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Institute on Ethics & Policy for Innovation

Ethics of Biobanking

Biobanks are large collections of biological materials that facilitate the prevention, early detection, and treatment of various medical conditions. Key ethical challenges of biobanks include issues of informed consent, difficulties returning results to participants, challenges with privacy and confidentiality, obstacles with sharing and accessing samples and data, issues regarding the ownership of samples and their potential commercialization, and the lack of identification of appropriate benefits for participants and communities. Future efforts should focus on the harmonization of ethical regulations and procedures for the collection, storage, and access to samples and data. Furthermore, the integration of community engagement practices that help researchers develop culturally relevant models for governance and consent should be prioritized.

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What are Biobanks?
A biobank is defined as “a collection of biological material and associated data.”1 This material often refers to a sample that is obtained from an individual human being, either living or deceased, and can provide biological data, such as genetic information.

Biobanks can be broadly categorized into population-based and disease-oriented biorepositories.2 Population-based biobanks study the development of complex and common diseases by examining the role of an individual’s genetic susceptibility and the role of exposure to external factors through information from laboratory tests, questionnaires, and clinical data. Disease-oriented biobanks promote the study of disease development, particularly cancer, to identify therapeutic strategies through the examination of biological samples.

Biobanks provide a platform of samples and data that can inform epidemiological studies and help to assess treatment efficacy across large populations, over long periods of time.4 Furthermore, biorepositories have an important role in precision medicine because they enable the identification of biomarkers associated with cancer, cardiovascular disease, and neurological disorders, and the prevention, early detection, and treatment of these conditions.3

Ethical Guidelines for Biobanking Research
Biobanking ethical guidelines are partly informed by the Declaration of Helsinki, which outlines the ethical conduct of medical research on human subjects.5 Given the need for guidelines that better suit the nature of biobanks, the World Medical Association established the Declaration of Taipei in 2016, which outlines ethical guidelines regarding the collection, use, and storage of samples and data of biorepositories.1, 6 Ethical recommendations for biobanking research have also been developed by international organizations, such as the Organisation for Economic Co-operation and Development.7

The management of biobanks, which first emerged during the 1990s, was revolutionized by the World Wide Web. As new technologies continue to facilitate data storage and sharing across national and international organizations, ethical concerns regarding how to inform and protect participants from exploitation, abuse of data, and privacy and confidentiality issues have intensified. The following section outlines key ethical challenges of biobanks that continue to spark debate among scholars, policy-makers, and governments.

Key Ethical Challenges of Biobanking Research
Informed Consent: The value of biobanks is based on the collection, storage, and sharing of large sets of data with researchers around the world, for a variety of projects, over a long period of time. For this reason, informing patients about how their data will be used, for what specific purposes, and who will have access to it, can be challenging.

Broad consent, as opposed to study-specific consent, is considered an effective way to optimize consent. This requires patient agreement to having their data used in future studies, as stated in the scope of the consent, without the need to reconsent or receive feedback on incidental findings.8 While this type of consent is the norm, it continues to be the subject of debate because of its assumption that risks to participants are minimal, which may not be true given the possibility for data re-identification. Furthermore, while participants can revoke consent, this is complicated by the fact that they are unaware of by whom and for what purposes their data are being used.9

An alternative form of authorization is dynamic consent, which requires the participant to reconsent to the use of data for each new project. This consent enhances autonomy and increases the participation and choices of patients. However, this form of consent can be costly and administratively burdensome.2

Return of Results: As a general ethical standard, each individual has the right to know, and the right not to know the findings of research. Given that results can be clinical, incidental, or emerge out of research interest, questions such as which results are returned to participants, when and how results are returned, and under what circumstances have sparked debate among biobanking researchers.10

Privacy and Confidentiality: While anonymization processes are always undertaken and strong efforts are made to protect patients’ privacy, the potential for patient re-identification through genetic information remains a possibility. Concerns regarding patient identification increase when data is collected from marginalized or vulnerable groups, which could lead to the potential discrimination and stigmatization of these populations. This could also exacerbate mistrust among groups that are already skeptical of medical research.11

Sample and Data Sharing: Important challenges relate to the lack of a legal framework or harmonization of governance guidelines regarding access, monitoring, and maintenance of data, particularly in low- and middle-income countries (LMICs).12 It remains important to develop governance frameworks that are tailored to particular national and institutional contexts and ensure that access to samples and data is transparent, equitable, and efficient.2

Ownership of Biological Material and Commercialization: Regarding the ownership of biological materials, the traditional view is that, once donated, participants do not own their samples.13 While biobanking research primarily focuses on research that improves medical knowledge, private entities such as pharmaceutical companies can benefit from the commercialization of data collected from pharmacogenomics research. This includes the use of materials from donors for potentially very profitable outcomes,10 such as improving treatments and developing gene patents, which are exclusive rights over a specific sequence of DNA used in genetic testing. The potential for such commercialization requires biobanks to effectively balance the costs and financial benefits of this type of research among companies, participants, and researchers.

