Impact of Open Data Policies on Consent to Participate in Human Subjects Research: Discrepancies between Participant Action and Reported Concerns

• Published in: PloS one Vol. 10; no. 5; p. e0125208
• Main Authors: Cummings, Jorden A., Zagrodney, Jessica M., Day, T. Eugene
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 20.05.2015; Public Library of Science (PLoS)
• Subjects: Access to Information - psychology; Adult; Analysis; Computer security; Computer Security - standards; Confidentiality; Confidentiality - psychology; Confidentiality - standards; Consent Forms - standards; Cybersecurity; Data Anonymization - psychology; Data Anonymization - standards; Data collection; Environmental policy; Ethics; Female; Human Experimentation - standards; Human Experimentation - statistics & numerical data; Human subjects; Humans; Informed consent; Innovations; Internet; Male; Marketing; Medical research; Open data; Policies; Privacy; Psychology; Research Subjects - psychology; Research Subjects - statistics & numerical data; Researchers; Scholarly publishing; Science; Security; Social networks; Studies; United States
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0125208

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.