Biobanking Case Study
ModulesBiobanking Case Study
This module aims to encourage reflection on the ethical issues involved in biobanking, cross-border collaborations and the need for alignment of practices across countries and between public and private institutions.
Learning outcomes
At the end of this module, learners will be able to:
- Identify and analyse the ethics issues and dilemmas associated with an example research proposal.
- Make suggestions for how the ethics issues might be addressed.
- Identify ethics guidelines and policies that are relevant to the proposed research.
Introduction
This case study is based around a research proposal submitted for review by a partnership between an EU research institute and an African medical research centre. It is a hypothetical case but draws inspiration from current discussions regarding the use of biobanking technologies in research. As you work through the module, we invite you to consider the ethics issues that are associated with this type of study from a variety of perspectives as well as how they might be addressed by a research ethics committee.
The Research Proposal
The proposal - Investigating the progression of COVID-19 in diverse population subgroups in Country X and Country Y
(a hypothetical case study)
Collaborating Institutions:
- XYZ Global Health Institute, Country X
- ABC Medical Research Center, Country Y
Background:
COVID-19 has affected populations worldwide, but the progression and severity of the disease appear to vary significantly among different population subgroups, based on factors such as genetics, socioeconomic status, environmental exposures, and healthcare access. These variations are particularly pronounced between high-income countries and low- or middle-income countries. Understanding these differences is critical to improving public health responses to COVID-19 and future pandemics.
This study aims to investigate the progression of COVID-19 in two diverse countries—Country X (a high-income country in Europe) and Country Y (a low- or middle-income country in Africa)—to identify genetic, environmental, and social factors influencing COVID-19 outcomes. Insights gained will be used to develop predictive models for disease severity and inform public health strategies for more effective pandemic preparedness and response.
Research objectives:
1. Comparative COVID-19 progression analysis: Examine how COVID-19 progresses in different subgroups (e.g., age, gender, ethnicity, and socioeconomic background) in Country X and Country Y.
2. Genetic and environmental risk factors: Identify genetic markers and environmental exposures (e.g., air pollution, living conditions) that affect COVID-19 severity and outcomes in the two countries.
3. Development of predictive models: Create models to predict disease risk and progression, incorporating genetic, demographic, and environmental data.
Study design:
The study will be conducted over three years and will involve both prospective and retrospective analysis. It will combine newly collected biosamples and health data with previously donated samples from existing biobanks.
1. Participant recruitment: The study will recruit 5,000 participants from each country. Participants will be selected based on age, gender, ethnicity, and socioeconomic status to ensure diverse representation.
2. Data collection: Biosamples (blood, nasal swabs, saliva) and demographic data (medical history, socioeconomic status, environmental exposures) will be collected from each participant. The samples will be processed and stored in a newly established biobank in both Country X and Country Y for long-term research use.
3. Secondary data use: The study will also utilise biosamples from pre-existing biobanks in both countries, originally collected for other health-related research purposes. These samples will be integrated into the analysis.
4. Data analysis: Researchers will conduct genomic sequencing and environmental exposure analysis to identify factors influencing disease severity. Statistical models will be developed to predict high-risk groups based on the data.
Expected outcomes:
1. Identification of key risk factors: The study will provide insights into the genetic, environmental, and social factors that influence COVID-19 severity in different subgroups across Country X and Country Y.
2. Predictive tools: The research will result in the development of predictive models to inform healthcare providers and public health officials about populations at higher risk of severe COVID-19 outcomes.
3. Improved public health response: The findings will contribute to more targeted interventions, enhancing pandemic preparedness and healthcare access, particularly for vulnerable groups in Country Y.
Expected contribution:
Live Poll
Please answer the following question, your responses will be recorded anonymously.
Question: As a member of the research ethics committee, what is your first impression of this proposal? Do you think that you would be in favour of approval for this project?
Feedback
In complex cases like this, it is always advisable to seek more information before making a decision. Research ethics committee members can do their own research around the topic, most often this involves asking the applicants for further information. REC members may also want to discuss the proposal with colleagues and other stakeholders, and if necessary, they can seek expert advice externally.
