The aim of this module is to support students, researchers, and research ethics reviewers in learning about and reflecting upon the ethics issues associated with the development and use of biobanking. '''Learning outcomes''' At the end of this module, learners will be able to: #Debate the pros and cons of various models of consent for biobanking samples. #Consider the core issues for biobank data processing related to data protection, data sharing, and privacy concerns. #Identify varied methods for dealing with incidental findings. #Access guidelines and regulations relevant to biobanking.
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The following case study about the 2013-15 Ebola outbreak in Sierra Leone illustrates some of the key ethical issues related to biobanking. '''The Ebola outbreak in Sierra Leone''' During the 2013-15 Ebola outbreak in Sierra Leone, ethical issues emerged in the context of biobanking, as researchers sought to understand and combat the deadly virus. A prominent case involved the establishment of biobanks to collect and store biological samples from Ebola patients for research purposes. Following a large-scale collection of diagnostic samples, diagnostic tests were mainly carried out by external laboratories under memoranda of cooperation or material transfer agreements. Biobanking operations in Sierra Leone contributed significantly to gaining an understanding of the outbreak, but the meeting of ethical standards was deemed inadequate with a lack of a complete inventory of the samples collected, and incomplete information about their potential future use, location, and ownership. One ethical concern centered around obtaining informed consent from individuals affected by the outbreak. With the urgency of the situation and the widespread fear of the virus, ensuring truly voluntary and informed participation became challenging. Issues of comprehension, especially in remote and vulnerable communities, raised questions about the validity of the consent process. Another ethical dilemma was the potential for exploitation. The influx of international researchers and organisations into Sierra Leone raised concerns about the fair distribution of benefits and resources. There were fears that the biological samples collected might be used for research benefiting external entities, potentially neglecting the welfare and healthcare needs of the local population. '''Feedback''' Balancing the need for rapid research to address the Ebola crisis with ethical considerations regarding consent, community engagement, and equitable benefits posed significant challenges during this public health emergency. The case underscores the importance of establishing and adhering to clear ethical guidelines and community involvement protocols in biobanking practices, especially in the context of infectious disease outbreaks in resource-limited settings.
'''Issues relating to consent to donate biomaterials and data to biobanks''' Clear procedures enabling biobank donors to give their informed consent to donate biological materials and health-related information are vital to ensure that they fully understand how their samples and data will be used. Donors should be made aware that biobanks do not routinely provide individual diagnoses, so that they are not falsely reassured when they do not receive results from the analysis of their biospecimens and data. RECs must assess the clarity and comprehensibility of consent forms, addressing any potential risks and benefits. [https://www.wma.net/policies-post/wma-declaration-of-taipei-on-ethical-considerations-regarding-health-databases-and-biobanks/ The WMA’s Declaration of Taipei] sets out the following criteria for informed consent for multiple and indefinite uses of biomaterials stored in a biobank, stating that consent is only valid if the concerned individuals have been adequately informed about: the purpose of the health database or biobank; the risks and burdens associated with collection, storage and use of data and material; the nature of the data or material to be collected; the procedures for return of results including incidental findings; the rules of access to the health database or biobank; how privacy is protected; the governance arrangements of the biobank; That if the data and material are made non-identifiable the individual may not be able to know what is done with their data/material and that they will not have the option of withdrawing their consent; Their fundamental rights and safeguards established in the Declaration; and when applicable, commercial use and benefit sharing, intellectual property issues and the transfer of data or material to other institutions or third countries.
Different models of consent offer distinct advantages and drawbacks in balancing ethical considerations and scientific advancements. We will first look at broad consent, before moving on to look at other models. For this form of consent, participants give permission for their data or biological samples to be used in a range of future research studies, rather than being limited to a single, specific study. Jurate Lekstutiene shares her thoughts on how the broad consent model is used in biobanking. Biobanking would not be possible without support from the society, without consent from biobank participants. However, during the consent process, usually it's impossible to accurately determine which health-related research will be conducted in the future. There are several ways how we could address this uncertainty. And the idea behind the broad consent model is that a person gives consent once, usually in writing, and then based on this consent, a biobank can collect and store samples and data for unlimited time, even after a biobank participants' death. And these samples and data can be used for extensive research involving different diseases.
