The evolving role of research ethics committees in the era of open data

Abstract

While open science gains prominence in South Africa with the encouragement of open data sharing for research purposes, there are stricter laws and regulations around privacy – and specifically the use, management and transfer of personal information – to consider. The Protection of Personal Information Act No. 4 of 2013 (POPIA), which came into effect in 2021, established stringent requirements for the processing of personal information and has changed the regulatory landscape for the transfer of personal information across South African borders. At the same time, draft national policies on open science encourage wide accessibility to data and open data sharing in line with international best practice. As a result, the operation of research ethics committees (RECs) in South Africa is affected by the conflicting demands of the shift towards open science on the one hand, and the stricter laws protecting participants’ personal information and the transfer thereof, on the other. This article explores the continuing evolving role of RECs in the era of open data and recommends the development of a data transfer agreement (DTA) for the ethical management of personal health information, considering the challenges that RECs encounter, which centres predominantly on privacy, data sharing and access concerns following advances in genetic and genomic research and biobanking.

Cross-border data sharing through the lens of research ethics committee members in sub-Saharan Africa

“…Frequent suggestions included the type of data being transferred, the storage location and duration, the data destruction process, data access management and security and the purpose of the data transfer. These suggestions mirror some of the many provisions to be incorporated into a DTA template offered by Mahomed and Labuschaigne to better safeguard participants‘ personal information and better guide RECs [ 62 ].…”

Challenges confronting nurses caring for persons diagnosed with intellectual disability at a Mental Health Institution in Gauteng, South Africa

“…To maintain their privacy, no information provided by the nurses was linked to them. Participants were not harmed during interviews because they were not humiliated and treated fairly and without bias or discrimination (Mahomed & Labuschaigne, 2023).…”

A Scoping Review on Analysis of the Barriers and Support Factors of Open Data

“…A significant ethical and societal dilemma is that the potentially great benefits of Open Data may not materialize due to data privacy concerns [30]. Normative standards for ethical scrutiny are currently lacking, which can lead to physical and psychological harm in the re-use of data [49]. Individual harmlessness is perceived to be at risk when data are sold, leading to re-identification or extortion, which can result in financial, physical, psychological, and emotional harm [30].…”

“…Risks and benefits of data sharing must, therefore, be carefully weighed [10,23,49], and it is unclear whether specific datasets can be ethically released [10]. There is also concern about subsequent unethical and inappropriate projects in secondary use with a risk to privacy [30,36,50].…”

“…Many legal aspects and standards on Open Data are still unresolved [2,11,25] and vaguely regulated [11,23], especially in the area of data security and consent procedures [23,34], as well as in the further, transparent use of data [23,30,40]. In addition, the traceability of data must be ensured, for example, if consent is revoked [19,49]. Currently, existing legal consent structures tend to restrict data use [23,34].…”