First Impressions from the REC Chairs
Email from the research ethics committee chair in Country X
Dear REC members,
In preparation for our meeting next week, I would be grateful if you could read through the attached proposal from the XYX/ABC partnership. I believe that there are some issues that will need to be addressed before we can consider approval for this project and would like to talk through the following in our discussions:
Consent issues – which consent model will be used?
Dual ethics approval
How will the samples be collected and stored?
Cross-border data sharing
I look forward to hearing your thoughts
Best wishes
Liam
Email from the research ethics committee chair in Country Y
Greetings REC members,
As you know, we have a meeting scheduled for next Wednesday. Please can you have a look at the attached proposal from the XYZ/ABC collaboration in advance of our meeting. I can see already from a quick look that there are issues relating to:
Issues concerning consent,
Ownership of biological materials and data
Intellectual property of results from research
Collection and storage of biological materials
Ensuring benefits are shared equitably between institutions and localities.
Reflection activity
As you can see, the REC chairs have each identified some ethical issues in the research proposal, did you spot any others? Can you identify the sections of the proposal which are relevant to the chairs’ concerns? Do you think that the geographical location of the two ethics committees will impact on their perspectives? Make a few notes of the issues that you have identified before moving on.
Dual Ethics Approval?
Email from new REC member Thomas in Country X to his REC chair:
Dear Liam,
Thank you for the email about our next REC meeting, I have started reading through the proposal, and just have a quick question that I wanted to ask – you mentioned dual ethics approval, which I take to mean that ethics approval will be sought both here and in Country Y.
Why is that? We are the XYZ Global Health Institute with a worldwide reputation – surely, it’s enough for us to grant ethics approval without another organisation being involved?
All the best
Thomas
Dual ethics approval is an important measure to take to avoid ethics dumping.
Ethics dumping refers to the unethical practice of conducting research in low- or middle-income countries (like Country Y) without adhering to the same ethical standards applied in high-income countries (like Country X). This proposal for studying COVID-19 progression in both countries must be vigilant to avoid ethics dumping by ensuring that consent and ethical approval are obtained independently in both countries, respecting local regulations, cultural norms, and standards of care. Participants in Country Y should not face lower ethical protections, and informed consent must be fully explained, ensuring that individuals understand how their data and biosamples will be used. Additionally, any findings or benefits must be equitably shared between both countries to avoid exploitation. Transparency, respect for autonomy, and local ethics oversight in both Country X and Country Y are crucial to ensure that the study is ethical and culturally appropriate across both settings. The TRUST global code of conduct for equitable research partnerships is a resource for all research stakeholders who want to ensure that international research is equitable and carried out without ‘ethics dumping’ and ‘helicopter research’.
Perspectives on Consent
The XYZ/ABC collaboration inform the REC that reconsent will be sought for the secondary use of biobank samples, where feasible. All new participants will give fully informed consent for the collection and storage of their biosamples and data. However, they do not specify which model(s) of consent will be used. Let us consider some different perspectives on this.
Maria:
As a potential new donor in Country X, I see the importance of research aimed at understanding COVID-19, especially how it affects different population groups. I appreciate the opportunity to contribute to a study that could potentially improve public health outcomes, not just here in my country, but across the world.
But I have some concerns about the collection and use of my biosamples and personal data. I want to make sure that my privacy is protected, and that any data from my samples is handled securely. I would like to know who will have access to my data and for what purposes, especially since this project involves collaboration with another country. Will my samples be used only for this study, or could they be used in future research? If so, I would want to be fully informed and have a say in whether I consent to future uses.
Another issue is data security. Given the sensitive nature of genetic and health information, I want to know that there are robust measures in place to prevent unauthorised access or breaches. Lastly, I would like transparency about how any findings, especially those related to my genetic data, might be shared and whether I’ll be informed of any significant results that could impact my health.
Pamela:
As a staff member in a biobank facility in Country Y, I was pleased to see more biobanking coming to my country. However, I do have some concerns regarding consent arrangements. The consent process should make sure that participants fully understand exactly what they are consenting to. Given the varying levels of literacy and familiarity with medical research in some communities, it’s crucial to ensure that informed consent is genuinely informed. Participants need to know what the study is about, how their samples will be used, and what future research they may contribute to.
