Frequently Asked Questions

Biobanking

A human biobank (also commonly referred to as a biorepository, repository, or tissue bank) is a collection of biological material and any relevant associated data and information stored in an organised system and held specifically for use in health and medical research. Their object is to provide a resource for researchers to advance our understanding of human health and disease. A biobank can be a stand-alone collection of samples for future research or an integral part of a basic research project, a clinical study or a clinical trial. Biobanks may also be comprised of animal or environmental (e.g. seeds, viruses, soil etc.) biospecimens.
For the purpose of this website and the NSW Health Pathology program, we focus our attention on "human" biospecimens.
Biobanking can involve one or more of the following operations:
  • Identification and consent of participants
  • Collection and processing of biospecimens
  • Storage of biospecimens and data
  • Data and records management
  • Release and distribution of biospecimens and data
Annotated data are specific information associated with a biospecimen; for example, participant and biospecimen information and/or health related clinical and outcome data. Biospecimens are obtained during clinic visits, diagnostic or therapeutic surgical procedures, or during autopsies. Biospecimens may be collected from both healthy people and those with disease conditions.

NSW Biobank Certification Program

Registration is the first phase of the NSW Biobank Certification Program, a NSW Health Pathology initiative. The goal of this phase is to collect basic information about the biobank/pathology laboratory and have one person (e.g. the biobank leader or the pathology laboratory leader) review Module 1: Basics of Biobanking.
Certification is the second phase of the NSW Biobank Certification Program, a NSW Health Pathology initiative. The program is based on the certification program designed and delivered in Canada by the Office of Biobank Education and Research (OBER) at the University of British Columbia (UBC) in Vancouver and the Canadian Tissue Repository Network (CTRNet). The NSW Biobank Certification Program contains Australian-specific content regarding the laws, regulations and guidelines applicable to research and information about both private and public health care.
For more information about the steps involved in the certification process, please see the Certification Program page.
Certification Accreditation
• No formal oversight body required for the Certification organisation • Requires existence of an oversight body for the Certification organisation
• The assessment body observes and judges the product, process or service and gives their written assurance that conformity is met • Conformity assessment must be formally demonstrated (e.g., lab demonstrates accurate test results on a known standard test sample)
Source: Matzke and O'Donoghue et al. BIOPRESERVATION AND BIOBANKING. 10(5) 2012
Yes. For more information, please see the Education Information page.
Yes. Many specialised biobanking topics are covered in the education modules. For example, a section focused on consenting children is included in Module 6: Informed Consent and details about autopsy derived biospecimens is included in Module 10: Pathology Focused Biobanking. More information about the modules can be found on the Education Information page.
Yes. The content in the education modules is based on standards and best practice guidelines including the ‘Best Practices for Repositories’ developed by the International Society for Biological and Environmental Repositories (ISBER). When ISBER best practices and other relevant standards are updated, the educational content will be reviewed and updated accordingly.

The NSW Biobank Certification Program aims to improve and harmonise biobanking standards through education and communication of best practices and standard operating procedures (SOPs).

Part of a statewide framework, it aims to enhance the quality of biobanking and help ensure we have a world-class, sustainable approach to managing human biobanks and associated medical research.

Biospecimen quality testing is not part of the NSW Biobank Certification Program nor is it part of the Canadian Biobank Certification Program, on which the NSW program is based. If a biobank or laboratory would like the quality of their biospecimens to be tested, a variety of services are available including the Proficiency Testing Program offered by ISBER (International Society for Biological and Environmental Repositories). Click here for more information.

