Biobank Lexicon

The aim of this lexicon is to pave the way for consensus on terms within the field of population biobanks. The procedure for defining the terms in this lexicon is based on information derived from selected texts describing international norms and the combined experience of the lexicon team. The definitions are formulated to be as simple and straightforward as possible and will be updated.

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A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Aliquot

A portion of a sample of biological material that has been divided into separated parts

Anonymization

The irreversible removal of personal identifiers from data or samples, such that no specific individual can be identified

Audit

A documented review of procedures in order to evaluate adherence to written standards operating practices (SOPs) or laws and regulations (adapted from ISBER Best Practices, 2005)

Biobank/biorepository

An organized collection of human biological material and associated information stored for one or more research purposes

Bioethics advisory body

An independent group to advise the biobank on ethical matters

Coding

Substituting a code for personally identifying information in such a way that linkage is only possible through a key

Cohort

A group of individuals identified by a common characteristic (e.g. demographic, exposures, illness...)

Confidentiality

The protection of information shared in a relationship of trust

Conflict of interest

Connections or interests (personal, social, financial or professional) that influence or, are perceived to influence, professional integrity and independance

Consent/informed consent

Voluntary and informed expression of the will of a person, or his/her legal representative, concerning the use(s) of their samples and data. Depending on the nature of the biobank, such consent can take various forms (e.g. broad, specific, implicit, proxy, reconsent...)

Custodian

Entity responsible for managing the biobank, including control over its release, use and access as well as sample/information destruction. Custodianship does not necessarily equate with ownership over the biobank contents

Data Trustee/Keyholder/Custodian

An independent third party, which controls information used to identify data and samples held within a biobank. The trustee/keyholder/custodian acts as an intermediary between the persons maintaining the biobank and the individuals who supply their tissues and information. Only the trustee/keyholder/custodian can link the donor's personal information with any samples or information held by the biobank

Data linkage

The task of linking together records representing the same entity (eg participant, protein, genetic information etc) from one or more data sources

Donor

Living or deceased individual who is the source of a sample or about whom the biobank information relates

Ethics review committee/research ethics committee

An independent committee for the ethical review of biobank activities and research

Feedback

Return of general or individual results to the participant

Gene

The fundamental physical and functional unit of heredity consisting of a sequence of DNA, occupying a specific position within the genome (Nuffield, 2006)

General/broad consent

An authorization for the future uses of samples and data stored in a population biobank

Genome

The total genetic material of an individual, or of a species (Nuffield, 2006)

Genotype

The entire genetic constitution of an individual as distinguished from their physical characteristics (adopted from Nuffield, 2006)

Governance

The process of policy orientation and management that guides and regulates research under ethical and scientific norms so that the results can be used for the benefit and improvement of the health of the population (adopted PAHO, 2005)

Harmonization

The process of unifying certain methodologies and approaches in order to achieve interoperability

Identifiability

Any combination of data that allows a specific person to be identified. There are various terms used to describe this (e.g. coding [single or double], linkage, traceability, pseudonyminization, etc)

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)

Interoperability

The ability of two or more systems or components to exchange meaningful information and to use the information that has been exchanged (NCI 2006)

Key

The connection between a code and a donor or between two codes that permits data linkage and identification

Knowledge transfer

Communication of general results and other information to the population

Longitudinal study

Research studies involving repeated observations of the same entity over time. In the biobank context, longitudinal studies sample a group of people in a given time period, and study them at intervals by the acquisition and analyses of data and/or samples over time

Material/data transfer agreement

A binding legal agreement between the provider of research materials and the recipient of the materials/data that sets forth conditions of transfer and use (adapted from NCI, 2006)

Participant

The individual who provides the data and biological sample (OECD, 2006)

Personal data

Any information that directly or indirectly identifies a specific individual

Phenotype

The observable or measurable traits of an individual as produced by its genotype and the environment (Nuffield, 2006)

Population biobank

A population biobank is a collection of biological materials that has the following characteristics:

The collection has a population basis; It is established, or has been converted, to supply biological materials or data derived therefrom for multiple future research projects; It contains biological materials and associated personal data which may include or be linked to genealogical, medical or lifestyle data and which may be regularly updated; It receives and supplies materials in an organized manner (Council of Europe, 2006).

Privacy

The right and freedom to control information about oneself

Prospective harmonization

Aims to influence study design and conduct in the early stages in order to make subsequent data and sample pooling more efficient

Public domain

The public domain comprises the body of knowledge and innovation in relation to which no person or other legal entity can establish or maintain proprietary interests (adapted from Wikipedia)

Public participation

The active involvement of a population or sub-population in the development, management and governance of a biobank (e.g. engagement, consultation, communication, debate inclusion of stakeholders...)

Quality

Conformity of a biospecimen or process with preestablished specifications or standards (ISBER 2005)

Retrospective harmonization

Aims to optimize the use of data and samples already collected or entered in different ways.

Return of results

Return of results and data by researchers to the population biobank

Sample

A biological specimen from the human body including e.g. tissue, blood, blood components, cell lines and biopsies ...

Secondary use(s)

Using data or samples in a way that differs from the original purpose

Surveillance

Systematic collection, monitoring and dissemination of health data to assist in planning, implementation and evaluation of public health

Traceability

The ability to locate a sample during any step of its donation, collection, processing, testing, storage, and disposition (ISBER, 2005)

Unidentifiable

Samples and data for which identifiable information was not collected, or, if collected, was not maintained and cannot be retrieved (adapted NCI, 2006)

Virtual biobank

A controlled (access) database on samples stored at different locations