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BIG - Biobanks

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Overview of the Ethical Landscape
Re-Use and Informed Consent
Privacy and Maintaining Anonymity
Ownership of Human Tissue
Public Involvement in Governance

Biobanks store and systematically organize biological tissue samples and related information for use in medical research. Recent advances in information technology have made biobanks more accessible to researchers than ever. While this new accessibility opens up new and potentially fruitful research methods, it has also given rise to many important ethical and policy issues for the future governance of biobanks. These issues usually fall within the following categories: informed consent for the use and re-use of donor tissue, maintaining privacy and anonymity for tissue donors, ownership of donor tissue, and public involvement in the governance of biobanks. For each of these categories, this information guide provides scholarly works that attempt to answer the ethical questions that these issues give rise to, as well as a general overview of the ethical landscape of contemporary biobanking.

Research assistance provided by James Baker, Jamshed Daruwala, and Paul Muriello.


Overview of the Ethical Landscape

Hoeyer presents a critical review of the framing of tissue storage as an ethical issue and solutions proposed, as well as an overview of the empirical studies of donor attitudes and interests.

Hoeyer, Klaus. "The ethics of research biobanking: a critical review of the literature." Biotechnology and Genetic Engineering Reviews 25.1 (2008): 429-452. PMID: 21412365

 

The European Union’s European Commission convened an expert group to deal with the ethical and regulatory challenges of international biobank research. Their report, published in 2012, explores the science, activities, public perceptions, regulation, and challenges for the governance of biobanks.

Gottweis, Herbert. “Biobanks for Europe: A challenge for governance. Report of the Expert Group on Dealing with Ethical and Regulatory Challenges of International Biobank Research.” European Commission, 2012. (link)


Re-Use and Informed Consent

Informed consent for the use and re-use of donor tissue for medical research is one of the most important ethical issues in biobank governance. Most ethicists argue that traditional models of consent which require that a patient be consented for each use are too strict, and propose a variety of alternate consent models for the use and re-use of biobank tissue samples.

 

Schwartz outlines the challenges of obtaining consent for the use and re-use of genetic material stored in biobanks.  Schwartz argues that critics of one-time consent are relying on a specificity requirement that isn’t supported by common conceptual frameworks of autonomy.

Schwartz, Peter H. “2009 Walter C. Randall Lecture in Bioethics: Autonomy and Consent in Biobanks.” The Physiologist 53.1 (2012): 1, 3-7. PMID: 20222497

 

Giesbertz et.  al. examine the ethics of opt-in and opt-out consent models for the collection and storage of tissue samples collected in the course of clinical care. They argue that while in most cases the difference between opt-in and opt-out is not so stark, the opt-in model may be necessary for certain situations.

Giesbertz, Noor AA, Annelien L. Bredenoord, and Johannes JM van Delden. "Inclusion of residual tissue in biobanks: opt-in or opt-out?." PLoS Biology 10.8 (2012): e1001373. PMID: 22899893

 

Burton reports in the BMJ that a proposal by an Australian biotech company to create a biobank for the population of Tonga was shot down after opposition groups criticized its consent practices.

Burton, Bob. "Proposed genetic database on Tongans opposed." BMJ: British Medical Journal 324.7335 (2002): 443. PMID: 11859041

 

In 2012 Wai Chan et. al. conducted a systematic review of patient’s experiences of donating their residual tissue samples, and the effect  different types of consent had on future research use of those tissues.

Chan, Tuck Wai, Sandra Mackey, and Desley Gail Hegney. "Patients' experiences on donation of their residual biological samples and the impact of these experiences on the type of consent given for the future research use of the tissue: a systematic review." International Journal of Evidence?Based Healthcare 10.1 (2012): 9-26. PMID: 22405414

 

Boniolo et. al. argue that for biobanks, traditional informed consent should be replaced with a kind of “trusted consent,” where consent is presumed for the re-use of stored tissue samples, unless that use presents significant risks or burdens to the people who donated the tissue.

Boniolo, Giovanni, Pier Paolo di Fiore, and Salvatore Pece. "Trusted consent and research biobanks: towards a ‘new alliance’between researchers and donors." Bioethics 26.2 (2012): 93-100. PMID: 20497169

 

Allen and McNamara discuss the value of the participant view of the consent process for the use of biobank tissues.  They argue that consent increases the level of trust participants have in researchers to use biobank resources for the public good, and modification of the consent process for biobanks ought to take into account the participant view.

