Glossary

Accreditation: Third-party attestation conveying formal demonstration of competence, impartiality, and consistent operation in performing specific activities. (adapted from ISBER Best Practices)

Anonymized data: see Biospecimen and Data types

Anonymous data: see Biospecimen and Data types

Assent: Agreement by participants who do not have the capacity to consent. (adapted from TCPS 2).

Audit: A documented review of procedures, records, database, equipment or facilities to assess whether they conform or adhere to the applied standards.

Biobank: An organized collection of searchable human biospecimens and associated data compiled for research purposes. Alternative terms include biorepository, biological resource center, repository or shorter terms such as collection and bank.

Biobank Leader: The person/people responsible for determining how the biobank is governed. The leader of a biobank may be an individual, group or committee. Alternative terms include “Principal Investigator” or “Director”.

Biobanking The functions associated with a biobank. The operation of a biobank typically involves conducting a range of linked functional processes focused on participant consent, collection, processing, annotation, storage, release and distribution of biospecimens and data.

Biohazard: A risk to human health or the environment arising from a biospecimen. (adapted from ISBER Best Practices)

Biological Safety Cabinet (BSC): An enclosed ventilated laboratory workspace designed to protect the users against biohazards and the biospecimens from contaminants. (adapted from ISBER Best Practices)

Biospecimen: A human biological specimen or sample including a tissue, organ, blood, plasma, skin, serum, DNA, RNA, protein, cell, hair, nail clipping, urine, saliva, other body fluids and materials related to human reproduction. (adapted from TCPS 2)

Biospecimen and Data types:

Certification: Third-party process designed to provide assurance that activities and processes conform to specific requirements.

Coded data: see Biospecimen and Data types

Confidentiality: An ethical and/or legal responsibility of individuals or organizations to safeguard information entrusted to them, from unauthorized access, use, disclosure, modification, loss or theft. (adapted from TCPS 2)

Consent: An indication of an informed, involuntary and ongoing agreement by an individual or third party to become a participant in a research project. (adapted TCPS 2)

Controlled document: Controlled documents are documents that undergo formal review and approval, controlled distribution, controlled modification and storage.  These include policies, standard operating procedures and guides and templates which are informed by the selected standard.

CTRNet Certification Program: The CTRNet Biobank Certification Program, is biobank quality improvement program which is primarily aimed at ‘formal’ biobanks. The objective of the program is to improve and harmonize biobanking standards through education of the whole biobank team and communication of best practices and SOPs. Key to the program are the online education modules which address all aspects of biobanking and focus on rationale underlying standards. Our certification program is applicable to all types of biobanks. For more information click here.

CTRNet Registration Program: The CTRNet Registration Program, is a biobank quality improvement program, primarily aimed  at researchers who are planning or conducting research projects that involve creating or working with collections of human research biospecimens. Registration provides individual researchers with education on biospecimens and biobanking and access to national standards. Information that the researcher enters in the registration form populates a biospecimen collection locator which serves as notification of potential future availability of biospecimens and advertises services provided by the laboratory and/or biobank involved in the biospecimen collection (For more information click here).

Custodianship: Responsibility for safe keeping of biospecimens and associated data and control of their use and eventual disposal in accordance with the terms of the consent given by the participant and as regulated by the Research Ethics Board. Custodianship implies some rights to decide how the biospecimens are used and by whom, and also the responsibility for safeguarding the interests of participants.

Directly identifying data: see Biospecimen and Data types

Formalin-fixed paraffin-embedded tissue processing (FFPE): Method for processing tissue in which the tissue is first fixed in formalin then set in paraffin. This method of processing generates tissue that is optimal for morphological assessment by microscopy but causes changes to biological molecules (DNA, RNA, protein) that presents challenges for gene expression studies and FFPE-derived molecules are not suited to all downstream applications. FFPE biospecimens can be stored at room temperature.

Governance: The processes and structures used to set the objectives for an entity, appoint the management whose responsibility it is to achieve these objectives and to oversee the operation (staff and processes) in its pursuit of these objectives. This includes:

Identifiable biospecimens or data: Biospecimens/data where the possibility of linking the biospecimen or data to an individual's identity exists, alone or in combination with other available information, regardless of how difficult it may be to do so. Also referred to as personal information. Also see Biospecimen and Data types. (adapted from TCPS 2)

Indirectly identifying data: see Biospecimen and Data types

Intellectual property (IP): A form of creative effort that can be protected through a trademark, patent, copyright, industrial design or integrated circuit topography. (adapted from Government of Canada)

Legacy event: A legacy event occurs when a specific project or biobank changes as a result of an unexpected, unlikely, or distant event such as 1) end of a defined scientific project 2) loss of funding 3) change/loss of leadership requests a biobank to accept a transfer of their materials from an existing collection or biobank.

