Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting

Background Maximizing comprehension is a major challenge for informed consent processes in low-literacy and resource-limited settings. Application of rapid qualitative assessments to improve the informed consent process is increasingly considered useful. This study assessed the effects of Rapid Ethical Assessment (REA) on comprehension, retention and quality of the informed consent process. Methods A cluster randomized trial was conducted among participants of HPV sero-prevalence study in two districts of Northern Ethiopia, in 2013. A total of 300 study participants, 150 in the intervention and 150 in the control group, were included in the study. For the intervention group, the informed consent process was designed with further revisions based on REA findings. Informed consent comprehension levels and quality of the consent process were measured using the Modular Informed Consent Comprehension Assessment (MICCA) and Quality of Informed Consent (QuIC) process assessment tools, respectively. Result Study recruitment rates were 88.7 % and 80.7 % (p = 0.05), while study retention rates were 85.7 % and 70.3 % (p < 0.005) for the intervention and control groups respectively. Overall, the mean informed consent comprehension scores for the intervention and control groups were 73.1 % and 45.2 %, respectively, with a mean difference in comprehension score of 27.9 % (95 % CI 24.0 % - 33.4 %; p < 0.001,). Mean scores for quality of informed consent for the intervention and control groups were 89.1 % and 78.5 %, respectively, with a mean difference of 10.5 % (95 % CI 6.8 -14.2 %; p < 0.001). Conclusion Levels of informed consent comprehension, quality of the consent process, study recruitment and retention rates were significantly improved in the intervention group. We recommend REA as a potential modality to improve informed consent comprehension and quality of informed consent process in low resource settings

Rapid ethical assessment on informed consent content and procedure in Hintalo-Wajirat, Northern Ethiopia: a qualitative study

Background Informed consent is a key component of bio-medical research involving human participants. However, obtaining informed consent is challenging in low literacy and resource limited settings. Rapid Ethical Assessment (REA) can be used to contextualize and simplify consent information within a given study community. The current study aimed to explore the effects of social, cultural, and religious factors during informed consent process on a proposed HPV-serotype prevalence study. Methodology A qualitative community-based REA was conducted in Adigudom and Mynebri Kebeles, Northern Ethiopia, from July to August 2013. Data were collected by a multi-disciplinary team using open ended questions concerning informed consent components in relation to the parent study. The team conducted one-to-one In-Depth Interviews (IDI) and Focus Group Discussions (FGDs) with key informants and community members to collect data based on the themes of the study. Tape recorded data were transcribed in Tigrigna and then translated into English. Data were categorized and thematically analyzed using open coding and content analysis based on pre-defined themes. Results The REA study revealed a number of socio-cultural issues relevant to the proposed study. Low community awareness about health research, participant rights and cervical cancer were documented. Giving a vaginal sample for testing was considered to be highly embarrassing, whereas giving a blood sample made participants worry that they might be given a result without the possibility of treatment. Verbal consent was preferred to written consent for the proposed study. Conclusion This rapid ethical assessment disclosed important socio-cultural issues which might act as barriers to informed decision making. The findings were important for contextual modification of the Information Sheet, and to guide the best consent process for the proposed study. Both are likely to have enabled participants to understand the informed consent better and consequently to comply with the study

Repeated Assessments of Informed Consent Comprehension among HIV-Infected Participants of a Three-Year Clinical Trial in Botswana

Informed consent (IC) has been an international standard for decades for the ethical conduct of clinical trials. Yet frequently study participants have incomplete understanding of key issues, a problem exacerbated by language barriers or lack of familiarity with research concepts. Few investigators measure participant comprehension of IC, while even fewer conduct interim assessments once a trial is underway.We assessed comprehension of IC using a 20-question true/false quiz administered in 6-month intervals in the context of a placebo-controlled, randomized trial for the prevention of tuberculosis among HIV-infected adults in Botswana (2004-2009). Quizzes were offered in both Setswana and English. To enroll in the TB trial, participants were required to have ≥ 16/20 correct responses. We examined concepts understood and the degree to which understanding changed over three-years. We analyzed 5,555 quizzes from 1,835 participants. The participants' highest education levels were: 28% primary, 59% secondary, 9% tertiary and 7% no formal education. Eighty percent of participants passed the enrollment quiz (Quiz1) on their first attempt and the remainder passed on their second attempt. Those having higher than primary education and those who took the quiz in English were more likely to receive a passing score on their first attempt (adjusted odds ratios and 95% confidence intervals, 3.1 (2.4-4.0) and 1.5 (1.2, 1.9), respectively). The trial's purpose or procedures were understood by 90-100% of participants, while 44-77% understood randomization, placebos, or risks. Participants who failed Quiz1 on their initial attempt were more likely to fail quizzes later in the trial. Pass rates improved with quiz re-administration in subsequent years.Administration of a comprehension quiz at enrollment and during follow-up was feasible in a large, international collaboration and efficiently determined IC comprehension by trial participants. Strategies to improve understanding of concepts like placebos and randomization are needed. Comprehension assessments throughout a study may reinforce key concepts

Currículo de la pre secundaria en Timor Oriental y su articulación con la secundaria general