One of my concerns is making sure that we clearly communicate the potential for secondary use of the samples and data. If their biosamples or data are used for studies beyond the original research, we need to explain that at the beginning, so participants aren't surprised or feel misled later.
Additionally, there's the issue of trust. Many people may be wary of how their data, especially genetic information, will be handled, particularly if it is shared across borders or with institutions in Country X. It is essential to reassure them about data security, confidentiality, and how their samples will be used ethically, respecting their autonomy and rights.
Adam:
When I first donated biosamples and data in Country Y I gave broad consent, which means that I provided consent just on that one occasion, and in doing so I gave permission for my samples to be used for future studies beyond the original research. I initially felt positive about contributing to research that could benefit public health and I trusted the system would handle my data responsibly.
But I’ve developed some concerns. Because I consented broadly, I’m unsure about how my samples have been used, or what they might be used for in the future. It’s unclear whether my samples are being used in ways I would agree with today. For example, I wonder if they’re involved in research that might not directly benefit my community or country, and whether any findings will be shared with us.
I also worry about the commercial use of my samples. I didn’t consent to my genetic data being used for profit-making ventures, and I would like more transparency on whether pharmaceutical companies or other private entities have accessed my data.
Most importantly, I want reassurance that my privacy and confidentiality are safeguarded. I trust that the biobank staff are doing their best, but I would appreciate regular updates on how my samples are being used, and confirmation that I can still withdraw consent if I feel uncomfortable in the future.
Lily:
As a biobank donor in Country X, I gave study-specific consent for one project, meaning that I was just consenting for my samples and data to be used for one specific piece of research. I felt confident that I understood how my samples and data would be used. Recently, I’ve been approached to allow my samples to be used in a new collaboration studying COVID-19 in both Country X and Country Y. While I understand the importance of this research, I have mixed feelings about expanding the use of my samples beyond the original study.
I’m concerned about ‘scope creep’. I initially agreed to a specific study, and now my data is being requested for something quite different. I would need clear information on what this new research involves, who will have access to my samples, and whether this could lead to additional projects I haven’t explicitly agreed to. I’m also unsure how the cross-border collaboration affects data protection and privacy, especially since Country Y may have different standards or regulations.
Analysis of Consent Models
The XYZ/ABC partnership has not mentioned which donor consent model they plan to use for this new venture. The chair of your REC has asked all members to look at the ethical implications involved in the choice between broad, study-specific, and dynamic consent and make a recommendation. Please watch the video about the different models and then vote in the poll to indicate your recommendation to the chair.
Broad consent
It should be noted that some African countries (for example Malawi, Zambia and Tanzania) do not permit the use of the broad consent model. For the purposes of this case study, please assume that Country Y does allow the use of broad consent.
Broad consent allows participants to give permission for their biosamples and data to be used not only for the current study but also for future, unspecified research. This model is commonly used in biobanking and large-scale genomic studies. While broad consent offers flexibility for researchers, enabling them to use the samples for a wide range of future projects without needing to recontact participants, it raises ethical concerns about autonomy.
Participants may not fully understand the future uses of their data, potentially leading to trust issues if their samples are used in research they didn’t anticipate or might not support. In this study, if broad consent is used, clear and transparent communication is essential, informing participants of the kinds of studies their samples may be used for and providing mechanisms for withdrawal at any time. Broad consent may be suitable given the scope of this project, but safeguards are needed to protect participants' rights.
2. Study-specific consent
Study-specific consent limits the use of biosamples and data to the project for which they were originally collected. In this case, participants would consent only to the use of their materials for research on COVID-19 progression in the two countries. This model respects participant autonomy more directly by ensuring they know exactly how their samples will be used.
However, it is more restrictive for researchers. If further research on the same samples is desired, such as future investigations into other diseases or pandemics, researchers would need to contact participants for re-consent, which can be logistically challenging, costly, and may reduce participation rates over time. For the COVID-19 study, study-specific consent could ensure that participants fully understand the research, but it may limit future discoveries or collaborations without additional administrative burdens.
