Journal article

How do consent forms for diagnostic high-throughput sequencing address unsolicited and secondary findings? A content analysis

DF Vears, E Niemiec, HC Howard, P Borry

Clinical Genetics | WILEY | Published : 2018

Abstract

Whole exome and whole genome sequencing are increasingly being offered to patients in the clinical setting. Yet, the question of whether, and to what extent, unsolicited findings (UF) and/or secondary findings (SF) should be returned to patients remains open and little is known about how diagnostic consent forms address this issue. We systematically identified consent forms for diagnostic genomic sequencing online and used inductive content analysis to determine if and how they discuss reporting of UF and SF, and whether patients are given options regarding the return of these results. Fifty-four forms representing 38 laboratories/clinics were analyzed. A quarter of the forms did not mention..

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University of Melbourne Researchers

Grants

Awarded by Swedish Foundation for Humanities and Social Science


Awarded by SIENNA project


Awarded by COST Action


Funding Acknowledgements

Swedish Foundation for Humanities and Social Science, Grant/Award Number: M13-0260:1; BBMRI-ERIC; SIENNA project, Grant/Award Number: 741716; COST Action IS1303 "Citizens' Health through public-private Initiatives: Public Health, Market and Ethical perspectives. Supported by COST (European Cooperation in Science and Technology); Erasmus Plus Joint International PhD Programme in Law, Science and Technology Fellowship; Research Foundation-Flanders (FWO-Vlaanderen)