CAREGIVER VOCABULARY

A

Access

The right to obtain or make use of or take advantage of something (as services or membership); the right to enter (NCI Thesaurus).

Activities of daily living (ADLs)

Actions a person must do by themselves to engage independently in everyday life, such as bathing, dressing, eating, being mobile, moving from bed to a chair and using the toilet.

Acute care

Medical care given for a short time to treat a specific illness or condition. This can include doctor visits, short hospital stays or surgery.

Adult care home

Also called an adult family-care home (AFCH) or group home. A small assisted living residence where employees provide for disabled adults or seniors who need help with certain tasks but want to remain as independent as possible. They are an alternative to more restrictive, institutional settings, such as nursing homes, which provide 24-hour nursing care.

Adult daycare

Centers that provide companionship and help to older adults who need supervision during the day. The programs can help give a break to a round-the-clock caregiver.

Advance directives

Written statements that communicate individuals’ medical preferences if they become unable to make their own health care decisions. Two types are possible:

1. A living will spelling out the types of medical treatment they want at the end of life if they are unable to speak for themselves.

2. A health care proxy, which identifies a health care agent or attorney-in-fact to serve as spokesperson on medical decisions for an individual who has lost the ability to communicate.

Aerosol

A fine mist or spray that contains minute particles (Centers for Disease Control and Prevention (CDC) Special Pathogens Branch, Glossary of Terms, http://hickmancharterscioly.pbworks.com/f/Glossary+_+CDC+Special+Pathogens+Branch.pdf ).

Age of Majority

The age—usually 18 or 21 years—at which a person achieves full legal rights to make one's own decisions, enter into contracts, and be held personally accountable for the consequences of one's actions (Taber's Medical Dictionary).

Aliquot

1. Pertaining to a portion of the whole; any one of two or more biospecimens of something, of the same volume or weight (NCI Thesaurus). 2. A process wherein a biospecimen is divided into separate parts which are typically stored in separate containers as individual biospecimens (ISBER 2018).

Alzheimer's disease

A type of progressive mental deterioration, affecting memory and the ability to process thoughts, that is one form of dementia.

Analyte

A substance or chemical constituent that is determined in an analytical procedure. Component represented in the name of a measurable quantity. This includes any element, ion, compound, substance, factor, infectious agent, cell, organelle, activity, property, or other characteristics which are to be determined. (ISBER 2018).

Ancillary Study

An additional or secondary trial that was not part of the original study design. An entirely new study, approved or funded by NIA, which will use the data and biospecimens collected by the main study. Ancillary studies attempt to answer questions not resolved through the main study.

Annotation

Explanatory information associated with a biospecimen (NCI Best Practices working definition).

Anonymized Biospecimens

1. Anonymized data and biospecimens 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 biospecimens 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). 2. Involves completely removing all identifying information from specimens and data, eliminating the possibility of re-identifying the participant or re-contacting donors. This also precludes any return of research results, possibility for donor withdrawal, and limits the use of the specimens in future research. (ISBER, 2018)

Anonymous

Identifiable personal information was not collected for the specimens and associated data or, if collected, was not maintained and cannot be retrieved, such that there is no way to trace the identity of the subject from whom the specimens were obtained. (ISBER, 2018)

Assay

A qualitative or quantitative analysis performed to determine the amount of a particular constituent in a biospecimen (adapted from NCI Thesaurus).

Assent

To agree, as to a proposal; concur. (ISBER, 2018)

Assisted living facility (ALF)

Housing for those who may need help living independently but do not need skilled nursing care. The level of assistance varies among residences and may include help with bathing, dressing, meals and housekeeping.

Assistive technology devices

Products that improve a person's ability to live and function independently. Low-tech assistive devices include canes and pill organizers; high-tech items include electric wheelchairs, hearing aids and smartphones.

Associated data

Any factual information affiliated with a biospecimen, including but not limited to research, phenotypic, clinical, epidemiologic, and biospecimen-resource procedural data (NCI Best Practices working definition).

Audit

1. A documented review of procedures, records, personnel functions, equipment materials, facilities, and/or vendors to evaluate adherence to written standard operating procedures or government laws and regulations (ISBER ,2018). 2. To perform an audit (Merriam-Webster's Online Dictionary).

Authorized Institutional Business Official

Someone in a senior position who is authorized to commit to procurements or the allocation of resources. The particular titles vary widely between institutions.

Autopsy Postmortem examination of the organs and tissues of a body to determine cause of death or pathological conditions. (ISBER, 2018)

Available Datasets/Biospecimens Datasets and biospecimens in the AgingResearchBiobank that are currently available for request by the scientific community.

Axenic State

State of non-contamination by or non-association with any other living organisms. (ISBER, 2018)

B

BSI

A computer system used to manage and maintain biospecimen inventories (also see Biorepository Informatics System)

Banking (Biobanking)

The process of storing material or specimens for future use.

Barcode

A machine-readable representation of information in a visual format on a surface (NCI Thesaurus).

Best Practice

A technique, process, or protocol that has been shown or is otherwise believed to be state-of-the- science in that it provides superior results to those achieved by any other technique, process, or protocol. Best practices may evolve as new evidence emerges. While best practices are consistent with all applicable ethical, legal, and policy statutes, regulations, and guidelines, they differ from guidance, policy, or law in that they are recommendations and are neither enforced nor required (NCI Best Practices working definition).

Biobank.

See Repository/Biorepository.

Biobank Internal Advisory Committee (BIAC)

The AgingResearchBiobank's scientific program staff committee.

Biobank Scientific Review Committee (BSRC)

The AgingResearchBiobank's expert review committee.

Biodiversity Biobank

A biobank holding molecular-level biodiversity biospecimens (e.g., from animals, plants, fungi, microorganisms; also includes many types of environmental biospecimens). (ISBER, 2018)

Biohazard

A biological or chemical substance that exerts toxic or pathologic effects on living entities (NCI Thesaurus).

Biological Safety Cabinet (Biosafety Cabinet, Biosafety Hood)

Cabinet designed to provide microbe-free work free work environment which enables workers to perform work on biospecimens in an isolated area

Biomarker

A biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. Also called molecular marker and signature molecule (NCI Online Cancer Dictionary).

Biomolecule

An organic molecule and especially a macromolecule (as a protein or nucleic acid) in living organisms (Merriam-Webster's Online Dictionary).

Biorepository

An organization, place, room, or container (a physical entity) where biospecimens are stored. In the context of the NCI Best Practices, only biorepositories containing human specimens intended for research purposes (research biorepositories) are addressed. The physical structure, policies, biospecimens, and data contained within it are defined collectively as a biospecimen resource, defined below (NCI Best Practices working definition).

Biorepository Informatics System

The software, hardware, written documents, support, and training that are necessary to annotate, track, and distribute biospecimens within a biorepository or biorepositories.

