Table 1. Checklist for Ethics Committee Review of Governance Arrangements in Proposed Genomics Research Studies.

Element	Explanation	Criteria
African intellectual leadership	The substantive contribution of scientists based at African institutions	Intellectual leadership or co-leadership of scientists at African institutions
Broad consent	Consent for the use of samples and/or data for unspecified future studies subject to conditions	Must be fully informed and voluntary Participants must be informed about the manner and extent to which they may withdraw from the study Must be supported by community engagement Must be supported by a good governance framework Must be subject to ethical review
Community engagement (CE)	The process of informing, consulting and actively involving relevant communities that have a legitimate interest in the research process	Must be an integral part of each research project Goals and process of CE must be clearly defined, planned and designed collaboratively This must be done at the start of the research CE must be evaluated
Ethics review	Ethics review promotes ethical conduct of research while providing assurances to the public that their welfare is being well taken care of as they contribute to knowledge and development	Every genomic research and biobanking study must be subject to ethics review Re-use of samples must be subject to review by a designated committee The use of samples must be subject to a sample access committee The use of data must be subject to data access committee review
Avoiding group harm or stigma	The reporting of genomic research results has the potential to aggravate existing stigma or marginalization, or punishment	Donors and research ethics comittees must be told about any risk of group harm or stigma with the use or re-use of samples Stigma related concerns about the sharing of genomic samples and data should be subject to stakeholder engagement Where there are stigma related concerns, individuals from the countries and/or institutions where obtained should be considered Descriptors that may be perceived to be stigmatizing or prejudicial must be avoided
Benefit sharing	Benefit sharing regulates that benefits and burdens are distributed fairly and it is therefore key to ensuring that research collaboration is fair	Genomics research may likely yield intangible benefits like knowledge generation and capacity building, some of which may only translate into tangible benefits in future generations. General study results can count as one study benefit and should be fed back to communities in which research is conducted. This is essential to maintaining trust and can be incorporated in community engagement activities. If there is a realistic expectation of tangible benefit to a group, a benefit sharing plan must be agreed to after stakeholder engagement Consideration must be given to how genomic and biobanking research may confer benefits on participants
Capacity building	Genomic research and biobanking conducted in Africa should lead to substantive building of research capacity, including both human resources and research infrastructure	A capacity building plan must be included as part of each research project This must include infrastructure, personnel and administrative capacity building
International collaboration and export of samples	International collaboration and export of samples should promote the goals of reducing global health inequality and exploitation and strengthening the research system in the country where the samples were collected	Export of samples must be subject to ethics review Exportation of samples and collaboration must help build local capacity Exportation of samples must be indicated in the consent documents Exportation of samples must be subject to materials transfer agreements
Feedback of individual genetic research results	The feedback of findings in the African context considering difficulties of validating research findings in a diagnostic facility, the absence of healthcare workers trained in genetics that could provide feedback, and limited validation of genomic research findings in African populations	There is a need for wide stakeholder engagement to determine when feedback of findings should be provided and a plan on how this would be applied.
Good governance	Good governance helps build and maintain public trust and ensure transparency of genomic and biobanking research	Governance framework must include oversight on the use and reuse of samples There must be compliance with local, national and international guidelines and regulations Entities controlling access to samples must be comprised of members primarily residing on the African continent