Background: Little empirical data are available on the extent to which capacity-building programs... more Background: Little empirical data are available on the extent to which capacity-building programs in research ethics prepare trainees to apply ethical reasoning skills to the design, conduct, or review of research. A randomized controlled trial was conducted in Botswana in 2010 to assess the effectiveness of a case-based intervention using email to augment in-person seminars. Methods: University faculty and current and prospective IRB/REC members took part in a semester-long training program in research ethics. Participants attended two 2-day seminars and were assigned at random to one of two on-line arms of the trial. Participants in both arms completed on-line international modules from the Collaborative Institutional Training Initiative. Between seminars, intervention-arm participants were also emailed a weekly case to analyze in response to set questions; responses and individualized faculty feedback were exchanged via email. Tests assessing ethics knowledge were administered at the start of each seminar. The post-test included an additional section in which participants were asked to identify the ethical issues highlighted in five case studies from a list of multiple-choice responses. Results were analyzed using regression and ANOVA. Results: Of the 71 participants (36 control, 35 intervention) enrolled at the first seminar, 41 (57.7%) attended the second seminar (19 control, 22 intervention). In the intervention arm, 19 (54.3%) participants fully completed and 8 (22.9%) partially completed all six weekly cases. The mean score was higher on the post-test (30.3/40) than on the pre-test (28.0/40), and individual post-and pre-test scores were highly correlated (r = 0.65, p < 0.0001). Group assignment alone did not have an effect on test scores (p > 0.84), but intervention-arm subjects who completed all assigned cases answered an average of 3.2 more questions correctly on the post-test than others, controlling for pre-test scores (p = 0.003). Conclusions: Completion of the case-based intervention improved respondents' test scores, with those who completed all six email cases scoring roughly 10% better than those who failed to complete this task and those in the control arm. There was only suggestive evidence that intensive case work improved ethical issue identification, although there was limited ability to assess this outcome due to a high drop-out rate.
Background: Training in responsible conduct of research and human subjects protections (RCR/HSP) ... more Background: Training in responsible conduct of research and human subjects protections (RCR/HSP) is seldom included in postgraduate medical education in low-and middle-income (LMIC) countries despite requirements that residents undertake research projects. Investigators introduced a Spanishlanguage training program in RCR/HSP for surgical residents in Guatemala using "off-the-shelf" on-line materials, developed a new in-person curriculum specific to the local context, and compared the two teaching modalities with the aim of generating recommendations to improve resident training. Methods: In 2018, surgical residents in three large urban hospitals in Guatemala City completed two on-line programs in RCR/HSP as well as pre-and post-training assessments. Residents in the intervention arm also completed seven weeks of in-person training. Assessments tested awareness of key concepts in the on-line courses with particular attention to international and Guatemalan research regulations. Group differences in matched (pre-and post-) mean scores were analyzed using t-tests to determine gains by study arm assignment. Results: Of the 160 surgical residents, 140 completed preand post-training assessments and were included in the analytic sample. Overall mean scores improved from 52.7 to 58.7 points out of 100.The differences in gains between the two arms were very small and there was insufficient statistical power to detect significance. Trainees completing inperson training reported greater confidence in recognizing ethical issues, understanding the legal and ethical requirements for research, and identifying, reporting and avoiding scientific misconduct than trainees who completed on-line training only. Conclusion: Differences in gains in RCR/HSP knowledge and self-efficacy between trainees completing on-line training only and those completing in-person as well as on-line training are too modest to preference one mode of instruction over another in this setting. Given the limited availability of RCR/HSP faculty, financial resources, and time in the surgical training schedule, however, the investigators recommend that academic authorities in Guatemala consider on-line training programs in RCR/HSP in all surgical residency programs as an affordable and scalable strategy to build ethical research skills in its surgical workforce. Background While RCR/HSP/research ethics training programs can vary significantly in content, they share the
Background: Concurrent with efforts to establish national and regional biorepositories in Africa ... more Background: Concurrent with efforts to establish national and regional biorepositories in Africa is widespread endorsement of ethics committees as stewards of the interests of individual donors and their communities. To date, ethics training programs for IRB members in Botswana have focused on ethical principles and international guidelines rather than on the ethical dimensions of specific medical technologies and research methodologies. Little is known about the knowledge and concerns of current and prospective IRB members in Botswana with respect to export, reuse, storage, and benefit-sharing of biospecimens. Methods: This qualitative study examined perspectives of IRB members in Botswana about the collection and use of biospecimens in research. Forty-one IRB members representing five committees in Botswana participated in discussions groups in March 2013. Transcriptions of audiotapes and field notes were analyzed to identify issues of concern that might be alleviated through education and capacity-building, and areas that required ongoing discussion or additional regulatory guidance. Results: Areas of concern included lack of understanding among patients and providers about the use of biospecimens in clinical care and research; reuse of biospecimens, particularly issues of consent, ownership and decision-making; export of specimens and loss of control over reuse and potential benefits; and felt need for regulatory guidance and IRB-member training. Local belief systems about bodily integrity and strong national identity in the construct of benefits may be at odds with initiatives that involve foreign biorepositories or consider such collections to be global public goods. Conclusion: Education is needed to strengthen IRB-member capacity to review and monitor protocols calling for the collection and use of biospecimens, guided by clear national policy on priority-setting, partnerships, review, and oversight. Engagement with local stakeholders is needed to harmonize fundamentally different ways of understanding the human body and community identity with the aims of contemporary biomedicine.
