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

• Jurisdiction: South Africa
• Date: 01 December 2022
• Published date: 01 December 2022
• DOI: 10.7196/SAJBL.2022.v15i3.822
• Pages: 80-83
• Author: S Mahomed,M Labuschaigne

December 2022, Vol. 15, No. 3 SAJBL 80

REVIEW

The global drive towards inter-connectedness, supported by the

notions of open science, open access and open data, will have

a significant impact on data sharing for research purposes. Data

sharing is credited with accelerating scientific breakthroughs and

facilitating the progress of research.[1] In addition to extending the

scope of scientific potential, societal benefits from open access to

data are also considerable, depending on the types and scale of data

made available to the public, including the improvement of social

welfare as society gains from accessible information and refining

public perceptions of transparency.[2]

To align South Africa (SA) with this growing trend towards open

science, the Draft National Open Science policy which encourages

open science, open data and open access, was approved for

stakeholder consultation in the first quarter of 2022.[3] Similarly, in

2021, the Draft National Data and Cloud policy[4] was published

with a vision of transforming SA into a data-driven digital economy.

Although both policies encourage open data sharing in line

with international best practice, the same period (2021) saw the

enactment of SA’s Protection of Personal Information Act No. 4 of

2013 (POPIA), which establishes minimum requirements for the

processing of personal information, including the grounds for lawful

processing. However, POPIA’s enactment was met with concerns

regarding its interpretation for research (specifically health research)

purposes,[5-7] as well as its application to already established research

practices in SA.

The operation of research ethics committees (RECs) in SA is

affected by the conflicting demands of the shift towards open

science on the one hand, and the stricter laws around protecting

participants’ personal information and the transfer thereof, on the

other. POPIA requires an added principles-based assessment when

personal information is shared between institutions, both locally

and across borders. A recent paper which explored the topic focused

on RECs functioning from a global and national perspective while

outlining the critical role that they play in reviewing health research

proposals when human biological materials are transferred between

institutions, as well as RECs as a party to the national SA material

transfer agreement (MTA) template.[8] The present article aims to

take these discussions one step further and provides an overview of

the continuing evolving role of RECs considering SA’s new privacy

framework. It offers an outline of POPIA, focusing on the legal

requirements when personal information/data are shared between

local and international institutions. It also considers health data

breaches and the challenges that RECs currently face in the context

of reviewing protocols involving data sharing and big data. The paper

concludes with assessing the value of DTAs in regulating the transfer

of data, which would in turn strengthen the operation of RECs

regarding legal and ethical compliance in this context.

Managing data transfers under POPIA

The underlying tension between achieving open data vis-à-vis the

strict privacy protections regarding the processing of personal

information in POPIA should be addressed to achieve the right

balance that will not hamper the progress of research. RECs are

increasingly required to reconcile the demands of open science

with legal privacy protections and to comply with ethical and legal

norms when data are transferred. Whereas the protection of personal

This open-access article is distributed under

Creative Commons licence CC-BY-NC 4.0.

The evolving role of research ethics committees in the era

of open data

S Mahomed,1,2 BCom, LLB, LLM, PhD; M Labuschaigne,1 BA Hons, MA, D Litt, LLB, LLD

1 Department of Jurisprudence, Unisa, Pretoria, South Africa

2 Steve Biko Centre for Bioethics, University of the Witwatersrand, Johannesburg, South Africa

Corresponding author: S Mahomed (mahoms1@unisa.ac.za)

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.

S Afr J Bioethics Law 2022;15(3):80-83. https://doi.org/10.7196/SAJBL.2022.v15i3.822