-up schedules and having experienced stressful life events in the past year. Conclusions Satisfaction scores were high and associated with increased visit attendance. Participants’ perceived benefits of study participation, most notably the potential for an improvement in the health of their child, were a significant motivator to enroll and remain in the study. The consistent theme of perceived health benefits as a motivator to join and remain in the study raises the question of whether participation in research results in actual improvements in health.
  • Thumbnail Image
    Item
    Open Access
    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.
  • Thumbnail Image
    Item
    Open Access
    Setting priorities in health research using the model proposed by the World Health Organization: development of a quantitative methodology using tuberculosis in South Africa as a worked example
    (2016) Hacking, Damian; Cleary, Susan
    BackgroundSetting priorities is important in health research given the limited resources available for research. Various guidelines exist to assist in the priority setting process; however, priority setting still faces significant challenges such as the clear ranking of identified priorities. The World Health Organization (WHO) proposed a Disability Adjusted Life Year (DALY)-based model to rank priorities by research area (basic, health systems and biomedical) by dividing the DALYs into ‘unavertable with existing interventions’, ‘avertable with improved efficiency’ and ‘avertable with existing but non-cost-effective interventions’, respectively. However, the model has conceptual flaws and no clear methodology for its construction. Therefore, the aim of this paper was to amend the model to address these flaws, and develop a clear methodology by using tuberculosis in South Africa as a worked example.MethodsAn amended model was constructed to represent total DALYs as the product of DALYs per person and absolute burden of disease. These figures were calculated for all countries from WHO datasets. The lowest figures achieved by any country were assumed to represent ‘unavertable with existing interventions’ if extrapolated to South Africa. The ratio of ‘cost per patient treated’ (adjusted for purchasing power and outcome weighted) between South Africa and the best country was used to calculate the ‘avertable with improved efficiency section’. Finally, ‘avertable with existing but non-cost-effective interventions’ was calculated using Disease Control Priorities Project efficacy data, and the ratio between the best intervention and South Africa’s current intervention, irrespective of cost.ResultsThe amended model shows that South Africa has a tuberculosis burden of 1,009,837.3 DALYs; 0.009% of DALYs are unavertable with existing interventions and 96.3% of DALYs could be averted with improvements in efficiency. Of the remaining DALYs, a further 56.9% could be averted with existing but non-cost-effective interventions.ConclusionsThe amended model was successfully constructed using limited data sources. The generalizability of the data used is the main limitation of the model. More complex formulas are required to deal with such potential confounding variables; however, the results act as starting point for development of a more robust model.Electronic supplementary materialThe online version of this article (doi:10.1186/s12961-016-0081-8) contains supplementary material, which is available to authorized users.
  • Thumbnail Image
    Item
    Open Access
    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.