=== '''Dynamic Consent''' === Dynamic consent utilises digital technology to enable ongoing communication with donors. It allows donors to tailor their consent preferences over time, providing a mechanism for enhanced donor engagement. While it fosters a more participatory approach to consent, its implementation can be resource-intensive and may pose technical and practical challenges. Practically, the need for continuous engagement puts a greater administrative burden on biobanks. This includes the labour associated with managing donor inquiries, concerns, and requests for consent withdrawal or modification, which can escalate costs and require more personnel. Furthermore, it can create a potential digital divide if some donors lack access to or familiarity with the necessary technology to engage with the consent process, potentially raising issues of equity and inclusivity. === '''Study Specific Consent''' === Involves donors providing informed consent for their data and samples being used for a single specific research study. Fresh consent would need to be sought by researchers should they wish to use data or samples in a new study. === '''Tiered Consent''' === Involving donors choosing from predefined categories of research by agreeing to the sub-area of medicine for which samples and data can be used in the future. They might, for example, select specific disease groups like cancer or cardiovascular disorders. This model of consent enhances donor autonomy and transparency but may hinder the adaptability of research projects. Additionally, it requires constant updates to accommodate evolving research fields. === '''Meta Consent''' === Involving pre-defined consent models for different layers. Based on this model, one person may choose broad consent for all types of health data and their usage contexts. Meanwhile, another person may choose broad consent for nationally funded projects involving genetic data, and specific consent for the use of any data in international and commercial scientific projects. To sum up, meta-consent is not just about granting or prohibiting consent but about applying different consent models to different layers of biobank research.
Use the links below to access and read the UK Biobank’s information sheet and consent form. [https://www.ukbiobank.ac.uk/media/ei3bagfb/participant_information_leaflet-baseline.pdf Example of a biobank information sheet from the UK Biobank] [https://www.ukbiobank.ac.uk/media/t22hbo35/consent-form.pdf Example of a biobank consent form from the UK Biobank] '''Feedback''' Broad consent models are commonly used by biobanks to streamline sample collection for diverse research purposes. These models allow participants to consent to a wide range of potential future studies, facilitating efficient research while maintaining ethical standards. However, ensuring transparency and understanding among participants regarding the scope of research remains paramount for ethical practice. What type of consent model is UK Biobank using in these examples?
== '''Consent Issues for Children Donating Materials to Biobanks''' == Consent extends beyond choosing an appropriate model for use, to other nuanced issues that need addressing in the training of researchers. These include involving children in biobanking, allowing for the withdrawal of consent, managing consent upon a donor's death, handling samples used without consent, respecting cultural norms and practices, and public health emergencies. '''Consent issues for children donating materials to biobanks''' In most jurisdictions, children cannot provide legally valid consent on their own, particularly for complex matters such as donating biological materials to biobanks. The ability to provide informed consent is typically associated with reaching the age of majority, which varies globally but is often around 18 years old. In situations involving children, the consent process usually involves obtaining permission from parents or legal guardians. These individuals are considered to have the legal authority to make decisions on behalf of the child, taking into account the child's best interests. The process of obtaining parental or guardian consent involves providing comprehensive information about the purpose of the donation, potential risks, and the intended use of the biological materials and health-related data. However, ethical considerations become more nuanced when dealing with older minors who may demonstrate the capacity for informed decision-making. In such cases, the involvement of the minor in the consent process, along with parental or guardian consent, may be considered. The specific regulations and ethical guidelines surrounding the involvement of minors in research may vary by jurisdiction and should be followed carefully to ensure the protection of minors' rights and wellbeing in the context of biobanking activities.
Consent Issues for Children Donating Materials to Biobanks
'''The right to withdraw consent''' The right to withdraw consent is a fundamental aspect of ethical research. While the motives behind withdrawal can differ greatly, operationalising withdrawal of consent remains complex, particularly if biobank data or samples have already been used in research. The withdrawal of consent should be documented, and samples and data should be destroyed safely or returned to the donor. '''The death of a donor''' The death of a donor can create ambiguity in terms of ongoing consent for the use of their samples. Guidelines differ globally: some suggest that consent should be presumed to continue after death, others advocate for re-consenting by next of kin. '''The use of samples without consent''' The use of samples without consent, often in the case of historical or residual samples, is another complex issue for consent, as well as for data sharing and privacy issues. In this case, decision-making about the use of samples involves balancing donor interests with the potential scientific value of such samples. '''Respecting cultural norms and practices''' Respecting cultural norms and practices, as in any research study, researchers and RECs should bear in mind the need to respect cultural norms when seeking informed consent from an individual. For instance, in some cultures it is expected that the head of a household or community elders would be asked to provide their consent for a member of the family/community participating in a research study or donating biospecimens and health-related data to a biobank.