3. Dynamic consent
Dynamic consent is an evolving, interactive consent model that allows participants to make decisions about the use of their samples over time. Through digital platforms, participants can update their preferences, choose which studies their biosamples can be used for, and even receive updates about how their data is being used. This model enhances autonomy and trust by giving participants more control and engagement throughout the research process.
In the context of this project, dynamic consent could address ethical concerns by ensuring that participants from both Country X and Country Y remain informed and can adjust their consent preferences as research evolves. However, it requires technological infrastructure and regular communication, which may be challenging, particularly in Country Y, where digital access could be limited. Moreover, dynamic consent can be resource-intensive to manage, making it less feasible for large-scale or long-term studies without proper funding.
Ethics trade-offs
Autonomy vs. flexibility: Study-specific and dynamic consent prioritise participant autonomy, ensuring that individuals have greater control over how their samples are used. In contrast, broad consent offers researchers more flexibility for future research but may compromise participants' ability to make informed decisions about every use of their data.
Participant trust: Broad consent risks eroding trust if participants feel disconnected from how their samples are used over time. Study-specific and dynamic consent foster trust by providing transparency and ongoing participant involvement.
Logistical considerations: Study-specific and dynamic consent models are administratively complex and may require more time, resources, and participant engagement. Broad consent, while simpler to manage for long-term projects, may reduce participant involvement and transparency.
Analysis of Consent Models-Live Poll
Which consent model would you recommend to be used by the XYZ/ABC partnership? Please select one answer from the choices below and then click to reveal how others have voted.
Feedback
Considering Ownerships
In the proposed study issues surrounding the ownership of biosamples, data, and intellectual property or IP are critical and must be addressed to avoid ethical conflicts. The following video provides an overview of ways in which this could be managed.
First, ownership of biosamples collected in each country needs to be clearly defined. Participants should be informed about who will own their samples once collected, whether it is the institution, the biobank, or a third party. Additionally, the ownership of data derived from these samples must be transparent, with clear agreements on how it will be stored, shared, and used, especially in cross-border collaborations.
Second, intellectual property issues must be clarified. Any discoveries, such as genetic markers or predictive models developed from the research, could have significant commercial and medical value. Fair agreements must ensure that both countries benefit from potential commercial gains, particularly ensuring that Country Y, as a lower-income nation, is not excluded from the benefits of research originating from its biosamples and data. Equitable sharing of benefits and clear IP agreements are essential to avoid exploitation.
Clear policies must be established regarding researcher access to biobank materials. Only researchers with approved projects and appropriate ethical oversight should be granted access. Issues of ownership of biological materials and IP arising from research need careful consideration. Samples typically remain the property of the biobank, but researchers may have access to data derived from those samples. Any IP developed from the research, for example, predictive models, genetic markers should be subject to collaborative agreements that ensure equitable sharing of benefits, especially between Country X and Country Y. It is essential to prevent exploitation, ensuring that all collaborators, including participants, benefit from research outcomes.
Governance
The governance of biobanking research is critical to ensuring that the collection, storage, and use of biosamples and data are conducted ethically and responsibly, especially in a cross-border, multi-institutional study such as the COVID-19 progression research in Country X and Country Y.
Here are some further issues that need consideration:
1. Collection and storage of biosamples and data
Both RECs need to satisfy themselves that governance protocols are in place to ensure that biosamples and data collected in both Country X and Country Y are handled with the highest ethical standards. This involves securing informed consent that is clear, culturally appropriate, and specific about how the samples will be stored, used, and potentially shared. The governance framework should include procedures to manage sample storage in biobanks, ensuring that materials are properly catalogued, securely stored, and accessible only to authorised personnel under strictly controlled conditions. Data must be pseudonymised or de-identified to protect participant identities and ensure confidentiality, particularly when genomic data or sensitive health information is involved.
Additionally, the implications of any return of results to donors should also be considered. The indefinite or long-term storage of biosamples in biobanks can present issues if participants are not fully aware of the potential for their data and samples to be used in future research beyond COVID-19. Participants must have the ability to withdraw consent at any time, with clear procedures for the destruction of their biosamples and data if requested.
