Reuse of health and clinical research data (including social care, and hereafter referred to as health research data) has major restrictions when compared to other research data in the biomedical domain. This primarily pertains to the concerns imposed by privacy, sensitivity and ethical issues raised by making data freely available. Meanwhile, research data management (RDM) practices such as the creation of data management plans (DMP), sharing datasets, the deposition of data in repositories, and the application of FAIR data principles to research outcomes are becoming increasingly common as they are required by funder mandates. Besides this requirement placed by funders there is also the wider need for researchers to share, find and access data to progress common goals as the primary value, and promote integrity and reproducibility.
The last few years have seen a rapid rise in uptake of the FAIR principles, which originated in the life sciences domain, but which have now been adopted to varying degrees across all research domains. Concomitant with the rise of FAIR datasets has been an increase in open research which urges researchers to make their data available for reuse, especially those that are publicly funded. However, an important caveat when thinking about FAIR when compared to open research is the phrase “as open as possible, as closed as necessary”.
The recent enforcement of the GDPR in Europe is a prime example of a legal framework that makes strict regulations around the processing and sharing of personal data and places the onus on the data controller to make sure provisions are in place to ensure this. Although the GDPR is the most far reaching data protection legislation currently in the world, there are other territories that have restrictions on secondary use of personal data and health data, e.g. USA (HIPAA), Ireland (Health Research Regulation), India (Personal Data Protection Bill) and S-Africa (Protection of Personal Information Act). As well as internationally enforced restrictions, there are those at national and local levels, and together they all require evidence that the sharing and reuse of health research data are carried out responsibly and in-line with stated aims. The legislation is not meant to impose barriers but to protect individuals' rights.
FAIR adoption in the health research domain is complicated by numerous factors including concerns regarding: ethical, moral, cultural, technical, and legal constraints of primary source data. We therefore propose this WG to address some of these issues to:
● Analyse and report legal and ethical issues surrounding data privacy of health research data at the national level.
● Identify commonalities across territories that can be a foundation for harmonisation of guidelines on FAIR adoption.
● Provide Health Research Performing Organizations (HRPOs) with a set of clear and simple guidelines for implementing FAIR Open Data policy in health research.
Therefore, the main purpose of this WG is to provide HRPOs (such as universities, public research institutes, hospitals, medical charities etc.) with a set of clear and simple guidelines, which will define, establish and enable implementation of an aligned FAIR data policy at the institutional level.