Incidental Findings in Data-Intensive Postgenomics Science and Legal Liability of Clinician–Researchers: Ready for Vaccinomics?

Abstract

Vaccinomics encompasses a host of multiomics approaches to characterize variability in host-environment (including pathogens) interactions, with a view to a more directed or personalized use of vaccine-based health interventions. Although vaccinomics has the potential to reduce adverse effects and increase efficacy of vaccines, the use of high-throughput, data-intensive technologies may also lead to unanticipated discoveries beyond the initial aims of a vaccinomics study--discoveries that could be highly significant to the health of the research participants. How do clinician-researchers faced with such information have to act? What are the attendant legal duties in such circumstances and how do they differ from the duties of non-clinician researchers? Together with a critical analysis of the international laws and policies framing researchers' duties with regard to incidental findings, this article also draws from Quebec's civil law--with its rich jurisprudence on clinician and researcher liability--as a case study to evaluate the potential legal implications associated with vaccinomics investigations. Given previous lessons learned from other data-intensive sciences, the education of clinician-researchers with regard to their roles, limitations, and legal obligations remains an important strategy to prevent potential legal complications and civil liability in vaccinomics research in the postgenomics era.

International normative perspectives on the return of individual research results and incidental findings in genomic biobanks

“…8 With next-generation sequencing technology producing vast amounts of data, the debate has become more complex due to the ensuing increase in incidental findings (IFs) in research. 9 IFs are defined as findings concerning a research participant that have potential health or reproductive importance and are discovered during the course of research but are outside the objectives of the project. 10 The rise of data-intensive science stemming from the use of high-throughput technology has led to a debate on the pertinence of returning IRRs and IFs in genomic biobanks.…”

Ethics education for clinician–researchers in genetics: The combined approach

“…We recommend that the Combined Approach described in this paper be used prescriptively, and be adopted by medical schools, clinics and hospitals to continually update physicians as to the ethical and legal obligations associated with medical genetics. Given the recent proliferation of genetic testing, research and personalized medicine, local physician associations should abide by the World Medical Association's Ethics Manual (2009) and initiate “workshops […] for their members to help guide them to adapt and cope with what is now recognized as the future of their practice: personalized medicine” ( Zawati et al, 2011 ). Such policy initiatives will ensure that human genetics is not only at the forefront of medical science, but is also ethically and morally just.…”