Nonprofit and Voluntary Sector Quarterly, Sep 1, 2007
The reader who picks up this book will no doubt marvel at the fecundity of Dennis Young, and just... more The reader who picks up this book will no doubt marvel at the fecundity of Dennis Young, and justifiably so. This is Dennis Young's fifth book in the past 10 years. It arises from papers presented at the second conference of the National Center on Nonprofit Enterprise (NCNE ...
Background: Ethical and regulatory guidance on the collection and use of human biospecimens (HBS)... more Background: Ethical and regulatory guidance on the collection and use of human biospecimens (HBS) for research forms an essential component of national health systems in Sub-Saharan Africa (SSA), where rapid advances in genetic-and genomic-based technologies are fueling clinical trials involving HBS and the establishment of large-scale biobanks. Methods: An extensive multi-level search for publicly available ethics regulatory guidance was conducted for each SSA country. A second review documented active trials listed in the WHO International Clinical Trials Registry Platform as of January 2015 in which HBS collection was specified in the protocol. Findings were combined to determine the extent to which countries that are study sites for HBS-related research are supported by regulatory guidance language on the collection, use, ownership and storage of biospecimens. Results: Of the 49 SSA countries, 29 had some form of national ethics guidance, yet only 17 provided language relating to HBS-related research, with specific guidance on consent (14), ownership (6), reuse (10), storage (9), and export/import/ transfer (13). Ten countries accounted for 84 % of the active clinical trials involving the collection of HBS in SSA. All except one of these countries were found to have some national guidance in the form of regulations, codes of ethics, and/or standard operating procedures; however, only seven of the ten offered any language specific to HBS. Conclusions: Despite the fact that the bulk of registered clinical trials in SSA involving HBS, as well as existing and proposed sites for biorepositories under the H3Africa Initiative, are currently situated in countries with the most complete ethics and regulatory guidance, variability in the regulations themselves may create challenges for planned and future pan-African collaborations and may require legislative action at the national level to revise. Countries in SSA that still lack regulatory guidance on HBS will require extensive health system strengthening in ethics governance before they can be full participants in the modern research enterprise.
Case study teaching has gained a strong foothold in science education. Advances in the field incl... more Case study teaching has gained a strong foothold in science education. Advances in the field include: q variations on methodology, from whole class discussion to the jigsaw approach q an increase in educational resources on the topic q over a thousand studies that show improved learning when case studies are used q a survey that illustrates students enjoy and benefit from case studies more on author
Background: A growing number of studies suggest that informal (illicit) fees for healthcare are p... more Background: A growing number of studies suggest that informal (illicit) fees for healthcare are prevalent in low and middle income countries. These fees are regressive and deeply embedded, often proving impervious to policy interventions. Methods: The author conducted a critical interpretive synthesis of peer reviewed literature, grey literature, global standards, and donor funding related to informal fees in order to assess their prevalence, critically interrogate the paradigms that are applied to understanding them, assess to what extent fees are addressed in global policy and funding, and propose future areas for policy and research. In contrast to a systematic review, critical interpretive synthesis fosters crossdisciplinary research that encompasses quantitative, qualitative, and conceptual work. As such, it can open new avenues of discussion on persistent public health problems whose roots reach into the political, social, and cultural realms. Pursuant to established methods for critical interpretive synthesis, key terms were searched in databases and selected journals. Resources were added through an iterative process of developing new lines of enquiry from the initial papers identified, and obtaining resources identified in paper citations. Findings: Patients and providers perceive informal fees on a continuum from gift giving to forced payment. The often disrespectful and coercive nature of fee requests undermines trust and future utilization, and perpetuates helplessness and disempowerment. Health system "hardware" drivers, such as low salaries, scarcity of health workers, and poor infrastructure are widely explored in the literature. "Software" drivers, such as values and norms, are less explored, except in a few qualitative investigations. Policy literature is dominated by rational choice approaches. While the prevalence of fees is well documented, maternal health strategies and donor policies acknowledge the relevance of all out of pocket fees (both formal and informal) with little e if any e attention to informal fees as such. Interpretation: The empirical literature about informal fees is limited by the paradigms applied. Rational choice approaches ignore cultural and practical meanings. International standards and strategies reflect this limitation, presumably exacerbated by reluctance to describe illicit practices. Two trends in international health and development offer opportunities. First, the emerging quality agenda in global health could include informal fees. Second, the governance field is evolving to focus on addressing the function of informal practice, rather than resorting solely to regulation and incentives to end it. Critical interpretive synthesis insights on the function of informal fees e from expression of consumer power to resistance of the health system e illuminates possible interventions beyond simple prohibition or incentives. This study is notable for its examination of both public health literature and policy. However, all data regarding informal fees were secondary, the key limitation of this study.
