Informed Consent Contexts in a Multidisciplinary Research Data Repository

Abstract

Secondary use of research data requires an understanding of the contexts in which it was collected. While depositors are often encouraged to describe methodological and structural contexts in the form of metadata and documentation, ethical contexts have received much less attention. As open data mandates and an ethos of FAIR (findable, accessible, interoperable, reuseable) data proliferate across disciplines, participant consent for unknown future secondary uses of data is increasingly sought, even for minimal risk research. Terms of broad consent generally establish limitations on data reuse, but those limitations may not be clear when data are accessed via an open repository. The absence of these contexts increases the risk that secondary uses of data will be inconsistent with the expectations of original research participants and may place unnecessary burden on research ethics boards.

This study examines the dataset records in a large, multidisciplinary data repository to determine the extent to which and how informed consent information is communicated to secondary users, and the degree to which conditions of access and use of data adhere to terms of informed consent. We identified all records published in Borealis: The Canadian Dataverse Repository between January 2022 and September 2024 containing individual-level human data. From those records, we analysed the frequency with which consent information was included and methods used to do so. We further compared terms of consent with the licensing, textual, and technological conditions placed on access and use of the data. Results indicate that informed consent contexts are infrequently provided alongside data and that access and use conditions align with terms of consent for a slim majority of the sample datasets.  Based on these findings, we provide recommendations for the development of repository policy and guidelines that harmonise terms of consent and data use, the standardisation of language establishing access and use conditions, the adoption of metadata schema describing ethical contexts, and additional collaboration among data stewards and research ethics boards.