Biobank Personnel

Abstract

Resources from biobanks and biorepositories, such as human samples, are of increasing interest to specialists in various fields. However, whilst biobanks provide a crucial service, their efficient and effective management can prove challenging. When establishing a biobank many factors should be considered, such as the need for appropriate infrastructure, equipment, financial support, and highly specialised and suitably qualified personnel. The number and qualifications of the necessary personnel depend both on the biobank’s size and type — i.e. a biobank that is large and diversified in terms of the stored material should be organised differently to a small biorepository. The core of the biobank should be composed of highly trained personnel that closely co-operate with the general and quality control manager. Due to the large amount of data related to the samples, an IT specialist might be needed. In the case of large population biobanks, personnel responsible for patient recruitment, documentation handling, sample collection and distribution to the biobank would be necessary. Furthermore, staff responsible for the infrastructure are also highly important, as they are the first responders to failures that may be critical for the biobank functioning. Depending on the type and size of the biobank/biorepository, some responsibilities and tasks could potentially be combined. Nevertheless, highly trained personnel with clear and precisely defined duties are the key to the proper functioning of a biobank.

Keywords

biobank biobank management biobank personnel biobank structure biobank quality biorepository

General information on the structure of a biobank

There are many definitions of ‘biobank’ — one of the most basic is that it represents a unit that collects, stores, and/or processes biological material of various origins and related data.^1–3 Several types of biobank exist, with the type depending on many factors, namely: the type of biobanked material; the origin of the material collected; the scale at which the material is obtained; and the purpose for which the biological material is collected.^2,4–6 Currently, the need for high-quality and reliable sources of biological material is generating an increased need for biobanks that are organised and run under a defined quality management system (QMS).^7,8 Biobanks can function as independent units or as part of a larger institution (e.g. a research or scientific centre), and can be based within universities, research institutes or clinical departments. Samples for depositing in the biobank can be obtained at collaborating units (e.g. during routine clinical procedures), or they can be collected directly at the biobank itself.

Entities conducting biobanking activities should ensure that they maintain the appropriate quality of the collected biological material and all associated data. The ISO 20387:2018 standard (Biotechnology — Biobanking — General requirements for biobanking) is one of the guidelines that can help to establish and maintain high standards in a biobank. This document specifies general requirements for the competence, impartiality and consistent operation of biobanks, including quality control (QC) requirements to ensure that high quality standards are maintained for the biological material and collected data.⁹ The collections stored in biobanks are often composed of unique biological material. The use of biological material sourced from reputable biobanks increases the credibility of the research, because biobanked samples are perceived as high-quality research material. This human-derived material should be viewed as a valuable resource that can help maximise the generation of consistent, reliable and translatable results, leading to the identification of new therapeutic targets and the development of new drugs or biomarkers for diagnostic and prognostic purposes. Specialised biobanks, which focus on collecting samples and data on a given disease, can have a significant impact on the progress of research in that area — for example, studies on rare or oncologic diseases go hand-in-hand with the development of personalised medicine, targeted therapies and omics analyses.^4,10–13

Sourcing and collecting the required amount of research material is a time-consuming process that can significantly delay an individual researcher’s studies if they have to undertake this onerous task independently. Hence, co-operation with biobanks on this aspect of a study can greatly support and accelerate the initiation of the research process.

The importance of a strong infrastructure

As biological resources are physically stored in a biobank, a well-designed and managed infrastructure is essential for the biobank to function properly. Depending on the type of biological material and the associated data, the laboratories have to meet the appropriate requirements. The storage of biological material often involves the use of refrigerators, freezers, low-temperature freezers or dewars with liquid nitrogen. These devices produce large amounts of heat and can release substances threatening to human life (e.g. nitrogen escaping from a dewar). Therefore, it is very important that the biobank laboratories are equipped with appropriate sensors (e.g. oxygen detectors), and properly operating ventilation and air conditioning systems. The design of a biobank’s premises should enable easy cleaning and ensure the biological safety of staff and visitors. In addition, tight control of the environmental conditions in a biobank is crucial for maintaining the appropriate quality of the research. In this context, the appropriate training of biobank personnel plays a very important role in reducing negative research outcomes due to poor quality biological material. Furthermore, with proper control measures in place, the occurrence and consequences of any adverse events that might occur in a biobank, such as health and safety incidents or power failure, can be significantly reduced. Thus, biobanks are only able to fulfil their role effectively, as a result of their dedicated and highly qualified personnel.