Journal of medical education and curricular development, 2019
METhOdS: The new ethics curriculum (PRACTICE) incorporates ethics short-courses into the universi... more METhOdS: The new ethics curriculum (PRACTICE) incorporates ethics short-courses into the university's system of nontraditional, creditbearing electives offered to students as part of their 6-year undergraduate medical education and complements existing didactic courses in normative ethics. Structured case-based activities allow for flexibility in design and scheduling, do not compete with core requirements of the existing curriculum, and enable students to develop critical reasoning approaches to ethical situations they will encounter in medical practice. Two preliminary workshops provided teaching opportunities for the faculty, stimulated student interest in future ethics courses, and provided an evidence base to guide the development of a formal curriculum. RESUlTS: The elective currently includes six 2-hour modules, each of which is a stand-alone unit with learning goals and objectives, brief didactic lecture, assigned readings, discussion case, and assessment. To date, more than 110 students have participated in the workshops and courses. Student feedback and evaluations are being used to refine pedagogical approaches and drive future course content. COnClUSiOnS: The PRACTICE course format offers a transformative model for ethics education in Guatemala that can be used in medical education throughout the country and region.
Background: Shared decision-making (SDM) is widely accepted as an essential feature of patient-ce... more Background: Shared decision-making (SDM) is widely accepted as an essential feature of patient-centered care. However, to our knowledge, there has been no empirical research on the factors that influence orthopaedic surgeons' use of SDM in Guatemala. Methods: Questions about physician attributes and SDM were included in a 2016 electronic survey distributed to the 221 members of the Asociación Guatemalteca de Ortopedia y Traumatología (AGOT). Results: A total of 114 (52%) of the AGOT-registered orthopaedic surgery residents and orthopaedic surgeons who were sent surveys returned them, and 79 of these surveys contained complete responses to study variables of interest. Of the 79 participants with complete responses, 73% reported that they discussed treatment options most of the time or always with their patients and 81% reported that they explained the reasons for treatment choices. Compared with residents, surgeons who had completed their residency in orthopaedic surgery or had subspecialty training had greater odds (odds ratio [OR] = 9.62; 95% confidence interval [CI] = 1.35, 68.53; p < 0.05) of explaining the reasons for their decisions rather than using other strategies when patients expressed different preferences. Residents and surgeons who discussed treatment choices with their patients were more likely to allow their patients to participate in treatment decisions than those who did not (OR = 2.88; 95% CI = 1.90, 4.36; p < 0.001). Conclusions: While findings from this exploratory study are limited by its small sample size and its narrow focus on physicians rather than on both patients and physicians, they nonetheless establish a roadmap for future study, particularly with respect to challenges in Guatemala to meaningful SDM that arise from context-specific cultural norms and practices. Clinical Relevance: SDM as a tool of practice remains underutilized by orthopaedic surgeons in clinical practice in Guatemala. This study may encourage more discussions regarding SDM in orthopaedic surgery elsewhere in Central America and prompt discussion in the region on the value of and need for postgraduate training in this area. S hared decision-making (SDM) in health care involves communication between the provider and patient that results, on one end of the spectrum, in patient-directed decision-making and, on the opposite end, in physician-directed decision-making 1. SDM requires an information exchange between physicians and patients intended to reach a treatment decision; physicians present the range of options and make a recommendation that reflects consideration of patients' own values, preferences, and beliefs 2-5. In 2001, the Institute of Medicine identified informed participation by patients in clinical decision-making as an essential feature of high-quality care 6. Since 2004, SDM has been endorsed by leading healthcare organizations in Europe and the United States, including the American Medical Association and the American College of Critical Care Medicine 7-9. Empowering patients with information regarding treatment has been linked to positive patient outcomes, better physician-patient communication, lower decisional conflict, and more realistic patient expectations about treatment options 10. Although empirical data on physician attributes associated with Disclosure: Partial salary support was provided to S.N. Martinez-Siekavizza and F. Barchi by the
Supplemental material, Appendix_A_and_B for Neighborhood Disorganization and Women's Sanitati... more Supplemental material, Appendix_A_and_B for Neighborhood Disorganization and Women's Sanitation Utilization Practices in Mathare Valley, Kenya by Samantha Winter, Francis Barchi and Millicent Ningoma Dzombo in Environment and Behavior
Objetivo: La meta de esta colaboracion multiinstitucional fue desarrollar un curriculo innovador ... more Objetivo: La meta de esta colaboracion multiinstitucional fue desarrollar un curriculo innovador y de etica relevante localmente, para las enfermeras en Botsuana. Antecedentes: Las enfermeras de Botsuana se enfrentan a desafios eticos que se ven agravados por falta de recursos, presiones para manejar tareas mas alla de la formacion o de los niveles profesionales, estres laboral y aislamiento profesional. La capacidad para ensenar etica de enfermeria en el aula y en los entornos de practica profesional ha sido limitada. Metodos: Se probo un curriculo piloto, incluyendo los casos fijados en los contextos locales con los profesores de enfermeria en Botsuana en 2012. Resultados: Treinta y tres por ciento de los profesores indicaron que estarian mas comodos ensenando etica. Un numero considerable de profesores tenian mas probabilidades de presentar el Codigo Deontologico del Consejo Internacional de Enfermeras al ensenar, practicar y orientar como resultado de la formacion. Basados en lo...
