Ethical principles for the usage and sharing of genomic data from research

Czech version

Authors: Věra Franková ^1,2; Hana Svozilová ^3,4,5; Viktor Stránecký ²; Kateřina Staňo Kozubík ^3,5; Josef Srovnal ^6,7; Lucie Benešová ⁸; Magdalena Uvírová ⁹; Milan Macek ¹⁰; Šárka Pospíšilová ^3,4,5
Authors‘ workplace: Ústav humanitních studií v lékařství 1. LF UK v Praze ¹; Klinika pediatrie a dědičných metabolických poruch 1. LF UK a VFN v Praze ²; Centrum molekulární medicíny, Středoevropský technologický institut (CEITEC) MU v Brně ³; Ústav lékařské genetiky a genomiky LF MU a FN Brno ⁴; Centrum molekulární biologie a genetiky, Interní hematologická a onkologická klinika LF MU a FN Brno ⁵; Ústav lékařské genetiky LF UP a FN Olomouc ⁶; Ústav molekulární a translační medicíny LF UP v Olomouci ⁷; Genomac výzkumný ústav, s. r. o. ⁸; EUC Laboratoře CGB, a. s. ⁹; Ústav biologie a lékařské genetiky 2. LF UK a FN Motol ¹⁰
Published in: Čas. Lék. čes. 2022; 161: 271-275
Category: Guidelines

Overview

The current significant development of human genome/exome sequencing in biomedical research is one of the important paths leading to personalized medicine. However, sequencing of human genetic information generates potentially sensitive and exploitable data, which leads to ethical, legal, and security issues. For this reason, it is necessary to follow several measures when working with these data, applying to their entire life cycle – i.e., acquisition, storage, processing, usage, sharing, archiving, and reuse. In addition, importance of good practice during the whole data life cycle is emphasized by current European trends towards open science and digital transformation.

Therefore, the following recommendations have been developed, establishing principles for work with the whole human genome sequences or parts of it in research context. The recommendations are based on two documents published by the Global Alliance for Genomics and Health (GA4GH) and on foreign literature, thus summarizing recent relevant guidance on most aspects of working with human genomic data.

Keywords:

Genomics – ethics – guidelines – standards – data sharing

Sources

Zákon č. 373/2011 Sb., o specifických zdravotních službách. Dostupné na: www.zakonyprolidi.cz/cs/2011-373
Global Alliance for Genomic and Health. Framework for Responsible Sharing of Genomic and Health-Related Data. GA4GH, 2019. Dostupné na: www.ga4gh.org/genomic-data-toolkit/regulatory-ethics-toolkit/framework-for-responsible-sharing-of-genomic-and-health-related-data
Global Alliance for Genomics and Health. Data Privacy and Security Policy. GA4GH, 2019. Dostupné na: www.ga4gh.org/wp-content/uploads/GA4GH-Data-Privacy-and-Security-Policy_FINAL-August-2019_wPolicyVersionsUPDATED.docx-2.pdf
Thorogood A, Dalpé G, Knoppers BM. Return of individual genomic research results: are laws and policies keeping step? Eur J Hum Genet. 2019; 27: 535–546.
Finnegan T, Hall A. Identification and genomic data. PHG Foundation, Cambridge, 2017. Dostupné na: www.phgfoundation.org/report/identification-and-genomic-data
National Human Genome Research Institute. Privacy in Genomics. Dostupné na: www.genome.gov/about-genomics/policy-issues/Privacy
Tavaglione N, Martin, AK, Mazger N et al. Fleshing Out Vulnerability. Bioethics 2017; 29(2): 98-107.

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