Problemas herdados nas últimas décadas conduziram Timor-Leste a reestruturar os currículos do ensino pré-secundário – EPS – e do secundário geral – ESG.1 Atendendo à importância de uma adequada articulação vertical ao longo dos ciclos de escolaridade e diante do cumprimento de uma primeira edição completa do EPS, importa estudar se tal currículo está alinhado com o do ESG, em particular no que respeita às Ciências e Tecnologia. Este artigo centra-se na análise do currículo do EPS e na avaliação da sua articulação com o do ESG. Não obstante existam décalages entre o currículo prescrito, o implementado e o apropriado, é relevante haver sintonia no nível dos currículos para uma educação e formação de boa qualidade, fundamentais à consecução dos Objetivos de Desenvolvimento do Milénio.Problems inherited from the last decades have led Timor-Leste to restructure its pre-secondary – EPS – and general secondary – ESG – curricula. Considering the importance of an adequate vertical articulation throughout the schooling cycles and before the conclusion of the first complete edition of the EPS, it is necessary to study if such a curriculum is aligned with the one of the ESG, in particular with regard to Science and Technology. This article focuses on the analysis of the EPS curriculum and the evaluation of its articulation with the one of ESG. Notwithstanding the décalages among the prescribed, the implemented and the appropriate curricula, it is relevant to have a fine-tuning at this level to ensure good quality education and training, essential to achieve the millennium development goals.Des problèmes hérités des dernières décennies ont conduit le Timor-Oriental à restructurer ses programmes d’enseignement présecondaire – EPS –, ainsi que ceux de l’enseignement secondaire général – ESG. Compte tenu de l’importance d’une bonne articulation verticale tout au long des cycles scolaires etvu qu’une première édition complète de l’EPS a déjà été mise en place, il est important de vérifier si ce programme s’aligne bien à celui de l’ESG, particulièrement en ce qui concerne les Sciences et la Technologie. Cet article se concentre sur l’analyse du programme de l’EPS et sur l’évaluation de son articulation avec celui de l’ESG. Nonobstant certains décalages entre le programme prescrit, celui qui a été mis en œuvre et celui qui est approprié, il est nécessaire que les programmes soient en phase pour atteindre une éducation et une formation de qualité, fondamentales pour la réalisation des Objectifs du Millénaire pour le Développement.Problemas heredados en las últimas décadas hicieron que Timor Oriental reestructurase los currículos de la educación pre secundaria – EPS – y de la secundaria general – ESG. En función de la importancia de una adecuada articulación vertical a lo largo de los ciclos de escolaridad y frente al cumplimiento de una primera edición completa do EPS, importa estudiar si tal currículo está alineado con el del ESG, en particular en lo que concierne a las Ciencias y Tecnología. Este artículo se centra en el análisis del currículo del EPS y en la evaluación de su articulación con el del ESG. No obstante la existencia de décalages entre el currículo prescrito, el implementado y el apropiado, es relevante que haya sintonía a nivel de los currículos para una educación y formación de calidad, fundamentales para la consecución de los Objetivos de Desarrollo del Milenio

Track E Implementation Science, Health Systems and Economics

Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/138412/1/jia218443.pd

Hyper-compressions: The rise of flash fiction in “post-transitional” South Africa

Blair, P. (2020). Hyper-compressions: The rise of flash fiction in “post-transitional” South Africa', The Journal of Commonwealth Literature, 55(1), 38-60. Copyright © 2018. Reprinted by permission of SAGE Publications.This article begins with a survey of flash fiction in “post-transitional” South Africa, which it relates to the nation’s post-apartheid canon of short stories and short-short stories, to the international rise of flash fiction and “sudden fiction”, and to the historical particularities of South Africa’s “post-transition”. It then undertakes close readings of three flash fictions republished in the article, each less than 450 words: Tony Eprile’s “The interpreter for the tribunal” (2007), which evokes the psychological and ethical complexities, and long-term ramifications, of the Truth and Reconciliation Commission; Michael Cawood Green’s “Music for a new society” (2008), a carjacking story that invokes discourses about violent crime and the “‘new’ South Africa”; and Stacy Hardy’s “Kisula” (2015), which maps the psychogeography of cross-racial sex and transnational identity-formation in an evolving urban environment. The article argues that these exemplary flashes are “hyper-compressions”, in that they compress and develop complex themes with a long literary history and a wide contemporary currency. It therefore contends that flash fiction of South Africa’s post-transition should be recognized as having literary-historical significance, not just as an inherently metonymic form that reflects, and alludes to, a broader literary culture, but as a genre in its own right

A narrative review of health research capacity strengthening in low and middle-income countries: lessons for conflict-affected areas

Abstract Conducting health research in conflict-affected areas and other complex environments is difficult, yet vital. However, the capacity to undertake such research is often limited and with little translation into practice, particularly in poorer countries. There is therefore a need to strengthen health research capacity in conflict-affected countries and regions. In this narrative review, we draw together evidence from low and middle-income countries to highlight challenges to research capacity strengthening in conflict, as well as examples of good practice. We find that authorship trends in health research indicate global imbalances in research capacity, with implications for the type and priorities of research produced, equity within epistemic communities and the development of sustainable research capacity in low and middle-income countries. Yet, there is little evidence on what constitutes effective health research capacity strengthening in conflict-affected areas. There is more evidence on health research capacity strengthening in general, from which several key enablers emerge: adequate and sustained financing; effective stewardship and equitable research partnerships; mentorship of researchers of all levels; and effective linkages of research to policy and practice. Strengthening health research capacity in conflict-affected areas needs to occur at multiple levels to ensure sustainability and equity. Capacity strengthening interventions need to take into consideration the dynamics of conflict, power dynamics within research collaborations, the potential impact of technology, and the wider political environment in which they take place