The Open Brain Consent: Informing research participants and obtaining consent to share brain imaging data

. 2021 May ; 42 (7) : 1945-1951. [epub] 20210201

Jazyk angličtina Země Spojené státy americké Médium print-electronic

Typ dokumentu úvodníky, Research Support, N.I.H., Extramural, práce podpořená grantem, Research Support, U.S. Gov't, Non-P.H.S.

Perzistentní odkaz   https://www.medvik.cz/link/pmid33522661

Grantová podpora
P41 EB019936 NIBIB NIH HHS - United States
R01 MH096906 NIMH NIH HHS - United States

Having the means to share research data openly is essential to modern science. For human research, a key aspect in this endeavor is obtaining consent from participants, not just to take part in a study, which is a basic ethical principle, but also to share their data with the scientific community. To ensure that the participants' privacy is respected, national and/or supranational regulations and laws are in place. It is, however, not always clear to researchers what the implications of those are, nor how to comply with them. The Open Brain Consent (https://open-brain-consent.readthedocs.io) is an international initiative that aims to provide researchers in the brain imaging community with information about data sharing options and tools. We present here a short history of this project and its latest developments, and share pointers to consent forms, including a template consent form that is compliant with the EU general data protection regulation. We also share pointers to an associated data user agreement that is not only useful in the EU context, but also for any researchers dealing with personal (clinical) data elsewhere.

Aalto University Espoo Finland

Biomedical Imaging Unit FISABIO CIPF Foundation for the Promotion of Health and Biomedical Research of the Valencian Community Valencia Spain

Bogazici University Istanbul Turkey

Centre for Clinical Brain Sciences University of Edinburgh Edinburgh United Kingdom

CHU Rennes France

Dartmouth College Hanover New Hampshire USA

Department of Advanced Imaging Modalities MRI Unit General Anti Cancer and Oncological Hospital of Athens St Savvas National and Kapodistrian University of Athens Athens Greece

Department of Biological Medicine and Engineering BUAA Beihang University Beijing China

Department of Neuroimaging King's College London London United Kingdom

Department of Neuroscience and Biomedical Engineering Aalto University Espoo Finland

Department of Neurosurgery and Neurology National and Kapodistrian University of Athens Athens Greece

Department of Neurosurgery St Anne's University Hospital Masaryk University Brno Czech Republic

Department of Otolaryngology Head and Neck Surgery Harvard Medical School Boston Massachusetts USA

Department of Psychological and Brain Sciences Dartmouth College Hanover New Hampshire USA

Department of Radiology and Nuclear Medicine Amsterdam University Medical Centers Amsterdam The Netherlands

Department of Radiology and Nuclear Medicine University Hospital Ghent Ghent Belgium

Dewallens and partners law firm Leuven Belgium and Antwerp Health Law and Ethics Chair and P2 research group Faculty of law University of Antwerp Antwerp Belgium

Donders Institute for Brain Cognition and Behaviour; Radboud University Nijmegen The Netherlands

Eindhoven University of Technology Eindhoven The Netherlands

Erasmus University Rotterdam Rotterdam The Netherlands

Faculty of Electrical Engineering University of Tuzla Tuzla Bosnia and Herzegovina

Ghent Institute for functional and Metabolic Imaging Ghent University Ghent Belgium

Helen Wills Neuroscience Institute University of California Berkeley California USA

Inria CNRS Inserm IRISA UMR 6074 Empenn ERL University of Rennes Rennes France

Inria University of Rennes CNRS Inserm IRISA UMR 6074 Empenn ERL U 1228 Rennes France

Institute for Experimental Psychology Heinrich Heine University of Düsseldorf Düsseldorf Germany

International Laboratory of Social Neurobiology Institute of Cognitive Neuroscience National Research University Higher School of Economics Moscow Russia

McGill University Montreal Neurological Institute and Hospital Montreal Quebec Canada

McGovern Institute for Brain Research Massachusetts Institute of Technology Cambridge MA USA; Department of Otolaryngology Head and Neck Surgery Harvard Medical School Boston Massachusetts USA

Memory and Aging Center Department of Neurology University of California San Francisco California USA

National Institute of Education Nanyang Technological University Singapore Singapore

NeuroDataScience ORIGAMI laboratory McConnell Brain Imaging Centre The Neuro Faculty of Medicine McGill University Montreal Quebec Canada

Oslo University Hospital Oslo Norway

Pasteur Institute Paris France

Radiology Department CHU Rennes Rennes France

School of Health Fujian Medical University Fuzhou China

School of Psychology Nanjing Normal University Nanjing China

Stanford University Stanford California USA

University of Verona Verona Italy

Zuckerman Mind Brain Behavior Institute Columbia University New York New York USA

Zobrazit více v PubMed

Abramian, D. , & Eklund, A. (2019). Refacing: Reconstructing anonymized facial features using GANs. Paper presented at 2019 IEEE 16th International Symposium on Biomedical Imaging (ISBI 2019) , 1104–1108. 10.1109/ISBI.2019.8759515 DOI

Bishop, D. V. M. (2016). Open research practices: Unintended consequences and suggestions for averting them. (commentary on the peer reviewers' openness initiative). Royal Society Open Science , 3(4), 160109. 10.1098/rsos.160109 PubMed DOI PMC

de Sitter, A. , Visser, M. , Brouwer, I. , Cover, K. S. , van Schijndel, R. A. , Eijgelaar, R. S. … Vrenken, H. (2020). Facing privacy in neuroimaging: Removing facial features degrades performance of image analysis methods. European Radiology , 30(2), 1062–1074. 10.1007/s00330-019-06459-3 PubMed DOI PMC