Biosafety

Safety with respect to the effects of biological research on humans and the environment (Merriam- Webster's Online Dictionary). The discipline addressing the safe handling and containment of infectious microorganisms and hazardous biological materials to prevent harm to workers, non-laboratory organisms, or the environment through the application of containment principles and risk assessment. (ISBER, 2018)

Biosafety Level

Specific combinations of work practices, safety equipment, and facilities, which are designed to minimize the exposure of workers and the environment to infectious agents. Biosafety level 1 applies to agents that do not ordinarily cause human disease. Biosafety level 2 is appropriate for agents that can cause human disease, but whose potential for transmission is limited. Biosafety level 3 applies to agents that may be transmitted by the respiratory route which can cause serious infection. Biosafety level 4 is used for the diagnosis of exotic agents that pose a high risk of life-threatening disease, which may be transmitted by the aerosol route and for which there is no vaccine or therapy (Centers for Disease Control and Prevention Special Pathogens Branch, Glossary of Terms, http://hickmancharterscioly.pbworks.com/f/Glossary+_+CDC+Special+Pathogens+Branch.pdf

Biospecimen

A quantity of tissue, blood, urine, or other human-derived material. A single biopsy may generate several biospecimens, including multiple paraffin blocks or frozen biospecimens. A biospecimen can comprise subcellular structures, cells, tissue (e.g., bone, muscle, connective tissue, and skin), organs (e.g., 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). Portions or aliquots of a biospecimen are referred to as biospecimens (NCI Best Practices working definition).

Biospecimen Inventory Data

Data about biological biospecimens from participants in sponsored studies.

Biospecimen Repository

Organization contracted to store and manage biological biospecimens from sponsored studies.

Biospecimen Resource

A collection of human specimens and associated data for research purposes, the physical entity in which the collection is stored, and all associated processes and policies. Biospecimen resources vary considerably, ranging from formal institutions to informal collections in a researcher's freezer (NCI Best Practices working definition).

Biospecimen Resource Governance

The set of authorities, processes, and procedures guiding key operational decisions made within the resource. Governance affects access to biospecimens as well as custodial relationships and responsibilities and should be part of the resource's general custodianship plan (NCI Best Practices working definition).

Biospecimen Resource Informatics System

The software, hardware, documentation, support, operating procedures, and training necessary to annotate, track, and distribute biospecimens within a biospecimen resource or resources (NCI Best Practices working definition).

Bloodborne Pathogen

Pathogenic microorganisms that are present in human blood and can cause disease in humans. These pathogens include, but are not limited to, hepatitis B virus and human immunodeficiency virus (Occupational Safety and Health Administration Bloodborne Pathogen Standards, 29 CFR § 1910.1030).

Bulk Relocation

The process for preparing and submitting biospecimens to biorepositories when the intent is to transfer specimens in bulk at the close of the study.

Business Plan

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)

C

Calibration

The process of adjusting the output or indication on a measurement instrument to agree with value of the applied standard, within a specified accuracy. (ISBER, 2018)

Cardiologist

A medical doctor who specializes in heart disorders.

Certificate of Confidentiality

Issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. It allows the Investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the Federal, State, or local level. Certificates of Confidentiality may be granted for studies collecting information that, if disclosed, could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation (Certificates of Confidentiality Kiosk Website, http://grants.nih.gov/grants/policy/coc/).

Chain of Custody

Refers to the chronological documentation or paper trail showing the full process of acquisition, transfer, handling, and disposition of physical or electronic materials. (ISBER, 2018)

Chronic disease

A condition that lasts one year or more and either requires ongoing medical attention or limits a person's ability to bathe, care for themselves, dress, eat or walk.

Clinical Data

1. Factual information (as measurements or statistics) or observations relating to the patient used as a basis for reasoning, discussion, or calculation pertaining to clinical trials, diagnosis, or treatment (NCI Best Practices working definition). 2. Data obtained through patient examination or treatment (NCI Thesaurus).

Clinical Research

Research conducted with human subjects or on material of human origin in which an investigator directly interacts with human subjects; includes development of new technologies, study of mechanisms of human diseases, therapy, clinical trials, epidemiology, behavior and health services research (NCI Thesaurus).

Clinical Trial

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, http://grants.nih.gov/grants/glossary.htm#C)

Code of Federal Regulations (CFR)

The annual collection of executive-agency regulations published in the daily Federal Register, combined with previously issued regulations that are still in effect (Black's Law Dictionary). See http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR for more information.

Coded

Having (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 biospecimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., the code); and (2) a key to decipher the code, enabling linkage of the identifying information to the private information or biospecimens (Office for Human Research Protections, Guidance on Research Involving Coded Private Information or Biological Specimens, http://www.hhs.gov/ohrp/policy/cdebiol.html). Coded biospecimens are labeled with at least one specific code and do not carry personal identifiers.

1. 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.

2. 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. Food and Drug Administration (FDA) April 2008).

Cohousing

A small planned community in which single-family homes, townhouses or rental units are clustered around amenities such as a community kitchen and dining room, common areas for sitting, craft and meeting rooms, gardens and potentially adult and child day care. The goal is to design a neighborhood where people of all ages and family statuses can rely on the informal, mutual support of neighbors to help out.

Cold Chain

A temperature-controlled supply chain. (ISBER, 2018)

Cold Ischemia

The time a tissue or organ is chilled during decreased blood perfusion or after the blood supply has been reduced or cut off. (ISBER, 2018)

Collection

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)

Combined Linkage File

A crosslink provided by the study coordinating center used to link (match) each biological biospecimen to a unique subject-visit.

Commercial Purposes

The sale, lease, license, or other transfer of the MATERIAL or MODIFICATIONS to a for-profit organization. COMMERCIAL PURPOSES shall also include uses of the MATERIAL or MODIFICATIONS by any organization, including RECIPIENT, to perform contract research, to screen compound libraries, to produce or manufacture products for general sale, or to conduct research activities that result in any sale, lease, license, or transfer of the MATERIAL or MODIFICATIONS to a for-profit organization. However, industrially sponsored academic research shall not be considered a use of the MATERIAL or MODIFICATIONS for COMMERCIAL PURPOSES per se, unless any of the above conditions of this definition are met.

Common Data Elements

Annotations collected in a uniform manner across multiple institutions to allow sharing of data in a standardized format (NCI Biorepository and Biospecimen Research Branch (BBRB) Glossary, http://biospecimens.cancer.gov/patientcorner/glossary.asp).

Comorbidity

The presence, or coexistence, of more than one disorder in the same person. They can occur at the same time or one after the other. Interactions between the illnesses can worsen the course of both.

Competence

In a legal sense, a person's ability to understand information, make a choice based on that information and communicate that decision in an understandable way.

