title: Mapping the inputs, analyses, and outputs of biobank research systems to identify sources of incidental findings and individual research results for potential return to participants.
abstract: Progress in the debate over returning incidental findings (IFs) and individual research results (IRRs) to research participants who provide specimens and data to biobanks in genetic and genomic research requires a new tool to allow comparison across heterogeneous biobank research systems and in-depth analysis of the sources and types of findings generated for potential return. This article presents a new visual mapping tool to allow systematic and standardized depiction of (i) the specimens initially collected, (ii) the materials and data sets then created, (iii) the analyses then performed, and finally (iv) the genetic and genomic results generated, including potential IFs and IRRs. For any individual biobank research system, this sequence of four maps can be created to anticipate the sources and types of IFs and IRRs to be generated, to plan how to handle them, and then to manage them responsibly over time. We discuss how this four-map tool was created and describe its application to four national biobank systems, thereby demonstrating that this tool can provide a common platform to visualize biobank content, anticipate how IFs and IRRs will arise in a biobank research context, and inform policy development.
authors.affiliation: Department of Educational Psychology, University of Minnesota, Minneapolis, Minnesota, USA.
authors.forename: Heather R
authors.initials: HR
authors.lastname: Bemmels
authors.forename: Susan M
authors.initials: SM
authors.lastname: Wolf
authors.forename: Brian
authors.initials: B
authors.lastname: Van Ness
mesh_terms: D035843:Biomedical Research / Q000941:ethics / Q000706:statistics & numerical data*; D005826:Genetics, Medical / Q000379:methods / Q000706:statistics & numerical data; D023281:Genomics / Q000941:ethics / Q000706:statistics & numerical data; D006801:Humans; D033162:Incidental Findings; D008490:Medical Informatics / Q000379:methods* / Q000706:statistics & numerical data; D035842:Research Subjects; D035844:Researcher-Subject Relations; D014015:Tissue Banks / Q000706:statistics & numerical data; D014342:Truth Disclosure / Q000941:ethics