New models of public health research: optimizing ethics in research using public health data in resource limited countries

Progress in public health retains the greatest potential to advance global health and innovation through research. The research arena has revolutionized through many methodological changes: changing research environments require changes to ethical practices. This is especially crucial in contexts where ethical growths are developmental. The health and demographic surveillance system (HDSS) is a public health model in the Global South which provides critical data for evidence generation. The model is common in countries where data availability for public health and for research is otherwise limited because of inadequate resources. Resource limitations and the general dwindling of global funding internationally require strategic alignment of health goals with cost effective research methodologies like research using public health data (RUPD). RUPD has therefore become a key tool in developing countries’ research progress towards meeting global health goals like the Sustainable Development Goals (SDGs). Africa is poised to meet the SDGs with RUPD as an efficient option for increasing scientific productivity without tallying up cost. The role of RUPD in the continent’s public health agenda is established. Like every new endeavor however, RUPD raises its own set of features, changes, and challenges for which there exists a comparatively narrower frame of opportunities for ethical practice than in traditional research. The goal of this project was primarily to evaluate whether and how to optimize or make the most possible good of traditional research ethics principles in RUPD. Optimization of ethical principles would offer the best protection of the interests and wellbeing of RUPD populations. This empirical study adopts a critical applied ethics approach, comprising a quantitative survey and qualitative interviews involving practitioners knowledgeable about RUPD in Ethiopia, Ghana, and Tanzania. The main findings are that the HDSS model offers a fertile environment for optimizing ethics in RUPD beyond the commonly required practice of research ethics review and protection of confidentiality. Optimizing the longstanding ethical principles that have brought major successes to the biomedical research arena is desirable for RUPD populations, science, and for the general development of ethics in the South. This study shows that doing so is possible without necessarily sacrificing values of comparable worth. Using critical applied ethics also permitted consideration to emerging global issues of important implications for the future of RUPD. Therefore, this thesis secondarily presents empirical views encapsulating both the affirmation and skepticism about public health data sharing from Africa. Such views are largely absent in ongoing data sharing deliberations and in the literature. They highlight issues affecting the under-resourced data-producing scientist and the new challenges in data sharing. Of additional interest to this study was the arrival of the new CIOMS Guidelines this past month in December 2016. It is better suited to RUPD than previous versions, but still leaves room for more to be done towards ethics in RUPD

Ethical principles for promoting health research data sharing with sub-Saharan Africa

A powerful feature of global health research is data-sharing with regions which bear the heaviest burden of disease. It offers novel opportunities for aggregating data to address critical global health challenges in ways higher than relying on individual studies. Yet there exist important stratifiers of the capacity to share data, particularly across the Global North-South divide. Systemic challenges that characterize sub-Saharan Africa and disadvantage the region's scientific productivity threaten the burgeoning data-sharing culture too. Like all endeavors requiring equal commitments under unequal circumstances, a strong ethical impetus is needed to help reduce inequities and imbalances to encourage adherence. This article discusses mandatory data-sharing in relation to peculiar challenges faced by sub-Saharan African scientists to suggest ethical principles for rethinking and reframing solutions. We propose six principles which mirror guidelines from the Institute of Medicine and encapsulate principles from the Emanuel Framework, Nairobi Data Sharing Principles, and the COHRED guidelines

Application of Ethical Principles to Research using Public Health Data in The Global South: Perspectives from Africa

Existing ethics guidelines, influential literature and policies on ethical research generally focus on real-time data collection from humans. They enforce individual rights and liberties, thereby lowering need for aggregate protections. Although dependable, emerging public health research paradigms like research using public health data (RUPD) raise new challenges to their application. Unlike traditional research, RUPD is population-based, aligned to public health activities, and often reliant on pre-collected longitudinal data. These characteristics, when considered in relation to the generally lower protective ethico-legal frameworks of the Global South, including Africa, highlight ethical gaps. Health and demographic surveillance systems are examples of public health programs that accommodate RUPD in these contexts. We set out to explore the perspectives of professionals with a working knowledge of these systems to determine practical ways of appropriating the foundational principles of health research to advance the ever growing opportunities in RUPD. We present their perspectives and in relation to the literature and our ethical analysis, make context relevant recommendations. We further argue for the development of a framework founded on the discussions and recommendations as a minimum base for achieving optimal ethics for optimal RUPD in the Global South