Confidentiality

Treatment of information so that it is not divulged in ways that are inconsistent with the understanding of the original disclosure. Particularly, the ethical principle or legal right that a physician or other health professional will hold secret all information relating to a patient, unless the patient gives consent permitting disclosure (NCI Thesaurus).

Conflict of interest

1. Exists when the designated official(s) reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the Public Health Service– funded research. Examples of conditions or restrictions that might be imposed to manage conflicts of interest include, but are not limited to: (1) Public disclosure of significant financial interests; (2) Monitoring of research by independent reviewers; (3) Modification of the protocol; (4) Disqualification from participation in all or a portion of the research funded by the Public Health Service; (5) Divestiture of significant financial interests; or (6) Severance of relationships that create actual or potential conflicts (42 CFR § 50.605). 2. Prejudice or bias that may occur when one's impartiality is compromised by opportunities for personal gain or occupational advancement, or by the chance that one's work may support a favored point of view or social agenda (Taber's Medical Dictionary).

Conservator

A person whom a court appoints to handle someone's affairs when that person cannot do the job. Usually, a conservator handles only finances.

Consumables (a.k.a. disposables)

Items that are liable to be used up or exhausted (NCI Best Practices working definition).

Consumer-directed personal assistance program

A Medicaid program available in several states that permits chronically ill and physically disabled people to choose, train and supervise workers who help them with activities of daily living such as bathing, light housework and meal preparation so they can remain in their homes. Some relatives and friends of participants can qualify to be paid through this program.

Container

1. An object that can be used to hold or transport some- thing. 2. Enclosure for one unit or more units of specimen(s). (ISBER, 2018)

Continence

The ability to control bowel and bladder function.

Continuing care retirement community (CCRC)

Housing that offers a variety of living options and services — including independent living, assisted living and skilled care, often all on the same campus — and is designed to meet a person's changing needs.

Copayment

Sometimes called copays. A fixed amount — $20, for example — that one pays for a health care service covered by insurance after payment of the deductible. Let's say your health plan's allowable cost for a doctor's office visit is $100. If you haven't yet met your deductible for the year, you'll pay the full $100. If you have met the deductible, you pay the $20 copay, usually at the time of the visit.

Cost Recovery.

Charging a sufficient amount for products and services such as biospecimen collection, processing, storage, and shipping, as well as sales of research substances and living organisms, to recover or partially recover operational fees incurred by a biospecimen resource (NCI Best Practices working definition).

Cryoprotectant

An additive or mixture of additives that allow living cells, tissues, organs, and organisms to survive exposure to cryogenic temperatures, of which the main type is a colligative cryoprotectant. This is a protective additive that must be able to penetrate the cell, applied to prevent damage caused by excessive cell volume changes and the toxic concentration of solutes (i.e., colligative injury). An osmotic cryoprotectant is an additive that does not penetrate the cell. It confers additional protection by osmotically withdrawing water from the cell (osmotic dehydration), consequently reducing the amount of water that is available to form ice. Mixtures of colligative and osmotic cryoprotectants are often used in plant, algal, and microbial cryoprotective solutions, as well as in cryoprotective solutions for some mammalian cells. (ISBER, 2018)

Culling

Reviewing and eliminating specimens in a collection or an entire collection either by destruction or transfer to a new custodian. (ISBER, 2018)

Curation

The act of organizing, formatting, editing and compiling study data and associated documentation.

Custodial care

Nonmedical care that helps individuals with bathing, dressing and other basic care that most people do themselves, such as using eye drops. It can occur in a range of environments including adult day care, assisted living centers and residential care facilities.

Custodianship

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).

D

Data

A collection or single item of factual information, derived from measurement or research, from which conclusions may be drawn (NCI Thesaurus).

Data Coordinating Center (DCC)

Organization or entity responsible for data management, monitoring, and analyses during clinical trials.

Data Packet.

Study Data and associated documentation that are transferred from a study site. Data packets include, at the minimum, the study dataset, protocol, and other documentation related to the data collection or configuration of the study.

Data and Biospecimen Request Form

A page on the AgingResearchBiobank website that a user fills out to apply to receive datasets or biospecimens and provide information on the planned use and need for the datasets or biospecimens; the web-based workflow system is used for communication between the requestor and the repository team, NIA review of the requests, and processing of approved requests for delivery to the applicant.

Data and Sample Distribution Agreement (DSDA)

A specific form of a Materials Transfer Agreement (MTA); an MTA between the providing organization and the requesting organization to distribute dataset(s)

Database

A structured collection of records or data that is stored in a computer system so that a computer program or person using a query language can consult it to answer queries. (ISBER, 2018)

Dataset

A datafile or a collection of interrelated data records (also se Study Dataset).

Dataset Integrity Check (DSIC)

The process of verifying that the data transferred from a DCC are complete and valid; the DSIC is performed by replicating select tables from publications based on the study data. The DSIC is performed by a Statistical Data Specialist.

De-Linking

Involves the use of unique code(s) to link specimens and data to donors. The repository or a third-party intermediary may act as an “honest broker” and hold the link between the codes and donor specimens and data. Researchers, receiving the specimens, receive the coded specimen(s). Regulations regarding de-identification may vary in different areas and investigators are encouraged to review local, state, and national/federal regulations and laws. (Also known as De-identifying). (ISBER, 2018)

Dehydration

Removal of water from a tissue. (ISBER, 2018)

Delirium

Short-term confused thinking and disrupted attention usually accompanied by disordered speech and hallucinations.

Dementia.

A general term for a decline in mental ability severe enough to interfere with daily life. Memory loss is an example. Alzheimer's disease is the most common cause of dementia, but not all dementia comes from Alzheimer's.

Demographic data

Information pertaining to the statistical characterization of human populations or segments of human populations; e.g., characterization by age, sex, race, or income (adapted from NCI Thesaurus).

Dermatologist

A medical doctor who specializes in skin disorders.

Desiccation

Excessive loss of moisture; the process of drying up. (ISBER, 2018)

Deviation

An intentional or unintentional event that is a departure from a procedure or a normal practice (ISBER, 2018).

Dewar

A specialized container to hold liquefied gases. A Dewar may also be referred to as a Dewar flask or Dewar vessel. (ISBER, 2018)

Discharge planner A professional who assists patients and their families in developing a method of care for a patient following a hospital or nursing home stay.

Discontinuation of participation

Discontinuation of a subject's participation in research means discontinuation of one or more of the following activities described in the IRB-approved protocol: (1) interacting or intervening with the subject; (2) collecting individually identifiable private information about the subject without the investigator interacting or intervening with the subject; (3) collecting individually identifiable biological specimens originating from the subject without the investigator interacting or intervening with the subject; or (4) using or testing individually identifiable biological specimens already collected by the Investigator (Office for Human Research Protections, Guidance on Important Considerations for When Participation of Human Subjects in Research Is Discontinued, https://www.federalregister.gov/articles/2010/09/21/2010-23517/guidance-on-withdrawal-of-subjects-from-research-data-retention-and-other-related-issues.

