TY - JOUR
T1 - Ethical, legal, and social implications in research biobanking
T2 - A checklist for navigating complexity
AU - Tzortzatou-Nanopoulou, Olga
AU - Akyuez, Kaya
AU - Goisauf, Melanie
AU - Kozera, Lukasz
AU - Mezinska, Signe
AU - Mayrhofer, Michaela Th
AU - Slokenberga, Santa
AU - Reichel, Jane
AU - Croxton, Talishiea
AU - Ziaka, Alexandra
AU - Makri, Marina
PY - 2024/9
Y1 - 2024/9
N2 - 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.
AB - 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.
KW - Elsi
KW - Biobanking
KW - Biomedical research
KW - Informed consent
KW - Personal data
KW - Research ethics committees
UR - https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=wosstart_imp_pure20230417&SrcAuth=WosAPI&KeyUT=WOS:001022573400001&DestLinkType=FullRecord&DestApp=WOS_CPL
U2 - 10.1111/dewb.12411
DO - 10.1111/dewb.12411
M3 - Article
C2 - 37428947
SN - 1471-8731
VL - 24
SP - 139
EP - 150
JO - Developing World Bioethics
JF - Developing World Bioethics
IS - 3
ER -