Sharing infectious disease related data and biological samples from low resource settings : perspectives on ethics and governance

The sharing of data and samples are increasingly promoted as crucial to the timely response to infectious disease outbreaks by bodies such as the World Health Organization. Data and sample sharing are often discussed as an ethical imperative that should occur in order to better understand diseases, and facilitate the development of timely innovations to respond to infectious diseases. However, data and sample sharing present a number of macro- and micro-level ethical considerations which need to be reconciled in practice. These include issues of consent, privacy, and the distribution of benefits. Furthermore, the urgent need to share and respond to infectious disease emergencies may also strain certain areas of best practice. Crucially, the perspectives of stakeholders involved in sharing data and samples in infectious disease contexts have not been well documented. This study aims to address the lack of emphasis on stakeholders’ views by foregrounding their perspectives and practical experiences of ethical issues and views on the role of ethics governance. To achieve these aims, I employed a qualitative methodology, including participant observation and semi-structured interviews to capture the experiences of 28 key stakeholders who were purposively sampled to represent a range of different roles and positions. The primary focus of this research was on gaining insights about sharing data and samples from low- and middle-income countries, given the disproportionate burden of infectious diseases in these settings. The findings, and subsequent analysis, illustrate that data and sample sharing in the infectious disease context take place within a complex moral world. The importance of sharing data, and the optimal use of samples, was underscored by interviewees in this study. However, the nature of the data, samples, disease and the modes of sharing were all reported to have particular ethical implications. A further finding is that sharing often takes place between a diverse set of individuals and organisations, who can be unfamiliar with one another and who at times have differing priorities, and make divergent arguments about how sharing ought to take place for it to be considered ethical. Outbreaks were noted to present particular challenges. Timeliness of data and sample sharing was considered ethically important in outbreak situations, but there were otherwise conflicting views on whether and how the urgent nature of the response ought to change practice. The pressures of an outbreak response also present practical limitations to meeting the usual requirements of good practice, such as obtaining informed consent. The findings show that aspects of practice that have ethical implications for data and sample sharing in the infectious disease context are insufficiently captured in current guidance documents.