Personal data processing in biobanks raises ethical issues that need careful consideration to ensure the protection of individuals' rights, privacy, and the responsible conduct of research. During the Ebola outbreak in Sierra Leone, data processing failures contributed to a lack of a complete inventory of the samples collected, and incomplete information about their potential future use, location and ownership. Navigating such issues requires adherence to established guidelines, ongoing ethical review, and engagement with stakeholders to ensure that data processing in biobanks aligns with ethical principles, legal frameworks, and societal expectations. Some key ethics issues connected to data processing in biobanks are described below after a short clarification of relevant terms. The terms anonymous and de-identified are often used interchangeably but do have different meanings. For the purposes of this module, we are using the terms in this way: * Anonymous – The dataset does not contain any identifiable information and there is no way to link the information back to identifiable information. This is an irreversible process. * De-identified – The dataset does not contain any identifiable information, but there is a way to link the information back to identifiable information. '''Data ownership''' Ethical concerns surrounding data ownership in biobanks revolve around defining and respecting the rights of various stakeholders involved. Donors contribute valuable biospecimens and personal data, raising questions about who ultimately owns this information. Generally, donors retain some rights over their samples and associated data, but biobanks also have responsibilities to steward these resources for the public good. Policies will vary from country to country and across different organisations. As an example, UK Biobank states that it is the owner of the intellectual property rights of the data and samples contained in the resource. The biobank grants researchers a limited, revocable, worldwide, royalty-free, non-exclusive licence (but not ownership rights) to use samples for a permitted purpose only. However, the intellectual property rights to the results data deriving from the research for the permitted purpose will under most circumstances belong to the researcher. Striking a balance between the interests of researchers, institutions, and donors is crucial. Clear and transparent consent processes are essential to inform donors about how their data will be used and who will have ownership or control over it.
'''Data sharing across borders''' International collaborations strive for diverse sample populations to avoid biases in research outcomes and to ensure that research findings are applicable and beneficial to global populations. However, the sharing of data across international borders increases the risk of privacy breaches and unauthorised access due to variations in data protection laws, hence robust security measures and compliance with diverse regulatory frameworks are crucial. Informed consent for international data sharing can be complex due to differences in cultural norms, legal requirements, and language barriers. Respect for the cultural values and norms of different donor populations might require adaption of the protocols for collection and use of samples and data to align with each cultural context. Additionally, determining who has control and sovereignty over the shared data can be contentious, and striking a balance between collaboration and respecting the rights of individual countries or institutions might pose an ongoing ethical challenge. Researchers and RECs will need to navigate the complexities of multiple jurisdictions to uphold consistent ethical standards.
Personal Data Processing Issues Activity
'''An example of a protocol to deal with incidental findings''' In addition to collecting biological samples, the population-based UK [https://www.nature.com/articles/s41467-020-15948-9#Sec19 Biobank also collect multi-modal images] from some donors which include MRIs, x-rays, and ultrasounds. Their protocol for dealing with incidental findings included the recruitment of 3rd party consultant radiologists to review scans that the biobank radiologists had flagged up if they had noticed signs of something clinically serious at the time of collection. The consultant radiologist then reviewed the images and advised the biobank if the donor and their healthcare practitioner should be notified. Of the donors who were notified of an incidental finding, all consulted their doctor, and 90% went on to further clinical assessments.
Work has been conducted in [https://www.nature.com/articles/s41431-023-01299-8 Germany] and the [https://www.bbmri.nl/sites/bbmri/files/Erasmus_MC_Handreiking_Interactieve_pdf_Engels_29_04_2020_V3.pdf Netherlands] to design guidelines for dealing with incidental findings arising from biobank research. Both sets of guidelines emphasise that processes for dealing with incidental findings need to be in place from the design stage of studies. '''Feedback''' Researchers working with secondary data collected by biobanks need to be aware of the original conditions of consent given by biobank donors, including whether they have been given the option to be notified of incidental findings and if so, did they opt in or out. Other considerations to take into account are the length of time that has passed since the donation was made, and whether the data has been utilised previously by other researchers. Notification of findings long after the donation, or by multiple researchers may be unwelcome to the donor. However, any such decisions about communicating incidental findings derived from secondary biobank data should be guided by the conditions of consent under which the original data was contributed.
