Access committee: The biobank committee responsible for determining which research applications will be supported by provision of biospecimens and/or data.
Access and release policy: a document that describes the procedures for handling requests from researchers to use (or access) biospecimens and/or data. The document also includes details on the application process and how the biospecimens and/or data will be provided to (or released) to the researcher.
Adverse event: Any event that caused harm or had the potential to cause harm to any biobank personnel or visitors, including but not limited to breach of security of the premises and its contents, or harm to biospecimens or data integrity or linkage.
Anonymous/anonymized biospecimens or data: The biospecimens/data never had associated identifiers (e.g. anonymous surveys), or are irrevocably stripped of identifiers, and a code is not kept to allow future re-linkage. Risk of re-identification of individuals from remaining indirect identifiers is low or very low (adapted from TCPS 2, 2010).
Audit: A documented review of procedures, records, database, equipment or facilities to assess whether they conform or adhere to the applied standards.
Biobank: Collection of human biospecimens and associated data compiled for research purposes. Biobanks may be independent or part of a network or part of a research project (e.g., a study or clinical trial). The CTRNet definition includes a range of types of biobanks as follows:
- Mono-user biobank= Collection aimed at supporting a specific, single research project (e.g., PI conducting breast cancer research, sets up a collection process for breast biospecimens for his/her research).
- Oligo-user biobank= Collection aimed at supporting several research groups, typically with a common research goal and within the same institution (e.g., members of a research consortium set up a collection process for biospecimens that they may all access).
- Poly-user biobank= Collection aimed at supporting undetermined, multiple users with REB-approved research projects through a defined access/application mechanism (e.g., any of the CTRNet charter member banks).
Biohazard: Microbial or antigenic entities presenting risk or potential risk to the well-being of other organisms, either directly through infection or indirectly through disruption of the environment.
Biohazardous Material: Any substance that contains or potentially contains biohazardous agents.
Biospecimens: A biological specimen from the human body including tissue, blood, blood components, cell lines, saliva and urine.
Certification: The second phase in the Certification program (see Registration for the first phase). The goals of this phase are to assign additional education modules based on biobank type and collect biobank documents that indicate that the biobank has adapted to best practice standards. The components are as follows:
1) the biobank provides additional information which enables the certification office to categorize it for the purpose of determining which education modules are applicable.
2) the biobank submits documentation demonstrating compliance with best practice based standards.
Coercion: An extreme form of undue influence, involving a threat of harm or punishment for failure to participate in research (TCPS 2, 2010).
Complaint: A grievance expressed formally or informally if the participant feels that the biobank has inappropriately collected, used or disclosed personal or medical information or in any way violated the terms of the Informed Consent Form.
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 (TCPS 2, 2010).
Confidentiality Disclosure Agreements (CDAs): Confidentiality agreements are contracts intended to protect information considered to be proprietary or confidential. Employees involved in executing a CDA promise not to divulge sensitive or protected information disclosed/accessed during employment.
Conflict of interest: Connections or interests (personal, social, financial or professional) that influence or, are perceived to influence, professional integrity and independence.
Cryopreservation: A process for storing biological material at very low temperatures for lengthy periods of time.
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 responsibility for safeguarding the interests of participants.
Database: A collection of information, records or data, organized so that it can easily be accessed, managed, and updated.
De-identified biospecimens or data: Biospecimens/data that have the direct identifiers removed and replaced with a code or number. Depending on access to the code, it may be possible to re-identify specific participants (e.g. the principal investigator retains a list that links the participants’ code names with their actual name so data can be re-linked if necessary). Also known as coded information (adapted from TCPS 2, 2010).
Desk Assessment: A type of assessment that Biobanks undergo to complete Certification. The Desk Assessment will consist of the Office verifying that the assigned online education modules have been completed and reviewing specific required documents provided by the Biobank. (See also Extended Assessment and Harmonization Assessment).
Extended Assessment: An optional type of assessment (in addition to the required Desk Assessment) that a Biobank may choose to undergo as part of Certification. An Extended Assessment will consist of in depth review of biobank operations, a teleconference interview and may include a site visit.
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.
Full Time Equivalent (FTE): FTE is a unit that indicates the workload of an employed person (or trainee/student/volunteer) in a way that makes workloads comparable across various contexts. FTE is often used to measure a worker's involvement in a project, or to track cost reductions in an organization. An FTE of 1.0 means that the person is equivalent to a full-time worker, while an FTE of 0.5 signals that the worker is half-time.
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. Governance mechanisms also provide internal controls and risk management systems. Management is accountable to the governance bodies that in turn are accountable to those who have appointed them (adapted from OECD Guidelines on Human Biobanks and Genetic Research Databases, 2009). This includes:
- External governance: External requirements for which the biobank has no authority but must fulfill).
- Internal governance: Mechanisms created by the biobank to fulfill certain requirements or roles.
Harmonization Assessment: An optional type of assessment that a Biobank may choose to undergo (in addition to Desk and Extended Assessment) as part of Certification. A Harmonization assessment will consist of an Extended Assessment focused on ensuring Biobank operations and practices are harmonized to an external standard chosen by the Biobank.
Hosting institution: The university, hospital or private entity that is the holder of the core funds for the biobank.
Identifiable (identified/identifying) 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 (adapted from TCPS 2, 2010). This includes:
Directly identifying information: The information identifies a specific individual through direct identifiers (e.g. name, social insurance number, personal health number).