Concurrent with efforts to establish national and regional biorepositories in Africa is widesprea... more Concurrent with efforts to establish national and regional biorepositories in Africa is widespread endorsement of ethics committees as stewards of the interests of individual donors and their communities. To date, ethics training programs for IRB members in Botswana have focused on ethical principles and international guidelines rather than on the ethical dimensions of specific medical technologies and research methodologies. Little is known about the knowledge and concerns of current and prospective IRB members in Botswana with respect to export, reuse, storage, and benefit-sharing of biospecimens. This qualitative study examined perspectives of IRB members in Botswana about the collection and use of biospecimens in research. Forty-one IRB members representing five committees in Botswana participated in discussions groups in March 2013. Transcriptions of audiotapes and field notes were analyzed to identify issues of concern that might be alleviated through education and capacity-bu...
Objectives: IPV is a significant public health problem worldwide impacting the physical and menta... more Objectives: IPV is a significant public health problem worldwide impacting the physical and mental health of millions of women. This study examines IPV in northern Botswana and identifies factors that may protect a woman from or predispose her to violence. Background: Despite research in other settings linking IPV to various risk factors including poverty, education, alcohol use and HIV status, very little empirical data exists about the phenomenon in Botswana. Methods: Structured interviews were administered to a random sample of 469 women aged 18 years and older in Maun, Botswana to gather socio-demographic information and assess women's experience with IPV. Logistic regression was used to identify factors predictive intimate partner violence in the past year. Results: 45% of respondents reported IPV in the past year. Major predictors of IPV included respondent alcohol use (OR 2.6, CI95 1.5, 4.6, p = .001), partner alcohol use (OR 2.4, CI95 1.5, 4.0, p = .001), depression (OR ...
Background: Little empirical data are available on the extent to which capacity-building programs... more Background: Little empirical data are available on the extent to which capacity-building programs in research ethics prepare trainees to apply ethical reasoning skills to the design, conduct, or review of research. A randomized controlled trial was conducted in Botswana in 2010 to assess the effectiveness of a case-based intervention using email to augment in-person seminars. Methods: University faculty and current and prospective IRB/REC members took part in a semester-long training program in research ethics. Participants attended two 2-day seminars and were assigned at random to one of two on-line arms of the trial. Participants in both arms completed on-line international modules from the Collaborative Institutional Training Initiative. Between seminars, intervention-arm participants were also emailed a weekly case to analyze in response to set questions; responses and individualized faculty feedback were exchanged via email. Tests assessing ethics knowledge were administered at the start of each seminar. The post-test included an additional section in which participants were asked to identify the ethical issues highlighted in five case studies from a list of multiple-choice responses. Results were analyzed using regression and ANOVA. Results: Of the 71 participants (36 control, 35 intervention) enrolled at the first seminar, 41 (57.7%) attended the second seminar (19 control, 22 intervention). In the intervention arm, 19 (54.3%) participants fully completed and 8 (22.9%) partially completed all six weekly cases. The mean score was higher on the post-test (30.3/40) than on the pre-test (28.0/40), and individual post-and pre-test scores were highly correlated (r = 0.65, p < 0.0001). Group assignment alone did not have an effect on test scores (p > 0.84), but intervention-arm subjects who completed all assigned cases answered an average of 3.2 more questions correctly on the post-test than others, controlling for pre-test scores (p = 0.003). Conclusions: Completion of the case-based intervention improved respondents' test scores, with those who completed all six email cases scoring roughly 10% better than those who failed to complete this task and those in the control arm. There was only suggestive evidence that intensive case work improved ethical issue identification, although there was limited ability to assess this outcome due to a high drop-out rate.
