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A framework for ethics review of applications to store, reuse and share tissue samples


The practice of biobank networking—where biobanks are linked together, and researchers share human tissue samples—is an increasingly common practice both domestically and internationally. The benefits from networking in this way are well established. However, there is a need for ethical oversight in the sharing of human tissue. Ethics committees will increasingly be called upon to approve the sharing of tissue and data with other researchers, often via biobanks, and little guidance currently exists for such committees. In this paper, we provide a structured approach to the ethical review of on-sharing of data and tissue for research purposes.

Biobanks and networks

Biobanking of human tissue for the purpose of biomedical research has rapidly increased over the past decade (Coppola et al. 2019). In many cases, requests will come to biobanks from researchers who seek only a limited amount of tissue for a specified research project. But it is increasingly common for these researchers to seek to retain the tissue for unspecified future research or to share it with yet more researchers or other biobanks (we refer this as ‘on-sharing’ in this article) (Kaye 2011).

The latter practice—which could in theory continue indefinitely—is a type of biobank networking, in which banks are linked together (often through specially created network hubs) and share samples (as well as expertise, resources etc.) both locally and across national borders (Chadwick et al. 2016; Morente et al. 2011). Some examples of large networks include Biobank Ireland Trust (Mee et al. 2013), the European Biobanking and BioMolecular Resources Research Infrastructure—European Research Consortium (BBMRI_ERIC) (Litton 2018), and the International Cancer Genome Consortium (Hudson (Chairperson) et al. 2010), but there are an increasing number of these networks. The benefits of storing and sharing samples in this way is well recognised, with advances in many areas of medical research—including genomic and personalised medicine—often contingent on access to comprehensive collections of tissue and associated data (Harris et al. 2012).

Biobank governance and the role of research ethics committees

Those governing biobanks need to have processes in place to deal with the initial collection of tissue for storage and its use in research and quality assurance projects and programs. Just as specific research projects need oversight, there is a similar need for oversight of situations in which researchers will keep residual tissue for unspecified future research, form networks with other biobanks or on-share tissue and data with other researchers (i.e. themselves becoming ‘biobanks’).

While researchers are generally seen to be the custodians or stewards of tissue and data, and therefore accountable for their responsible and respectful use (NHMRC 2010), it is now broadly expected that biobanks (i.e. those storing and sharing tissue and data) have similar custodianship obligations and must have in place adequate systems of governance including ethical oversight (Gille et al. 2020). In this context, the field of ‘biobank governance’ has emerged—a broad interdisciplinary field that deals with the practical application of ethical standards in biobanking (Langhof et al. 2019, p. 176).

Biobank governance mechanisms vary depending on the size of the biobank and whether it exists within an established network. However, access to samples and data will often be overseen by access committees and/or scientific committees (Kaye 2011; Langhof et al. 2018, p. 1576)—which make decisions regarding access based on eligibility criteria and scientific rationale. But biobanks and biobanking research also requires ethical oversight by Research Ethics Committees (RECs) (also known as Institutional Review Boards) (Lemrow et al. 2007; McHale 2011). While specialist ethics committees may be established for a particular biobank, in other cases guidance is likely to be sought from existing ethical review processes.

There are numerous models of RECs and biobank governance structures; some may combine functions of a REC or access committee into a single body while others keep these separate (McHale 2011; Verlinden et al. 2016, p. 4). While some have suggested that RECs may not be ethically necessary for each release of material from biobanks—given the time and resource commitment this requires (Strech 2015)—we would suggest that ethical processes must be in embedded in the governance of biobanks to ensure the probity of decisions regarding requests for subsequent storage, reuse and/or on-sharing. This is consistent with the requirements of the World Medical Association’s (WMA) Declaration on health data and biobanks (World Medical Association 2016, Art 19).

Ethical issues in requests for storage, reuse and on-sharing within a biobank network

Requests made to a biobank for retention, reuse and on-sharing of tissue and data both intensify the ethical issues that arise in relation to a single research project and raise distinct issues. This is because approving such requests entails, at least to some extent, biobanks relinquishing custodianship of the tissue (and related data) for which it is responsible. This, in turn, means that processes need to be put in place to ensure that:

  1. 1.

    Those who have donated their tissue are provided with relevant information about how samples and data are stored, used and shared (Gille et al. 2020), including associated relinquishment of custodianship.

  2. 2.

    Custodianship is relinquished by the transferor and accepted by the transferee, meaning that downstream researchers/biobanks inherit obligations of custodianship that come with the tissue, are trustworthy, and have robust governance mechanisms in place to safeguard the ethical use of the tissue.

Little detailed guidance is currently available to REC members asked to approve requests for storage, re-use and on-sharing of tissue samples with other biobanks researchers (see e.g. Mascalzoni et al. 2015). We identify a range of specific issues that we consider RECs ought to consider when reviewing such requests, in order to move beyond the conservative ‘one researcher, one project, one jurisdiction’ model of ethics oversight (Kaye 2011, p. 377).

A structured approach to ethics review of requests for storage, reuse or on-sharing of tissue and data (see Table 1)

Table 1 Considerations for ethical and scientific review of proposals to store, reuse and/or on-share material

Donor consent in biobanking compared to donor consent to biobank networks

Issues of consent dominate the literature on the ethical and legal dimensions of tissue banks. There are a number of different models for consent to biobanking. Some of these provide little or no information to donors about future use of tissue (blanket consent), some require the provision of information regarding the operation of the biobank and its institutional governance for future research (broad consent) and others require fully informed consent every time the tissue is used in research (specific consent) (see Table 2).

Table 2 Models of biobanking consent

Most of the literature is concerned with the issue of future unspecified use of tissue in research and the problem of incidental findings during research within a biobank, but there has been little discussion of the problem of seeking consent to biobank networking. One group that has examined this is the WMA through their Declaration of Taipei on Ethical Considerations Regarding Health Databases and Biobanks (World Medical Association 2016).