Legacy plan: A legacy plan acts to guide the “who, what, when, where, why and how” biospecimens and associated data should be distributed or destroyed following a precipitating event (e.g. loss of/change in funding or leadership) or planned end to a project.

Liquid nitrogen (LN2): Coolant used to cool and store samples. Nitrogen becomes liquid at - 196ºC. Samples stored in the vapor phase of liquid nitrogen are -190ºC and warmer, depending on the distance from the liquid phase.

Locator: A listing, registry or catalogue of biobanks, accessible to researchers through a public website.

Material transfer agreement (MTA): A legal agreement that defines terms and conditions including the rights and obligations attached to the transfer of biospecimens and/or data from the biobank to recipient and the use of the biospecimens/data.

Optimal Cutting Temperature (OCT) compound: The name used for polyethylene glycol/sucrose-based freezing medium. OCT compound preserves ultrastructure and prevents tissue from desiccation, degradation, acts as an insulator from thermal variation and minimizes crystal formation. It is especially useful for preserving fresh-frozen tissue that may need to be sectioned.

Participant: An individual (patient or healthy person, if applicable) who is the source of the biospecimen or data. Also sometimes referred to with the terms, “subject” or “donor”.

Policy: A set of formal statements directing staff decision-making. It enables and guides informed action, prescribes limits, assigns responsibilities and accountabilities. It must align with the mission and vision of the organization. Typically a policy answers the question of ‘what’ is to be done but does not prescribe the details of ‘how’ it is to be done. Also see controlled document.

Privacy: An individual’s right to be free from intrusion or interference by others. (adapted from TCPS 2)

Quality Assurance (QA): Systems in place to monitor a process to provide confidence that the process will result in a high quality output/product (e.g., implementation of an education/training program to ensure biobank personnel are adequately trained to optimally perform their role). QA is part of quality management.

Quality Control (QC): Procedures to test the quality of the units of output to ensure the quality requirements have been met (e.g. assessing the integrity of nucleic acids that are extracted from a set of biospecimens) and the output (e.g. biospecimens, data) is fit for purpose. QC is part of quality management.

Quality Management Systems (QMS): The overall, integrated program in place to ensure the entire biobank operation achieves the following: 1) conforms to the biobank’s established SOPs; 2) conforms to standards and all applicable regulations; and 3) continuous improvement of all biobank processes. The QMS includes planning, implementation, documentation, assessment, and improvement of biobank practices.

Research: A disciplined inquiry or systematic investigation, including research development, testing, and evaluation, undertaken to extend knowledge. Human health research includes research aimed at extending knowledge on our understanding of the structure, function and disorders of the human body.

Research Ethics Board (REB): An independent body (a review board or a committee, institutional, regional, national or supranational) constituted of medical and scientific professionals and non-medical members) established by an institution to review the ethical acceptability of all research involving humans conducted within the institution’s jurisdiction or under its auspices. Also sometimes known as an “Institutional Research Board” (IRB), “Human Research Ethics Committee” (HREC) or “Ethics Committee”.

Required Operational Practice (ROP): The CTRNet Biobank Registration and Certification Program includes a set of 13 ROPs that define the key principles of biobank operations that a biobank should adhere to in order to meet the current best practice standards. Different from standard operating procedures (SOPs) which provide the details for a given procedure such that personnel can repeat the process correctly each time with no operator-variability. Also see controlled document.

Secondary use: The use of biospecimens or data in a way that differs from the original research purpose.

Security: Measures taken to protect biospecimens, data, and the overall biobank facility. This includes physical, administrative and technical safeguards.

Standard Operating Procedure (SOP): A document used to provide the details for a given procedure such that personnel can repeat the process correctly each time with no operator- variability. Also see controlled document.

Vulnerable Participant/Group: An individual or group who may require additional special consideration or protection in the context of research, due to a potential for inequitable treatment, exclusion, coercion, or increased risk of individual or group harms. “Vulnerability” may occur as a consequence of the nature of the research and/or circumstances of the individual or group and may be either temporary or permanent. (adapted from ISBER Best Practices)

Waiver of consent: In some cases Research Ethics Boards (REBs) may approve a biobank collection to proceed without requiring consent from the individuals from whom the biospecimens were collected. This is referred to as a ‘waiver of consent’. Canadian REBs base their decisions on whether to issue a waiver of consent on the criteria described in TCPS 2.

Withdrawal of consent: The situation that arises when an individual has consented to participate in a biobank and then at a later time communicates to the biobank that they wish to reverse this consent decision. The biobank must irreversibly destroy all remaining biospecimens and all identifiable data relating to the individual and biospecimens. In the case that biospecimens or data were released to a researcher prior to the revocation, the biobank should retain an anonymized record of the biospecimen release (biospecimen code number and who received those biospecimens).