A model for obtaining parental informed consent for HIV clinical trials research with pediatric patients

Philosophiae Doctor - PhDAll research involving human subjects should be conducted in accordance to the general ethical principles of autonomy or respect for persons, beneficence and justice. Competent adults can exercise their autonomy and can choose to take on risk for the sake of others, therefore are able to protect their own interests while in the pediatric research the ‗best interests of the child‘ takes precedence over autonomy. In other words giving informed consent in the pediatric context, is not ‗who decides‟ but „what is the best decision for the child‟. Due to lack of consensus gold standard to guide researchers and assess the quality of parental informed consent in Botswana, the practical and ethical challenges posed in obtaining parental informed consent for child enrolment in pediatric HIV clinical trials were examined. The study aimed to determine the readability of the consent forms used in pediatric HIV clinical trials; assess communication methods, practices and perceptions of the trial staff regarding the informed consent process; assess the extent to which parents recall and understand the information disclosed to them and their satisfaction with the informed consent process as well as to identify and describe the reasons for parental approval to child enrolment into HIV clinical trial studies

Building Research Capacity in Botswana: A Randomized Trial Comparing Training Methodologies in the Botswana Ethics Training Initiative

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 \u3c 0.0001). Group assignment alone did not have an effect on test scores (p \u3e 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\u27 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

Promoting ethics and integrity in research and innovation for development in Africa : the role of Africa’s science granting councils : a discussion paper prepared for the Science Granting Councils Initiative (SGCI) master class of 2021

The paper advocates for Science Granting Councils (SGC) to enhance ethics and integrity activities as part of their responsibilities for supporting ethical conduct of research and innovation. SGCs should play a leading role in facilitating development of, or revision of research policies to ensure that ethics and integrity issues are addressed satisfactorily. The African science enterprise through SGCs, needs to adapt to growing concerns if it is to remain relevant. The paper provides an in- depth report of current and existing challenges within the purview of the Science Granting Councils, which was provided to SGCs from 15 participating African countries at the SGCI Masterclass event

Strengthening the role of African Science Granting Councils in promoting ethics and integrity in research and innovation

“Ethics and Integrity in Research and Innovation in Development” was the theme of the 2020 Science Granting Council’s (SGC) Masterclass. African SGCs need to enhance their activities and roles as part of their responsibilities in supporting ethical conduct of research and innovation. The African science enterprise through SGCs, needs to adapt to growing concerns if it is to remain relevant. SGCs should play a leading role in facilitating development of, or revision of research policies to ensure that ethics and integrity issues are addressed satisfactorily. This policy brief is a response to the growth in research being conducted in African countries.United Kingdom’s Foreign, Commonwealth and Development Office (FCDO)Swedish International Development Cooperation Agency (Sida)South African’s National Research Foundation (NRF)German Research Foundation (DFG

Ending the evidence gap for pregnancy, HIV and co-infections: ethics guidance from the PHASES project.

INTRODUCTION: While pregnant people have been an important focus for HIV research, critical evidence gaps remain regarding prevention, co-infection, and safety and efficacy of new antiretroviral therapies in pregnancy. Such gaps can result in harm: without safety data, drugs used may carry unacceptable risks to the foetus or pregnant person; without pregnancy-specific dosing data, pregnant people face risks of both toxicity and undertreatment; and delays in gathering evidence can limit access to beneficial next-generation drugs. Despite recognition of the need, numerous barriers and ethical complexities have limited progress. We describe the process, ethical foundations, recommendations and applications of guidance for advancing responsible inclusion of pregnant people in HIV/co-infections research. DISCUSSION: The 26-member international and interdisciplinary Pregnancy and HIV/AIDS: Seeking Equitable Study (PHASES) Working Group was convened to develop ethics-centred guidance for advancing timely, responsible HIV/co-infections research with pregnant people. Deliberations over 3 years drew on extensive qualitative research, stakeholder engagement, expert consultation and a series of workshops. The guidance, initially issued in July 2020, highlights conceptual shifts needed in framing research with pregnant people, and articulates three ethical foundations to ground recommendations: equitable protection from drug-related risks, timely access to biomedical advances and equitable respect for pregnant people's health interests. The guidance advances 12 specific recommendations, actionable within the current regulatory environment, addressing multiple stakeholders across drug development and post-approval research, and organized around four themes: building capacity, supporting inclusion, achieving priority research and ensuring respect. The recommendations describe strategies towards ethically redressing the evidence gap for pregnant people around HIV and co-infections. The guidance has informed key efforts of leading organizations working to advance needed research, and identifies further opportunities for impact by a range of stakeholder groups. CONCLUSIONS: There are clear pathways towards ethical inclusion of pregnant people in the biomedical research agenda, and strong agreement across the HIV research community about the need for - and the promise of - advancing them. Those who fund, conduct, oversee and advocate for research can use the PHASES guidance to facilitate more, better and earlier evidence to optimize the health and wellbeing of pregnant people and their children