According to the WMA Declaration, if a biobank collects and stores data and biological material for multiple and indefinite use, consent is only valid if the donors/participants have been adequately informed about: the purposes of the biobank; the risks and burdens associated with collection, storage and use of the 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 biobank; how privacy is protected; governance arrangements; that in case 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; their fundamental rights and safeguards; and when applicable, commercial use, benefit sharing and intellectual property issues (World Medical Association 2016, Art 12). We would argue that these requirements are a form of deep broad consent where quite a lot of information is provided regarding the institutional governance of future research but little to nothing is said about what the tissue will actually be used for (given that, as a practical matter, no one knows how the tissue will be used in the future, at the time the tissue is collected).

Importantly, the WMA also notes that donors need to be informed about the transfer of data or material to other institutions or third countries, as part of their consent process (World Medical Association 2016, Art 12). Tissue donors therefore need to know not only that their tissue might be used in research projects approved by the institutional REC overseeing the biobank to which they have donated, but also that custodianship might be transferred (entirely or in part) to a different researcher or biobank (NHMRC 2018, para. 3.2.12(g)). Informing donors demonstrates respect for research participants’ right of choice (World Medical Association 2013, Art 25, 26) and helps to maintain the generally high levels of public trust in biobanking research (Domaradzki and Pawlikowski 2019). Consent forms should therefore include a statement such as:

Samples may be made available to, or shared with other researchers and laboratories, who may also store and share samples for future (publicly or privately funded) research which has been approved by a system of ethics review.

Information about commercial involvement

It is increasingly the case that there is commercial involvement in research, including biobanking research (Nicol et al. 2016, p. 80). Given that trust in commercial research is generally lower than in public research (NHMRC 2018, para. 3.2.12(j)), it is particularly important for tissue donors to be informed about relinquishment of custodianship to commercially funded researchers or private biobanks (Caulfield et al. 2014). Consent forms should, therefore, adhere to the need for transparency and explicitly address the possibility of commercialisation, with researchers being prepared to explain what that means to potential participants.

Likely scientific utility of storage, reuse and on-sharing of material

In addition to reviewing any specific research projects that are being proposed, RECs should consider whether there a clear scientific rationale for long-term storage, reuse or on-sharing of material. This may be informed by advice from a scientific committee. Both the Australian National Statement on Ethical Conduct in Human Research and the International Society for Biological and Environmental Repositories (ISBER) Best Practice Guidelines are explicit in requiring a sufficient scientific rationale before research will be approved (NHMRC 2018, para. 1.1; ISBER 2018, L2.7)). The ISBER Guidelines note that ‘[s]pecimens and/or data should only be made available for ethical and scientifically appropriate research that is expected to contribute to scientific discovery’ (ISBER 2018, L2.7).

Governance and ethics processes of the biobank seeking to store, re-use or on-share tissue

In order for RECs to be satisfied that it is ethically acceptable for a biobank to relinquish custodianship of tissue samples to another laboratory or biobank (henceforth ‘secondary’ biobank), they require information about the governance and operations of that biobank. Consistent with WMA requirements, it is necessary for a ‘primary’ biobank to know about a ‘secondary’ biobank’s mechanisms for protection of individuals, transparency, participation and inclusion of individuals and their communities and accountability.

As described in Table 1, we suggest that there needs to be detailed information provided to the REC about how the secondary biobank maintains and traces their samples (and associated data), the financial viability and sustainability of the biobank, its management structure and its processes for benefit sharing and mechanisms of communicating with donors and other stakeholders. Similarly, RECs will need to consider the secondary biobank’s processes for ethical and scientific review processes as well as mechanisms to address ethical concerns outlined in Table 1.

Information specific to on-sharing of material

Where on-sharing is anticipated in an application to a REC, additional information should be provided. This includes the secondary biobank’s current or intended practice for sharing tissue samples with other laboratories or biobanks or any collaborative agreements with entities (whether public or private). Information should be provided on processes in place for regulating access to samples and on scientific and ethical oversight mechanisms. Details should also be provided regarding whether commercialisation or cost recovery will occur in the provision of tissue to others.

To oversee these processes, ethics committees also need to have some cognisance not only of ethical issues, but also of legal issues raised by the sharing of tissue and data by biobanks. While committee members need not have intimate knowledge of all relevant laws, they do need to have a broad awareness of the existence of legislation regulating human tissue, confidentiality and privacy of personal and genetic material; biological material transfer agreements (Chalmers et al. 2014; Mascalzoni et al. 2015; Nielsen et al. 2018); potential issues of ownership of tissue samples and potential downstream commercialisation including through obtaining intellectual property rights.


As research and biobanks become increasingly global and networked, it is likely to become the norm for ethics committees and scientific reviewers to be charged with overseeing long-term storage, reuse and potentially widespread sharing of tissue and associated data. In essence, this means that decisions need to be made about who is, and is not, a responsible custodian of material and what practices are, and are not, likely to be compatible with public trust. As is the case with individual research projects, rigorous and timely ethical and scientific review processes—using frameworks such as those provided here—need to be established to support the next phase of genomic and personalised medicine.


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The authors would like to acknowledge the research assistance of Kristina Chelberg, funded by the Australian Centre for Health Law Research, Queensland University of Technology.

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Correspondence to Shih-Ning Then.

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Then, SN., Lipworth, W., Stewart, C. et al. A framework for ethics review of applications to store, reuse and share tissue samples. Monash Bioeth. Rev. 39, 115–124 (2021).

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  • Biobanks
  • Ethics review
  • Human tissue
  • Research
  • Biobank networks