Ethical, legal, and social implications in research biobanking: A checklist for navigating complexity

被引：11

作者：

Tzortzatou-Nanopoulou, Olga ^{[1
,2
,3
,18
]}

Akyuez, Kaya ^{[4
,5
]}

Goisauf, Melanie ^{[6
]}

Kozera, Lukasz ^{[5
]}

Mezinska, Signe ^{[7
]}

Mayrhofer, Michaela Th ^{[8
,9
,10
,11
,12
,13
,14
]}

Slokenberga, Santa ^{[15
]}

Reichel, Jane ^{[16
]}

Croxton, Talishiea ^{[17
]}

Ziaka, Alexandra ^{[18
]}

Makri, Marina ^{[19
]}

机构：

[1] Biobanking & BioMol Resources Res Infrastruct Euro, ELSI Serv & Res, Graz, Austria

[2] Supreme Court Athens, Athina, Greece

[3] Acad Athens, Technol Transfer Off, Biomed Res Fdn, Athens, Greece

[4] Univ Vienna, Dept Sci & Technol Studies, Vienna, Austria

[5] BBMRI ERIC, Graz, Austria

[6] European Res infrastruct BBMRI ERIC, Graz, Austria

[7] Univ Latvia, Riga, Latvia

[8] BBMRI ERIC, LSI Serv & Res, Graz, Austria

[9] Ctr Rech Med Sci Sante & Soc, Vienna, Austria

[10] Univ Vienna, Vienna, Austria

[11] Alpen Adria Univ Klagenfurt Vienna Graz, Inst Sci Technol & Soc Studies, Vienna, Austria

[12] Vienna Univ Technol, Vienna, Austria

[13] Med Univ Graz, Graz, Austria

[14] Univ Newcastle, Newcastle, Australia

[15] Uppsala Univ, Adm Law, Uppsala, Sweden

[16] Stockholm Univ, Adm Law, Fac Law, Stockholm, Sweden

[17] Univ Maryland Baltimore UMB, Sch Med, Inst Human Virol, Baltimore, MD USA

[18] Biomed Res Fdn Acad Athens, Athens, Greece

[19] AUTh, Sch Med, Thessaloniki, Greece

来源：

DEVELOPING WORLD BIOETHICS | 2024年 / 24卷 / 03期

关键词：

biobanking; biomedical research; ELSI; informed consent; personal data; research ethics committees; GENETIC INFORMATION; BIG DATA; CONSENT; IMPACT; SPECIMENS; RELATIVES; RIGHTS;

D O I：

10.1111/dewb.12411

中图分类号：

B82 [伦理学（道德学）];

学科分类号：

摘要：

Biobanks' activity is based not only on securing the technology of collecting and storing human biospecimen, but also on preparing formal documentation that will enable its safe use for scientific research. In that context, the issue of informed consent, the reporting of incidental findings and the use of Transfer Agreements remain a vast challenge. This paper aims to offer first-hand tangible solutions on those issues in the context of collaborative and transnational biobanking research. It presents a four-step checklist aiming to facilitate researchers on their compliance with applicable legal and ethical guidelines, when designing their studies, when recruiting participants, when handling samples and data, and when communicating research results and incidental findings. Although the paper reflects the outcomes of the H2020 B3Africa project and examines the transfers from and to the EU as a case study, it presents a global checklist that can be used beyond the EU.

引用

页码：139 / 150

页数：12

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