Fig. Dr. Dorcas Kamuya, an ethics Research Associate, giving a presentation about the institutional review board (IRB) procedures at KEMRI Welcome Trust.
The NeuroDev research protocol is closely monitored by the ethics committees of Harvard University, the University of Cape Town, Kenya Medical Research Institute, and Aga Khan University. In developing the protocol, we worked closely with a designated bioethicist in South Africa and Kenya to consult on complex moral questions relating to the study. In addition, we engaged with the NeuroGenE program in the bioethics of neuropsychiatric genetics. Our bioethics advisors are Dorcas Kamuya in Kenya, Jantina de Vries in South Africa and Ilina Singh at Oxford University.
Background ethical concerns for the NeuroDEV study relate to equity, ensuring that study benefits would accrue to patients and participants in Kenya and South Africa, the vulnerability of NeuroDEV research participants and considerations about the return of individual genetic research results.
Principles of Collaboration
Throughout the collaboration, the NeuroDev leadership have sought to emphasise principles of transparency, inclusive deliberation and shared decision-making – all of which are essential to an equitable collaboration. As a commitment to promoting African led research, the study is adhering to H3Africa data sharing guidelines.
Research in Ethics
The novelty of NeuroDev's methods in the context of urban South Africa and rural Kenya has generated a number of questions for consideration. These include, but are not limited to:
The photography of children with developmental differences and the sharing of those photos for scientific benefit
Communication around the generation and storage of lymphoblastic cell lines
The return genetic results
The inclusion of adults with neurodevelopmental disorders in our study
These questions are at the source of ongoing discussion and, in some cases, formal inquiry. Independent ethical research inspired by the NeuroDev study is being overseen by the research teams of our ethics advisors.