TY - JOUR

T1 - How do consent forms for diagnostic high-throughput sequencing address unsolicited and secondary findings? A content analysis

AU - Vears, D. F.

AU - Niemiec, E.

AU - Howard, H. C.

AU - Borry, P.

N1 - Funding Information: D.V. is a Postdoctoral Research Fellow of the Research Foundation-Flanders (FWO-Vlaanderen). E.N. has been supported by Erasmus Plus Joint International PhD Programme in Law, Science and Technology Fellowship. This work was facilitated by the COST Action IS1303 'Citizen's Health through public-private Initiatives: Public health, Market and Ethical perspectives,' supported by COST (European Cooperation in Science and Technology) (http://www.cost.eu). Part of this work has been supported by the SIENNA project (under grant agreement No. 741716) and the BBMRI-ERIC. Funding Information: 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) Publisher Copyright: © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

PY - 2018/10

Y1 - 2018/10

N2 - 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 UF or SF. Forms used a variety of terms to discuss UF and SF, sometimes using these interchangeably or incorrectly. Reporting policies for UF varied: 5 forms stated that UF will not be returned, 15 indicated UF may be returned, and 28 did not specify their policy. One-third indicated their laboratory returns SF. Addressing inconsistent terminology and providing sufficient information about UF/SF in consent forms will increase patient understanding and help ensure adequate informed consent.

AB - 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 UF or SF. Forms used a variety of terms to discuss UF and SF, sometimes using these interchangeably or incorrectly. Reporting policies for UF varied: 5 forms stated that UF will not be returned, 15 indicated UF may be returned, and 28 did not specify their policy. One-third indicated their laboratory returns SF. Addressing inconsistent terminology and providing sufficient information about UF/SF in consent forms will increase patient understanding and help ensure adequate informed consent.

KW - bioethics

KW - genomics

KW - incidental findings

KW - inductive content analysis

KW - informed consent

UR - http://www.scopus.com/inward/record.url?scp=85050381417&partnerID=8YFLogxK

U2 - 10.1111/cge.13391

DO - 10.1111/cge.13391

M3 - Journal article

C2 - 29888485

AN - SCOPUS:85050381417

VL - 94

SP - 321

EP - 329

JO - Clinical Genetics

JF - Clinical Genetics

SN - 0009-9163

IS - 3-4

ER -