No abstract

Ethical decision-making frameworks assist in identifying the issues at stake in a particular setting and thinking through, in a methodical manner, the ethical issues that require consideration as well as the values that need to be considered and promoted. Decisions made about the use, sharing, and re-use of big data are complex and laden with values. This paper sets out an Ethics Framework for Big Data in Health and Research developed by a working group convened by the Science, Health and Policy-relevant Ethics in Singapore (SHAPES) Initiative. It presents the aim and rationale for this framework supported by the underlying ethical concerns that relate to all health and research contexts. It also describes a set of substantive and procedural values that can be weighed up in addressing these concerns, and a step-by-step process for identifying, considering, and resolving the ethical issues arising from big data uses in health and research. This Framework is subsequently applied in the papers published in this Special Issue. These papers each address one of six domains where big data is currently employed: openness in big data and data repositories, precision medicine and big data, real-world data to generate evidence about healthcare interventions, AIassisted decision-making in healthcare, public-private partnerships in healthcare and research, and cross-sectoral big data.

There is a growing expectation, or even requirement, for researchers to deposit a variety of research data in data repositories as a condition of funding or publication. This expectation recognizes the enormous benefits of data collected and created for research purposes being made available for secondary uses, as open science gains increasing support. This is particularly so in the context of big data, especially where health data is involved. There are, however, also challenges relating to the collection, storage, and re-use of research data. This paper gives a brief overview of the landscape of data sharing via data repositories and discusses some of the key ethical issues raised by the sharing of health-related research data, including expectations of privacy and confidentiality, the transparency of repository governance structures, access restrictions, as well as data ownership and the fair attribution of credit. To consider these issues and the values that are pertinent, the paper applies the deliberative balancing approach articulated in the Ethics Framework for Big Data in Health and Research (Xafis et al. 2019) to the domain of Openness in Big Data and Data Repositories. Please refer to that article for more information on how this framework is to be used, including a full explanation of the key values involved and the balancing approach used in the case study at the end.

Background Biomedical research is overseen by numerous Institutional Review Boards (IRBs) in Singapore but there has been no research that examines how the research review process is perceived by the local research community nor is there any systematic data on perceptions regarding the review process or other research ethics processes and IRB characteristics. The aim of this study was to ascertain general views regarding the overall perceived value of ethics review processes; to measure perceptions about local IRB functions and characteristics; to identify IRB functions and characteristics viewed as important; and to compare these views with those of other international studies. Methods An online survey was used with the main component being the IRB-Researcher Assessment Tool (IRB-RAT), a validated tool, to evaluate perceptions of ideal and actual IRB functions and characteristics held by Singaporean researchers and research support staff. Data were analysed descriptively first, with mean and SD of each item of IRB-RAT questionnaire reported, excluding the respondents whose answers were unknown or not applicable. The Wilcoxon Sign Rank test was used to compare the ideal and actual ratings of each IRB-RAT item, while the Mann-Whitney U test was used to compare the ratings of each IRB-RAT item between respondents with different characteristics. The Z-test was used to compare the mean ratings of our cohort with the mean ratings reported in the literature. The correlation between our mean ideal scores and those of two international studies also employing the IRB-RAT was examined. Results Seventy-one respondents completed the survey. This cohort generally held positive views of the impact of the ethics review process on: the quality of research; establishing and maintaining public trust in research; the protection of research participants; and on the scientific validity of research. The most important ideal IRB characteristics were timeliness, upholding participants’ rights while also facilitating research, working with investigators to find solutions when there are disagreements, and not allowing biases to affect reviews. For almost all 45 IRB-RAT statements, the rating of the importance of the characteristic was higher than the rating of how much that characteristic was descriptive of IRBs the respondents were familiar with. There was a significant strong correlation between our study’s scores on the ideal IRB characteristics and those of the first and largest published study that employed the IRB-RAT, the US National Validation (USNV) sample in Keith-Spiegel et al. [19]. Conclusions An understanding of the perceptions held by Singaporean researchers and research support staff on the value that the ethics review process adds, their perceptions of actual IRB functions and characteristics as well as what they view as central to high functioning IRBs is the first step to considering the aspects of the review process that might benefit from improvements. This study provides insight into how our cohort compares to others internationally and highlights strengths and areas for improvement of Singapore IRBs as perceived by a small sample of the local research community. Such insights provide a springboard for additional research and may assist in further enhancing good relations so that both are working towards the same end.

With the recent report of a live birth after use of mitochondrial replacement therapy, sometimes called 'three-parent IVF', the clinical application of the technique is fast becoming a reality. While the United Kingdom allows the procedure under regulatory scrutiny, it remains effectively outlawed in many other countries. We argue that such prohibitions may violate individuals' procreative rights, grounded in individuals' interest in genetic affinity. The interest in genetic affinity was recently endorsed by Singapore's highest court, reflecting an emphasis on the importance of biological ties found across the globe. We apply that reasoning to make the case for a right to 'three-parent IVF'.