Allen, Judy, and Beverley McNamara. "Reconsidering the value of consent in biobank research." Bioethics 25.3 (2011): 155-166. PMID: 19659851

 

Grizzle highlights how misunderstandings about how biobanks function can lead some researchers and policymakers to underestimate their usefulness. Grizzle also warns that it is important to understand the inner workings of biobank facilities before enacting sweeping changes in their consent policies.

Grizzle, William E. "A Critical Need for Increased Understanding of the Use of Human Tissues in Biomedical Research." Journal of cancer science & therapy 4.9 (2012): 16. PMID: 23264856

 

Mitchell et. al. argue that the relation of participants to biobanks is best understood as one of a business entity (a participant) who has ownership of a “trade secret” they cannot utilize, but some other entity (a biobank) can. In their view, biobanks ought to be institutions held in the public trust that obtain “licensure” from participants to use their tissue in continuing research.

Mitchell, Robert, et al. "Genomics, biobanks, and the trade-secret model." Science 332.6027 (2011): 309-310. PMID: 21493846


Privacy and Maintaining Anonymity

When patient data is collected and stored in a database, the privacy of those patients is put at risk. Ethicists and privacy experts argue that biobanks, because they are essentially large-scale aggregations of patient data, present a special problem with regards to patient privacy and require special solutions beyond what current privacy protection standards dictate.

 

Ursin explores the issue of privacy for biobank participants by determining which information or activities participation in biobanks puts at risk are not the legitimate concern of others. Ursin argues that privacy and property rights ought to be viewed as duties to promote public good rather than control of an object.

Ursin, Lars Oystein. "Privacy and property in the biobank context." Hec Forum. Vol. 22. No. 3. Springer Netherlands, 2010. PMID: 21493846

 

Kaye argues that new communications technology and data sharing policy threaten to overrun current governance mechanisms that aim to protect privacy, and that a new system of e-governance ought to be developed in order to safeguard participant privacy.

Kaye, Jane. "The tension between data sharing and the protection of privacy in genomics research." Annual Review of Genomics and Human Genetics 13 (2012): 415-431. PMID: 22404490

 

Kamm et. al. argue that personalized medicine research requires large-scale data aggregation of the sort that puts the privacy of biobank participants at risk. They also propose study designs that ensure the security of patient privacy.

Kamm, Liina, et al. "A new way to protect privacy in large-scale genome-wide association studies." Bioinformatics (2013). PMID: 23413435

 

Hobbs et. al. conduct a review of the attitudes of British and German populations regarding privacy protection, reciprocity, and benefit sharing. They found that ongoing individual and communal reciprocity may alleviate participant’s concerns with privacy security.

Hobbs, A., et al. "The privacy-reciprocity connection in biobanking: comparing German with UK strategies." Public Health Genomics 15.5 (2012): 272-284. PMID: 22722691

 

Pullman et. al. conducted a conjoint analysis survey of the Canadian public’s perception of the relative importance of privacy and confidentiality in biobank research. They found that although subjects described themselves as “private,” they consistently ranked privacy and confidentiality as the least important of the variables they considered.

Pullman, Daryl, et al. "Personal privacy, public benefits, and biobanks: a conjoint analysis of policy priorities and public perceptions." Genetics in Medicine 14.2 (2012): 229-235. PMID: 22261752

 

Kaufman et. al. surveyed a representative population of US adults to determine their attitudes about the importance of privacy in biobank research. Although privacy concerns were pervasive in their attitudes, 60% of subjects said they would still participate in biobank research.

Kaufman, David J., et al. "Public opinion about the importance of privacy in biobank research." American journal of human genetics 85.5 (2009): 643. PMID: 19878915


Ownership of Human Tissue

When you donate tissue to a biobank, who has ownership of that tissue? Does the biobank now own that tissue, or is ownership of human tissue something that cannot be transferred? Is it even useful to think about ownership of human tissue from within a framework of property rights? Ethicists and lawyers consider these questions and propose some answers in the articles below.

 

Allen et. al. review the existing regulations regarding ownership of human tissue in the context of educating researchers.

Allen, Monica J., et al. "Human tissue ownership and use in research: what laboratorians and researchers should know." Clinical chemistry 56.11 (2010): 1675-1682. PMID: 20852133

 

Feldman argues that current patent law regarding the ownership of human tissue is a result of piecing together disparate notions of tissue ownership, and has resulted in policy that fails to appreciate the rights a person has to their own cells.

