TY - JOUR

T1 - Readability of informed consent forms for whole-exome and whole-genome sequencing

AU - Niemiec, Emilia

AU - Vears, Danya F.

AU - Borry, Pascal

AU - Howard, Heidi Carmen

N1 - Funding Information: Acknowledgements The authors would like to thank the reviewer for the insightful and helpful comments. This article is based upon work 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). Emilia Niemiec is supported by an Erasmus Mundus Joint International Doctoral Program in Law, Science and Technology Fellowship. This work has been also supported by the Swedish Foundation for Humanities and Social Sciences (Riksbankens Jubileumsfond under grant M13-0260:1), the Biobanking and Molecular Resource Infrastructure of Sweden (BBMRI.se), the BBMRI-ERIC, the Ministère de l’Économie, de la Science et de l’Innovation du Québec, PSR-SIIRI-850 (Canada) and the Research Fund Flanders (Belgium). None of these funding sources have had any involvement in the preparation of this article. Publisher Copyright: © 2017, The Author(s).

PY - 2018/4/1

Y1 - 2018/4/1

N2 - Whole-exome and whole-genome sequencing (WES, WGS) can generate an unprecedented amount of complex information, making the informed consent (IC) process challenging. The aim of our study was to assess the readability of English IC forms for clinical whole-exome and whole-genome sequencing using the SMOG and Flesch-Kincaid formulas. We analysed 36 forms, most of which were from US providers. The median readability grade levels were 14.75 (the SMOG formula) and 12.2 (the Flesch-Kincaid formula); these values indicate the years of education after which a person would be able to understand a text studied. All forms studied seem to fail to meet the average recommended readability grade level of 8 (e.g. by Institutional Review Boards of US medical schools) for IC forms, indicating that the content of the forms may not be comprehensible to many patients. The sections aimed at health care professionals (HCPs) in the forms indicate that HCPs should be responsible for explaining IC information to the patients. However, WES and WGS may be increasingly offered by primary care professionals who may not (yet) have sufficient training to be able to communicate effectively with patients about genomics. Therefore, to secure an adequate, truly informed consent process, the task of developing good, legible examples of IC forms along with educating HCPs in genomics should be taken seriously, and adequate resources should be allocated to enable these tasks.

AB - Whole-exome and whole-genome sequencing (WES, WGS) can generate an unprecedented amount of complex information, making the informed consent (IC) process challenging. The aim of our study was to assess the readability of English IC forms for clinical whole-exome and whole-genome sequencing using the SMOG and Flesch-Kincaid formulas. We analysed 36 forms, most of which were from US providers. The median readability grade levels were 14.75 (the SMOG formula) and 12.2 (the Flesch-Kincaid formula); these values indicate the years of education after which a person would be able to understand a text studied. All forms studied seem to fail to meet the average recommended readability grade level of 8 (e.g. by Institutional Review Boards of US medical schools) for IC forms, indicating that the content of the forms may not be comprehensible to many patients. The sections aimed at health care professionals (HCPs) in the forms indicate that HCPs should be responsible for explaining IC information to the patients. However, WES and WGS may be increasingly offered by primary care professionals who may not (yet) have sufficient training to be able to communicate effectively with patients about genomics. Therefore, to secure an adequate, truly informed consent process, the task of developing good, legible examples of IC forms along with educating HCPs in genomics should be taken seriously, and adequate resources should be allocated to enable these tasks.

KW - Genetic counselling

KW - Informed consent

KW - Readability

KW - Whole exome sequencing

KW - Whole genome sequencing

UR - http://www.scopus.com/inward/record.url?scp=85028617527&partnerID=8YFLogxK

U2 - 10.1007/s12687-017-0324-6

DO - 10.1007/s12687-017-0324-6

M3 - Journal article

AN - SCOPUS:85028617527

VL - 9

SP - 143

EP - 151

JO - Journal of Community Genetics

JF - Journal of Community Genetics

SN - 1868-310X

IS - 2

ER -