Background: Little empirical data are available on the extent to which capacity-building programs... more Background: Little empirical data are available on the extent to which capacity-building programs in research ethics prepare trainees to apply ethical reasoning skills to the design, conduct, or review of research. A randomized controlled trial was conducted in Botswana in 2010 to assess the effectiveness of a case-based intervention using email to augment in-person seminars. Methods: University faculty and current and prospective IRB/REC members took part in a semester-long training program in research ethics. Participants attended two 2-day seminars and were assigned at random to one of two on-line arms of the trial. Participants in both arms completed on-line international modules from the Collaborative Institutional Training Initiative. Between seminars, intervention-arm participants were also emailed a weekly case to analyze in response to set questions; responses and individualized faculty feedback were exchanged via email. Tests assessing ethics knowledge were administered at the start of each seminar. The post-test included an additional section in which participants were asked to identify the ethical issues highlighted in five case studies from a list of multiple-choice responses. Results were analyzed using regression and ANOVA. Results: Of the 71 participants (36 control, 35 intervention) enrolled at the first seminar, 41 (57.7%) attended the second seminar (19 control, 22 intervention). In the intervention arm, 19 (54.3%) participants fully completed and 8 (22.9%) partially completed all six weekly cases. The mean score was higher on the post-test (30.3/40) than on the pre-test (28.0/40), and individual post-and pre-test scores were highly correlated (r = 0.65, p < 0.0001). Group assignment alone did not have an effect on test scores (p > 0.84), but intervention-arm subjects who completed all assigned cases answered an average of 3.2 more questions correctly on the post-test than others, controlling for pre-test scores (p = 0.003). Conclusions: Completion of the case-based intervention improved respondents' test scores, with those who completed all six email cases scoring roughly 10% better than those who failed to complete this task and those in the control arm. There was only suggestive evidence that intensive case work improved ethical issue identification, although there was limited ability to assess this outcome due to a high drop-out rate.
Background: Training in responsible conduct of research and human subjects protections (RCR/HSP) ... more Background: Training in responsible conduct of research and human subjects protections (RCR/HSP) is seldom included in postgraduate medical education in low-and middle-income (LMIC) countries despite requirements that residents undertake research projects. Investigators introduced a Spanishlanguage training program in RCR/HSP for surgical residents in Guatemala using "off-the-shelf" on-line materials, developed a new in-person curriculum specific to the local context, and compared the two teaching modalities with the aim of generating recommendations to improve resident training. Methods: In 2018, surgical residents in three large urban hospitals in Guatemala City completed two on-line programs in RCR/HSP as well as pre-and post-training assessments. Residents in the intervention arm also completed seven weeks of in-person training. Assessments tested awareness of key concepts in the on-line courses with particular attention to international and Guatemalan research regulations. Group differences in matched (pre-and post-) mean scores were analyzed using t-tests to determine gains by study arm assignment. Results: Of the 160 surgical residents, 140 completed preand post-training assessments and were included in the analytic sample. Overall mean scores improved from 52.7 to 58.7 points out of 100.The differences in gains between the two arms were very small and there was insufficient statistical power to detect significance. Trainees completing inperson training reported greater confidence in recognizing ethical issues, understanding the legal and ethical requirements for research, and identifying, reporting and avoiding scientific misconduct than trainees who completed on-line training only. Conclusion: Differences in gains in RCR/HSP knowledge and self-efficacy between trainees completing on-line training only and those completing in-person as well as on-line training are too modest to preference one mode of instruction over another in this setting. Given the limited availability of RCR/HSP faculty, financial resources, and time in the surgical training schedule, however, the investigators recommend that academic authorities in Guatemala consider on-line training programs in RCR/HSP in all surgical residency programs as an affordable and scalable strategy to build ethical research skills in its surgical workforce. Background While RCR/HSP/research ethics training programs can vary significantly in content, they share the
Background: Concurrent with efforts to establish national and regional biorepositories in Africa ... more Background: Concurrent with efforts to establish national and regional biorepositories in Africa is widespread endorsement of ethics committees as stewards of the interests of individual donors and their communities. To date, ethics training programs for IRB members in Botswana have focused on ethical principles and international guidelines rather than on the ethical dimensions of specific medical technologies and research methodologies. Little is known about the knowledge and concerns of current and prospective IRB members in Botswana with respect to export, reuse, storage, and benefit-sharing of biospecimens. Methods: This qualitative study examined perspectives of IRB members in Botswana about the collection and use of biospecimens in research. Forty-one IRB members representing five committees in Botswana participated in discussions groups in March 2013. Transcriptions of audiotapes and field notes were analyzed to identify issues of concern that might be alleviated through education and capacity-building, and areas that required ongoing discussion or additional regulatory guidance. Results: Areas of concern included lack of understanding among patients and providers about the use of biospecimens in clinical care and research; reuse of biospecimens, particularly issues of consent, ownership and decision-making; export of specimens and loss of control over reuse and potential benefits; and felt need for regulatory guidance and IRB-member training. Local belief systems about bodily integrity and strong national identity in the construct of benefits may be at odds with initiatives that involve foreign biorepositories or consider such collections to be global public goods. Conclusion: Education is needed to strengthen IRB-member capacity to review and monitor protocols calling for the collection and use of biospecimens, guided by clear national policy on priority-setting, partnerships, review, and oversight. Engagement with local stakeholders is needed to harmonize fundamentally different ways of understanding the human body and community identity with the aims of contemporary biomedicine.
