Ethical Considerations about the Collection of Biological Samples for Genetic Analysis in Clinical Trials

Autor/inn/en	Galende-Domínguez, Inés; Rivero-Lezcano, Octavio M.
Titel	Ethical Considerations about the Collection of Biological Samples for Genetic Analysis in Clinical Trials
Quelle	In: Research Ethics, 19 (2023) 2, S.220-226 (7 Seiten)Infoseite zur Zeitschrift PDF als Volltext Verfügbarkeit
Zusatzinformation	ORCID (Rivero-Lezcano, Octavio M.)
Sprache	englisch
Dokumenttyp	gedruckt; online; Zeitschriftenaufsatz
ISSN	1747-0161
DOI	10.1177/17470161231152077
Schlagwörter	Genetics; Medical Research; Patients; Ethics; Donors; Human Body; Information Security; Informed Consent + Suchen Sie Ihr Suchwort? Humangenetik; Patient; Ethik; Menschlicher Körper
Abstract	Progress in precision medicine is being achieved through the design of clinical trials that use genetic biomarkers to guide stratification of patients and assignation to treatment or control groups. Genetic analysis of biomarkers is, therefore, essential to complete their objectives, and this involves the study of biological samples from donor patients that have been recruited according to criteria previously established in the design of the clinical trial. Nevertheless, it is becoming very common that, in the solicitation of biological samples, purposes that are beyond the objectives of the stated therapeutic trial research are introduced, like the development of ill-explained exploratory studies or the use in unspecified future research. In the digital era, the sequencing of patients' DNA needs to be considered as a serious security matter, not only for the patients, but also for their relatives. Genetic information may be easily stored, even forever, in digital files. This engenders a permanent risk of being stolen or misused in many ways. Furthermore, re-identification of sample donors is technically feasible through their genetic data. For these reasons, genetic analysis of samples collected in clinical trials should be restricted to the accomplishment of their main objectives or well justified goals. (As Provided).
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Erfasst von	ERIC (Education Resources Information Center), Washington, DC
Update	2024/1/01