Disinfectant

An agent that reduces the number of viable microorganisms. (ISBER, 2018)

Disposal

Systematic destruction of medical waste and other biohazardous waste (NCI Best Practices working definition).

Disposition

Final destination of biospecimens (ISBER, 2018).

Distribution

A process that includes receipt of request for biospecimens, selection of appropriate biospecimens, and final inspection, in conjunction with subsequent shipment and delivery of biospecimens to another biospecimen resource, biospecimen collection center, or laboratory (NCI Best Practices working definition).

Do not resuscitate (DNR) order

A type of advance directive in which a person states that health care providers should not attempt to restart the heart through cardiopulmonary resuscitation if the heart or breathing stops.

Document

A piece of written, printed, or electronic matter that provides information or evidence or that may serve as an official record. v. - Record, register, report (something) in written, photographic, or other form. (ISBER, 2018)

Donor

Living or deceased individual who is the source of the specimen in accordance with established medical criteria, procedures and privacy regulations. In some countries the term SUBJECT or “individual” may be used in the same context as donor, especially as the context relates to human specimens. (ISBER, 2018)

Dry Ice

Solid phase carbon dioxide (CO2). CO2 solidifies at -78.5ºC. (ISBER, 2018)

Durable power of attorney

A legal document that gives someone you choose the authority to act financially, legally and medically in your place if you become incapacitated and unable to handle matters on your own. It remains in effect until the person who grants it either cancels it or dies.

dbGaP

The database of Genotype and Phenotype (dbGaP) that was developed by the National Center for Biotechnology Information (NCBI) to archive and distribute the results of studies that have carried out high density genotyping.

E

End-of-life doula

Also known as a death doula. An individual who provides nonmedical comfort and support to a dying person and their family. This may include education and guidance as well as emotional, spiritual or practical care.

End user

1. A health care practitioner, scientist, or laboratory staff member who performs an appropriate procedure, test, or archival function (ISBER 2018). 2. The ultimate consumer of a finished product (Merriam- Webster's Online Dictionary).

Endocrinologist

A medical doctor who specializes in hormonal and metabolic disorders, including diabetes.

Environmental Monitoring System

An automated, centralized monitoring system that monitors environmental conditions and alarms in conjunction with remote access, security features, and electronic data storage. (ISBER, 2018)

Environmental Specimen Banks (ESBS)

Collect, preserve, and manage environmental biospecimens (e.g., leaves, soil, water, animal or human tissue and fluid, ice cores, etc.), derivatives and associated data through standardized protocols. Biospecimens are obtained through monitoring projects and surveys in order to support research, document environmental change, and/or to assess the effectivity of or necessity for regulatory acts. (ISBER, 2018)

Epidemiologic

Of or relating to epidemiology, the study of the causes, incidence, and distribution of disease in the population and its application for prevention or control (NCI Thesaurus).

Ergonomics

The science that explores human abilities and limitations, and applies that knowledge to improve a person's interactions with their environment, tools, products, and practice. (ISBER, 2018)

Ethics Review Committee

See Institutional Review Board

Evaluation

Systematic, objective appraisal of the significance, effectiveness, and impact of activities or condition according to specified objectives and criteria (NCI Thesaurus).

Extended care

Short-term or temporary care in a rehabilitation hospital or nursing home with the goal of returning a patient home.

Extended Study

The second round of funding of the main study; a continuation. There are contractual differences from the main study but the protocol remains the same. An extended study can 1) continue where the main study left off and recruit and process patients or 2) edit the data in preparation for analysis (manuscripts are produced during this phase). Additionally, in some cases there can be a second extension. Also referred to as a Follow-up Study.

External Biospecimen Request

A request for a study's biospecimens by a researcher who is not part of the study or the study's network.

Extramural

External to the National Institutes of Health (NCI Best Practices working definition).

F

Family and Medical Leave Act (FMLA)

A federal labor law that provides certain employees with up to 12 weeks per year of unpaid, job-protected leave to accommodate some family and medical situations. The law also requires that employees' group health benefits be maintained during the leave.

Family or informal caregiver

Any relative, partner, friend or neighbor who has a significant personal relationship with and provides a broad range of assistance for an adult with a chronic or disabling condition.

Federated Collections

Created when specimens are collected, processed, and stored at physically separated sites that each function as the specimen custodian for its local collection while related data is managed through a central database. ISBER, 2018)

Fit for Purpose (var. - (Fitness for Purpose)

Suitable; appropriate, of a necessary standard, for its intended use. (ISBER, 2018)

Follow-up Study

The second round of funding of the main study; a continuation. There are contractual differences from the main study but the protocol remains the same. A Follow-up Study can 1) continue where the main study left off and recruit and process patients or 2) edit the data in preparation for analysis (manuscripts are produced during this phase). Additionally, in some cases there can be a second follow-up. Also referred to as an Extended Study.

Freeze-Dried

Dehydrated for storage by conversion of the water content of a frozen specimen to a gaseous state under vacuum. Also called lyophilized. (ISBER, 2018)

G

Gastroenterologist

A medical doctor who specializes in digestive disorders.

Genomics

The study of the complete genetic complement of an organism or organ (Taber's Medical Dictionary).

Genotyping

The process of determining differences in the genetic make-up (genotype) of an individual. This is accomplished by examining an individual's DNA sequence through biological assays and comparing it to another individual's sequence or a reference sequence. Results should review the alleles an individual has inherited from their parents. Small variations in genetic sequence within populations, such as single-nucleotide polymorphisms (SNPs) may be identified.

Geriatric care manager

Also called an aging life care professional. A specialist who assesses a person's mental, physical, environmental and financial conditions to create a care plan to assist in arranging housing, medical, social and other services.

Geriatrician

A medical doctor who has completed a residency in either family medicine or internal medicine and focuses on older adults.

Glass Transition

The temperature at which a polymer transitions from a hard, glassy material to a soft, rubbery material. (ISBER, 2018)

Guardianship

A court-sanctioned legal relationship in which a person is given legal authority over another when that other person is unable to make safe and sound decisions regarding his or her person or property.

H

Health care proxy

A type of durable power of attorney in which people appoint another person to make health care decisions for them if they become unable to do so.

Hematologist

A medical doctor who specializes in blood disorders.

HIPAA

Health Insurance Portability and Accountability Act of 1996, Public Law 104-191, 45 CFR Parts 160, 162, and 164. Part 160.103 of the HIPPA law regulates individually identifiable health information that is related to a person's past, present, or future health or treatment and is transmitted or maintained in any form or medium by a covered entity.