Feldman, Robin. "Whose Body is It Anyway-Human Cells and the Strange Effects of Property and Intellectual Property Law." Stan. L. Rev. 63 (2010): 1377. PMID: 21774193

 

Skene argues that rulings inconsistent with general principles of human tissue ownership in Australian courts are constraining judges’ ability to utilize those principles. Skene suggests only Parliament can repair this schism by introducing new legislation regarding ownership of human tissue.

Skene, Loane. "The current approach of the courts." Journal of medical ethics (2013). PMID: 23427217

 

Nisbet and Fahy conducted a review of English-language publications and transcripts to determine the impact of the book The Immortal Life of Henrietta Lacks on the biobank debate. Of the themes identified, informed consent, protecting vulnerable populations, and donor compensation were the most frequent.

Nisbet, Matthew C., and Declan Fahy. "Bioethics in popular science: evaluating the media impact of The Immortal Llife of Henrietta Lacks on the biobank debate." BMC medical ethics 14.1 (2013): 1-9. PMID: 23446115

 

Roche critiques objections that have been raised to the recognition of DNA as personal property. Roche argues that there are legal principles that support the notion of property rights for DNA, and suggests changes in the law based on those notions.

Roche, Patricia. "The property/privacy conundrum over human tissue." HEC forum. Vol. 22. No. 3. Springer Netherlands, 2010. PMID: 20737193

 

Andanda systemically reviews key questions related to ownership and intellectual property rights for commercial technology developed from human tissue, and how those questions relate to tissue samples collected from populations of developing countries.

Andanda, P. A. "Human-tissue-related inventions: ownership and intellectual property rights in international collaborative research in developing countries." Journal of medical ethics 34.3 (2008): 171-179. PMID: 18316458

 

Björkman and Hansson examine the issue of ownership rights to human tissue through the lens of property relations as socially constructed bundles of rights, and suggest five principles of bodily rights that may be used to construct bundles of rights that are ethically sound.

Björkman, Barbro, and Sven Ove Hansson. "Bodily rights and property rights." Journal of medical ethics 32.4 (2006): 209-214. PMID: 16574874

 

MacQueen and Alleman examine the values and perspectives of various cultures relating to the collection and usage of human tissue for HIV research.

MacQueen, Kathleen M., and Patty Alleman. "International perspectives on the collection, storage, and testing of human biospecimens in HIV research." IRB: Ethics and Human Research 30.4 (2008): 9-14. PMID: 18767319

 

Sándor et. al argue that use of the term “biobank” has caused some to view biobank institutions and the practice of biobanking as a commercial practice, and as such has framed the debate about the ethics of human tissue ownership as a kind of business ethics issue rather than a human rights issue.

Sándor, Judit, et al. "The case of biobank with the law: between a legal and scientific fiction." Journal of Medical Ethics 38.6 (2012): 347-350.


Public Involvement in Governance of Biobanking

Given that the ability of biobanks to function depends on how willing patients are to donate tissue, and that patients seem more willing to donate tissue when there are more opportunities to offer input on how biobanks ought to operate, the question arises as to whether or not and to what degree patient donors ought to be involved in the governance of biobanks. Although most ethicists and policy experts argue that patient involvement in the governance of biobanks ought to be robust, some say that approach to patient involvement is not feasible.

 

Cordell conceptualizes the biobank as a social institution that operates for the public good, and from there derives principles for the governance of biobanks that are ethically sound. Cordell argues that consideration of public need ought to be taken into account when determining policy for a given biobank.

Cordell, Sean. "The biobank as an ethical subject." Health Care Analysis 19.3 (2011): 282-294. PMID: 21842138

 

O’Doherty and Hawkins argue that the ethical ambiguities that biobanks give rise to necessitate public engagement with biobanks, and that one way to increase the likelihood of public engagement being taken up as a matter of policy is to frame the ethical issues of biobanking as issues of public interest.

O’Doherty, Kieran C., and Alice Hawkins. "Structuring public engagement for effective input in policy development on human tissue biobanking." Public health genomics 13.4 (2010): 197-206. PMID: 20395688

 

O’Doherty et. al. propose four principles to inform a kind of governance that might be sufficient to supplant specificity requirements of informed consent.

