title: Impact of Open Data Policies on Consent to Participate in Human Subjects Research: Discrepancies between Participant Action and Reported Concerns.
abstract: Research outlets are increasingly adopting open data policies as a requisite for publication, including studies with human subjects data. We investigated whether open data policies influence participants' rate of consent by randomly assigning participants to view consent forms with and without discussion of open data policies. No participants declined to participate, regardless of condition, nor did rates of drop-out vs. completion vary between conditions. Furthermore, no significant change in potential consent rates was reported when participants were openly asked about the influence of open data policies on their likelihood of consent. However, follow-up analyses indicated possible poor attention to consent forms, consistent with previous research. Moreover, thematic analysis of participants' considerations of open data policy indicated multiple considerations such as concerns regarding confidentiality, anonymity, data security, and study sensitivity. The impact of open data policies on participation raises complex issues at the intersection of ethics and scientific innovation. We conclude by encouraging researchers to consider participants as stakeholders in open data policy and by providing recommendations for open data policies in human subjects research.
authors.affiliation: Department of Psychology, University of Saskatchewan, 9 Campus Drive, Saskatoon, Saskatchewan, Canada.
authors.forename: Jorden A
authors.initials: JA
authors.lastname: Cummings
authors.affiliation: Department of Psychology, University of Saskatchewan, 9 Campus Drive, Saskatoon, Saskatchewan, Canada.
authors.forename: Jessica M
authors.initials: JM
authors.lastname: Zagrodney
authors.affiliation: Office of Safety and Medical Operations, The Children's Hospital of Philadelphia, 3401 Civic Center Blvd., Philadelphia, Pennsylvania, United States of America.
authors.forename: T Eugene
authors.initials: TE
authors.lastname: Day
mesh_terms: D022126:Access to Information / Q000523:psychology*; D000328:Adult; D016494:Computer Security / Q000592:standards; D003219:Confidentiality / Q000523:psychology / Q000592:standards; D032962:Consent Forms / Q000592:standards; D000068240:Data Anonymization / Q000523:psychology / Q000592:standards; D005260:Female; D006805:Human Experimentation / Q000592:standards* / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D035842:Research Subjects / Q000523:psychology* / Q000706:statistics & numerical data