Profile of acute poisoning in three health districts of Botswana

Background: This study sought to characterise acute poisoning cases seen in three health districts of Botswana. Method: A retrospective review of patients’ records was conducted and included patients treated from January 2004 to December 2005. Data on the demographic status of the patients, information about the poisonous agent(s) involved, and the circumstances and outcomes of the poisoning incidents were recorded on a pre-tested data collection form. Results: A total of 590 cases of acute poisoning were included in the analysis. The most affected age category was that of children aged less than six years, who constituted 33.4% of the cases. Most incidents were recorded in the urban district of Gaborone. Seventy-eight percent (78%) of the incidents were accidental, with the remainder being intentional. The poisonous agents involved were pharmaceuticals (26.6%), natural toxins (25.6%), household products (14.6%), foods (14.4%), alcohol (6.9%), traditional medicines (4.7%), unspecified agents (3.2%), and agrochemicals (2.7%). The most common route of poison exposure was by oral (82.2%), followed by dermal contact (16.5%), while the inhalation of gases occurred in 1.2% of cases. An incidence rate of 4.7/1000, a case fatality rate of 3.8/100, and 1.5% of deaths were recorded over the two-year period. Conclusion: In conclusion, it can be stated that acute poisoning involved mainly young children and resulted in an incidence rate of 4.7/1000, a case fatality rate of 3.8/100, and 1.5% of deaths over the two-year period. There were differences based on age category, gender and residence of the victims, the types of toxic agents involved, as well as the circumstances and the outcomes of the poisoning incidents. Given the fact that pharmaceuticals, natural toxins, household products and foods were the agents most commonly involved, targeted interventions should take these differences into account in addressing the problem of acute poisoning

Feeding back of individual genetic results in Botswana: mapping opportunities and challenges

Abstract Purpose We explored the views of Botswana stakeholders involved in developing, implementing and applying ethical standards for return of individual study results from genomic research. This allowed for mapping opportunities and challenges regarding actionability requirements that determine whether individual genomic research results should be fed back. Methods Using in-depth interviews, this study explored the views of sixteen (16) stakeholders about the extent, nature and timing of feedback of individual genomic research findings, including incidental findings that arise in the context of African genomics research. Coded data was analyzed through an iterative process of analytic induction to document and interpret themes. Results Overall, respondents were of the view that feedback of actionable individual genomic results was an important outcome that could benefit participants. However, a number of themes surfaced that pointed to opportunities and challenges that exist in Botswana that could help in planning for feeding back of individual genomic results that were mapped. Some of the opportunities cited by the respondents included the existence of good governance; democracy and humanitarianism; universal healthcare system; national commitment to science; research and innovation to transform Botswana into a knowledge-based economy; and applicable standard of care which could promote actionability. On the other hand, contextual issues like the requirement for validation of genomic research results in accredited laboratories, high cost of validation of genomic results, and linkage to care, as well as lack of experts like genomic scientists and counselors were considered as challenges for return of individual results. Conclusion We propose that decisions whether and which genomic results to return take into consideration contextual opportunities and challenges for actionability for return of results in a research setting. This is likely to avoid or minimize ethical issues of justice, equity and harm regarding actionability decisions

Participant views on practical considerations for feedback of individual genetic research results: a case study from Botswana

ABSTRACTKey to discussions around feedback of individual results from genomics research are practical questions on how such results should be fed back, by who and when. However, there has been virtually no work investigating these practical considerations for feedback of individual genetic results in the context of low-and middle-income countries (LMICs), especially in Africa. Consequently, we conducted deliberative focus group discussions with 6 groups of adolescents (n = 44) who previously participated in a genomics study in Botswana as well as 6 groups of parents and caregivers (n = 49) of children who participated in the same study. We also conducted in-depth interviews with 6 adolescents and 6 parents or caregivers. Our findings revealed that both adolescents and parents would prefer to receive their individual genetic results in person, with adolescents preferring researchers to provide feedback, while parents preferred doctors who are associated with the study. Both adolescents and parents further expressed that feedback should be supported by counselling but differed on the timing of feedback, with preferences ranging from feedback as quickly as possible to feedback at project end. In conclusion, decisions on practicalities for feedback of results should be done in account of participants’ context and considerations of participants’ preferences

The features and qualities of online training modules in research ethics: a case study evaluating their institutional application for the University of Botswana

Research ethics remains a cornerstone of the scientific enterprise as it defines the boundaries of responsible conduct of research. Our aim was to systematically identify, review and test online training courses in research ethics which could be considered most appropriate for future training at the University of Botswana (UB). We used an evaluative tool that included both descriptive and evaluative criteria for assessing the strengths, weaknesses and appropriateness of 10 online research ethics courses which are publicly accessible. We then assembled Focus Group Discussions (FGDs) to engage the UB community to select the best 2–3 online courses that are considered most suited for use in future training of research ethics at UB. Twenty respondents participated in three FGDs. Our findings show that there is limited research ethics training capacity in low resourced academic institutions like UB. Online training opportunities could be used to address this challenge. Our analysis reveal that out of the 10 online courses reviewed, CITI program, Family Health International, and Training and Resource in Research Ethics Evaluation have characteristics that would make them suitable for utilization in Botswana. We believe the findings from this case study will be of value to other similarly situated research institutions