A process wherein a specimen is divided into separate parts which are typically stored in separate containers as individual samples. The term aliquot may also be used as a noun to denote a single sample (ISBER 2008 Best Practices for Repositories)
An additional or secondary trial that was not part of the original study design.
Anonymized data and samples are initially single or double coded but the link between the subjects' identifiers and the unique code(s) is subsequently deleted. Once the link has been deleted, it is no longer possible to trace the data and samples back to individual subjects through the coding key(s). Anonymization is intended to prevent subject re-identification. (Guidance for Industry: E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories. FDA April 2008).
Someone in a senior position who is authorized to commit to procurements or the allocation of resources. The particular titles vary widely between institutions.
Standard operating procedures that are considered state-of-the-science consistent with all applicable ethical, legal, and policy statutes, regulations, and guidelines. (NCI Best Practices working definition)
Coordinating center that manages the operational activities of both the NHLBI Biorepository and the Data Repository. It also provides a single web-based user interface to give interested researchers an access point to both resources.
An organization, place, room, or container (physical entity) where biospecimens are stored. In the context of the NCI Best Practices, only biorepositories containing human specimens collected with an intention to use them for research purposes (research biorepositories) are addressed. The physical structure, policies, and the biospecimens and data contained within it are defined collectively as a biospecimen resource, defined below (NCI Best Practices working definition).
The software, hardware, written documents, support, and training that are necessary to annotate, track, and distribute biospecimens within a biorepository or biorepositories.
The committee responsible for oversight of the collections and determining if new collections meet the criteria for inclusion in the repositories.
A quantity of tissue, blood, urine, or other biologically derived material. The NHLBI Biologic Specimen Repository stores human biospecimens. Portions or aliquots of a biospecimen are referred to as samples (NCI Best Practices working definition).
A collection of human biological specimens and associated data for research purposes, the physical entity where the collection is stored, and all relevant processes and policies. Biospecimen resources vary considerably, ranging from formal organizations to informal collections of materials in an individual researcher's freezer (NCI Best Practices working definition).
A computer system used to manage and maintain biospecimen inventories (Also see Biorepository informatics system)
This is the process for preparing and submitting biospecimens to BioLINCC when the intent is to transfer specimens in bulk at the close of the study. This is the preferred process for submission of biospecimen collections to BioLINCC.
A formal statement of a set of business goals, the reasons why they are believed attainable, and the plan for reaching those goals. It may also contain background information about the organization or team attempting to reach those goals. (Wikipedia)
Factual information (as measurements or statistics) or observations used as a basis for reasoning, discussion, or calculation pertaining to clinical trials, diagnosis, or treatment (NCI Best Practices working definition).
Patient-oriented research, including epidemiologic and behavioral studies, outcomes research, and health services research. Patient-oriented research is research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) in which a researcher directly interacts with human subjects. It includes research on mechanisms of human disease, therapeutic interventions, clinical trials, and development of new technologies, but does not include in vitro studies using human tissues not linked to a living individual. Studies falling under 45 CFR 46.101(a) (4) are not considered clinical research for purposes of this definition. (NIH grants glossary, https://grants.nih.gov/grants/glossary.htm#C)
A biomedical or behavioral research study of human subjects designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. (NIH grants glossary, https://grants.nih.gov/grants/glossary.htm#C)
The codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. (GPO Access, http://www.gpoaccess.gov/cfr/index.html). The Federal Register is the official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents. (GPO Access, http://www.gpoaccess.gov/fr/index.html)
Means that (1) identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., the code); and (2) a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens. (Office for Human Research Protections, Guidance on Research Involving Coded Private Information or Biological Specimens, https://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf?link_time=2018-12-12_04:59:32.950678)
Coded biospecimens are labeled with at least one specific code and do not carry personal identifiers.
- Single-coded biospecimens. Biospecimens are labeled with a single code and do not carry any person. It is possible to trace the biospecimens back to a given individual.
- Double-coded. Biospecimens are initially labeled with a single specific code and do not carry any personal identifiers. They are then relabeled with a second code, which is linked to the first code via a second coding key. It is possible to trace the biospecimens back to an individual by use of both coding keys.
(Guidance for Industry: E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories. FDA April 2008).
- The act of gathering things together; having been brought together in one place (NCI Thesaurus).
- An accumulation of objects gathered for study, comparison, or exhibition (Merriam-Webster Dictionary)
The state of having the dissemination of certain information restricted. (Black's Law Dictionary) See Privacy.
The caretaking responsibility for biospecimens that extends from collection through research use. Responsible custodianship requires careful planning and transparent policies to ensure the long-term physical quality of the biospecimens, the privacy of human research participants, the confidentiality of associated data, and the appropriate use of biospecimens and data (NCI Best Practices working definition).