Home health agency

A company or nonprofit, often certified by Medicare, that provides health-related services such as nursing, personal care, social work, or occupational, physical or speech therapy in a client's home.

Home health aide (HHA)

A trained and certified health care worker who assists a patient in the home. Duties typically include help with hygiene and exercise, light household work such as meal preparation, and monitoring the patient's condition.

Homemaker services

Light housekeeping, meal preparation, washing clothes, shopping and other tasks workers from state-certified agencies perform for people who need assistance in their homes. Medicare does not cover these services, but some states’ Medicaid programs help qualified low-income adults pay for them.

Honest Broker

An individual, organization, or system acting for, or on behalf of, a covered entity to collect and provide health information to research investigators in such a manner whereby it would not be reasonably possible for the investigators or others to identify the corresponding patients-subjects directly or indirectly. The honest broker cannot be one of the investigators. The information provided to the investigators by the honest broker may incorporate linkage codes to permit information collation and/or subsequent inquiries (i.e., a “re- identification code”); however, the information linking this reidentification code to the patient's identity must be retained by the honest broker and subsequent inquiries are conducted through the honest broker (NCI Thesaurus).

Hospice care

A treatment regime for people who have an advanced, life-limiting, often incurable illnesses. Considered a type of palliative care, hospice focuses on the patient's psychological well-being and on managing symptoms of a disease rather than the disease itself, so they can spend their last days with dignity and quality, surrounded by loved ones.

Human Research Participant

See Human Subject

Human Subject

A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information (45 CFR § 46.102(f)).

I

Ice Nucleation (also termed “seeding”)

The point at which ice crystals are first initiated in a cryopreserved biospecimen; usually applied in the context of controlled rate cooling. (ISBER, 2018)

Identifiable

The identity of the subject is or may readily be ascertained by the investigator or associated with the information (45 CFR § 46.102(f)).

Identifier/Identifying/Identifiable Information

Information (e.g., name, social security number, medical record or pathology accession number, etc.) that would enable the identification of the subject. For some specimens this information might include the taxon name and collection number. (ISBER, 2018)

Incident.

Any unplanned occurrence that deviates from Standard Operating Procedures (SOPs) or applicable government laws and regulations during specimen retrieval, processing, labeling, storage, or distribution that may affect subsequent use of those specimens. (ISBER, 2018)

Incoming Data Transfer Agreement (IDTA)

Agreement between NIA and the organization transferring data to the AgingResearchBiobank.

Incoming Human Materials Transfer Agreement (IHMTA).

Agreement between NIA and the organization transferring resources (biospecimens/data) to the AgingResearchBiobank.

Incontinence

Inability of a person's body to control bowel or bladder functions.

Incremental Biospecimen Transfer

This is the process for preparing and submitting biospecimens to biorepositories 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.

Informatics

An occupational discipline which unites information science with computer science. It is concerned with the development of techniques for the collection and manipulation of data, and the use of such data (NCI Thesaurus).

Independent living

An age-restricted option for a house, condominium or apartment — sometimes offered as part of a continuing care retirement community — that has few services as part of the basic rate. Those that are included are more often related to convenience, such as grass cutting or a clubhouse.

Informed Consent

1. A decision to participate in research, taken by a competent individual who has received the necessary information; who has adequately understood the information; and who, after considering the information, has arrived at a decision without having been subjected to coercion, undue influence or inducement, or intimidation (Council for International Organizations of Medical Sciences [CIOMS]. International Ethical Guidelines for Biomedical Research Involving Human Subjects. “Guideline 4: Individual Informed Consent” [2002]). 2. 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)).

Infrastructure

The basic facilities, equipment, or underlying framework that are necessary for a system or organization to function (NCI Thesaurus).

Institutional Review Board (IRB)

A specially constituted review body established or designated by an entity to protect the rights and welfare of human subjects recruited to participate in biomedical or behavioral research. The relevant regulatory requirements for an IRB are provided at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.107 and 21 CFR 56 (Trans-NIH Bioethics Committee Framework Guidelines). 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 2018 Best Practices for Repositories)

Intellectual Property A commercially valuable product of the human intellect, in a concrete or abstract form, such as a copyrightable work, a protectable trademark, a patentable invention or a trade secret (Black's Law Dictionary).

Internal Biospecimen Request

A request for study biospecimens by a researcher who is part of the network or study from which the biospecimens originated.

Interoperability

The ability of systems or tools to both access and use data from a remote data resource (BBRB Glossary, http://biospecimens.cancer.gov/patientcorner/glossary.asp).

Invention

Any art or process (way of doing or making things), machine, manufacture, design, or composition of matter, or any new and useful improvement thereof, or any variety of plant, which is or may be patentable under the patent laws of the United States (U.S. Patent and Trademark Office, Glossary of Terms, https://www.uspto.gov/learning-and-resources/glossary#sec-I).

Inventory

1. A detailed, itemized list, report, or record of biospecimens in a biospecimen resource, especially a periodic survey of all stored biospecimens (NCI Best Practices working definition). 2. The act or process of taking an inventory (Merriam-Webster's Online Dictionary).

L

Label

Any written, printed, or graphic material on or affixed to a biospecimen container or package (ISBER 2018).

Legacy Data

Data collected during a study that has since been completed.

Licensed practical nurse (LPN) A person who has completed nursing or vocational training and obtained a state license that authorizes the person to take care of basic duties in settings such as hospitals, nursing homes and long-term care facilities.

Lifecycle (Repository Lifecycle)

A series of stages through which a repository passes during its lifetime. (ISBER, 2018)

Limited Data Set (LDS)

A dataset from which direct personal identifiers have been excluded, but which may contain indirect personal identifiers. A data use agreement accompanies an LDS and stipulates the permitted uses and disclosures that can be made by the recipient of the data. The requirements for a limited data set are specified in the HIPAA regulations in 45 CFR Part 164.514 (e)(1)-(4).

Linkage File

A list that associates biological biospecimens 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.

Liquid Nitrogen (LN)

Coolant used to cool and store biospecimens. Nitrogen becomes liquid at -196ºC. Biospecimens stored in the vapor phase of liquid nitrogen are -190ºC and warmer, depending on the distance from the liquid phase. (ISBER, 2018)

Liquid Nitrogen Dry Shipper

A container used for sending biospecimens in the vapor phase of liquid nitrogen. (ISBER, 2018)

Living will

A legal document in which the signer requests to be allowed to die rather than be kept alive by artificial means if disabled beyond a reasonable expectation of recovery.

Long-term care insurance

Coverage that helps policyholders pay for long-term care in their home or at a nursing home or assisted living facility, or for other designated services, depending on the policy.

