Glossary
Annotation—explanatory or extra information associated with a particular biospecimen. Annotations may be added either by the pathologist or resource collector.
Biospecimen—human tissue including everything from subcellular structures like DNA to cells,
tissue (bone, muscle, connective tissue, and skin), organs (liver, bladder, heart, and kidney),
blood, gametes (sperm and ova), embryos, fetal tissue, and waste (urine, feces, sweat, hair and
nail clippings, shed epithelial cells, and placenta).1
Central Institutional Review Board (CIRB)—a model that features a "facilitated review"
process that streamlines local IRB review for national multicenter cancer treatment trials. Local
IRBs can access CIRB reviews and decide whether or not to utilize the CIRB review for a
particular protocol. If there are no concerns about local context, the Chair (or subcommittee) of
the local IRB can decide to accept the CIRB review in lieu of a full board review.
CGxP—refers collectively to Current Good Laboratory Practices, Good Clinical Practices, and
Good Manufacturing Practices, as defined by the Food and Drug Administration, to describe
what records should be kept or what information is considered to be an official record.
Coded samples—also designated as "linked" or "identifiable," are supplied by repositories to
investigators from identified specimens using a code rather than personal identifying
information, such as a name or a Social Security number.
Confidentiality—a principle emergent from a relationship in which something about an
individual, information, or material has been shared (with some degree of loss of privacy) in
confidence.
Covered entity—a health plan, healthcare clearinghouse, and certain healthcare providers that
transmit protected health information electronically for certain covered transactions, as defined
in the Health Insurance Portability and Accountability Act of 1996.
Data—values derived from scientific experiments or diagnostic procedures organized especially
for scientific analysis, in a numerical form suitable for processing by computer.
Human subject—a living individual about whom an investigator conducting research obtains
(1) data through intervention or interaction with the individual or (2) identifiable private
information.
Identifiable—linked to personal information in such a way that the person from whom the
material is obtained could be identified by name, patient number, or clear pedigree location (i.e.,
his or her relationship to a family member whose identity is known). Identified samples are
supplied by repositories from identified specimens and have a personal identifier (such as a name
or patient number) that allows the researcher to link the biological information derived from the
sample directly to the individual from whom the material was obtained.
Incidence—number of cases of disease having their onset during a prescribed period of time.
Informed consent—an educational process between the investigator and the prospective subject
(or the subject’s legally authorized representative) as a means to ensure respect for persons;
mutual understanding of research procedures, risks, rights, and responsibilities; and continuous
voluntary participation.
Matching (uninvolved) tissue—usually refers to the matching tissue type from which the tumor
developed. Looks histologically normal but may demonstrate molecular changes (e.g., terminal
ductal alveolar unit from patients with breast cancer).
Metastatic lesion—metastases to lymph nodes or distant organs; direct extensions do not satisfy
such requests from most investigators.
Minimal risk—the probability and magnitude of harm or discomfort anticipated in the research
are not greater in and of themselves than those ordinarily encountered in daily life or during the
performance of routine physical or psychological examinations or tests.
Network—a collection of activities and organizations that use shared data standards and
business rules to carry out a common purpose.
Normal tissue—used as the control for a specific type of tumor but comes from a patient
without this type of cancer.
Patent—a property right granted by the Government to an inventor. In order to be patentable, an
invention must contain an idea that serves some utility, is novel, and is "nonobvious" to an
average person who is "skilled in the arts of the specified field."
Prevalence—number of cases of a disease, infected persons, or persons with some other
attribute present during a particular interval of time.
Primary tumor—the first site at which a tumor arises. This may not be clear for diffuse
neoplastic processes such as lymphoma.
Privacy—the state or condition of limited access to an individual and/or to information about
that individual.
Protected health information—any health information that is collected by a covered entity and
is individually identifiable.
Quality assurance (QA)—an integrated system of management activities involving planning,
implementation, documentation, assessment, and improvement to ensure that a process or item is
of the type and quality needed for the project.
Quality control (QC)—specific tests defined by the QA program to be performed to monitor
procurement, processing, preservation, storage, and specimen quality and to test accuracy. These
may include but are not limited to performance evaluations, testing, and controls used to
determine accuracy and reliability of the repository's equipment and operational procedures, as
well as monitoring of the supplies, reagents, equipment, and facilities.
Research—systematic investigation, including research development, testing, and evaluation,
designed to develop or contribute to generalizable knowledge.
Sample—a subset of a specimen. Researchers requesting access to tissues in the repository are
usually provided with a sample of that specimen.
Specimen—a sample, as of tissue, blood, or urine, used for analysis and diagnosis. A single
biopsy may generate several specimens, including a number of slides, paraffin blocks, and frozen
specimens.
Tissue procurement—a fee paid for the right to acquire tissue specimens from a repository, as
in a vendor relationship, with no further obligation to jointly publish with the tissue provider.
Tissue sharing—collaboration whereby no or nominal funds are exchanged for the privilege of
analyzing tissue specimens with the purpose of publishing findings with the collector of the
tissue specimens.
Unidentified or "anonymous" samples—samples supplied by repositories to investigators from
a collection of unidentified human biological specimens and can never be traced to an individual.
Unlinked or "anonymized" samples lack identifiers or codes that can link a particular sample to
an identified specimen or a particular human being but may have been derived from an identified
sample in the repository.
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