Establishing a Multi-Country Sickle Cell Disease Registry in Africa: Ethical Considerations.

Nchangwi Syntia Munung,Furahini Tluway,Jantina De Vries,Vivian Paintsil,Raphael Zozimus Sangeda,Marsha Treadwell,Obiageli E Nnodu,Emmanuel Balandya,Mario Jonas,Julie Makani,Gaston Mazandu,Victoria Nembaware,Daima Bukini,Ambroise Wonkam

doi:10.3389/fgene.2019.00943

Abstract

Sickle cell disease (SCD) is one of the most prevalent genetic conditions in sub-Saharan Africa. It is a chronic, lifelong disease often characterized by severe pain. However, SCD has received little investment terms of health research, though there is currently a growing pool of SCD data from health and research facilities in different countries. To facilitate research on SCD in Africa, the SickleInAfrica consortium has established a SickleInAfrica registry. The registry will store a systematic collection of longitudinal data from persons with SCD across sub-Saharan Africa, and currently, participants are being enrolled in Ghana, Nigeria, and Tanzania. In establishing this registry, the SickleInAfrica consortium decided to actively identify and anticipate possible ethical issues that may arise in the development and management of the registry. This was motivated, in part, by the near absence of well documented ethical issues for registry research in Africa, more-so for registries enrolling participants across multiple countries and for a genetic condition. The consortium aims to establish standards for the equitable use of data stored in the registry. This paper presents a comprehensive report on the ethical considerations that came up in setting up a genetic disease registry across multiple African countries and how they were addressed by the SickleInAfrica consortium. Major issues included: active involvement of patients in the initiation and management of the registry; questions of assent and re-consent; the importance of ensuring that fears of exploitation are not replicated in African–African research collaborations; and the importance of public engagement in the management of registries. Drawing on this experience, SickleInAfrica plans to set up an ethics helpdesk for genetic disease registries and research in Africa.

Highlights

Sickle cell disease (SCD) is a life-threatening monogenetic condition that affect millions of people globally (Ware et al, 2017)
Drawing on our experience of setting up a multi-country African SCD registry, we report on ethical legal and social issues (ELSIs) that are likely to emerge when setting up disease registries in Africa
The consortium will make publicly available the ELSI resources developed by the consortium as well as provide support to similar initiatives

Summary

INTRODUCTION

Sickle cell disease (SCD) is a life-threatening monogenetic condition that affect millions of people globally (Ware et al, 2017). Recognising the need and importance for an SCD registry, the Sickle Pan-African Research Consortium (SPARCo), in 2017, kick-started plans for a centralized SCD registry in sSA that will store clinical information of persons with SCD, including behavioral and demographic information, such as: age, gender, ethnicity, and family history. To achieve this objective, SPARCO collaborated with another African initiative, the SickleInAfrica data coordinating centre (SADaCC), to form the SickleInAfrica consortium, a consortium made up predominantly of African researchers and research institutions. The SickleInAfrica consortium is predominantly an African–African (south–south) research collaboration and presents an opportunity to critically highlight issues of equity and fairness in south–south research partnerships

DISCUSSION

CONCLUSION

DATA AVAILABILITY STATEMENT