title: 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.
authors: Centre of Genomics and Policy, McGill University, Montréal, Québec, Canada. man.zawati@mcgill.ca
authors: Ma'n H
authors: MH
authors: Zawati
authors: Matthew
authors: M
authors: Hendy
authors: Yann
authors: Y
authors: Joly
mesh_terms: D003219:Confidentiality; D030881:Disclosure; D023281:Genomics; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence; D006801:Humans; D033162:Incidental Findings; D016365:Liability, Legal; D010820:Physicians / Q000941:ethics / Q000331:legislation & jurisprudence*; D011792:Quebec; D012108:Research Personnel / Q000941:ethics / Q000331:legislation & jurisprudence*; D014611:Vaccination / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000639:trends