Further resources
Most relevant EU or international guidelines or standards related to biobanking:
Africa Centres for Disease Control and Prevention (CDC) Establishment of a Biobanking Network as a Sustainable Mechanism to Accelerate Development and Evaluation of Diagnostic Tests in Africa https://africacdc.org/download/establishment-of-a-biobanking-network-as-a-sustainable-mechanism-to-accelerate-development-and-evaluation-of-diagnostic-tests-in-africa/
BBMRI-ERIC Common Service ELSI
https://www.bbmri-eric.eu/elsi/
CIOMS (2016) International ethical guidelines for health-related research involving humans https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf
Council of Europe – Biobanks https://www.coe.int/en/web/bioethics/biobanks/-/asset_publisher/lcb5Z6eMEwYb/content/research-on-biological-materials-of-human-origin-new-recommendations-to-member-stat-1
Council of Europe (2016) Recommendation CM/Rec(2016)6 of the Committee of Ministers to member States
on research on biological materials of human origin https://search.coe.int/cm#{%22CoEIdentifier%22:[%22090000168064e8ff%22],%22sort%22:[%22CoEValidationDate%20Descending%22]}
European Commission (2018) Data protection in the EU
https://commission.europa.eu/law/law-topic/data-protection/data-protection-eu_en
ISBER (International Society for Biological and Environmental Repositories) (2024) Best practices for repositories https://www.isber.org/page/BPR
NHS Health Research Authority (2021) Research tissue banks and research databases
Last updated on 12 Oct 2021
NIH (2024) Genomic Data Sharing (GDS) Policy https://sharing.nih.gov/genomic-data-sharing-policy
OECD Guidelines for Human Biobanks and Genetic Research Databases (HBGRDs)
pdf: https://www.oecd.org/health/biotech/44054609.pdf
World Medical Association (2016) Declaration of Tapei on ethical considerations regarding health databases and biobanks
Bibliography
Amoakoh-Coleman, M., Vieira, D. & Abugri, J. Ethical considerations for biobanking and use of genomics data in Africa: a narrative review. BMC Med Ethics 24, 108 (2023). https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-023-00985-y
Annaratone L, De Palma G, Bonizzi G, Sapino A, Botti G, Berrino E, Mannelli C, … &, Marchiò C; Alleanza Contro il Cancro (ACC) Pathology and Biobanking Working Group (2021) Basic principles of biobanking: from biological samples to precision medicine for patients. Virchows Arch. 2021 Aug;479(2):233-246. doi: 10.1007/s00428-021-03151-0. Epub 2021 Jul 13. PMID: 34255145; PMCID: PMC8275637. Available at:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8275637/
Ashcroft JW, Macpherson CC (2019) The complex ethical landscape of biobanking The Lancet Public Health June 2019. Available at: https://pubmed.ncbi.nlm.nih.gov/31155216/
Bruns A, Winkler EC Dynamic consent: a royal road to research consent? Journal of Medical Ethics Published Online First: 24 July 2024. doi: 10.1136/jme-2024-110153 https://pubmed.ncbi.nlm.nih.gov/39048154/
Casati S, Ellul B, Mayrhofer MT, Lavitrano M, Caboux E, Kozlakidis Z. Paediatric biobanking for health: The ethical, legal, and societal landscape. Front Public Health. 2022 Sep 27;10:917615. doi: 10.3389/fpubh.2022.917615. PMID: 36238242; PMCID: PMC9551217. https://pubmed.ncbi.nlm.nih.gov/36238242/
Dagher G. (2022) Quality matters: International standards for biobanking. Cell Prolif. 2022 Aug;55(8):e13282. doi: 10.1111/cpr.13282. Epub 2022 Jun 16. PMID: 35709534; PMCID: PMC9357355. Available at: https://pubmed.ncbi.nlm.nih.gov/35709534/
ESMO (2019) The Establishment of Pan-Africa's First Biobank https://www.esmo.org/oncology-news/the-establishment-of-pan-africa-s-first-biobank
