Although data involving children and other vulnerable populations such as incompetent adults deserve special protections, disproportionately restrictive data access policies may in fact thwart data-driven innovations used to inform evidence-based standards of their care. To this end, we contend that responsible data governance in pediatric genomics relies on a proportionate balance between data protection and opportunities for innovation made possibly through data sharing. Sparse empirical attention has been paid, however, to understanding what constitutes ‘responsible’ sharing from ethical, legal, social and scientific standpoints when data involves pediatric populations, specifically.A systematic review of reasons according to Sofaer and Strech (2012) with quality appraisal of empirical studies was conducted in order to fill this aforementioned knowledge gap.
It is our intent that all children benefit form the sharing of pediatric genomic and associated clinical data; such sharing requires stakholder cooperation across the clinical translational continuum. These points to consider offer a platform from which to launch a stronger commitment to collaboration through data sharing across stakeholder communities.
The transition toward an sIRB system is a landmark move in the history of research ethics as an example of reg- ulatory reformation evolving in parallel with advances in the science it seeks to govern.
Ethics review is a pre-requisite to conducting research involving humans in Canada, and indeed in most international jurisdictions. The Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (TCPS2) serves as the national policy frame- work for research ethics review in Canada, and outlines three potential oversight models: independent, delegated and reciprocal. While the independent model preserves institu- tional oversight of research, it contributes to a duplicative system that can unduly delay research and impose barriers to research collaboration. This analysis centres on a 2015 reform to the policy model of research ethics review for collaborative, multi-site stud- ies in the province of Québec.
Biomedical research post sequencing of the first human genome is increasingly eroding a traditional ecology of individual- ist science. It is, furthermore, normalising collective innovation and shared scientific discovery.1 2 Achieving sound statistical power in a genome-wide association study, for example, can often be well beyond the scope of any one researcher’s capacity. For this reason and others, the scientific imperative of research collaboration can be more pronounced in the ‘omics’ disci- plines,3 where millions of data points are needed to make global inferences about links between the human genome and disease.
The plurality of terms used for policies and models of research ethics review that activate the principle of mutual recognition is the focus of this paper. An index of the terms equivalence, reciprocity, centralization and mutual acceptance from the USA, Canada, UK and Australia, respectively, will be com- pared. In addition to differences in nomen- clature, policies that operationalize mutual recognition between RECs also vary in their degree of legislative formality.
The participation of vulnerable populations in biomedical research— such as minors and incompetent adults—has in the past, and will continue to be a central consideration in bioethics considering they warrant special protections against potential rights violations and exposure to undue risk. These populations, however, should not be excluded from the opportunity to benefit from scientific progress through their research participation. The promises of personalized medicine for improved diagnosis and treatment of pediatric diseases further underscores this pressing need for their inclusion. This chapter provides both a retrospective and prospective analysis of research participation, with a special focus on the involvement of minors and incompetent adults in the data-intensive research typical of personalized medicine and genomic translation. The authors propose reverse vulnerability as one conceptual lens through which to examine the ethical intersectionalities associated with data-intensive research participation within both populations.