Long-term care ombudsman

An advocate for residents of nursing homes, residential care homes and assisted living facilities. Ombudsmen are trained to resolve problems; they provide information on how to find a facility and what to do to get high-quality care.

Longitudinal Data

Data in which the same units are observed over multiple time periods (U.S. Department of Labor, Bureau of Labor Statistics, Glossary, http://www.bls.gov/bls/glossary.htm#L

Lot (Batch)

A quantity of reagents, supplies or containers that is processed or manufactured at one time and identified by a unique identification number. (ISBER, 2018)

Lyophilized

Dehydrated for storage by conversion of the water content of a frozen specimen to a gaseous state under vacuum. Also called freeze-dried. (ISBER, 2018)

M

Main Study

Sites participating in sponsored studies.

Mask ID

Substitute unique subject identifier used to replace an existing subject identifier for additional protection of confidentiality.

Material Transfer Agreement

1. An agreement that governs the transfer of tangible research materials and data between two organizations, when the recipient intends to use it for his or her own research purposes. It defines the rights and obligations of the provider and the recipient with respect to the use of the materials (ISBER 2018). 2 Generally 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).

Meals on Wheels

A service that delivers daily hot meals to the homes of elderly or disabled people.

Medicaid

Government-provided health care coverage for eligible low-income adults, children, pregnant women, elderly adults and people with disabilities. States and the U.S. government share the cost of Medicaid, with states administering the program according to federal requirements. As of May 2021, nearly 76 million people were covered in Medicaid, and enrollment has grown by more than 18 percent during the COVID-19 pandemic.

Medical doctor (M.D.)

A health care professional who has graduated from an approved medical school, received additional training in a hospital, passed a federal medical licensing exam and qualified for a state license. Specialists must complete an additional three to nine years of postgraduate work in their practice area.

Medicare

A federal government program that provides medical insurance if you are 65 or older, under 65 and receiving Social Security Disability Insurance, or under 65 and diagnosed with end-stage renal disease (ESRD). Medicare Part A is hospital insurance, and Medicare Part B covers certain doctors’ services, outpatient care, medical supplies and preventive services. In 2020, 62.6 million people were enrolled in Medicare, 54.1 million of them on the basis of age.

Medicare Advantage

Also called Medicare Part C. Private health plans that offer all benefits covered by "original" Medicare (parts A and B) but may also provide non-Medicare-covered benefits such as prescription drug coverage, dental and vision coverage, and even gym memberships, usually for an additional premium.

Medicare Savings Program (MSP)

A federally funded, state-administered program that helps people with limited income and resources pay some or all of their Medicare premiums, deductibles, copayments and coinsurance. Four types of MSP are available:

1. Qualified Medicare Beneficiary (QMB) for people also enrolled in Medicaid.

2. Specified Low-Income Medicare Beneficiary (SLMB), which helps pay for Part B premiums only.

3. Qualifying Individual programs (QI and QI-1), which have slightly higher income limits but still help pay for Part B only,

4. Qualified Disabled & Working Individuals (QDWI), which helps pay for Part A premiums.

Medicare telehealth services

Medicare-covered visits with health care professionals conducted via phone or video chat. Initially offered on a limited basis to people in rural areas, these services have expanded considerably during the COVID-19 pandemic, with telehealth now available to all Medicare enrollees and for a greater variety of visits and services at least until the end of the federally declared public health emergency.

Medigap

Also called Medicare Supplemental Insurance. Private policies designed to pay costs not covered using original Medicare. For example, Medigap plans might cover your Medicare copayments, coinsurance and deductibles, or services original Medicare doesn't cover, such as care when you travel outside the United States.

Memory cafe

A gathering place that provides a safe and supportive environment where individuals with dementia or other brain disorders and their caregivers can socialize, provide mutual support and exchange information.

Memory care communities

Separate facilities or specialized units of an assisted living center that focus on helping people with Alzheimer's disease and other forms of dementia, where the staff is specifically trained to deal with recall problems and other impairments.

N

National Family Caregiver Support Program (NFCSP)

A federal program that provides grants to states and territories for efforts to provide respite care, training, counseling and other supports that help caregivers to care for loved ones at home for as long as possible.

Natural History Collections

(e.g., museums, herbaria, zoological and botanical gardens, aquaria, etc.). Repositories that enable and perform object- or specimen-based scientific research, store a diversity of traditional specimens (e.g., live organisms, dried skins, skeletons, pinned insects, herbarium sheets, whole organisms in preservative, and microscopes slides) and often also frozen biospecimens. (ISBER, 2018)

Necropsy

See Autopsy.

Nephrologist

A medical doctor who specializes in kidney disorders.

Network

A collection of studies that address a common set of diseases.

Neurologist

A medical doctor who specializes in nervous system disorders.

Nurse practitioner (NP)

Also known as advanced practice registered nurse (APRN). A primary-care provider with graduate training in advanced practice nursing who has the authority to order tests, write referrals and prescribe medicines.

Nursing home

A public or private residential facility providing a high level of long-term personal or medical care for chronically ill, disabled and older people who are unable to care for themselves properly.

O

Oncologist

A medical doctor who specializes in cancer treatment.

Ongoing Trials

Sponsored studies that are currently collecting data and/or biospecimens.

Open Period

The period following the close of the proprietary period (see definition below). A committee may be responsible for distribution and release of data and/or biospecimens for studies and collections in the Open Period.

Operating Manual (Operations Manual, Manual of Operations)

Contains procedures, instructions, and guidance for use by operational personnel in the execution of their duties. Documents the step-by-step instructions on how to complete a task or handle a specific situation in the workplace. (ISBER, 2018)

Ophthalmology

A medical doctor who specializes in eye disorders and surgery.

Orthopedic surgeon

Or orthopedist. A medical doctor who specializes in bone and connective tissue disorders.

Osteopath (DO)

Also called a doctor of osteopathic medicine. A doctor who has completed four years of medical school and has had 300 to 500 additional hours in the study of hands-on manual medicine and the body's musculoskeletal system. These doctors are state licensed and may have completed a two- to six-year residency and passed state examinations to become board certified.

Otolaryngologist

Or otorhinolaryngologist. A medical doctor who specializes in ear, nose and throat (ENT) problems.

Outgoing Data Transfer Agreement (ODTA)

Agreement between NIA and the requesting organization receiving data from the AgingResearchBiobank.

Outgoing Human Resources Transfer Agreement (OHRTA)

Agreement between NIA and the requesting organization receiving resources (biospecimens/data) from the AgingResearchBiobank.

Outpatient care

Also called ambulatory care. Health care procedures and treatment that do not require overnight hospitalization.

P

Package

A product container with any accompanying materials or components (NCI Thesaurus).

