Biobanking: Ethics Issues
ModulesBiobanking: Ethics Issues
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.
Module Introduction
Biobanks are specialised repositories that collect and store biological samples and information from various sources (animals, plants, microorganisms, humans, etc.).The focus of this module is on human biobanks which collect and store biological samples from human donors (for example: saliva, urine, blood) and health-related data such as health records, family history, lifestyle, genetic, occupational, and residential information for research purposes and the development of new diagnostic procedures, preventive measures, and treatments.
The Ebola Outbreak in Sierra Leone
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.
Donating To Biobanks: Consent Issues
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.
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;
Broad Consent
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.
Further Models of Consent
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.Consent Issues Activity
Use the links below to access and read the UK Biobank’s information sheet and consent form.
Example of a biobank information sheet from the UK Biobank
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.
Consent Issues for Children Donating Materials to Biobanks
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.
Other Consent-Related Topics
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
Personal Data Processing Issues
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.
Personal Data Processing Issues Cont.
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.
Personal Data Processing Issues Activity
