Consent & Data Sharing
Governance and privacy in a provincial data repository:
A cross-sectional analysis of longitudinal birth cohort parent participants’ perspectives on sharing adult vs. child research data
Shawn X. Dodd, Kiran Pohar Manhas, Stacey Page, Nicole Letourneau, Xinjie Cui and Suzanne Tough
ABSTRACT: Research data abound and are increasingly shared through a variety of platforms, such as biobanks for precision health and data repositories for reuse of research and administrative data. Data sharing presents great opportunities as well as significant ethical and legal concerns, such as privacy, consent, governance, access, and communication. Respectful data governance calls for stakeholder engagement during platform development. This stakeholder-engagement study used a web-based survey to capture the views of research participants about governance strategies for secondary data use. Survey response rate was 60.8% (n = 346). Parents’ primary concern was ensuring appropriate data re-use of data, even over privacy. Appropriate re-use included project-specific access and limiting access to researchers with more-trusted affiliations like academia. Other affiliations (e.g. industry, government and not-for-profit) were less palatable. Parents considered pediatric data more sensitive than adult data and expressed more reluctance towards sharing child identifiers compared to their own (p-value<0.001). This study stresses the importance of repository governance strategies to sustain long-term access to valuable data assets via large-scale repository.
Parental perspectives on consent for participation in large-scale, non-biological data repositories
Kiran Pohar Manhas, Stacey Page, Shawn X. Dodd, Nicole Letourneau, Aleta Ambrose, Xinjie Cui and Suzanne C. Tough
BACKGROUND: Data sharing presents several challenges to the informed consent process. Unique challenges emerge when sharing pediatric or pregnancy-related data. Here, parent preferences for sharing non-biological data are examined.
METHODS: Groups (n = 4 groups, 18 participants) and individual interviews (n = 19 participants) were conducted with participants from two provincial, longitudinal pregnancy cohorts (AOB and APrON). Qualitative content analysis was applied to transcripts of semi-structured interviews.
RESULTS: Participants were supportive of a broad, one-time consent model or a tiered consent model. These preferences were grounded in the perceived obligations for reciprocity and accuracy. Parents want reciprocity among participants, repositories and researchers regarding respect and trust. Furthermore, parents’ worry about the interrelationships between the validity of the consent processes and secondary data use.
CONCLUSIONS: Though parent participants agree that their research data should be made available for secondary use, they believe their consent is still required. Given their understanding that obtaining and informed consent can be challenging in the case of secondary use, parents agreed that a broad, one-time consent model was acceptable, reducing the logistical burden while maintaining respect for their contribution. This broad model also maintained participant trust in the research and secondary use of their data. The broad, one-time model also reflected parents’ perspectives surrounding child involvement in the consent process. The majority of parents felt decision made during childhood were the parents responsibility and should remain in parental purview until the child reaches the age of majority.
Parent perspectives on privacy and governance for a pediatric repository of non-biological, research data
Kiran P. Manhas, Stacey Page, Shawn X. Dodd, Nicole Letourneau, Aleta Ambrose, Xinjie Cui and Suzanne C. Tough
Research data repositories (RDRs) are data storage entities where data can be submitted, stored, and subsequently accessed for purposes beyond the original intent. There is little information relating to non-biological RDRs, nor considerations regarding pediatric data storage and re-use. We examined parent perspectives on pediatric, non-biological RDRs. Qualitative, descriptive methods including both interviews and focus groups were used. Purposive sampling of adult participants in two provincial birth cohorts yielded 19 interviewees and 18 focus group participants (4 groups). Transcripts were analyzed by thematic content analysis. Parent research participants strongly supported the sharing of their own, and their child’s, non-biological research data. Four themes emerged: that altruism has limits, that participants have ongoing privacy concerns, that some participants need the assurance of congruent values between themselves and researchers/research questions, and that opinions diverge for some governance issues. The establishment of RDRs is important and maximizes participants’, researchers’, and funders’ investments. Participants as data donors have concerns relating to privacy, relationships, and governance that must be considered in RDR development.