Development of a policy on ingestion of human subjects datasets: An institutional assessment and large-scale repository scan

Abstract

Background: The Data Repository for the University of Minnesota (DRUM) is a publicly available collection of digital research data generated by University of Minnesota researchers, students, and staff. Within DRUM, there are 43 datasets with human subjects data. A human subject is a living individual about whom a researcher obtains, uses, studies, analyzes, or generates information. Datasets published in DRUM are openly available, broadly disseminated, and downloadable without restriction. Because of the sensitive nature of human subjects data, and the potential issues with publishing such data in a publicly accessible repository, we assess all human subjects data before acceptance. Ongoing conversations with researchers and other campus units regarding human subjects data in DRUM have brought to light the need for an analysis of our own processes as well as a scan of other repositories’ practices and policies for the purpose of formalizing a human subjects policy for DRUM.

Description: We analyzed DRUM’s accepted and rejected human subjects datasets since 2013, in order to evaluate DRUM’s past and current practices regarding human subjects data, the ethical considerations we have weighed, and the actions we have taken in regards to these datasets. This presentation will provide specific examples of rejected datasets and the recommendations that curators made to researchers, and also detail the ethical considerations of publishing de-identified human subjects data when the study participants have not been notified. DRUM’s ongoing efforts to educate and establish campus-wide understanding of the issues led to the second aim of this study: we conducted a scan of 105 repositories that ingest human subjects data and analyzed 1) language related to participant consent on the website and 2) language related to participant consent in the deposit agreement. Finally, the presentation will detail the process of formulating a formal DRUM policy on human subjects dataset submissions based on the results of the analyses.

Conclusion: We’ll detail the outcome of the human subjects policy inventory and any progress made as a result of ongoing outreach efforts by DRUM curators at the University of Minnesota. We'll also discuss next steps in getting the new DRUM human subjects policy approved.