Enrolment and Team Members

The Biobank Leader is responsible for ensuring the completion and renewal of certification. The Biobank leader must assign roles and education modules to team members, ensure completion of education modules among team members, provide the required documentation for auditing, and be the point of contact for feedback received. This role may be delegated to a less senior staff member, upon approval from the Principle Investigator or equivalent.
After the Biobank Leader creates an account and enrols in the NSW Biobank Certification Program, he/she will then:
  1. Complete the following steps to register the Biobank:
    1. Complete the Registration Form.
    2. Complete the online introductory overview education module Basics of Biobanking (Module 1).
    3. Receive a record of registration and education module 1 completion report.
    4. Receive access to the best practice standards documents and share these with their biobank team members.
  2. Complete the following steps to certify the Biobank:
    1. Invite the biobank team members to create accounts.
    2. Assign* relevant education modules to biobank team members.
    3. Complete required* education module(s) including the test(s) at the end of each module.
    4. Complete a checklist of existing key biobank documentation.
    5. Ensure biobank team members have completed their required education modules.
    6. Upload documents for review by the NSW Biobank Certification Officer.
    7. Submit the Biobank's Declaration of Compliance with best practices.
    8. Receive a completion of certification and education module completion reports.
* For more information about the difference between ‘assigned’ and ‘required’ education, please see the FAQ below ‘What is the difference between ASSIGNED and REQUIRED education?’
The ‘Pathology Laboratory Leader’ is the most responsible person in the pathology laboratory for biobank activities. Examples of the ‘Pathology Laboratory Leader’ include: a Pathologist, Laboratory Manager, Research Manager, Biobank Manager, Senior Scientist etc.
If you are a Leader of a Research Pathology Laboratory that engages in biobanking activities, please enrol as a ‘Pathology Laboratory Leader’. Pathology Laboratories include both diagnostic, clinical and/or research laboratories.
If you are a leader of a private pathology laboratory that engages in biobanking activities, please enrol as a ‘Pathology Laboratory Leader’. Pathology laboratories include private and public laboratories as well as research laboratories.
If you work on one or more clinical trials that include biobanking, please enrol as a ‘Biobank Leader’. If there is no specific name for the collection of biospecimens, please enter the name of the clinical trials centre or appropriate hospital department and/or clinic for the ‘Biobank Name’ when completing the registration form.
After the Pathology Laboratory Leader creates an account and enrols in the NSW Biobank Certification Program, he/she will then:
  1. Complete the following steps to register the Pathology Laboratory:
    1. Complete the Registration Form.
    2. Complete the online introductory overview education module Basics of Biobanking (Module 1).
    3. Receive a record of registration and education module 1 completion report.
    4. Receives access to the best practice standards documents and shares these with their pathology laboratory team members who are involved in biobanking activities.
  2. Complete the following steps to certify the biobanking activities in the pathology laboratory:
    1. Invite the pathology lab team members (who are involved in research and/or biobanking activities) to create accounts.
    2. Assign* relevant education modules to pathology lab team members.
    3. Complete required* education module(s) including the test(s) at the end of each module.
    4. Complete a checklist of existing key pathology lab documentation.
    5. Ensure team members have completed required education modules.
    6. Upload documents for review by the NSW Biobank Certification Officer.
    7. Submit the Biobank's Declaration of Compliance with best practices.
    8. Receive a completion of certification and education module completion reports.
* For more information about the difference between ‘assigned’ and ‘required’ education, please see the FAQ below ‘What is the difference between ASSIGNED and REQUIRED education?’
If you are a leader/manager of more than one biobank, you may register and certify them all under the same account. To do this, enrol as a biobank leader and complete the registration form about ONE of your biobanks. Then, click on ‘Register a new Biobank’ under the ‘My Biobanks’ tab. A new registration form will appear and you may enter the details of the second biobank. Repeat the process for additional biobanks. There is no limit to the number of biobanks that you may register and subsequently certify.
If you manage a biobank that is part of a biobank network, we recommend that each node or site manager register their biobank if they have separate ethics committee approvals. Many biobanks in networks use different standard operating procedures (SOPs) and policies so we recommend that they register separately. The biobank registration form asks a question about whether or not your biobank is part of a network. If ALL biobanks in the network fall under one ethics approval and use the same SOPs, then the person who manages the overall biobank network approval may be the appropriate person to register the biobank network as a whole.
If you are a leader of both a biobank and a pathology lab, enrol in the program as a biobank or pathology laboratory and complete the registration form. Then, please contact us and let us know that you would like to register a biobank AND a pathology laboratory. We will update your account so that you may register both a biobank and a pathology laboratory under the same user account.
The most appropriate person to register a multi-centre trial will depend on how the site is managed. If a site has a separate ethics approval, we recommend that each site manager register the clinical trial. The site ‘leader’ is likely the best person to identify and invite the appropriate team members to enrol into the program and assign each team member the relevant education modules. If ALL sites fall under one ethics approval, the person who manages the overall ethics approval may be the appropriate person to register the clinical trial as a single entity if they are familiar with the team members and duties of staff at each site.
If you are a leader/manager of an active biobank as well as many retrospective collections we would recommend that you register the active biobank as a minimum. Registering in the program is voluntary. You may decide to register retrospective collections if you wish to advertise them separately on the biobank locator and/or if some of your team members work on the retrospective collections alone and you would like these team members to access the education modules.
Team members of biobanks and pathology laboratories must wait until the Biobank Leader or Pathology Laboratory Leader has registered their biobank or pathology laboratory into the program. Once the leader has registered the Biobank/Pathology Laboratory, he/she will progress to the certification stage and invite team members to join the program. Team members will receive an email with a link to an enrolment page. The link will allow team members to create accounts that are ‘connected’ to their biobank/pathology laboratory.
Clicking on ‘Education Only’ will give users access to the biobank education modules. Users will not be able to access the Registration or Certification Programs for Biobanks or Pathology Laboratories. Please click on ‘Education Only’ if you're not part of a biobank or a pathology laboratory but would like access to education material. For example, you may wish to access ‘Education Only’ if you are a member of an ethics committee and would like more information about biobanking.
If you are a member of an ethics committee or biobank governance committee and would like access to the education modules, we encourage you to register under the ‘Education Only’ section. To access ‘Education Only’, click on the ‘Enrol’ tab and look for the information and link under the heading ‘Education Only’. You may create an account and access Module 1: Basics of Biobanking. To access all of the education modules, please contact us and let us know the name of your ethics committee and/or about your involvement in biobank governance.
If the Biobank Leader/Pathology Laboratory Leader has invited you to enrol in the program but you haven’t received an invitation email with a link, please check your spam folder. If the email is not in your spam folder, please contact us.
If you are a Team Member and work with many biobanks and/or pathology laboratories, you may be linked to all of the relevant biobanks via invitation from the Biobank/Pathlab leader.

