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Population Biobanks Lexicon

Public Population Project in Genomics (P3G) & Promoting Harmonization of Epidemiological Biobanks in Europe (PHOEBE)

Introduction

The aim of this lexicon is to pave the way for consensus on terms within the field of population biobanks. The vocabulary comprises terminology concerning information on the collection, use, release, return of information, and governance of biobank samples as well as administrative concepts.

The procedure for defining the terms herein was based upon information derived from selected texts describing international norms plus the combined experience of the lexicon team. The definitions are formulated to be as simple and straightforward as possible.

It has not been possible to fully solve all terminological issues, thus, the vocabulary should be considered a "living document", a document that will hopefully be discussed and revised over time.

aliquot

A portion of a biological material (sample) 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 the information associated with the material stored for one or more research purposes and capable of being linked.

bioethics advisory body

An independent group to advise the biobank on ethical matters

coding

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

confidentiality

The protection of information shared in a relationship of trust

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, access and 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.

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

Committee for the ethical review of biobank activities and research

general/broad consent

An authorization to the further uses of samples and data stored in a population biobank subject to certain oversight mechanisms

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

The process by which any combination of data allows a specific person to be identified. There are various terms used to describe this process (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

data linkage

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

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 transfer agreement

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

personal data

Any information that directly or indirectly may be used to identify a specific person

privacy

The right and freedom to control information about oneself

population biobank

A population biobank is a collection of biological materials that has the following characteristics:
1. The collection has a population basis;
2. It is established, or has been converted, to supply biological materials or data derived therefrom for multiple future research projects;
3. 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;
4. It receives and supplies materials in an organized manner
(Council of Europe, 2006)

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

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

retrospective harmonization

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

return of results

A process that may include four different situations:
1. return of results and data by researchers to the population biobank
2. communication of general results to the population
3. return of general results to the participant
4. return of individual results to the participant

sample

A biological specimen from the human body including e.g. tissue, blood, blood components, waste products and biopsy

secondary use(s)

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

traceability

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

unidentifiable

Samples 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

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