Nonprofit and Voluntary Sector Quarterly, Sep 1, 2007
The reader who picks up this book will no doubt marvel at the fecundity of Dennis Young, and just... more The reader who picks up this book will no doubt marvel at the fecundity of Dennis Young, and justifiably so. This is Dennis Young's fifth book in the past 10 years. It arises from papers presented at the second conference of the National Center on Nonprofit Enterprise (NCNE ...
Background: Ethical and regulatory guidance on the collection and use of human biospecimens (HBS)... more Background: Ethical and regulatory guidance on the collection and use of human biospecimens (HBS) for research forms an essential component of national health systems in Sub-Saharan Africa (SSA), where rapid advances in genetic-and genomic-based technologies are fueling clinical trials involving HBS and the establishment of large-scale biobanks. Methods: An extensive multi-level search for publicly available ethics regulatory guidance was conducted for each SSA country. A second review documented active trials listed in the WHO International Clinical Trials Registry Platform as of January 2015 in which HBS collection was specified in the protocol. Findings were combined to determine the extent to which countries that are study sites for HBS-related research are supported by regulatory guidance language on the collection, use, ownership and storage of biospecimens. Results: Of the 49 SSA countries, 29 had some form of national ethics guidance, yet only 17 provided language relating to HBS-related research, with specific guidance on consent (14), ownership (6), reuse (10), storage (9), and export/import/ transfer (13). Ten countries accounted for 84 % of the active clinical trials involving the collection of HBS in SSA. All except one of these countries were found to have some national guidance in the form of regulations, codes of ethics, and/or standard operating procedures; however, only seven of the ten offered any language specific to HBS. Conclusions: Despite the fact that the bulk of registered clinical trials in SSA involving HBS, as well as existing and proposed sites for biorepositories under the H3Africa Initiative, are currently situated in countries with the most complete ethics and regulatory guidance, variability in the regulations themselves may create challenges for planned and future pan-African collaborations and may require legislative action at the national level to revise. Countries in SSA that still lack regulatory guidance on HBS will require extensive health system strengthening in ethics governance before they can be full participants in the modern research enterprise.
Case study teaching has gained a strong foothold in science education. Advances in the field incl... more Case study teaching has gained a strong foothold in science education. Advances in the field include: q variations on methodology, from whole class discussion to the jigsaw approach q an increase in educational resources on the topic q over a thousand studies that show improved learning when case studies are used q a survey that illustrates students enjoy and benefit from case studies more on author
Background: A growing number of studies suggest that informal (illicit) fees for healthcare are p... more Background: A growing number of studies suggest that informal (illicit) fees for healthcare are prevalent in low and middle income countries. These fees are regressive and deeply embedded, often proving impervious to policy interventions. Methods: The author conducted a critical interpretive synthesis of peer reviewed literature, grey literature, global standards, and donor funding related to informal fees in order to assess their prevalence, critically interrogate the paradigms that are applied to understanding them, assess to what extent fees are addressed in global policy and funding, and propose future areas for policy and research. In contrast to a systematic review, critical interpretive synthesis fosters crossdisciplinary research that encompasses quantitative, qualitative, and conceptual work. As such, it can open new avenues of discussion on persistent public health problems whose roots reach into the political, social, and cultural realms. Pursuant to established methods for critical interpretive synthesis, key terms were searched in databases and selected journals. Resources were added through an iterative process of developing new lines of enquiry from the initial papers identified, and obtaining resources identified in paper citations. Findings: Patients and providers perceive informal fees on a continuum from gift giving to forced payment. The often disrespectful and coercive nature of fee requests undermines trust and future utilization, and perpetuates helplessness and disempowerment. Health system "hardware" drivers, such as low salaries, scarcity of health workers, and poor infrastructure are widely explored in the literature. "Software" drivers, such as values and norms, are less explored, except in a few qualitative investigations. Policy literature is dominated by rational choice approaches. While the prevalence of fees is well documented, maternal health strategies and donor policies acknowledge the relevance of all out of pocket fees (both formal and informal) with little e if any e attention to informal fees as such. Interpretation: The empirical literature about informal fees is limited by the paradigms applied. Rational choice approaches ignore cultural and practical meanings. International standards and strategies reflect this limitation, presumably exacerbated by reluctance to describe illicit practices. Two trends in international health and development offer opportunities. First, the emerging quality agenda in global health could include informal fees. Second, the governance field is evolving to focus on addressing the function of informal practice, rather than resorting solely to regulation and incentives to end it. Critical interpretive synthesis insights on the function of informal fees e from expression of consumer power to resistance of the health system e illuminates possible interventions beyond simple prohibition or incentives. This study is notable for its examination of both public health literature and policy. However, all data regarding informal fees were secondary, the key limitation of this study.
