Since sequencing the human genome, biomedical research has increasingly become a data-intensive venture that requires collaboration, including in pediatrics. The rigorous statistical power in order to make sound scientific associations between the human genome and childhood disease etiology necessitate that researchers work in concert and share data, often across provincial and national borders. To do so, studies must undergo research ethics review. Current policy models of research ethics review in Canada, however, are proving incompatible and ill adept to the collaborative ethos that research in these disciplines espouses. The existing institution-by-institution mechanism of ethics approval in Canada invites inconsistency; exacerbates procedural delays through duplication; is costly to the research system; and precludes collaboration in high-priority areas of pediatric research.
Furthermore, little empirical research to date examines the true resource burdens that existing ethics review policies impart on the innovation process in pediatric genomic research, nor whether a policy framework can be developed to facilitate data sharing despite these burdens. A better understanding of how research ethics review policies (dis)enable collaboration in the data-intensive disciplines—including genomics and related ‘omics’ fields—is therefore critical to ensuring the translation of medical innovation for Canadian children and youth.
My dissertation research will explore the relationship between research ethics review governance in Canada and data sharing practices for data-intensive health research involving children. Using multiple case study and policy Delphi, project PEdiatric Data Intensive Genomics and REsearch Ethics (PEDIGReE) will examine the effects of existing ethics review approval mechanisms on the propensity to share genomic and associated clinical data involving children. From these findings, I will develop a policy framework based on a prioritized list of ethical, legal, social and scientific criteria for data sharing in Canadian pediatric genomics. Taken together, project PEDIGReE fills a knowledge void at the nexus of empirical bioethics and health policy development of ethics governance and data sharing in pediatrics.