Indirectly identifying information: The information can reasonably be expected to identify an individual through a combination of indirect identifiers (e.g. date of birth, place of residence, or unique personal characteristic).
Informed and Voluntary Consent: A process by which an individual freely and voluntarily confirms his or her willingness to participate in the biobank, after having been informed of all aspects of the research that are relevant to the their decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.
Intellectual property: Creative ideas and expressions of the human mind that have commercial value and receive the legal protection of a property right (e.g. patents, copyright, licenses (adapted from NCI, 2006).
Leader/Biobank leader: the person/people responsible for determining how the biobank is governed). The leader of a Biobank may be a/an:
- Individual: The biobank is led by one principal investigator
- Group: The biobank is led by a research group
- Institution: The biobank is led by an institution e.g. part of another leadership role or committee within a hospital or university
Material Transfer Agreement (MTA): A legal agreement that defines terms and conditions attached to the transfer of biospecimens and/or data from the biobank to recipient and the use of the biospecimens/data.
Mono-user Biobank: see ‘Biobank’
Oversight bodies: individuals, committees or groups that provide supervision of a research project. Examples include: REB (research ethics committee), Scientific Advisory Committee and Access Committee.
Oligo-user Biobank: see ‘Biobank”
OCT: “Optimal Cutting Temperature” compound is the name used for polyethylene glycol/sucrose-based freezing medium. OCT 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 volunteer, if applicable) who is the source of the biospecimen or data. Also sometimes referred to with the terms, ‘subject’, ‘donor’, or ‘case’.
Personal information: All information about individuals, living or dead. This includes written and electronic records and information obtained from biospecimens. See ‘identifiable information’.
Policy: Clear, concise, non-negotiable, formal statement directing staff decision-making. It enables and guides informed action, prescribes limits, assigns responsibilities and accountabilities and is secondary to legislation and by-laws. It must align with the mission and vision of the organization. All staff members are required to comply with policy statements. 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.
Poly-user Biobank: See ‘Biobank’
Post-procedure consent: Consent obtained after the individual has undergone a medical procedure (e.g., surgery or biopsy to remove the tumor; phlebotomy).
Principal investigator: The leader of a research team who is responsible for the conduct of the research, and for the actions of any member of the research team (TCPS 2, 2010).
Privacy: An individual’s right to be free from intrusion or interference by others (TCPS 2, 2010).
Procedure: A specified sequence of actions undertaken to achieve the desired outcome. Typically a procedure answers the question of ‘how’ something is to be done.
Processing: All operations involved in the preparation, preservation and packaging of biospecimens.
Pre-procedure consent: Consent obtained prior to the individual undergoing a medical procedure (e.g., surgery or biopsy to remove the tumor; phlebotomy).
Public registry (of Biobanks): is a listing or catalog of Biobanks that is accessible to the public (e.g. on a public web site).
Quality: Conformance of a biospecimen or process with pre-established specifications or standards (ISBER Best Practices, 201205).
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).
• The CTRNet Biobank Registration and Certification Program builds in aspects of QA for the various biobank processes.
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).
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 all applicable regulations; and 3) continuous improvement of all biobank processes. The QMS includes planning, implementation, documentation, assessment, and improvement of biobank practices.
Quality Representative: The personnel member responsible for ensuring that the quality management system is established, implemented, maintained and updated. The specific duties include: assuring compliance with all SOPs, policies and regulatory requirements; ensuring all complaints are documented and corrective and preventative measures are put into place; managing regular audits of biobank processes and procedures; and ensuring all personnel are trained in all procedures related to their roles.
Raw data: Data that have not been subjected to refinement, processing or any other manipulation. Raw data may have the following attributes: possibly containing errors, not validated; in different formats; not coded; and requiring confirmation or citation.
Recruitment: The processes and activities used to identify and recruit participants for the biobank.
Registration: The first phase in the Certification program. The goal is to provide the best practice-based standards and foundational knowledge for these standards. The components include the following:
1) biobank submits registration form and completes the on-line introductory education module ‘Basics of Biobanking’
2) CTRNet provides registration record and links to the best practice-based standards.
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 ‘Institutional Research Boards’ (IRBs) or ‘Boards of Record’ (BORs).
Revoked consent: see withdrawal of consent.
ROP (Required operational practice): The CTRNet Biobank Registration and Certification Program includes a set of 13 ROPs that are meant to define the key principles of biobank operations that a biobank should adhere to in order to meet the current best practice standards. Different from SOPs (Standard Operating Procedures) which are meant to provide the details for a given procedure such that personnel can repeat the process correctly each time with no operator-variability.
Safety: Processes, procedures and technologies to ensure freedom from danger or harm (ISBER Best Practices, 2012).
Scale/size (of Biobank): The scale of a Biobank refers to the number of biospecimens being collected each year. The scale can divided into small, medium and large as follows:
- Small: less than 200 biospecimens collected each year
- Medium: 200-1000 biospecimens collected each year
- Large: over 1000 biospecimens collected each year
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.
Storage: Maintenance of biospecimens for future use.
Tri-Council Policy Statement- Ethical Conduct for Research Involving Humans, 2nd edition (TCPS2): The official human research ethics policy of three Canadian Agencies, the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council (NSERC) and the Social Sciences and Humanities Research Council (SSHRC).
Undue influence: May arise when prospective participants are recruited by person in a position of authority creating the possibility that voluntariness of consent is compromised (e.g., employer recruiting employee).
Waiver of consent: In some cases Research ethics Boards (REBs) may approve a given study or 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 TCPS2 Article 12.3.
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).