Benefit Sharing: While financial compensation for participating in biobanking research is generally discouraged, researchers often fail to identify appropriate benefits to participants and communities, particularly in LMICs. Calls continue to grow for researchers to engage with communities to co-develop the design, governance, and data sharing of biobanking projects, in order to:14
a) Increase the validity of informed consent and identify appropriate benefits and risks to research participation
b) Demonstrate respect, develop trust between researchers and participants, and prevent exploitation of people and communities
c) Develop culturally relevant models of governance and consent
d) Identify effective ways to build expertise and infrastructure capacity in LMICs

Given that biobanks have undergone a decentralized evolution since the 1990s, there is a need for regulation and procedure harmonization that enables the collection and storage of, and access to, samples and data in an ethical manner. The industry and the public sector must adopt ethical guidelines that maximize sample value, but also protect participants and communities. Regarding the conduct of biobanking in LMICs, scholars emphasize the need to integrate community engagement practices that inform the design of culturally relevant governance and informed consent models in biobanking projects.15 16 Lastly, there is a need to systematize monitoring and evaluation of community engagement strategies within research projects.14

  1. The World Medical Association. WMA Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks [Internet]. 2020 [cited 2021 Oct 21]. Available from: https://www.wma.net/policies-post/wma-declaration-of-taipei-on-ethical-considerations-regarding-health-databases-and-biobanks/
  2. Coppola L, Cianflone A, Grimaldi AM, Incoronato M, Bevilacqua P, Messina F, et al. Biobanking in health care: evolution and future directions. J Transl Med [Internet]. 2019 May 22 [cited 2021 Oct 20];17(1):172. Available from: https://doi.org/10.1186/s12967-019-1922-3
  3. Liu A, Pollard K. Biobanking for Personalized Medicine. Adv Exp Med Biol. 2015;864:55–68.
  4. Dillner J, Andersson K. Biobanks collected for routine healthcare purposes: build-up and use for epidemiologic research. Methods Mol Biol. 2011;675:113–25.
  5. World Medical Association. WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects [Internet]. 2018 [cited 2020 Jun 14]. Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
  6. The World Medical Association. Declaration of Taipei [Internet]. 2016 [cited 2021 Oct 21]. Available from: https://www.wma.net/what-we-do/medical-ethics/declaration-of-taipei/
  7. Organisation for Economic Co-operation and Development. OECD Guidelines on Human Biobanks and Genetic Research Databases [Internet]. 2009. Available from: https://www.oecd.org/sti/emerging-tech/44054609.pdf
  8. Mikkelsen RB, Gjerris M, Waldemar G, Sandøe P. Broad consent for biobanks is best – provided it is also deep. BMC Medical Ethics [Internet]. 2019 Oct 15 [cited 2020 Apr 20];20(1):71. Available from: https://doi.org/10.1186/s12910-019-0414-6
  9. Stein DT, Terry SF. Reforming Biobank Consent Policy: A Necessary Move Away from Broad Consent Toward Dynamic Consent. Genetic Testing and Molecular Biomarkers [Internet]. 2013 Dec 1 [cited 2021 Oct 21];17(12):855–6. Available from: https://www.liebertpub.com/doi/abs/10.1089/gtmb.2013.1550
  10. Budimir D, Polašek O, Maruši? A, Kol?i? I, Zemunik T, Boraska V, et al. Ethical aspects of human biobanks: a systematic review. Croat Med J [Internet]. 2011 Jun [cited 2021 Sep 3];52(3):262–79. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3118708/
  11. McInnes RR. 2010 Presidential Address: Culture: The Silent Language Geneticists Must Learn— Genetic Research with Indigenous Populations. Am J Hum Genet [Internet]. 2011 Mar 11 [cited 2021 Aug 10];88(3):254–61. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3059421/
  12. Bull S, Bhagwandin N. The ethics of data sharing and biobanking in health research. Wellcome Open Res [Internet]. 2020 Nov 16 [cited 2021 Aug 5];5:270. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7670475/
  13. Widdows H, Cordell S. The Ethics of Biobanking: Key Issues and Controversies. Health Care Anal [Internet]. 2011 Jul 22 [cited 2021 Oct 20];19(3):207. Available from: https://doi.org/10.1007/s10728-011-0184-x
  14. Tindana P, Campbell M, Marshall P, Littler K, Vincent R, Seeley J, et al. Developing the science and methods of community engagement for genomic research and biobanking in Africa. Global Health, Epidemiology and Genomics [Internet]. 2017 ed [cited 2021 Aug 5];2. Available from: https://www.cambridge.org/core/journals/global-health-epidemiology-and-genomics/article/developing-the-science-and-methods-of-community-engagement-for-genomic-research-and-biobanking-in-africa/906BBC5A05C1AC4C62DB442B0CF22DE5
  15. Beaton A, Hudson M, Milne M, Port RV, Russell K, Smith B, et al. Engaging M?ori in biobanking and genomic research: a model for biobanks to guide culturally informed governance, operational, and community engagement activities. Genet Med. 2017 Mar;19(3):345–51.
  16. Moodley K, Beyer C. Tygerberg Research Ubuntu-Inspired Community Engagement Model: Integrating Community Engagement into Genomic Biobanking. Biopreservation and Biobanking [Internet]. 2019 Dec 1 [cited 2021 Aug 5];17(6):613–24. Available from: https://www.liebertpub.com/doi/full/10.1089/bio.2018.0136

October 2021