Scientists from various fields are creating new laboratories based on increasingly advanced technologies.¹⁴ Thus, one of the key elements in the efficient and effective operation of a biobank is a properly qualified personnel base.^15–17

The personnel working in a biobank must meet several requirements and have specific skills. In Poland, there are no clear guidelines describing the proper operation of a biobank or requirements regarding its personnel base. Therefore, the initial step in establishing a biobank should primarily focus on determining its purpose and most important processes. On the basis of this biobank profile, personnel with specific qualifications should be selected so that their skill set is consistent with the biobank’s goals and strategy. It should not be forgotten that an important element influencing the size and skill set of the staff team is the allocated budget — which is very often limited, especially in state-funded scientific institutions. When planning the recruitment of biobank personnel, experience in a similar field or type of institution, or experience in general good laboratory practice, is desirable. Specific guidelines regarding staff qualifications can be found in quality standards such as ISO 20387:2018.

Based on knowledge about the processes in various types of biobanks (including our own experiences), the published literature on biobank functioning, and the requirements presented in the ISO standards, we have developed an example of a biobank organisational model. This model includes information about the basic arrangement of biobank personnel, and details of their responsibilities (Figure 1).

Figure 1.

An example model of biobank personnel and their key responsibilities.The areas of responsibility for each staff member are listed in the respective linked boxes; QMS = quality management system.

Biobank Supervisor

According to the model presented, the Biobank Supervisor functions as the head of the biobank facility. This person’s responsibilities include:

— teamwork coordination;

— ensuring financial continuity;

— creating laboratory rules;

— public relations;

— contracting with partners on co-operative projects;

— coordinating ongoing projects;

— ensuring data security and compliance with legal and ethical regulations;

— supervising and supporting researchers; and

— other administrative activities.

In addition, the biobank supervisor is responsible for arranging and monitoring staff training, managing documentation and databases, supervising material transfer agreements, and providing technical and substantive content for potential scientific publications based on the in-house use of the biobanked material. Appointing a supervisor is necessary for the proper functioning of the biobank; however, parts of the responsibilities listed would be delegated to the Quality Assurance (QA) Specialist (who is responsible for ensuring the quality of the biobank) or the Biobank Manager.

These two senior members of staff report to the Biobank Supervisor and are responsible for overseeing a wide range of tasks, as delegated by the Biobank Supervisor. These delegated tasks are undertaken by a very diverse group of personnel, referred to here and in Figure 1 as ‘Other’ personnel. There should be very close co-operation between the Biobank Supervisor and the ‘Other’ personnel, via the QA Specialist and the Biobank Manager.

Researchers

All research activities (usually undertaken by the in-house ‘Researchers’) should be approved by the Biobank Supervisor. To make the best use of the researchers’ skills, they should focus solely on activities related to the isolation of material and its registration in the data management system, preparation of test samples, general material testing, analysis of results, and all tasks related directly to the collection and analysis of biological samples. The results obtained are often shared in the form of peer-reviewed scientific publications.

‘Other’ personnel

Staff in the ‘Other’ personnel category include not only individuals working with biological material in the laboratories, but also those working in many other areas of expertise — for example, in IT or administration. Reading from left to right in the ‘Other’ personnel group shown across the bottom of Figure 1, we can identify staff types that are crucial to the biobank’s successful running:

Patient Recruiters

These people are responsible for sample procurement via successful patient recruitment. They represent the first contact with a potential donor of biological material, or with the doctor collecting it. Direct contact with patients requires excellent interpersonal communication skills. Communication with a patient, if performed competently, facilitates the establishment of a relationship of trust between the recruiter and the patient. Honest, accurate, transparent and easy-to-understand information about the purpose and method of collection of the biological material forms the basis of successful donor recruitment. During the conversation, the patient recruiter should avoid the use of overtly scientific terms. Furthermore, this person should be responsible for providing the patient with all the documents connected with the biological material donation (such as the informed consent form and a medical questionnaire).