Requirements of the NSW Biobank Certification Program

The registration form collects information about the type of biobanking activities and the biobank/laboratory operations. For example there are questions about the number and type of biospecimens collected, the number of staff, restrictions (if any) regarding access to biospecimens/data for research and whether or not identifiable data is collected. The information provided in the registration form is used to determine which education modules are required for certification. A small biobank that collects biospecimens for a single research project will be required to complete fewer educational modules than a large biobank that collects biospecimens for a wide range of projects. All biobanks/laboratories wishing to certify in the program will have access to all of the education modules. However, the number of education modules that MUST BE COMPLETED in order to certify a biobank/laboratory will differ depending on the responses provided by the biobank/laboratory leader in the registration form. See the FAQ ‘Which education modules are REQUIRED for registration and certification’ below for more information.
The NSW Biobank Certification Program is currently voluntary and there are no immediate plans to make the program mandatory.
Registration:
To register a biobank/pathology laboratory, the leader must review Module 1: Basics of Biobanking (no test is required).
Certification:
To certify a biobank or pathology lab, the biobank/laboratory leader and all team members must complete Module 1: Basics of Biobanking (including the test) as a minimum. Additional education modules are required depending on the type of biobank and biobanking activities conducted as recorded in the registration form. The biobank/pathology laboratory leader may view a list of required education modules for their biobank/pathology laboratory by clicking on the ‘My Biobanks’ tab and then clicking on ‘Certification Status’. The education modules REQUIRED for biobanks and pathology laboratories are outlined in Tables 1 and 2 respectively below.
Table 1. Educational Requirements for Biobanks
Target Accrual (biospecimens) User Identifiable data collected? Leadership Required Education Modules
<200 Any Any Any Baseline = Biobank leader and all team members must complete Module 1: Basics of Biobanking
≥ 200 Mono1 Any Any Baseline (see above)
≥ 200 Oligo2 or Poly3 No Individual Baseline (see above)
≥ 200 Oligo2 or Poly3 No Group Baseline (see above) and Modules 2, 7 and 8 must be completed by the leader or at least one team member.
≥ 200 Oligo2 or Poly3 No Institution Baseline (see above) and Modules 2, 3, 4, 5, 7 and 8 must be completed by the leader or at least one team member.
≥ 200 Oligo2 or Poly3 Yes Any Baseline (see above) and Modules 2-9 must be completed by the leader or at least one team member.

