Ethics and Social Value Propositions
At 54gene, we pride ourselves as being a conscientious organization. We believe in treating our partners, collaborators and people that use our services or participate in our research studies with respect – respect for their values, socio-cultural orientations, and contributions. In pursuing our mission to advance the knowledge of African genomics and promote inclusion in precision medicine through innovative basic, translational, and clinical research, we are committed to doing business that is anchored in the principles of respect, social value and accountability.
How we ensure respect for our research partners and participants
Our principle of respect underpins our commitment to ethical research operations – which includes our research partners and research participants.
In our collaboration with specific research sites, we follow a strict site selection criteria, which provides us assurances on the capacity – human and infrastructural – to host a proposed study at the site, as well as the site’s policies and history of alignment with extant regulations for ethical research and financial fiduciary responsibilities. We work in collaboration with lead investigators at the site to ensure compliance with institutional policies for ethical research in the areas of research administration; research participant recruitment, consenting and confidential protection; reporting of research findings and feedback of results of genomics findings. We value and respect the intellectual capacities of our lead investigators and their teams, by seeking their inputs in design of our research studies and collaborating with them in publishing findings from the studies based on best practice authorship principles.
We are committed to upholding the research participants’ rights to autonomous and informed decision making and voluntary participation. Our participants are only enrolled in our studies when they have provided informed consent. We ensure that all our study site staff are trained in informed consent and confidentiality before activation. During the informed consent process, participants are made aware of the procedures, risks and potential benefits of our studies. Our unique interest in facilitating translational research and precision medicine that benefits Africans through sharing of data with pharmaceutical and diagnostics companies is explained sufficiently in the consent process. This is in addition to our commitment to also share data with African researchers as part of our vision to empower the next generation of African genomics researchers.
How we ensure our studies add value
Our approach of treating the site investigation leads and their teams as partners and not contractors is at the heart of our commitment to promote social value of our research. All our site investigators are individuals that have interests in genomics research. We involve the site teams in decisions about the appropriateness of our proposed research study designs. To foster their interests in genomics research, we make commitments to share research data with them that would enable them answer important questions that would be impactful in improving healthcare for Africans. Our scientific advisory team include representatives from the site investigators to work hand in hand with our data access and ethics committee, making sure that we only use our participants’ data for purposes that provide greatest scientific value.
For our participants, the value of our research lies in our focus to address diseases that are of priority to African populations, and the benefit that could reach them as a result of participation. As an organization whose sole purpose is to foster genomics research that improves healthcare for African populations, our studies primarily focus on those that are of priority to Africans. This includes the rising burden of non-communicable diseases such as hypertension, diabetes, stroke, dyslipidemia, chronic kidney diseases, fatty liver diseases and sickle cell diseases. We are also focusing on communicable diseases that have continued to burden African populations such as malaria, hepatitis, tuberculosis and infectious hemorrhagic diseases.
The genomics research studies we are supporting are aimed largely at generating knowledge insights on how the genome of African populations affects the various diseases that we would be studying. By doing so, we hope to learn how to better manage these diseases clinically, or identify peculiar genes that could either be targeted with a new drug or for which the development of a new diagnostic could help improve patient outcomes. These latter two processes are the points where we are committed to provide greatest value for our participants. In our aspiration to facilitate translational research, we hope to interrogate the data we have with a team of experts trained in bioinformatics and biocomputational/pharmaceutical modelling to identify new drug/diagnostic targets. Where we succeed in identifying such targets and collaborate with a pharmaceutical company to co-develop the product, we are committed to ensure that the African populations that are supporting our studies have early access to the new product and at a fair price that reflects their contributions.
However, most of the data we would be sharing with other scientists is not aimed at product development, rather for basic scientific insights. In these instances, we only expect to receive some fees for our efforts in collecting samples and phenotypic data, DNA extraction, genotyping and sequencing (for a subset of the samples), and curation of the all the data for use. Where this happens, we are re-investing between 5%-20% of proceeds from any such data uses to benefit the health systems of countries in which we have operations. Our African Centre for Translational Genomics (ACTG), will facilitate discussions by a committee of scientists, policy makers and civil society on how best to utilize such resources.
Our ethos and accountability commitments
As a company founded with the overarching vision of creating impact for Africans and the global community, a significant number of our operations, management and leadership staff are Africans. Our management and leadership staff have vast experiences, having built their careers in global institutions and recognized as astute professionals. Collectively, we approach our work with professionalism and hold ourselves to high levels of integrity. All our staff are driven by our dream of putting Africa on the global health innovation map and ensuring that Africans benefit from our research and the therapeutics developed. We pride ourselves in our dedication to ethical practice through alignment with our professional codes of conduct, national and international guidelines on research ethics, and genomics research/biobanking governance.
As a genomics research services and development company, we conduct our research studies following receipt of ethics approvals from appropriate health research ethics committees. Our consent process is designed to uphold the right to autonomous decision making by potential research participants and consent authorizations are obtained following due processes that optimizes understanding and comprehension before asking participants to sign consent forms. Our participants receive sufficient information on our aspirations to add value and create more impact through collaborations with pharmaceutical and other similar companies that help develop drugs and diagnostics to improve human health.
We are committed to keeping the data of our research participants confidential - through our internal processes and when we have cause to share data with other investigators in and outside Africa. In our internal processes, only authorized staff have access to participant data in de-identified form, which is usually during the process of curation, quality control and archival. A differential access protocol is implemented for our research and biobanking teams such that no staff is able to link participant data with their identifiable information. Data sharing with external parties will use a secure proprietary portal that provides access to anonymized data only, which is limited to the data requested and upon approval by our ethics and data access committee.
Our biobank primarily supports storage, curation, archival and sharing of the data and samples collected from our research studies for secondary purposes. As a world standard biobank, our processes and operations are governed by international best practices for biobanking, the Nigerian National Health Research Ethics Committee and relevant authorities in the Lagos State Ministry of Health (and similar bodies with a mandate to oversee biobank operations in other countries).
We have established a number of committees to support accountability of our operations in line with guidelines issued by International Society for Biological and Environmental Repositories (ISBER). These committees are composed of experienced and senior scientists, researchers and professionals that are independent of 54gene. Through their collective work, the Committees ensure that we share data or samples only in line with consent provisions we have received from our research participants, as well as the provisions of the ethics approvals and supporting material and data transfer agreements.