Examining the Ethical Arguments for Establishing Immortalised Lymphoblastic Cell Lines in Kenya

This NIH Fogarty project is being co-led by Dr Dorcas Kamuya in Kenya and Prof. Ilina Singh in Oxford. In Kenya the team includes Ms Dorothy Chepkirui, Dr Patricia Kipkemoi, Dr Mary Bitta, Prof. Charles Newton and Prof. Amina Abubakar. In Oxford, the team includes Dr Rosemary Musesengwa, Dr Michael Wee and Dr Alexandra Almeida. This Fogarty grant relates to our work as part of the Stanley Global Collections Initiative on Neuropsychiatric Genetics in African Populations (NeuroGAP) and the NeuroDEV study on the genetics of childhood neurodevelopmental disorders.

The project will examine the ethical and socio-cultural issues involved in the generation of immortalised cell lines, especially in the context of Low and Middle-Income Countries (LMICs). In Oxford, our main aim is to develop normative guidance on the use and storage of immortalised cell lines, to support the work of bioethicists and scientists in Kenya.

As genomic research gains ground in countries like Kenya, the need for readily available cell lines will continue to grow. Cell lines that have been modified to multiply indefinitely, i.e. immortalised cell lines, are of particular value since they provide a perpetual source of DNA. This will reduce the need for constant resampling of participants, and will also open up other forms of scientific research, such as testing cellular responses of infection or developing new biological products.

In Western, high income settings, there is continuing debate about the best regulatory framework for the long-term storage and use of biospecimens such as cell lines.

However, in the African context, the generation of immortalised cell lines is a relatively novel technique. We do not know of any empirical studies that have been conducted to ascertain the acceptability of such practices among local communities. Moreover, culturally competent and context sensitive ethical guidance is needed to support the work of genomics researchers.

Henrietta Lacks and controversies surrounding the HeLa cells – the first immortal human cell line ever created, derived from cervical tissue taken from an African-American woman during a routine procedure, without consent or subsequent acknowledgement of her enormous contribution to science and medicine – is a cautionary tale for this area of biomedical research. Some of the earliest ethical issues to emerge from reflection on cases such as HeLa cells were the importance of privacy and how to manage identifiability of donors from cell lines; how to determine the appropriate model of consent; and how to approach the possibility of using tissue samples for techniques not known at the time of consent (and therefore not explicitly consented to). Given the revenue generated by HeLa cells, another abiding question has been whether donors of cell lines have a legitimate stake in any profits – or indeed medical discoveries – gained from use of their biospecimens.

There are also important culture-specific questions that need to be addressed. Genomic research may unsettle questions of identity within local communities (the case of the Havasupai tribe in America being an important example), and there may be a range of different views on the moral and cultural status of biospecimens.

Robust ethical reflection, genuinely consultative engagement with stakeholders, and the establishment of sound protocols are key to securing long-term trust and collaboration from the public in scientific research. Hence, this project will involve a large-scale empirical study in which a wide range of stakeholders – local community members, scientists and regulators – will be asked to share their views on cell line creation in Kenya. The project team will also engage in rigorous normative analysis of the ethical issues surrounding cell line creation, and will be in continuous dialogue with ethicists and regulatory experts on an international level. Our collaborative, multi-stakeholder approach aims to ensure that the normative guidance produced at the end of this project will meet the highest international standards and will also accurately reflect local concerns identified in the empirical study.