The number of genomics research and biobanking projects taking place on the African content is growing steadily. A critical feature of such research is the broad sharing of data and samples for secondary use by investigators who were not originally involved in their collection. Such ‘open science’ holds considerable potential for facilitating scientific discovery but it also evokes important ethical challenges that need to be addressed for its successful implementation, not least where research takes place in the African research context, which evokes questions about equity and fairness. Whilst the ethical and regulatory constructs to allow sharing and re-use of scientific resources are being developed, it is not surprising that the ethical review and regulatory infrastructure in Africa does not yet accommodate sharing and secondary use. Yet African people’s broad genetic diversity could be a key to addressing the high burden of disease in the continent and Africa offers many unique opportunities to advance an ethic of sharing. This Framework aims to set out the principles and actions that should be considered as pertinent ethical concerns for genomic research and biobanking in Africa.
The H3Africa biorepository program is committed to adhering to high ethical standards and practices in the reception, processing, storage and distribution of human Biospecimen and accompanying data for research purposes. H3Africa biorepositories share required ethical approvals and participant ethically approved consent from submitting sites. Biospecimen and data access applications is reviewed and approved by the H3Africa Data and Biospecimen Access committee (DBAC) to ensure that among other things the research is in line with the participants’ consent. The standard of “minimal risk” shall be considered in the review process.
- Protocol for Obtaining Core Phenotypes
- H3Africa Publications Policy FINAL January-2014
- H3Africa Guidelines for Community Engagement
- H3Africa Guideline for Informed Consent
- H3Africa Feedback of Individual Genetic Results Policy
- H3Africa Data and Biospecimen Access Committee Guidelines
- H3Africa DBAC Policy and Guidance for managing conflicts of interest
- H3Africa Archive Submission Statement
- H3A DECISION TREE FOR FEEDBACK OF INDIVIDUAL GENETIC RESULTS
- Ethics and Governance Framework for Best Practice in Genomic Research and Biobanking in Africa
- Draft Biospecimen Release MTA 20 AUG 2018