1Mono biobanks are defined as those with a collection aimed at supporting a specific, single research project.
2Oligo biobanks are defined as those with a collection aimed at supporting several research projects, a research group or a research consortium.
3Poly biobanks are defined as those with collections aimed at supporting undetermined, multiple users with ethics approved research projects, through a defined access/application mechanism.

Table 2. Educational Requirements for Pathology Laboratories
Pathology lab staff spin blood/urine/fluid and/or perform DNA/RNA/protein extraction for research? Pathology lab staff consent participants for research? Required Education Modules
No No Baseline = Pathology Laboratory leader and all team members must complete Module 1: Basics of Biobanking and Module 10: Biobanking Focused within Pathology Departments.
No Yes/Unsure Baseline and Module 6 must be completed by the leader or at least one team member.
Yes No Baseline and Modules 7 and 8 must be completed by the leader or at least one team member.
Yes Yes Baseline (see above) and Modules 6, 7 and 8 must be completed by the leader or at least one team member.
Required education:
refers to those education modules that must be completed in order for a biobank to be certified. See the FAQ ‘Which education modules are REQUIRED for registration and certification?’ for more information.
Assigned education:
refers to education modules that are recommended or ‘assigned’ to team members by the biobank/pathology laboratory leader. The leader assigns relevant modules to staff based on their role and activities in the biobank/laboratory. The leader may insist that their biobank personnel complete these education modules. However, these education modules are not required by the NSW Biobank Certification Program.
To certify a biobank, the Biobank Leader will be asked to upload the following documents for review:
  1. Biospecimen collection and processing standard operating procedure (SOP);
  2. Biospecimen storage and retrieval SOP;
  3. Document outlining the biobank’s governance structure;
  4. Biobank’s ethics approval letter or certificate;
  5. Obtaining informed consent SOP (unless the biobank has obtained a waiver of consent);
  6. Biospecimen Access and Release SOP/policy and
  7. Copy of the currently approved biobank participant information sheet/consent form (if applicable).
If the biobank leader does not have one or more of the required documents, templates will be provided to assist the biobank leader in their creation. More information about which SOP should be submitted for review is in the FAQ below ‘I have many types of biospecimen standard operating procedures. Which one should I submit for review?’
To certify the biobanking activities of a pathology laboratory, the Pathology Laboratory Leader will be asked to upload the following documents for review:
  1. NATA accreditation certificate for the laboratory (if applicable; it is understood that some research laboratories may not be NATA accredited);
  2. Biospecimen collection and processing standard operating procedure (SOP);
  3. SOP/policy describing how diagnostic biospecimens are released for research projects/biobanks;
  4. Pathology laboratory declaration page of the Site Specific Assessment (SSA) form related to governance approval of biobanks (if applicable).
If the pathology laboratory leader does not have one or more of the required documents, templates will be provided to assist the laboratory leader in their creation. More information about which SOP should be submitted for review is in the FAQ below ‘I have many types of biospecimen standard operating procedures. Which one should I submit for review?’
It is understood that most biobanks will have more than one standard operating procedure (SOP) for different types of biospecimens that are collected and processed. We recommend that the biobank/laboratory leader select a representative SOP for review. For example, if your biobank collects tissue, blood and urine from patients with breast cancer, the most representative SOP will likely be the tissue collection and processing SOP. If your biobank is a ‘brain biobank’, the most representative SOP is likely the brain tissue SOP. If your biobank is a leukaemia biobank, the most representative SOP likely focuses on bone marrow collection and processing.
No, archived SOPs are not required for certification. For a list of documents reviewed by the NSW Biobank Certification Officer, please see the FAQs above.
The NSW Biobank Certification Program is based on the standards outlined in the Required Operational Practices (ROPs). To certify a biobank/laboratory, the Biobank/Pathology Laboratory Leader must sign a ‘Declaration of Compliance’. The ‘Declaration of Compliance’ includes statements about the ROPs including ‘the ROPs have been read’, ‘I agree with the principles outlined in the ROPs’ and ‘I will strive to be in compliance with biobanking best practices’. Therefore, it is not required to meet all ROPs to be certified however, you must agree with the principles and agree to STRIVE to be in compliance. If you do not agree with the principles outlined in the ROPs and/or do not agree to strive to be in compliance, the biobank will not be certified.
No. The standard operating procedures (SOPs) are templates that the biobank/laboratory may use to create and/or update their own SOPs.
To register a biobank, the biobank leader must provide some information about the type of biobank and the biobank operations. This information is used to determine which education modules will be required for the biobank to complete for registration. For example there are questions about the number and type of biospecimens collected, whether the biobank collects biospecimens for a specific research project or whether the biobank has an ‘open access’ policy and whether or not identifiable data is collected. A small biobank that collects biospecimens for a specific research project only will be required to complete fewer educational modules than a large biobank with an open access policy. All biobanks/laboratories wishing to certify in the program will have access to all of the education modules. However, the number of education modules that MUST BE COMPLETED in order to certify a biobank/laboratory will differ depending on the responses provided by the biobank/laboratory leader in the registration form.