Journal of medical education and curricular development, 2019
METhOdS: The new ethics curriculum (PRACTICE) incorporates ethics short-courses into the universi... more METhOdS: The new ethics curriculum (PRACTICE) incorporates ethics short-courses into the university's system of nontraditional, creditbearing electives offered to students as part of their 6-year undergraduate medical education and complements existing didactic courses in normative ethics. Structured case-based activities allow for flexibility in design and scheduling, do not compete with core requirements of the existing curriculum, and enable students to develop critical reasoning approaches to ethical situations they will encounter in medical practice. Two preliminary workshops provided teaching opportunities for the faculty, stimulated student interest in future ethics courses, and provided an evidence base to guide the development of a formal curriculum. RESUlTS: The elective currently includes six 2-hour modules, each of which is a stand-alone unit with learning goals and objectives, brief didactic lecture, assigned readings, discussion case, and assessment. To date, more than 110 students have participated in the workshops and courses. Student feedback and evaluations are being used to refine pedagogical approaches and drive future course content. COnClUSiOnS: The PRACTICE course format offers a transformative model for ethics education in Guatemala that can be used in medical education throughout the country and region.
Background: Shared decision-making (SDM) is widely accepted as an essential feature of patient-ce... more Background: Shared decision-making (SDM) is widely accepted as an essential feature of patient-centered care. However, to our knowledge, there has been no empirical research on the factors that influence orthopaedic surgeons' use of SDM in Guatemala. Methods: Questions about physician attributes and SDM were included in a 2016 electronic survey distributed to the 221 members of the Asociación Guatemalteca de Ortopedia y Traumatología (AGOT). Results: A total of 114 (52%) of the AGOT-registered orthopaedic surgery residents and orthopaedic surgeons who were sent surveys returned them, and 79 of these surveys contained complete responses to study variables of interest. Of the 79 participants with complete responses, 73% reported that they discussed treatment options most of the time or always with their patients and 81% reported that they explained the reasons for treatment choices. Compared with residents, surgeons who had completed their residency in orthopaedic surgery or had subspecialty training had greater odds (odds ratio [OR] = 9.62; 95% confidence interval [CI] = 1.35, 68.53; p < 0.05) of explaining the reasons for their decisions rather than using other strategies when patients expressed different preferences. Residents and surgeons who discussed treatment choices with their patients were more likely to allow their patients to participate in treatment decisions than those who did not (OR = 2.88; 95% CI = 1.90, 4.36; p < 0.001). Conclusions: While findings from this exploratory study are limited by its small sample size and its narrow focus on physicians rather than on both patients and physicians, they nonetheless establish a roadmap for future study, particularly with respect to challenges in Guatemala to meaningful SDM that arise from context-specific cultural norms and practices. Clinical Relevance: SDM as a tool of practice remains underutilized by orthopaedic surgeons in clinical practice in Guatemala. This study may encourage more discussions regarding SDM in orthopaedic surgery elsewhere in Central America and prompt discussion in the region on the value of and need for postgraduate training in this area. S hared decision-making (SDM) in health care involves communication between the provider and patient that results, on one end of the spectrum, in patient-directed decision-making and, on the opposite end, in physician-directed decision-making 1. SDM requires an information exchange between physicians and patients intended to reach a treatment decision; physicians present the range of options and make a recommendation that reflects consideration of patients' own values, preferences, and beliefs 2-5. In 2001, the Institute of Medicine identified informed participation by patients in clinical decision-making as an essential feature of high-quality care 6. Since 2004, SDM has been endorsed by leading healthcare organizations in Europe and the United States, including the American Medical Association and the American College of Critical Care Medicine 7-9. Empowering patients with information regarding treatment has been linked to positive patient outcomes, better physician-patient communication, lower decisional conflict, and more realistic patient expectations about treatment options 10. Although empirical data on physician attributes associated with Disclosure: Partial salary support was provided to S.N. Martinez-Siekavizza and F. Barchi by the
Supplemental material, Appendix_A_and_B for Neighborhood Disorganization and Women's Sanitati... more Supplemental material, Appendix_A_and_B for Neighborhood Disorganization and Women's Sanitation Utilization Practices in Mathare Valley, Kenya by Samantha Winter, Francis Barchi and Millicent Ningoma Dzombo in Environment and Behavior
Objetivo: La meta de esta colaboracion multiinstitucional fue desarrollar un curriculo innovador ... more Objetivo: La meta de esta colaboracion multiinstitucional fue desarrollar un curriculo innovador y de etica relevante localmente, para las enfermeras en Botsuana. Antecedentes: Las enfermeras de Botsuana se enfrentan a desafios eticos que se ven agravados por falta de recursos, presiones para manejar tareas mas alla de la formacion o de los niveles profesionales, estres laboral y aislamiento profesional. La capacidad para ensenar etica de enfermeria en el aula y en los entornos de practica profesional ha sido limitada. Metodos: Se probo un curriculo piloto, incluyendo los casos fijados en los contextos locales con los profesores de enfermeria en Botsuana en 2012. Resultados: Treinta y tres por ciento de los profesores indicaron que estarian mas comodos ensenando etica. Un numero considerable de profesores tenian mas probabilidades de presentar el Codigo Deontologico del Consejo Internacional de Enfermeras al ensenar, practicar y orientar como resultado de la formacion. Basados en lo...
