Defining biobanks: To be or not to be…… what was the question?

“Is a biobank a facility or research project?” This was a question asked in an international biobanking community forum back in April 2021. Answers were equivocal with many respondents taking an each way bet saying ‘both’. But this is not new. A decade ago Shickle et al warned that whilst “many authors have attempted to describe biobanks based on various combinations of… characteristics… such lists only serve to demonstrate the heterogeneity of biobanks.” (1). Similarly Hewitt and Watson concluded that whilst “the term ‘biobank’ may be applied to biological collections of human, animal, plant or microbial samples, …. there was no consensus on whether a collection’s purpose, size or level of access should determine whether it is called a biobank” (2). Clearly, defining what a biobank is, has been a quandary that persists today. Does this equivocation reflect that biobanks represent a wide range of activities with varying purposes and diverse operational structures? Or does it harbour a scattered understanding where any tissue collection regardless of purpose and practice is to be eligible to be called a biobank? (3)

With the International Organisation of Standardization (ISO) standards specifying general requirements for biobanking with the publication of ISO 20387:2020 should we expect a firmer delineation of what should be called a ‘biobank’? With ISO, a biobank is defined as a ‘legal entity or part of a legal entity that performs biobanking’, which is easily applied to a facility. When defining a research project as a biobank however, that ‘project’ would need to demonstrate that, if put before a court of law, it would be viewed as an entity (operation, company, organization) that can enter into contracts as well as having legal rights and responsibilities to meet this definition. It is perceivable that research projects could be viewed as legal entities as acquisition of biospecimens require donor consent which is a form of contract and comes with legal rights and responsibilities. Equally though, this would mean a research project that collects and stores biospecimens would then be subject to the rigours of the full range of biobanking accredited practices as framed by the ISO standard. This may or may not be desired by the investigators. When Shaw et al surmises that “definitions are an important issue because the laws and regulations designed to govern biobanks are unlikely to be effective if biobankers ….. are reluctant to define them as such due to the regulatory requirements which can ensue” (4) can we expect that ‘biobanks’ by definition may not necessarily want to behave like biobanks in practice thus rendering the application of defined terms arbitrary.

So does defining what a biobank is, really matter? Historically biobanks are either formed to facilitate a research investigation or are the result of a research project or clinical trial. Despite facilitating scientific enquiry, a biobank facility that enables projects does not make it ‘research’ unless itself addresses a hypothesis. Conversely, a research project that collects samples doesn’t necessarily mean it is facilitating biobanking. What if some entities that collect tissue for research were not defined as biobanks? Should they be characterised as a sample cohort, an archive, or even a biohoard (5), and if so, how would this be determined? What if we did away with definitions, and base our characterisation of an entity as a biobank on what they do and their expected outcomes? Indeed ISO defines biobanking as a process which enables the acquisition and storage of biospecimens, “together with some or all of the activities related to collection, preparation, preservation, testing, analysing and distributed defined biological material as well as related information and data.” If a biobank is then identified by what it does, our characterisation of an entity that is distinguished as a ‘biobank’ and not a cohort, archive or biohoard should raise the following questions.

What level of accessibility does your entity provide researchers? Do you ensure biospecimens get used in research and are you concerned that we learn as much as possible from every sample we biobank? If so, does your collection practices ensure biospecimens will be fit-for-purpose in the future and are you current with respect to research trends and needs? Does the availability of your collection cause researchers to consider new hypotheses and do you make it easier for researchers to get what they need, not harder? Limited accessibility may mean your collection should be defined as an archive.

Featured Partners

Does your entity provide a level of ongoing agency for the public and research communities? As biospecimens are donated, does your entity provide end to end engagement from the donor to the research investigator, and back again, with you acting as a ‘middle man’? What role does your entity play in determining the best, widest and most realistic use of the samples? How does it ensure responsible decision making on distribution of the resource, who gets them and follows up for how they have been used? If the biobanking is being performed by the end user (ie the researcher) with no level of agency, the collection may be defined as a cohort.

What level of accountability does your entity take for the distribution of biospecimens, knowing where the samples have come from, where they have been stored and how they will be used? Can your entity be subject to an audit or meet accreditation requirements and does it meet required standards of practice? Can the entity clearly identify who is ultimately responsible for the sample collection, their ethical use and their distribution? When accountability is not clearly established, there is a risk the collection will become a biohoard.

 

References

1. Shickle et al, Pathobiology 77, 181-190, 2010.
2. Hewitt and Watson, Biopreservation and Biobanking, 11(5), 309-315, 2013.
3. Bledsoe et al, Biopreservation and Biobanking, 17(3), 204-208, 2019.
4. Shaw et al, Clinical Genetics, 85, 223-227, 2014
5. Catchpoole, Journal of Health Services and Research Policy, 21(2), 140-142, 2016

advertisement