IT Specialists

These staff are responsible for undertaking any tasks connected with IT systems in general, including: installation of hardware and software; updates; software maintenance; data import (e.g. from questionnaires); data management (including backup, recovery, protection, transfer); and the selection and maintenance of an appropriate and ‘fit for purpose’ IT system. This all serves to facilitate and optimise the work of the entire team.

Laboratory Technicians/Nurses/Students/Lab Assistants

The responsibilities and tasks will depend mainly on their qualifications and expertise, and can include: sample registration in the system; biological material preparation; storage of samples; material inventory; disposal of biological waste material; dispatch of samples; routine maintenance and control of equipment; and general patient service.

Administrative/Technical Staff

These personnel play an essential role in the functioning of a biobank. They are suitably qualified staff responsible for the basic infrastructure of the building (e.g. medical waste disposal, air conditioning maintenance, disinfection and cleaning of surfaces). Biobanks are often located within units of organisations that employ their own building administrators, but sometimes the regular cleaning staff do not have adequate training to properly care for high-maintenance infrastructure, such as that present within a biobank. Thus, it is important that appropriate training is provided, covering information on how to clean surfaces/laboratory equipment, and how to deal with the different types of medical/laboratory waste including the potential risks and how it should be disposed of.

Quality Assurance and Quality Control Specialists

Considering the work undertaken by the biobank, close attention should be paid to the provision of a suitable quality management system (QMS). Thus, the QA Specialist plays an important role, and should be responsible for: quality objectives and policy; quality training courses; non-compliance and risk management; audits; and general management of the QMS. The correct operation of the QMS is crucial. A properly organised system reduces the risk of mistakes, and helps to ensure the quality of the biobanked biological material. The QA Specialist is also responsible for creating document templates that enable proper documentation of the processes taking place in the biobank. This person is also responsible for ensuring that all biobank personnel are familiar with its procedures (like standard operating procedures (SOPs) and other technical procedures). Together with the Biobank Supervisor, the QA Specialist should also outline the scope of the employees’ responsibilities and entitlements, and confirm that they are familiar with them.

The Quality Control (QC) Specialist is responsible for ensuring the proper quality control of the collected material stored in the biobank. The QC Specialist must ensure that any processes undertaken by the biobank are performed in compliance with existing applicable standards and procedures (such as SOPs or other technical procedures), and that new procedures are properly validated and verified before their implementation at the biobank.

Scientific/Ethics Committee

The process of biobanking is associated with significant ethical responsibility. For this reason, biobanks should set up a scientific/ethics committee, comprised of people who are specialists in the field of ethics, as applied to scientific research. A common practice is to seek the assistance of an external bioethics committee, which can give opinions on planned research projects.

Working as a team

An appropriately balanced staff team is key to the effective and efficient operation of a biobank. Many aspects of the biobank’s success depend on co-operation between these employees, and working in a biobank requires good communication skills and complementarity between different employees’ areas of expertise. For example, the process of creating documents, such as informed consent and medical questionnaire forms, requires co-operation between researchers, IT specialists, administrative officers, biobank supervisors, medical personnel/physicians and bioethics committee members. The crucial information associated with the process of biological material donation should be described briefly in an informed consent form. This document should include other important information, such as the purpose of the collection of the biological material, information about its use, and details of how it will be coded and stored.¹⁸ A medical questionnaire is often attached to the informed consent form. The medical questionnaire is a document in which the patients can provide information about their medical history, personal habits (including diet, exercise, use of stimulants, etc.) and medication. This information collected from the donor can be crucial to determine the causes of any phenomena observed during the analysis of individual samples. Such valuable content in informed consent and medical questionnaire forms can only be obtained through efficient collaboration between different biobank employees.