Factual information derived from scientific experiments or diagnostic procedures organized especially for scientific analysis in a numerical form suitable for digital transmission or processing by computer, digitally transmitted or processed and used as a basis for reasoning, discussion, or calculation. (NCI Best Practices working definition)
A data file or a collection of interrelated data records (also see Study Data Set)
Systematic destruction of medical waste and other biohazardous waste. (NCI Best Practices working definition)
A process that includes receipt of request for specimens, selection of appropriate specimens, and final inspection, in conjunction with subsequent shipment and delivery of specimens to another repository, specimen collection center, or laboratory. (ISBER 2008 Best Practices for Repositories).
A living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information. (45 CFR 46.102(f))
This is the process for preparing and submitting biospecimens to BioLINCC when the intent is to transfer specimens over the course of the study. This practice is discouraged and will only be granted under exceptional circumstances.
The legally effective consent of the human subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent. Whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence (45 CFR 46.116(a)).
Any board, committee, or other group formally designated by an institution to review biomedical research involving humans as subjects, to approve the initiation of the research and conduct periodic review of such research. (ISBER 2008 Best Practices for Repositories)
Any written, printed or graphic material on or affixed to a specimen container or package (ISBER 2008 Best Practices for Repositories)
A list that associates biological samples with the relevant clinical data. It is used to match the IDs that were used for the biospecimens to those that were used for the clinical records for all of the study subjects.
Generally is utilized when any proprietary material is exchanged, and when the receiving party intends to use it for his/her own research purposes. Neither rights in intellectual property nor rights for commercial purposes may be granted under this type of agreement. (NIH Office of Technology Transfer)
The period following the close of the proprietary period (see definition below). The NHLBI Repository Allocation committee is solely responsible for distribution and release of data and/or biospecimens for studies and collections in the Open Period.
- The clinical study collecting the data and/or biospecimens.
- The principal or primary study (see ancillary study).
Freedom from intrusion of others in one's private life (Merriam Webster); the right to be let alone (Black's Law Dictionary)
Any procedure employed after specimen collection but prior to its distribution, including preparation, testing, and releasing the specimen to inventory and labeling. (ISBER 2008 Best Practices for Repositories)
A period of time in which biospecimens and/or clinical data are stored in the NHLBI repository prior to their availability for sharing according to the NHLBI Data Set sharing policy timeline. During the Proprietary Period, the BioLINCC website directs requesting researchers to the Parent Study for additional information on data and biospecimens, because that information may not yet be available to BioLINCC.
Individually identifiable information transmitted by electronic media, maintained in electronic media, or transmitted or maintained in any other form or medium. (45 CFR 160.103) (See HHS Office for Civil Rights HIPAA, https://www.hhs.gov/ocr/hipaa/)
The committee responsible for determining if requests for datasets and/or biospecimens meet the criteria for use in research studies. They are also responsible for assuring that critical last vials are not removed without valid scientific justification.
An entity that receives, stores, processes and/or disseminates specimens, as needed. It encompasses the physical location as well as the full range of activities associated with its operation. It may also be referred to as a biorepository (ISBER 2008 Best Practices for Repositories)
Systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102(d)).
Biospecimen or study datasets, or both.
The removal, acquisition, recovery, harvesting, or collection of specimens (ISBER 2005).
- Portions of biospecimens (NCI Best Practices working definition).
- A single unit containing material derived from one specimen (ISBER 2008 Best Practices for Repositories).
A description of the contents of the shipped package (ISBER 2008 Best Practices for Repositories). In the context of the NHLBI Biorepository, an electronic shipping manifest must be sent prior to shipment. A hard copy of the shipping manifest must be included with the shipment.
The quantitative or qualitative information linked to the biospecimen which may include: type of specimen (i.e. plasma, urine), type of fixative or additives, some demographic data, and laboratory test results.
Established or prescribed methods to be followed routinely for the performance of designated operations or in designated situations (Merriam-Webster Dictionary)
A group of standard operating procedures (SOPs) detailing specific policies of a repository and the procedures required to be used by the staff/personnel. (ISBER 2008 Best Practices for Repositories).
The accumulated biospecimens collected by a clinical study. (NHLBI working definition)
The information collected and recorded from study participants through periodic examinations and follow-up contacts, not including original specimens or images.
An aggregate of cells with different specialized characteristics that are organized anatomically, usually in the fixed framework of an organic matrix. The architectural organization that is maintained contributes to the performance of the specific collective function. Tissues are parts of organs. The term tissue is most often referred to in the context of solid tissue, as originating from a solid organ; however, tissue also can be defined broadly to include collections of cells and the extracellular matrix and/or intercellular substances from bodily fluids such as blood (NCI Best Practices working definition).
Acronyms and Abbreviations
Biologic Specimen and Data Repository Information Coordinating Center
BioRepository Organizing Committee
Biospecimen inventory identifier
Division of Blood Diseases and Resources
Division of Prevention and Population Sciences
National Heart, Lung, and Blood Institute
Repository Allocation Committee
Research Material Distribution Agreement
Standard Operating Procedures