Could Covid-19 Challenge Trials be Reasonably Rejected as Morally Impermissible? A Contractualist Perspective

"In challenge experiments, research subjects are exposed to a pathogen agent in order to study a certain disease, and/or to determine the amount of infecting dosage, and/or to test the efficacy of a vaccine. General discussions on challenge experiments have already been undertaken in contemporary medical research and these uptakes generate an ongoing debate about their ethical permissibility. Recently, these research issues have focused also on Covid-19 challenge trials in which the determination of the infecting dosage, the efficacy test of vaccines and the immune response of people who already passed through the disease have been investigated. In my paper, I will offer a philosophical perspective on these specific trials, based on T. M. Scanlon’s version of contractualism. I will start by briefly presenting the features of Scanlon’s contractualist ethical theory and by formulating the moral principles which could support Covid-19 challenge trials. Thereafter, I will search for reasonable rejections in order to be able to establish whether this type of trials is ethically permissible or not. In the second part of my presentation, I will tackle Scanlon’s view on medical experimentation in general and his subsequent distinction between direct harm and accidental harm, in order to argue for its relevance for the case of Covid-19 challenge trials. I will demonstrate that according to the general contractualist perspective, these trials are not ethically justifiable. Finally, I will search for a consolidation of my argument, by considering a tighter version of contractualism to be applied to the domain of medical research. Research reported in this presentation was supported by Fogarty International Center of the National Institutes of Health under award number R25TW01051. "

Advancing collaborations in health research and clinical trials in Sub-Saharan Africa: development and implementation of a biostatistical collaboration module in the Masters in Biostatistics Program at Stellenbosch University

Background Sub-Saharan Africa continues to carry a high burden of communicable diseases such as TB and HIV and non-communicable diseases such as hypertension and other cardiovascular conditions. Although investment in research has led to advances in improvements in outcomes, a lot still remains to be done to build research capacity in health. Like many other regions in the world, Sub-Saharan Africa suffers from a critical shortage of biostatisticians and clinical trial methodologists. Methods Funded through a Fogarty Global Health Training Program grant, the Faculty of Medicine and Health Sciences at Stellenbosch University in South Africa established a new Masters Program in Biostatistics which was launched in January 2017. In this paper, we describe the development of a biostatistical and clinical trials collaboration Module, adapted from a similar course offered in the Health Research Methodology program at McMaster University. Discussion Guided by three core principles (experiential learning; multi-/inter-disciplinary approach; and formal mentorship), the Module aims to advance biostatistical collaboration skills of the trainees by facilitating learning in how to systematically apply fundamental statistical and trial methodological knowledge in practice while strengthening some soft skills which are necessary for effective collaborations with other healthcare researchers to solve health problems. We also share some preliminary findings from the first four cohorts that took the Module in January–November 2018 to 2021. We expect that this Module can provide an example of how to improve biostatistical and clinical trial collaborations and accelerate research capacity building in low-resource settings. Funding source Fogarty International Center of the National Institutes of Health.

Effect of Access to Workplace Supports for Breastfeeding Among Formally Employed Mothers in Kenya

Objectives We evaluated the availability of workplace breastfeeding (BF) supports, and the associations between these supports and BF practices among formally employed mothers in Kenya – where many women work in horticulture farms and legislation requiring workplace BF supports is being implemented. We hypothesized that the availability of supports would be associated with a higher prevalence and greater odds of exclusive breastfeeding (EBF). Methods We conducted repeated cross-sectional surveys among formally employed mothers at 1–4 days, 6 weeks, 14 weeks, and 36 weeks (to estimate 24 weeks) postpartum at 3 health facilities in Naivasha from Sept. 2018 to Oct. 2019, 13 months after the 2017 Kenyan Health Act, which requires workplace BF support, was passed. We evaluated the associations of workplace BF supports with EBF practices using tests of proportions and adjusted logistic regression. Results Among formally employed mothers (n = 564), reported workplace supports included on-site housing (16.8%), on-site daycare (9.4%), and private lactation spaces (2.8%). Mothers who used workplace on-site childcare were more likely to practice EBF than mothers who used community- or home-based childcare at both 6 weeks (95.7% versus 82.4%, p = 0.030) and 14 weeks (60.6% versus 22.2%, p < 0.001; [aOR (95% CI) = 5.11 (2.3, 11.7)]. Likewise, mothers who visited daycares at or near workplaces were more likely to practice EBF (70.0%) compared to those who did not visit a daycare (34.7%, p = 0.005) at 14-weeks. Among all mothers, 84.6% with access to workplace private lactation spaces practiced EBF, compared to 55.6% without such spaces, p = 0.037. Mothers who live in on-site housing were twice as likely [aOR (95% CI) = 2.06 (1.25, 3.41)] to practice EBF compared to those without access to on-site housing. Conclusions Formally employed mothers in Kenya who used on-site childcare, lived in on-site housing, and had access to private workplace lactation rooms are more likely to practice EBF than mothers who lack these supports, while the use of community-based childcare in this context is associated with a lower prevalence of EBF. As the Kenya Health Act is implemented, provision of these supports and strategies to help women visit their children in daycare can enable EBF among employed mothers. Funding Sources NIH Fogarty International Center.

Lower Prevalence of Exclusive Breastfeeding Among Employed Mothers: Results from a Cross-Sectional Survey in Naivasha, Kenya

Objectives We compared the prevalence of exclusive (EBF) and continued breastfeeding (BF) among formally employed, informally/self-employed, and non-employed mothers in Naivasha, Kenya, where the commercial agriculture and hospitality industries employ many women. Methods We conducted a cross-sectional survey from Sept. 2018 to Oct. 2019. Mothers of infants presenting to 3 health facilities were asked about their BF status and reasons for EBF cessation at four postpartum points: prior to discharge (n = 296), 6-weeks (n = 298), 14-weeks (n = 295), and 36-weeks (n = 297). BF status at 24-weeks was estimated at the 36-week visit. We used separate multivariable logistic regression models to compare the prevalence of early initiation (within 1-hr of birth) and EBF, between groups at each time-point, controlling for maternal age, education, HIV status, delivery setting, delivery type, and infant morbidity. We collapsed the non-employed, informal and self-employed groups into one category due to a lack of differences between these groups across all analyses. Results 65.6% of those formally employed reported early initiation of BF, compared to 75.6% without formal employment, although differences were not significant in adjusted models [OR = 0.62, 95% CI = 0.35, 1.14]. Upon hospital discharge, >96% in both groups reported practicing EBF. At 6 weeks, EBF prevalence did not significantly differ between mothers with (94.0%) and without formal employment (86.6%), [OR = 2.00, 95% CI = 0.81, 4.95]. By 14-weeks, formally employed mothers had a lower EBF prevalence compared to mothers without formal employment, 47.2% versus 78.8%, [OR = 0.19, 95% CI = 0.11, 0.33]. The lower EBF prevalence among formally employed mothers was also observed at 24-weeks (15.8% versus 48.9% [OR = 0.72, 95% CI = 0.11, 0.33]. At 36-weeks, the prevalence of continued BF was ≥98% in both groups [OR = 0.72, 95% CI = 0.11, 4.89]. The primary reasons reported for early EBF cessation were return to work (46.5%), belief that it is appropriate to feed other foods based on the child's age (33.5%), and perceived milk insufficiency (13.7%). Conclusions Formally employed mothers in Kenya experience shorter durations of EBF compared to mothers who are not formally employed by 14-weeks postpartum. These mothers may benefit from additional supports to help prolong the period of EBF. Funding Sources NIH Fogarty International Center.