Background: Due to decreasing cost, and increasing speed and precision, genomic sequencing in research is resulting in the generation of vast amounts of genetic data. The question of how to manage that information has been an area of significant debate. In particular, there has been much discussion around the issue of 'secondary findings' (SF)-findings unrelated to the research that have diagnostic significance.
Sources Of Data: The following includes ethical commentaries, guidelines and policies in respect to large-scale clinical genomics studies.
Areas Of Agreement: Research participant autonomy and their informed consent are paramount-policies around SF must be made clear and participants must have the choice as to which results they wish to receive, if any.
Areas Of Controversy: While many agree that clinically 'actionable' findings should be returned, some question whether they should be actively sought within a research protocol.
Growing Points: SF present challenges to a growing field; diverse policies around their management have the potential to hinder collaboration and future research.
Areas Timely For Developing Research: The impact of returning SF and accurate estimates of their clinical utility are needed to inform future protocol design.
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http://dx.doi.org/10.1093/bmb/ldx009 | DOI Listing |
The 18 Workshop on Recent Issues in Bioanalysis (18 WRIB) took place in San Antonio, TX, USA on May 6-10, 2024. Over 1100 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 18 WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.
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