O’Doherty, Kieran C., et al. "From consent to institutions: designing adaptive governance for genomic biobanks." Social Science & Medicine 73.3 (2011): 367-374. PMID: 21726926

 

Patients are becoming more interested in the results of large-scale longitudinal medical research, and some argue this places an ethical obligation on researchers to share their results with participants. Wallace and Kent examine the effect this change has had on projects that have returned results to their participants.

Wallace, Susan E., and Alastair Kent. "Population biobanks and returning individual research results: mission impossible or new directions?." Human genetics 130.3 (2011): 393-401. PMID: 21643981

 

Biobanks can be a tool to further public health, but the collectivist ethical principles that underlie public health are in tension with the individualist ethical principles (autonomy, informed consent, privacy) that are often applied to biobanking. Meslin and Garba argue that a human rights approach to public health ethics may be able to resolve this tension.

Meslin, Eric M., and Ibrahim Garba. "Biobanking and public health: is a human rights approach the tie that binds?." Human genetics 130.3 (2011): 451-463. PMID: 21761137

 

Gottweis and Lauss observe that despite expectations to the contrary, contemporary biobanks have experienced numerous failures. They suggest poor governance is the cause, and recommend a participatory governance structure to protect against future failures.

Gottweis, Herbert, and Georg Lauss. "Biobank governance: heterogeneous modes of ordering and democratization." Journal of community genetics 3.2 (2012): 61-72. PMID: 22147279

 

McHale outlines the legal and ethical challenges posed by biobanks, and questions the feasibility of governance structures that include participant input for answering these challenges.

McHale, Jean V. "Accountability, governance and biobanks: the ethics and governance committee as guardian or as toothless tiger?" Health Care Analysis 19.3 (2011): 231-246. PMID: 21938513

 

Gottweis, Chen, and Starkbaum survey the relationships between biobanks and the populations they serve, and how these populations perceive biobanks. They examine current governance structures and how they respond to public views about biobanks.

Gottweis, Herbert, Haidan Chen, and Johannes Starkbaum. "Biobanks and the phantom public." Human genetics 130.3 (2011): 433-440. PMID: 21773770

 

Gaskell et. al. examine public attitudes toward biobanks in Europe, and identify several factors that public support for biobanks is dependent on; people’s engagement with biobanks; concerns about privacy, trust in the institutions and entities that govern biobanks. They argue that biobank developers need to take these factors into account in order to create a successful pan-European biobank infrastructure.

Gaskell, George, et al. "Publics and biobanks: Pan-European diversity and the challenge of responsible innovation." European Journal of Human Genetics (2012). PMID: 22669414

 

Simon, Newbury, and L’Heureux conducted a focus group study to examine public perspectives on community advisory board (CAB) involvement with biobank research. Participants recognized the privacy benefits of CAB involvement, but also noted that the goals of CABs may be antithetical to the goals of research.

Simon, Christian M., Elizabeth Newbury, and Jamie L. ’Heureux. "Protecting participants, promoting progress: public perspectives on community advisory boards (CABs) in biobanking." Journal of Empirical Research on Human Research Ethics 6.3 (2011): 19-30. PMID: 21931234

 

O’Doherty, Hawkins, and Burgess conducted a deliberative democracy study to construct guidelines for informed consent, privacy, collection of tissue, governance, and how to mediate introductions between biobanks and potential participants.

O’Doherty, Kieran C., Alice K. Hawkins, and Michael M. Burgess. "Involving citizens in the ethics of biobank research: Informing institutional policy through structured public deliberation." Social Science & Medicine (2012). PMID: 22867865

 

Watson, Kay, and Smith examine the practical and ethical issues that large-scale biobanks give rise to. They argue that public engagement and reporting research results is important for the profile of biobanks.

Watson, R. William G., Elaine W. Kay, and David Smith. "Integrating biobanks: addressing the practical and ethical issues to deliver a valuable tool for cancer research." Nature Reviews Cancer 10.9 (2010): 646-651. PMID: 20703251

 

Meslin argues that while top-down approaches to biobank governance have their merits, bottom-up approaches must also be considered. In Meslin’s view, top-down approaches fail to appreciate possible donor concerns, which if aren’t met may discourage donors from participating in biobank research, which is antithetical to the purpose of biobanks. Meslin advocates a bottom-up approach that better addresses potential donor concerns.

Meslin, Eric M. "The value of using top-down and bottom-up approaches for building trust and transparency in biobanking." Public Health Genomics 13.4 (2010): 207-214. PMID: 20395689

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