Duan, D. , Xia, S. , Rekik, I. , Wu, Z. , Wang, L. , Lin, W. , … Li, G. (2020). Individual identification and individual variability analysis based on cortical folding features in developing infant singletons and twins. Human Brain Mapping , 41(8), 1985‐2003. 10.1002/hbm.24924 PubMed DOI PMC

Gaspar, C. M. , Rousselet, G. A. , & Pernet, C. R. (2011). Reliability of ERP and single‐trial analyses. NeuroImage , 58(2), 620–629. 10.1016/j.neuroimage.2011.06.052 PubMed DOI

Gymrek, M. , McGuire, A. L. , Golan, D. , Halperin, E. , & Erlich, Y. (2013). Identifying personal genomes by surname inference. Science , 339(6117), 321–324. 10.1126/science.1229566 PubMed DOI

Halchenko Yaroslav, Vborghesani, Chris Gorgolewski , Yarikoptic‐private, Satrajit Ghosh , Kieseler Marie‐Luise, Pellman John, & Hu Chuan‐Peng. (2019). Datalad/open‐brain‐consent 0.2.4. Zenodo. 10.5281/zenodo.3403176 DOI

Khan, A. , Capps, B. J. , Sum, M. Y. , Kuswanto, C. N. , & Sim, K. (2014). Informed consent for human genetic and genomic studies: A systematic review. Clinical Genetics , 86(3), 199–206. 10.1111/cge.12384 PubMed DOI

Leppäaho, E. , Renvall, H. , Salmela, E. , Kere, J. , Salmelin, R. , & Kaski, S. (2019). Discovering heritable modes of MEG spectral power. Human Brain Mapping , 40(5), 1391–1402. 10.1002/hbm.24454 PubMed DOI PMC

Milham, M. P. , Craddock, R. C. , Son, J. J. , Fleischmann, M. , Clucas, J. , Xu, H. , … Klein, A. (2018). Assessment of the impact of shared brain imaging data on the scientific literature. Nature Communications , 9(1), 1–7. 10.1038/s41467-018-04976-1 PubMed DOI PMC

Mourby, M. , Mackey, E. , Elliot, M. , Gowans, H. , Wallace, S. E. , Bell, J. , … Kaye, J. (2018). Are ‘pseudonymised’ data always personal data? Implications of the GDPR for administrative data research in the UK. Computer Law and Security Review , 34(2), 222–233. 10.1016/j.clsr.2018.01.002 DOI

Plis, S. M. , Sarwate, A. D. , Wood, D. , Dieringer, C. , Landis, D. , Reed, C. , … Calhoun, V. D. (2016). COINSTAC: A privacy enabled model and prototype for leveraging and processing decentralized brain imaging data. Frontiers in Neuroscience , 10, 365. 10.3389/fnins.2016.00365 PubMed DOI PMC

Poldrack, R. A. , Barch, D. M. , Mitchell, J. P. , Wager, T. D. , Wagner, A. D. , Devlin, J. T. … Milham, M. P. (2013). Toward open sharing of task‐based fMRI data: The openfMRI project. Frontiers in Neuroinformatics, 7, 12. 10.3389/fninf.2013.00012 PubMed DOI PMC

Ravindra, V. , & Grama, A. (2019). De‐anonymization attacks on neuroimaging datasets. ArXiv:1908.03260 [Cs, Eess, q‐Bio] . http://arxiv.org/abs/1908.03260

Rocher, L. , Hendrickx, J. M. , & de Montjoye, Y.‐A. (2019). Estimating the success of re‐identifications in incomplete datasets using generative models. Nature Communications , 10. 10.1038/s41467-019-10933-3, 3069 PubMed DOI PMC

Ruiz‐Blondet, M. V. , Jin, Z. , & Laszlo, S. (2017). Permanence of the CEREBRE brain biometric protocol. Pattern Recognition Letters , 95, 37–43. 10.1016/j.patrec.2017.05.031 DOI

Sheehan, M. J. , & Nachman, M. W. (2014). Morphological and population genomic evidence that human faces have evolved to signal individual identity. Nature Communications , 5(1), 1–10. 10.1038/ncomms5800 PubMed DOI PMC

Sheller, M. J. , Edwards, B. , Reina, G. A. , Martin, J. , Pati, S. , Kotrotsou, A. , … Bakas, S. (2020). Federated learning in medicine: Facilitating multi‐institutional collaborations without sharing patient data. Scientific Reports, 10(1), 12598. 10.1038/s41598-020-69250-1 PubMed DOI PMC

Staunton, C. , Slokenberga, S. , & Mascalzoni, D. (2019). The GDPR and the research exemption: Considerations on the necessary safeguards for research biobanks. European Journal of Human Genetics , 27(8), 1159–1167. 10.1038/s41431-019-0386-5 PubMed DOI PMC

Thompson, P. M. , Stein, J. L. , Medland, S. E. , Hibar, D. P. , Vasquez, A. A. , Renteria, M. E. , … Drevets, W. (2014). The ENIGMA consortium: Large‐scale collaborative analyses of neuroimaging and genetic data. Brain Imaging and Behavior , 8(2), 153–182. 10.1007/s11682-013-9269-5 PubMed DOI PMC

World Medical Association . (2001). World medical association declaration of Helsinki. Bulletin of the World Health Organization , 79(4), 373–374. PubMed PMC

World Medical Association . (2017). The world medical association declaration of Taipei . https://www.wma.net/policies‐post/wma‐declaration‐of‐taipei‐on‐ethical‐considerations‐regarding‐health‐databases‐and‐biobanks/

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