An update on the “empirical turn” in bioethics: analysis of empirical research in nine bioethics journals

International audienceBackground: A review of literature published a decade ago noted a significant increase in empirical papers across nine bioethics journals. This study provides an update on the presence of empirical papers in the same nine journals. It first evaluates whether the empirical trend is continuing as noted in the previous study, and second, how it is changing, that is, what are the characteristics of the empirical works published in these nine bioethics journals.Method: A review of the same nine journals (Bioethics; Journal of Medical Ethics; Journal of Clinical Ethics; Nursing Ethics; Cambridge Quarterly of Healthcare Ethics; Hastings Center Report; Theoretical Medicine and Bioethics; Christian Bioethics; and Kennedy Institute of Ethics Journal) was conducted for a 12-year period from 2004 to 2015. Data obtained was analysed descriptively and using a non-parametric Chi-square test.Results: Of the total number of original papers (N = 5567) published in the nine bioethics journals, 18.1% (n = 1007) collected and analysed empirical data. Journal of Medical Ethics and Nursing Ethics led the empirical publications, accounting for 89.4% of all empirical papers. The former published significantly more quantitative papers than qualitative, whereas the latter published more qualitative papers. Our analysis reveals no significant difference (χ2 = 2.857; p = 0.091) between the proportion of empirical papers published in 2004–2009 and 2010–2015. However, the increasing empirical trend has continued in these journals with the proportion of empirical papers increasing from 14.9% in 2004 to 17.8% in 2015.Conclusions: This study presents the current state of affairs regarding empirical research published nine bioethics journals. In the quarter century of data that is available about the nine bioethics journals studied in two reviews, the proportion of empirical publications continues to increase, signifying a trend towards empirical research in bioethics. The growing volume is mainly attributable to two journals: Journal of Medical Ethics and Nursing Ethics. This descriptive study further maps the still developing field of empirical research in bioethics. Additional studies are needed to completely map the nature and extent of empirical research in bioethics to inform the ongoing debate about the value of empirical research for bioethics

“You Cannot Collect Data Using Your Own Resources And Put It On Open Access”: Perspectives From Africa About Public Health Data-Sharing

Data-sharing is a desired default in the field of public health and a source of much ethical deliberation. Sharing data potentially contributes the largest, most efficient source of scientific data, but is fraught with contextual challenges which make stakeholders, particularly those in under-resourced contexts hesitant or slow to share. Relatively little empirical research has engaged stakeholders in discussing the issue. This study sought to explore relevant experiences, contextual, and subjective explanations around the topic to provide a rich and detailed presentation of what it means to different stakeholders and contexts to share data and how that can guide practice and ethical guidance. A qualitative design involving interviews was undertaken with professionals working in public health institutions endowed with data (HDSS), ethics committees, and advisory agencies which help shape health research in Africa. A descriptive form of thematic analysis was used to summarize results into six key themes: (1) The role of HDSSs in research using public health data and data-sharing; (2) Ownership and funding are critical factors influencing data-sharing; (3) Other factors discourage data-sharing; (4) Promoting and sustaining data-sharing; (5) Ethical guidance structures; and (6) Establishing effective guidance. The themes reveal factors regarding the willingness or not to share and an intricate ethical system that current discourse could reflect. Many of the concerns resonate with the literature, but a whole other gamut of people and process issues; commitments, investments, careers, and the right ethical guidance are needed to realize a sustainable goal of reaching ‘share’ as a default

Defining Health Research for Development: The perspective of stakeholders from an international health research partnership in Ghana and Tanzania

The study uses a qualitative empirical method to define Health Research for Development. This project explores the perspectives of stakeholders in an international health research partnership operating in Ghana and Tanzania.; We conducted 52 key informant interviews with major stakeholders in an international multicenter partnership between GlaxoSmithKline (GSK, Vaccine Developer) and the global health nonprofit organisation PATH and its Malaria Vaccine Initiative program (PATH/MVI, Funder-Development Partner), (RTS, S) (NCT00866619). The respondents included teams from four clinical research centres (two centres in Ghana and two in Tanzania) and various collaborating partners. This paper analyses responses to the question: What is Health Research for Development?; Based on the stakeholders' experience the respondents offered many ways of defining Health Research for Development. The responses fell into four broad themes: i) Equitable Partnerships; ii) System Sustainability; iii) Addressing Local Health Targets, and iv) Regional Commitment to Benefit Sharing.; Through defining Health Research for Development six key learning points were generated from the four result themes: 1) Ensure there is local research leadership working with the collaborative partnership, and local healthcare system, to align the project agenda and activities with local research and health priorities; 2) Know the country-specific context - map the social, health, legislative and political setting; 3) Define an explicit development component and plan of action in a research project; 4) Address the barriers and opportunities to sustain system capacity. 5) Support decentralised health system decision-making to facilitate the translation pathway; 6) Govern, monitor and evaluate the development components of health research partnerships. Overall, equity and unity between partners are required to deliver health research for development

