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

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.

F cell numbers are associated with an X‐linked genetic polymorphism and correlate with haematological parameters in patients with sickle cell disease

“…A future larger study may benefit from the multi-country consortium created by SickleInAfrica and H3Africa. [40][41][42] It will be important to investigate further age and gender effects, particularly because the latter may be different in the pre-and post-pubertal age groups.…”

“…We acknowledge the limitations of our present study in terms of sample size; however, this does not detract from the positive associations we have observed, but it may mean that some other associations may have been missed. A future larger study may benefit from the multi‐country consortium created by SickleInAfrica and H3Africa 40–42 . It will be important to investigate further age and gender effects, particularly because the latter may be different in the pre‐ and post‐pubertal age groups.…”

Caring for Africa’s sickle cell children: will we rise to the challenge?

“…The Sickle Pan-African Research Consortium (SPARCO) has developed multilevel guidelines that can be used at all levels of healthcare, to provide standardized management for patients with SCD. SPARCO is also enrolling a large prospective multicountry SCD cohort in Tanzania, Nigeria, and Ghana, with harmonized data collection and management, and deep consideration of ethical and societal aspects [67,68]. The Sickle Cell Support Society of Nigeria has 39 centers in all six geopolitical zones.…”

The Sickle Cell Disease Ontology: Enabling Collaborative Research and Co-Designing of New Planetary Health Applications

“…This included the data sharing and authorship policies and consent/assent forms. Details of the processes followed in developing the ELSI framework have been published in a separate article (Munung et al, 2019 ). The consortium agreed to develop ELSI research questions, which could answer important questions for the implementation and application of the SCDO for research purposes.…”