Best Practices for Ethical Sharing of Individual-Level Health Research Data From Low- and Middle-Income Settings

Abstract

Sharing individual-level data from clinical and public health research is increasingly being seen as a core requirement for effective and efficient biomedical research. This article discusses the results of a systematic review and multisite qualitative study of key stakeholders’ perspectives on best practices in ethical data sharing in low- and middle-income settings. Our research suggests that for data sharing to be effective and sustainable, multiple social and ethical requirements need to be met. An effective model of data sharing will be one in which considered judgments will need to be made about how best to achieve scientific progress, minimize risks of harm, promote fairness and reciprocity, and build and sustain trust.

Towards a genomics-informed, real-time, global pathogen surveillance system

“…Complicating the existence of a rapid, open, transparent response is the fact that no matter the setting, there are often conflicting interests at work. In an outbreak scenario, conflict may result from governments wishing to keep an outbreak quiet and/or from the tension between lower-income and middle-income countries with few resources for generating and using data and the researchers or response teams from better-resourced settings 115 . Indeed, the conflicting values in outbreak responses meet the definition of a 'wicked' problem, where issues resist simple resolution and span multiple jurisdictions and where each stakeholder has a different perspective on the solution.…”

Role of a regulatory and governance framework in human biological materials and data sharing in National Biobanks: Case studies from Biobank Integrating Platform, Taiwan and the National Biorepository, Uganda

“…Human biological materials and data sharing from Biobanks is increasingly being used to support collaborative national and international health research. These approaches have the potential to increase scientific efficiency by maximizing the utility of human biological materials and data for researchers and funders 8 . Managing data flows into and out of Biobanks gives rise to various ethical challenges which are exacerbated in some LMIC settings due to disparities in infrastructure, resources and capacity 7 .…”

“…Data sharing is a key component in Biobanking as they are increasingly being used to support global health research 7 . Greater data sharing maximizes the value and utility of datasets and minimizes the costs of unnecessary duplication of research 8 . A study by de Vries et al (2017) on content analysis of ethics guidelines, policies and procedures of 22 African countries indicates that African regulation is either absent, outdated, conservative or difficult to navigate 9 .…”

Understanding Ethical, Legal and Societal Issues (ELSIs) in Human Biobanking and Genomics for Research and Healthcare in Zimbabwe: The Genomics Inheritance Law Ethics and Society (GILES) initiative

“…Biobanks of human biospecimen collections are key resources for understanding individual and population diversity, and are integral to healthcare research, medical care, and drug discovery 1,2 . Linked to biobanking, advances in technology are enabling large-scale biochemical and genomic analysis, generating substantial amounts of data of personal and health relevance with ethical implications for communities and populations [3][4][5][6] . Although the benefits of human biobanking and genomics applications are well recognised, ethical, legal and social challenges arise alongside unclear regulations and policies, and limited understanding among research scientists, healthcare professionals and the wider public 7 .…”