Biobank and Pathology Laboratory Locators

The locators are lists of biobanks and pathology laboratories that have registered and/or certified in the NSW Biobank Certification Program AND have agreed to be listed on the locator. Having your resource listed on the locator is entirely optional. The name of the biobank/laboratory and status (e.g. registered, registration pending, certified) are visible to anyone who visits the site. In the Biobank Locator, additional information is visible when the user clicks on the name of the biobank including the type of biospecimens collected and the email address for inquiries.
The main purpose of the Biobank Locator is to allow biobanks to advertise the availability of their biospecimens to potential researchers. Biobanks and pathology laboratories may also use the information in the locator to collaborate and/or network with other biobanks. Stakeholders such as ethics committee members or funders may use the locators to confirm whether or not a biobank and/or pathology laboratory has registered or certified in the program.
All visitors to the site may view the locators. Click on the ‘Biobank Locator’ tab to view the list of biobanks and the ‘Pathlab Locator’ tab to view the list of pathology laboratories.

Other Questions

All research involving human biospecimens in Australia requires ethics review as per the National Statement on Ethical Conduct in Human Research. Biobanks apply for ethics review commonly at the institutional level. The ethical and privacy laws that shape the ethics landscape exist at the local, state and federal level.
While there is no international organisation that governs biobanking, the International Society for Biological and Environmental Biorepositories (ISBER) is an international forum that addresses the technical, legal, ethical, and managerial issues relevant to repositories of biological and environmental specimens. More information about ISBER can be found at www.isber.org.

The NSW Biobank Certification Program is a NSW Health Pathology initiative and funded by NSW Health. The goal is to first roll out and test the program in NSW and consideration will then be given to expand the program nationally.
If you are a biobank or clinical trial with sites in NSW and other states or territories, at the moment only the NSW site may register with the program. If you are in Australia but outside NSW, please contact us to express interest at NSWPATH-Biobanking@health.nsw.gov.au. It is anticipated that the program will subsequently be made available for other states and territories but that a fee will be levied to cover the costs of delivering the program.

Biobanks outside Australia may access the Canadian program, on which the Australian version is based, at biobanking.org.
Registration:
The leader of a biobank and/or pathology laboratory in NSW may register their biobank or laboratory without charge. Registration includes access to education module 1: The Basics of Biobanking.
Certification:
See certification for up to date information regarding costs.
New team members may be invited to access the education by the biobank leader or pathology laboratory leader at any time while the certification is valid.
The information in the registration form may be changed or edited by the Biobank Leader or Pathology Laboratory Leader who registered the biobank/laboratory. To edit the information, including whether your biobank/laboratory is listed on the locator, click on ‘Update Registration Form’ under the ‘My Biobank’ or ‘My Pathlabs’ tab.
If the Biobank Leader or Pathology Laboratory Leader who registered your biobank/laboratory has left the organisation and no other staff members can access the ‘leaders’ account, please contact us. We will transfer the ‘ownership’ of the account to another staff member.
Once a biobank or pathology laboratory is certified, the certification will be valid for 3 years provided that the biobank maintains ethics approval during this time period. Before the certification expires, the biobank or pathology laboratory will receive a reminder to renew their certification.
For more information about this program, please contact us.