Palliative care

Specialized medical care that focuses on providing relief from the symptoms and stress of a serious illness. The goal is to improve quality of life for both the patient and the family. Unlike hospice care, which is typically given to people with terminal conditions who are nearing the end of life, palliative care can coincide with treatments to arrest or cure a disease.

Paraffin Embedded

A method of preserving biospecimens where they are chemically or otherwise fixed and then infiltrated with molten wax, which later solidifies (NCI Best Practices working definition).

Parent Study

1. The clinical study collecting the data and/or biospecimens. 2. The principal or primary study (see Ancillary Study)

Patent

A property right granted by the U.S. Government to an inventor “to exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States” for a limited time in exchange for public disclosure of the invention when the patent is granted (U.S. Patent and Trademark Office, Glossary of Terms, https://www.uspto.gov/learning-and-resources/glossary#sec-P).

Patient advocate

A professional who can resolve concerns about someone's health care experience, particularly problems that cannot be taken care of immediately.

Personal care services (PCS)

A broad term used to refer to help with personal hygiene and other self-care, such as bathing, dressing, eating, going to the bathroom, maintaining personal appearance and walking, provided by in-home personal care aides (PCAs). Some PCAs also help with meal preparation, grocery shopping and money management.

Personal emergency response system (PERS)

Also known as a medical alert system. An alarm system that lets someone experiencing a medical or personal emergency such as a fall summon help. Traditional systems are triggered by the user pressing a button on a wearable device like a bracelet, sending a radio signal to a console connected to a phone, which calls an emergency response center. In recent years, some smartphones and other connected devices like smartwatches have incorporated medical alert functions.

Physician assistant (PA)

A health care professional with a master's degree who works in collaboration with a medical doctor or doctor of osteopathic medicine, often in a primary care setting.

Podiatrist (DPM)

A doctor with specialized training in treating foot and ankle problems.

Power of attorney (POA)

A legal document that gives someone you choose the authority to act on your behalf, usually on financial matters.

Preservation

Use of chemical agents, alterations in environmental conditions, or other means during processing to prevent or retard biological or physical deterioration of a biospecimen (ISBER 2018).

Prevalence

The total number of cases of a given disease in a specified population at a designated time. It is differentiated from “incidence,” which refers to the number of new cases in the population at a given time (NCI Thesaurus).

Primary care physician (PCP)

The doctor that you see first for checkups and health problems. Sometimes these health care professionals have family practices for all ages; others specialize in internal medicine for adults or pediatrics for children.

Privacy

1. The condition or state of being free from public attention to intrusion into or interference with one's acts or decisions (Black's Law Dictionary). 2. The ability of a person to control the availability of information about and exposure of him- or herself (adapted from NCI Thesaurus).

Private Information

Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record) (45 CFR § 46.102(f)).

Procedure

A series of steps designed to result in a specific outcome when followed in order (ISBER 2018).

Process Validation Studies

The process of demonstrating that a specific procedure will consistently produce expected results within predetermined specifications (ISBER 2018).

Processing

Any procedure employed after biospecimen collection but prior to its distribution, including preparation, testing, and releasing the biospecimen to inventory and labeling (ISBER 2018).

Project Management

The application of knowledge, skills, tools and techniques to a broad range of activities to meet the requirements of the particular project.

Proprietary Period

A period of time in which biospecimens and/or clinical data are stored in a biorepository prior to their availability for sharing according to the NIH/NIA Resources Sharing Policy timeline.

Protected Health Information (PHI). )

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, http://www.hhs.gov/ocr/hipaa/)

Proteomics

The global analysis of cellular proteins. Proteomics uses a combination of sophisticated techniques including two-dimensional (2D) gel electrophoresis, image analysis, mass spectrometry, amino acid sequencing, and bio-informatics to resolve comprehensively, to quantify, and to characterize proteins. The application of proteomics provides major opportunities to elucidate disease mechanisms and to identify new diagnostic markers and therapeutic targets (NCI Thesaurus).

Protocol

A comprehensive study protocol addresses all of the following topics:

• Summary of proposed research aims

• Analytes or parameters to be tested

• Type of assay(s)/platform(s) to be used

• Scientific background and rationale

• Sample size rationale and calculations

Psychiatrist

A medical doctor who specializes in emotional and mental disorders.

Psychologist

A specialist, but not a medical doctor, who can talk with patients and their families about emotional and personal matters and can help them make decisions.

Published Manuscript

Report of findings of an NIA-sponsored study that is made public through inclusion in a recognized print or online outlet.

Q

Quality

Conformance of a biospecimen or process with pre-established specifications or standards (ISBER, 2018).

Quality Assurance

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. Same as quality management system (ISBER, 2018).

Quality Control

Specific tests defined by the QA or QMS Program to be performed to monitor procurement, processing, preservation and storage; biospecimen quality; and test accuracy. These may include but are not limited to performance evaluations, testing, and controls used to determine accuracy and reliability of the biospecimen resource's equipment and operational procedures as well as monitoring of the supplies, reagents, equipment, and facilities (ISBER, 2018).

Quality Management System

See Quality assurance.

R

Radiologist

A medical doctor who specializes in X-rays and related procedures such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and ultrasound tests.

Reach-Through Rights

Rights claimed by the provider of materials to the recipient's downstream discoveries to which the provider would not otherwise be entitled through its ownership or patent coverage of the material alone. Examples of reach-through rights required by providers in exchange for use of their material by the recipient might include ownership of recipient's discoveries, license exclusivity, or payments upon the sale of the discovery. Reach-through rights may give the provider an unfairly high level of compensation for the research use of the material by the recipient (NCI Best Practices working definition).

Registered nurse (RN)

A health professional who has graduated from a nursing program, passed a state board examination and has a state license.

Rehabilitation hospital

A medical facility providing therapy and training for the restoration of physical function or cognitive skills following a serious injury, illness or medical event (such as a stroke).

Remote patient monitoring (RPM)

A subcategory of telehealth services that allows patients to use mobile medical devices and technology to gather patient-generated health data, such as weight, blood pressure and heart rate, and send it to health care professionals.

Repository

An entity that receives, stores, processes, and/or disseminates specimens, as needed. It encompasses the physical location a well as the full range of activities associated with its operation. It may also be referred to as a biorepository (ISBER, 2018).

Repository Allocation Committee (RAC)

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.

Research

1. Systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (CFR 45 § 46.102(d)). 2. Systematic investigation into a subject in order to discover facts, establish or revise a theory, or develop a plan of action based on the facts discovered (NCI Thesaurus).

Research Resources

Biospecimen or study datasets, or both.

Resource Sharing

The sharing of materials and data in a timely manner (NCI Thesaurus).

Respite care

Short-term or temporary care of a sick, disabled or older person for a few hours, days or weeks, designed to provide relief to the regular caregiver.

Retrieval

The removal, acquisition, recovery, harvesting, or collection of biospecimens (ISBER 2018).