The Ethics of End-of-Trial Obligations in a Pediatric Malaria Vaccine Trial: The Perspectives of Stakeholders From Ghana and Tanzania

This study explores stakeholder experiences and perspectives on end-of-trial obligations at the close of a phase II/III Pediatric Malaria Vaccine Trial (PMVT) [GSK/PATH-MVI RTS, S) ( NCT00866619 ]. We conducted 52 key informant interviews with major stakeholders of an international multicentre PMVT in Ghana and Tanzania. The responses fell into four main themes: (a) Communicating End-of-Trial, (b) Maintaining Health Care Services, (c) Dissemination of Results, and (d) Post-Trial Access. Interviewee responses shared important practical experiences and insights that complement current thinking in the literature on research ethics guidance: (a) accompany end-of-trial communication with information on personal and family health care responsibilities, (b) establish public health indicators to measure the impact of research on a health care system

Perceptions on Birth Preparedness and Complication Readiness: Perspectives of Pregnant Women

Birth preparedness and complication readiness (BPCR) involves preparing for childbirth, bearing in mind the possible complications. The concept of BPCR has the potential to improve the awareness and utilization of suitable medical facilities to ensure safe delivery and minimize maternal and neonatal mortality. The purpose of the study was to explore pregnant women’s perspectives on the benefits and barriers of BPCR in the Northern Ghana. The study employed an exploratory descriptive design using a qualitative approach. Purposive sampling was used to recruit 13 participants. Data was collected through individual face-to-face interviews. The data was analyzed using qualitative content analysis. Out of the 13 participants, the age range for participants was 17 to 37 years; more than half were married, but less than half had no formal education. The participants indicated their understanding of BPCR by explaining the concept of BPCR, dangers signs, and prevention of danger signs. A varied source of information on BPCR was reported including the midwives or clinic, media, and family. The participants indicated that the benefits of BPCR include ensuring adequate preparation, delivery of a healthy child, and arranging for support. The barriers to BPCR were inadequate information, lack of finances, lack of transport, lack of support from the family, and lack of community support. The study findings indicate that the participants were generally informed about the concept of BPCR. However, to enable pregnant women prepare adequately for childbirth, there is a need to involve the husbands in the education on BPCR. The use of mass media to get families and communities educated on the importance of BPCR will enable them to support pregnant women

Medical informatics in medical research - the Severe Malaria in African Children (SMAC) Network's experience.

OBJECTIVES: Computers are widely used for data management in clinical trials in the developed countries, unlike in developing countries. Dependable systems are vital for data management, and medical decision making in clinical research. Monitoring and evaluation of data management is critical. In this paper we describe database structures and procedures of systems used to implement, coordinate, and sustain data management in Africa. We outline major lessons, challenges and successes achieved, and recommendations to improve medical informatics application in biomedical research in sub-Saharan Africa. METHODS: A consortium of experienced research units at five sites in Africa in studying children with disease formed a new clinical trials network, Severe Malaria in African Children. In December 2000, the network introduced an observational study involving these hospital-based sites. After prototyping, relational database management systems were implemented for data entry and verification, data submission and quality assurance monitoring. RESULTS: Between 2000 and 2005, 25,858 patients were enrolled. Failure to meet data submission deadline and data entry errors correlated positively (correlation coefficient, r = 0.82), with more errors occurring when data was submitted late. Data submission lateness correlated inversely with hospital admissions (r = -0.62). CONCLUSIONS: Developing and sustaining dependable DBMS, ongoing modifications to optimize data management is crucial for clinical studies. Monitoring and communication systems are vital in multi-center networks for good data management. Data timeliness is associated with data quality and hospital admissions