Privacy and data security: The collection of sensitive health and genetic data raises privacy concerns. De-identification or pseudonymisation must be used to protect participants' identities, but even this carries the risk of re-identification. Strict data protection protocols, including secure storage, encryption, and restricted access, must be implemented to prevent data breaches, especially when data is shared across borders. Both countries' legal frameworks must be respected, particularly data protection laws like the GDPR in Country X. Given the evolving nature of regulations, particularly with the European Health Data Space and its impact on data sharing, RECs must remain agile. Ethical guidelines should be regularly reviewed to stay aligned with changing policies and participant rights.
3. Cross-border transfers of biosamples and data
In a collaborative project between Country X (Europe) and Country Y (Africa), governance must address the challenges of cross-border transfers of biosamples and data, which are subject to different regulatory regimes. In Country X, strict GDPR regulations govern data protection and privacy, requiring explicit consent for cross-border data sharing. Similar standards may not exist in Country Y, which raises ethical concerns around participant rights and the safeguarding of data once it leaves the country.
Material Transfer Agreements (MTAs) and Data Sharing Agreements (DSAs) must be in place to ensure that samples and data transferred between countries are subject to harmonised standards of privacy, security, and ethical use, regardless of the country of origin. It would be wise for the RECs to secure advice from an expert with specialist knowledge of collaborations between the EU and Africa to ensure that procedures are aligned.
4. Potential for racial bias
Governance mechanisms must also address the potential for racial bias in the collection, analysis, and interpretation of biosamples and data, particularly when comparing diverse population groups across Country X and Country Y. Without careful oversight, the study may unintentionally perpetuate biased assumptions or lead to misinterpretation of genetic differences. Researchers must adopt an ethically sound approach that recognises the socioeconomic and environmental factors that contribute to health disparities, rather than attributing differences solely to genetic or racial categories.
Particular attention should also be paid to the language used in all documentation to avoid perpetuating such biases. Governance should include independent ethics advisory boards to monitor the study’s methodology and ensure that findings are not used to justify or reinforce racial stereotypes. Both RECs should inquire as to the extent that AI and machine learning will be used – and what protocols will be in place to manage potential biases, transparency issues and ethical risks associated with automated decision-making.
5. Commercial vs. public partnership
The nature of the partnership—whether commercial or public—significantly impacts the ethical landscape of biobanking governance. In a commercial partnership, the risk of exploitation of biosamples for profit, particularly those from Country Y, is heightened. There may be concerns about whether the benefits of the research will be equitably shared or if the data will be used to develop commercial products that primarily benefit private entities in high-income countries. Governance should establish clear benefit-sharing mechanisms, ensuring that any IP or products developed from the research provide fair returns to both Country Y and its participants.
In contrast, a public partnership involving government or academic institutions might focus more on public health goals and equity, but governance frameworks should still ensure that public interests are protected, and that transparency is maintained regarding the use of samples and data. Regardless of whether the collaboration is public or private, governance should include oversight committees that ensure ethical standards are upheld, and that participants' rights and interests are prioritised. Both RECs should seek further information about whether this is a commercial partnership and if there are any plans to develop commercial products.
Conclusion
Relevant Policies and Guidelines
In addition to the guidelines discussed below, we have produced a checklist for RECs on the use of biobanking in research, attached at the end of this page. We hope that this will be useful for REC members considering proposals involving biobanking. Please also see the further resources section which includes the most relevant EU or international guidelines or standards related to biobanking, a bibliography and useful websites.
In Europe, biobanking is governed by regulations in the European Union's Clinical Trials Regulation and the Human Tissue and Cells Directive which provides guidelines for sample collection, storage, and ethical considerations. Guideline 8 in 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 General Data Protection Regulation (GDPR), which addresses the processing of personal data.
The International Society for Biological and Environmental Repositories (ISBER) provides guidelines for best practices, and the OECD's Guidelines on Human Biobanks and Genetic Research Databases offer international recommendations. 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, African and other 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.
