Informed Consent Contexts and Research Data Sharing

DESCRIPTION OF SESSION

FAIR (Findable, Accessible, Reusable, Interoperable) research data do not exist as discrete entities. Rather, they form a part of larger packages of information, the whole of which is essential to reuse. Secondary use of research data requires access to the contexts of their collection, management, and organization, usually in the form of documentation and metadata that accompany data files when they are shared. While research data management educational initiatives and data repository guidelines have clearly communicated the importance of providing methodological and structural contexts when sharing non-sensitive data, ethical contexts have received much less attention. Ethical contexts, which include information about ethics oversight for data collection and the terms of participant consent, are crucial for secondary use of data. Just as documentation and description allow secondary researchers to understand the nature of a dataset, ethical contexts reveal limits on reuse established during the original data transaction. As broad consent procedures become more commonplace across disciplines and at all levels of data sensitivity, it is increasingly important that the terms of consent are made clear when data are shared. Knowledge of the original terms of consent allows secondary researchers to act in accordance with participant expectations and may reduce the burden on research ethics boards when deliberating on secondary uses of human data. This presentation will outline a study that examined the extent and nature of informed consent contexts in the datasets of a large multidisciplinary data repository. We examined all individual-level human datasets published in the Borealis data repository between January 2022 and September 2024 to determine the frequency and methods with which informed consent information was shared, how intent to share data is described in letters of consent, and the degree to which access and use conditions adhere to the original terms of consent. We found that informed consent contexts are infrequently included with public datasets and, among those datasets that include consent information, only a slight majority impose conditions of data access and use that reflect the original terms of consent. Going further, a qualitative analysis of consent documentation suggests that the provision of information with respect to data sharing is generally sparse, with few details provided about confidentiality or future uses of research data. This presentation will provide recommendations for ways in which ethics boards and repository stewards can collaborate to help ensure that commitments to participants are framed and enacted accurately and that ethical contexts are clearly communicated when research data are shared. Key Outcomes Attendees will advance their understanding of: * The importance of communicating the consent contexts of open datasets to potential secondary researchers; * How terms of research data access and use are established in data repositories, and the importance of harmonizing conditions of secondary data use with terms of consent; * How research ethics boards and data stewards can collaborate to ensure that terms of broad consent for unknown future use of data are enacted in accordance with participant expectations.