Definitions of common research terms.
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.
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.
Coded biospecimens or data
Direct identifiers are removed from the information represented by the data and replaced with a code. 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 names so data can be re-linked if necessary).
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.
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.
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:
- 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.
Incidental Findings
Unanticipated discoveries made in the course of research that are outside the scope of the research.
Informed and Voluntary Consent
An indication of an informed, voluntary and ongoing agreement by an individual or third party to become a participant in a research project.
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" or "donor".
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 Boards (REBs)
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”.
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).
All of these research terms have been adapted from the Biobank Resource Centre (BRC) glossary