The wide range of responsibilities and the associated job titles may vary between establishments and should be tailored to the individual needs of the biobank. The number of people employed in a biobank depends on its character and size. It is worth mentioning that the division of duties between individual employees may be different from that presented here, depending on many factors — for example, the type of biobank or the competencies of the individual employees. When organising a biobank’s staff, however, it is important to take into account the scope of responsibilities associated with each of the positions.

From the donor to biobanked sample

Donors of biological material collected for biobanking are often voluntary patients undergoing various medical procedures. This is due to the fact that the biobank can receive and use waste material generated during medical treatments. The general process of biobanking biological material is presented in Figure 2.

Figure 2.

An overview of the general process of obtaining and storing biological material from donors.

Initially, potential donors of biological material have to be identified. This is usually undertaken by medical personnel or a patient recruiter from the biobank. During the visit, the patient learns about the possibility of taking part in scientific research studies, the valuable contribution that their donated biological material could make to scientific progress, and general information regarding donor rights. If a patient decides to donate their biological material for research purposes, they then have to be familiarised with the concept of informed consent and complete the relevant informed consent form and a medical questionnaire. After filling in and signing the required documentation, the patient becomes a ‘research participant’ and the biological material can be collected.

The biological material is usually collected in the treatment room, and the person collecting biological material is often also responsible for checking the accuracy and completeness of the associated documentation. After the biological material is collected, the sample can be transferred to the biobank. When biobank staff (researchers/laboratory technicians) receive the sample, they will firstly check that the associated documentation (i.e. informed consent form, medical questionnaire, waybill) is all correct. If the documents are completed correctly, the sample can be registered and coded.¹⁹ The coding process is an important element of sample preparation for biobanking. Typically, samples are pseudonymised, which makes it impossible for scientists to identify the donor and ensures the protection of donor data. However, at the same time, pseudonymisation ensures that the sample can be re-associated with the donor in certain cases (e.g. for legal purposes or in the case of incidental findings), but then only by authorised personnel.

After registration and coding, the sample can be taken to the laboratory, where it is processed by researchers prior to storage in the biobank. Compliance with established quality standards plays a major part in this process, as failure to adhere to these standards will adversely affect the quality of the biological material.²⁰ In view of the importance of quality control, the involvement of the QA Specialist, and the supervision of the QC Specialist, is necessary at every step of the biobanking procedure. The biological samples collected for storage in the biobank are usually unique specimens. Thus, during sample processing, researchers must be careful to work according to established procedures, in order to prevent any loss of quality of such valuable resources. These highly-trained and qualified researchers are ultimately responsible for the integrity and quality of the samples being processed. In the final stage of processing, the sample is prepared for long-term storage. The protocols for this process vary widely, depending on the type of material that is being biobanked.^21,22

Conclusions

The recent increase in interest in biobanks has widened the range of tools available to researchers, to help push forward scientific progress in a variety of fields relating to human diseases and their effective treatments. The development of biobanking technology is inseparably connected with the professional development of the personnel who work in this area. An optimal level of biobanked specimen quality, and thus optimal validity of the resulting research carried out on the specimens, can only be achieved through the employment of appropriately trained and qualified staff within the biobank.

Robust biobank management not only facilitates the work of the actual biobank staff, but also that of any research laboratories connected with it. The appropriate identification of all tasks and responsibilities, as well as the selection of the appropriate number of employees with specific competencies and the detailed communication of their responsibilities to them, are key elements in biobank management.

An increasing number of institutions throughout Europe, and indeed the world, are creating biobanks/biorepositories of biological material. Biobanking has become not only a global trend facilitating access to a wide range of biological material, but also a general research necessity. Reputable biobanks that are sources of high-quality biological material are an essential prerequisite for reliable human-focused research and development projects.

Footnotes

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by Ministry of Science and Higher Education in Poland, grant DIR/WK/2017/2018/01-1.

ORCID iD

Anna Chróścicka

Angelika Paluch

Ilona Kalaszczyńska

Ilona Szabłowska-Gadomska

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