Geiger, J., Fuchs, J., Starke, M. et al. GBA/GBN-position on the feedback of incidental findings in biobank-based research: consensus-based workflow for hospital-based biobanks. Eur J Hum Genet 31, 1066–1072 (2023). Available at: https://doi.org/10.1038/s41431-023-01299-8
Graham M, Hallowell N, Solberg B The Northern European Returning Results Network, et al. Taking it to the bank: the ethical management of individual findings arising in secondary research. Journal of Medical Ethics 2021;47:689-696. https://pubmed.ncbi.nlm.nih.gov/33441306/
Healthtalk.org What is biobanking and why is it important? Available at: https://healthtalk.org/experiences/biobanking/what-biobanking-and-why-it-important/
Lewis J, Holm S. Organoid biobanking, autonomy and the limits of consent. Bioethics. 2022 Sep;36(7):742-756. doi: 10.1111/bioe.13047. Epub 2022 May 9. PMID: 35531912; PMCID: PMC9542633.https://pubmed.ncbi.nlm.nih.gov/35531912/
Lieb, W.; Strathmann, E.A.; Röder, C.; Jacobs, G.; Gaede, K.I.; Richter, G.; Illig, T.; Krawczak, M. (2024) Population-Based Biobanking. Genes 2024, 15, 66. Available at: https://www.mdpi.com/2073-4425/15/1/66
Littlejohns, T.J., Holliday, J., Gibson, L.M. et al. The UK Biobank imaging enhancement of 100,000 participants: rationale, data collection, management and future directions. Nat Commun 11, 2624 (2020). Available at: https://pubmed.ncbi.nlm.nih.gov/32457287/
Masiye F, Jaoko W, Rennie S. Stakeholder views on informed consent models for future use of biological samples in Malawi and South Africa. BMC Med Ethics. 2023 Jan 19;24(1):4. doi: 10.1186/s12910-023-00882-4. PMID: 36658544; PMCID: PMC9854061. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9854061/
Mascalzoni, D., Melotti, R., Pattaro, C. et al. Ten years of dynamic consent in the CHRIS study: informed consent as a dynamic process. Eur J Hum Genet 30, 1391–1397 (2022). https://www.nature.com/articles/s41431-022-01160-4
Mikkelsen, R.B., Gjerris, M., Waldemar, G. et al. Broad consent for biobanks is best – provided it is also deep. BMC Med Ethics 20, 71 (2019). https://doi.org/10.1186/s12910-019-0414-6
Solbakk JH, Holm S, Hofmann B, The Ethics of Research Biobanking, Springer New York, NY, 2009, https://doi.org/10.1007/978-0-387-93872-1
Singh S, Cadigan RJ, Moodley K (2022) Challenges to biobanking in LMICs during COVID-19: time to reconceptualise research ethics guidance for pandemics and public health emergencies? Journal of Medical Ethics 2022;48:466-471. Available at: https://pubmed.ncbi.nlm.nih.gov/33980656/
Tzortzatou-Nanopoulou O, Akyüz K, Goisauf M, Kozera Ł, Mežinska S, Th Mayrhofer M, Slokenberga S, Reichel J, Croxton T, Ziaka A, Makri M. Ethical, legal, and social implications in research biobanking: A checklist for navigating complexity. Dev World Bioeth. 2024 Sep;24(3):139-150. doi: 10.1111/dewb.12411. Epub 2023 Jul 10. PMID: 37428947. https://pubmed.ncbi.nlm.nih.gov/37428947/
Zhao, Y., Zhang, W. (2018). An International Collaborative Genetic Research Project Conducted in China. In: Schroeder, D., Cook, J., Hirsch, F., Fenet, S., Muthuswamy, V. (eds) Ethics Dumping. SpringerBriefs in Research and Innovation Governance. Springer, Cham. Available at: https://link.springer.com/chapter/10.1007/978-3-319-64731-9_9
Useful websites
The African Society of Human Genetics https://www.afshg.org/
The Human Hereditary and Health (H3Africa) website contains many useful resources related to genomic science and associated technologies in Africa https://h3africa.org/
National Commission for Science, Technology and Innovation - NACOSTI – Kenya nacosti.go.ke
The Science for Africa Foundation https://scienceforafrica.foundation/
TRUST (2018) The TRUST Code – A Global Code of Conduct for Equitable Research Partnerships, DOI: https://www.globalcodeofconduct.org/