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Biobanking Case Study
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instruction goal: 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.
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instruction step text: [[File:Bio3Image2.png|center|frameless|600x600px]] 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.
instruction step title: Live Poll
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instruction step text: [[File:Bio3Image5.png|center|frameless|600x600px]] 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 a…
instruction step title: Perspectives on Consent
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instruction step text: [[File:Bio3Image6.png|center|frameless|600x600px]] 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 mo…
instruction step title: Analysis of Consent Models
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instruction step text: [[File:Bio3Image7.png|center|frameless|600x600px]] 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''' For this COVID-19 study, broad consent might be appropriate if combined with strong safeguards for participant rights and mechanisms for withdrawal. However, if participant autonomy is a priority, especially given the cultural diversity between Country X and Country Y, dynamic consent may be the ideal model, despite its logistical challenges. Study-specific consent could also be ethically valid for this particular study, though it may limit future research potential.
instruction step title: Analysis of Consent Models-Live Poll
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instruction step text: [[File:Bio3Image9.png|center|frameless|600x600px]] 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 r…
instruction step title: Governance
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instruction step text: [[File:Bio3Image10.png|center|frameless|600x600px]] 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 [https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:102:0048:0058:en:PDF 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 [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9357355/ 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://www.isber.org/page/BPR General Data Protection Regulation] (GDPR), which addresses the processing of personal data. [https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf The International Society for Biological and Environmental Repositories] (ISBER) provides guidelines for best practices, and the [https://www.oecd.org/health/biotech/guidelines-for-human-biobanks-and-genetic-research-databases.htm OECD's Guidelines on Human Biobanks and Genetic Research Databases] offer international recommendations. [https://doi.org/10.3390/genes15010066 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, or…
instruction step title: Relevant Policies and Guidelines
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instruction step text: [[File:Bio3Image1.png|center|frameless|600x600px]] '''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 b…
instruction step title: The Research Proposal
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instruction step text: [[File:Bio3Image3.png|center|frameless|600x600px]] ===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.
instruction step title: First Impressions from the REC Chairs
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instruction step text: [[File:Bio3Image4.png|center|frameless|600x600px]] '''Feedback''' 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. [https://www.globalcodeofconduct.org/ 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’.
instruction step title: Dual Ethics Approval?
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instruction step text: [[File:BioImage8.png|center|frameless|600x600px]] 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.
instruction step title: Considering Ownerships
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