'''Ethics review processes for biobanking''' Ethics review processes for biobanking vary across the world. Looking at European countries as an example of the variations, we see that in many countries, independent ethics review bodies, typically RECs, evaluate the ethical acceptability of research projects that intend to use biobank resources. In some countries, RECs also review the establishment of a biobank itself. In other countries, REC approval for biobank research is only necessary in exceptional cases. For example, in the UK, biobanks may obtain general ethics approval to conduct a broad range of biobank research, thereby relieving researchers of the need to seek separate ethics approval. In Finland, REC permission is required to set up a biobank, and the evaluation of biobank research is typically performed by the directors of the biobank, with REC approval necessary only under specific circumstances. It is also worth noting that in some countries, RECs are responsible for additional obligations, such as allowing biobank controllers to identify and contact gene donors to get their written consent for renewing, supplementing or verifying a description of their state of health. They might also be responsible for authorising the transfer of biobanked samples and health-related data to other biobanks established in the same country or abroad. Different ethics governance practices across different biobanks in Europe also reflect different models of oversight recommended at the international level. For instance, the [https://www.oecd.org/health/biotech/guidelines-for-human-biobanks-and-genetic-research-databases.htm OECD guidelines for Human Biobanks and Genetic Research Databases] recommend that RECs should assess biobank research with a specific focus on determining whether the purpose of the planned biobank research study falls within the scope of previously given consent or whether it requires (re)consent. Meanwhile, the [https://www.wma.net/policies-post/wma-declaration-of-taipei-on-ethical-considerations-regarding-health-databases-and-biobanks/ WMA Taipei Declaration] expands the scope of ethical oversight by recommending that RECs should evaluate not only biobank research, but also approve the establishment of a biobank and monitor ongoing biobank activities.
'''Guidelines and Regulations''' In Europe, biobanking is governed by regulations in the [https://health.ec.europa.eu/medicinal-products/clinical-trials/clinical-trials-regulation-eu-no-5362014_en? European Union's Clinical Trials Regulation] and the [https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32004L0023 Human Tissue and Cells Directive] which provides guidelines for sample collection, storage, and ethical considerations. Guideline 8 in [https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf? CIOMS International ethical guidelines for health-related research involving humans] sets out recommended practices for the collection, storage and use of biological materials and related data. Also relevant is the [https://commission.europa.eu/law/law-topic/data-protection/legal-framework-eu-data-protection_en General Data Protection Regulation] (GDPR), which addresses the processing of personal data. [https://www.isber.org/page/BPR? The International Society for Biological and Environmental Repositories] (ISBER) provides guidelines for best practices, and the [https://www.bbmri-eric.eu/library/oecd-guidelines-for-human-biobanks-and-genetic-research-databases-hbgrds-2009/? OECD's Guidelines on Human Biobanks and Genetic Research Databases] offer international recommendations. [https://pmc.ncbi.nlm.nih.gov/articles/PMC9357355/? Multiple national and regional regulations] further shape biobanking practices worldwide, emphasising ethical, legal, and privacy considerations. It is important to remember that different guidelines and regulations will apply to biobanks and related research projects in order to comply with the requirements of different institutions, organisations and geographical locations. The further resources section lists and provides links to other relevant EU or international guidelines or standards related to biobanking in health and healthcare, but you may need to explore further afield to locate those that apply to different situations. Make a note of which regulations and/or guidelines relating to the use biobanking are most relevant to your institution/geographical location.
Governance, Guidelines & Regulations Cont.
You can try these questions to see whether your learning from this module addresses the intended learning outcomes. No one else will see your answers. No personal data is collected. What is a key distinction between the broad consent and study-specific consent models used for individuals donating biological samples to a biobank?
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BBMRI-ERIC Common Service ELSI https://www.bbmri-eric.eu/services/common-service-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/Pages/result_details.aspx?ObjectId=090000168064e8ff 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 https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/research-tissue-banks-and-research-databases/ 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) https://www.bbmri-eric.eu/library/oecd-guidelines-for-human-biobanks-and-genetic-research-databases-hbgrds-2009/? World Medical Association (2016) Declaration of Tapei on ethical considerations regarding health databases and biobanks https://www.wma.net/policies-post/wma-declaration-of-taipei-on-ethical-considerations-regarding-health-databases-and-biobanks/
Most relevant EU or international guidelines or standards related to biobanking
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://doi.org/10.1186/s12910-023-00985-y Annaratone L, De Palma G, Bonizzi G, Sapino A, Botti G, Berrino E, Mannelli C, Arcella P, Di Martino S, Steffan A, Daidone MG, Canzonieri V, Parodi B, Paradiso AV, Barberis M, 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. 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 https://doi.org/10.1016/S2468-2667(19)30081-7 ClloudLIMS (2020) Informed consent: considerations for biobanks March 11 2020 https://cloudlims.com/informed-consent-dynamic-broad-tiered-and-meta-consent-for-biobanking/ 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. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9357355/ 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). 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. Healthtalk.org What is biobanking and why is it important? https://healthtalk.org/experiences/biobanking/what-is-biobanking-and-why-is-it-important/ 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. https://doi.org/10.3390/genes15010066 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). https://doi.org/10.1038/s41467-020-15948-9 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 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. https://jme.bmj.com/content/48/7/466 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. https://doi.org/10.1007/978-3-319-64731-9_9