Concurrent with efforts to establish national and regional biorepositories in Africa is widesprea... more Concurrent with efforts to establish national and regional biorepositories in Africa is widespread endorsement of ethics committees as stewards of the interests of individual donors and their communities. To date, ethics training programs for IRB members in Botswana have focused on ethical principles and international guidelines rather than on the ethical dimensions of specific medical technologies and research methodologies. Little is known about the knowledge and concerns of current and prospective IRB members in Botswana with respect to export, reuse, storage, and benefit-sharing of biospecimens. This qualitative study examined perspectives of IRB members in Botswana about the collection and use of biospecimens in research. Forty-one IRB members representing five committees in Botswana participated in discussions groups in March 2013. Transcriptions of audiotapes and field notes were analyzed to identify issues of concern that might be alleviated through education and capacity-bu...
Objectives: IPV is a significant public health problem worldwide impacting the physical and menta... more Objectives: IPV is a significant public health problem worldwide impacting the physical and mental health of millions of women. This study examines IPV in northern Botswana and identifies factors that may protect a woman from or predispose her to violence. Background: Despite research in other settings linking IPV to various risk factors including poverty, education, alcohol use and HIV status, very little empirical data exists about the phenomenon in Botswana. Methods: Structured interviews were administered to a random sample of 469 women aged 18 years and older in Maun, Botswana to gather socio-demographic information and assess women's experience with IPV. Logistic regression was used to identify factors predictive intimate partner violence in the past year. Results: 45% of respondents reported IPV in the past year. Major predictors of IPV included respondent alcohol use (OR 2.6, CI95 1.5, 4.6, p = .001), partner alcohol use (OR 2.4, CI95 1.5, 4.0, p = .001), depression (OR ...
Background: Little empirical data are available on the extent to which capacity-building programs... more Background: Little empirical data are available on the extent to which capacity-building programs in research ethics prepare trainees to apply ethical reasoning skills to the design, conduct, or review of research. A randomized controlled trial was conducted in Botswana in 2010 to assess the effectiveness of a case-based intervention using email to augment in-person seminars. Methods: University faculty and current and prospective IRB/REC members took part in a semester-long training program in research ethics. Participants attended two 2-day seminars and were assigned at random to one of two on-line arms of the trial. Participants in both arms completed on-line international modules from the Collaborative Institutional Training Initiative. Between seminars, intervention-arm participants were also emailed a weekly case to analyze in response to set questions; responses and individualized faculty feedback were exchanged via email. Tests assessing ethics knowledge were administered at the start of each seminar. The post-test included an additional section in which participants were asked to identify the ethical issues highlighted in five case studies from a list of multiple-choice responses. Results were analyzed using regression and ANOVA. Results: Of the 71 participants (36 control, 35 intervention) enrolled at the first seminar, 41 (57.7%) attended the second seminar (19 control, 22 intervention). In the intervention arm, 19 (54.3%) participants fully completed and 8 (22.9%) partially completed all six weekly cases. The mean score was higher on the post-test (30.3/40) than on the pre-test (28.0/40), and individual post-and pre-test scores were highly correlated (r = 0.65, p < 0.0001). Group assignment alone did not have an effect on test scores (p > 0.84), but intervention-arm subjects who completed all assigned cases answered an average of 3.2 more questions correctly on the post-test than others, controlling for pre-test scores (p = 0.003). Conclusions: Completion of the case-based intervention improved respondents' test scores, with those who completed all six email cases scoring roughly 10% better than those who failed to complete this task and those in the control arm. There was only suggestive evidence that intensive case work improved ethical issue identification, although there was limited ability to assess this outcome due to a high drop-out rate.
Uploads
Papers by Francis Barchi