Retrospective

Relating to or being a study or collection (as of a dis- ease) that looks back on or deals with past events or situations. (ISBER, 2018)

Rheumatologist

A medical doctor who specializes in pain and other symptoms related to joints and other parts of the musculoskeletal system, such as bones, cartilage, ligaments, muscles and tendons.

S

Safety

Processes, procedures, and technologies to ensure freedom from danger or harm. (ISBER, 2018)

Sales of Research Substances and Living Organisms

Section 2043 of the 21st Century Act enacted December 13, 2016 (p. 114-255) authorizing the Secretary, HHS, to direct contractors to collect payments on behalf of the Secretary under Section 301 of the Public Health Services (PHS) Act for the costs incurred to make research substances and living organisms available to individuals and entities for biomedical and behavioral research.

Sample

1. A portion of a biospecimen (NCI Best Practices working definition). 2. A single unit containing material derived from one biospecimen (ISBER, 2018). 3. Serving as an illustration or example (Merriam- Webster's Online Dictionary).

Secondary Research

Any research use beyond the scope of the primary study. See Primary research (NCI Best Practices working definition).

Senior center

A physical location providing opportunities for older adults to get active, enjoy various social activities and improve their overall quality of life.

Shipping Manifest

A description of the contents of the shipped package (ISBER, 2018). An electronic shipping manifest must be sent prior to shipment. A hard copy of the shipping manifest must be included with the shipment.

Simple Letter Agreement (SLA)

Streamlined form of material transfer agreement approved for use at the NIH. The NIH encourages the use of the SLA to facilitate exchanges between academic institutions (NCI Technology Transfer Branch, https://ttc.nci.nih.gov/forms/mta.php and http://ttc.nci.nih.gov/).

Site ID

Unique combination of letters and numbers that identifies each study site that contributes data to a biorepository.

Skilled care

Nursing or rehabilitation services that a doctor orders and that licensed health professionals such as nurses and physical therapists provide.

Social Security

The U.S. government's social insurance program, providing monthly benefit payments to retired workers age 62 and older; their spouses (or ex-spouses), children and survivors; and people with disabilities that prevent them from working for an extended period. The system is funded by payroll tax contributions workers make throughout their careers, with monthly benefit amounts determined primarily by their lifetime earnings history.

Social Security Disability Insurance (SSDI)

Monthly benefit payments to people below retirement age with a significant illness or impairment that prevents them from working for at least a year or is expected to result in death. Eligibility is based on past work in which the person paid Social Security taxes and is reviewed periodically to make sure the disability continues to restrict them from working.

Space Planning

The process of designing the layout of a building, suite, or laboratory for optimal efficiency in the intended purpose (NCI Best Practices working definition).

Specimen

See Biospecimen.

Specimen Characterization Data

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.

Stakeholder

One that has a stake or an interest in an enterprise. In the context of the NCI Best Practices, the term stakeholder embraces research participants, patient advocates, researchers, clinicians, and biospecimen resource operational/managerial personnel (NCI Best Practices working definition).

Standard Operating Procedure (SOP)

An established procedure to be followed in carrying out a given operation or in a given situation (NCI Thesaurus).

Standard Operating Procedures (SOPs) Manual

A group of SOPs detailing specific policies of a repository and the procedures required to be used by the staff/personnel (ISBER 2018).

Standard Precautions

The CDC publication titled “Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2007” is also known as “Standard Precautions.” Standard precautions are based on the principle that all blood, body fluids, secretions, excretions except sweat, nonintact skin, and mucous membranes may contain transmissible infectious agents, and include a group of infection-prevention practices. These include: hand hygiene; use of gloves, gown, mask, eye protection, or face shield, depending on the anticipated exposure; and safe injection practices. Also, equipment or items in the patient environment likely to have been contaminated with infectious body fluids must be handled in a manner to prevent transmission of infectious agents (“Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2007,” http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf).

Steering Committee (SC)

A policy/governance committee.

Sterility

Absence of detectable, viable, contaminating microorganisms. (ISBER, 2018)

Storage

Maintenance of biospecimens under specified conditions for future use (ISBER 2018).

Study Collection

The accumulated biospecimens collected by a clinical study.

Study Dataset

The information collected and recorded from study participants through periodic examinations and follow-up contacts, not including original specimens or images.

Sub-Study

An additional protocol within a study that did not require review by the main study's Ancillary Study Committee.

Subject

Also referred to as human subject. See Donor. (ISBER, 2018)

Sundown syndrome or sundowning.

A state of confusion that occurs later in the afternoon and into the night. It is most often found in patients who have dementia or Alzheimer's disease and includes a range of behaviors such as increased confusion, anxiety, agitation and sleeplessness.

Supplemental Security Income (SSI)

A program the Social Security Administration oversees that pays monthly benefits to people with limited income and resources who are disabled, blind, or age 65 or older.

Surrogate

An individual appointed to act in place of another.

Sustainable

Any recognized category in the taxonomic hierarchy. For many purposes, the category “species” is the most important. (ISBER, 2018)

T

TG

The glass transition temperature marks the temperature at which a fluid becomes so viscous it appears solid. The extreme viscosity reduces diffusion and molecular restructuring, slowing reactions that might otherwise cause biospecimens to deteriorate. The Tg for pure water is -132ºC. (ISBER, 2018)

Telemetry

A system that allows for measurements to be taken from a distance, usually via radio wave transmission and reception of the information. (ISBER, 2018)

Tissue

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 a 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).

Totipotency

In the context of plants, means that a single somatic (non-germ line) cell has the ability to differentiate along a developmental pathway and regenerate a plant. More generally, the potential for an undifferentiated cell to regenerate into a complete new plant. (ISBER, 2018)

U

Uniform Biological Material Transfer Agreement (UBMTA)

A Master Agreement among the NIH, universities, and other nonprofit research facilities used to expedite transfer of research materials among noncommercial entities (NCI Technology Transfer Branch, https://ttc.nci.nih.gov/forms/mta.php). More information about the terms of the UBMTA and its signatories is available at (http://www.bioinfo.com/ubmta.html ).

Unique Identifier

A set of characters used as a code that is unique in the context or the system for which it is created. It serves as a means of identification and reference (often instead of a name) for an entity, person, thing, function, procedure, activity, variable, or body of data (NCI Thesaurus).

Urologist

A medical doctor who specializes in disorders of the male reproductive system as well as the male and female urinary tract.

Use Case

A document that describes the interaction between a user (or other initiator of the interaction) and a system, represented as a sequence of simple steps leading to a particular goal (NCI Thesaurus).

V

Validation (of procedures or equipment)

1. The act of confirming a product or service meets the requirements for which it was intended (Babylon Business Dictionary). 2. A statistical method of partitioning a biospecimen of data into subsets such that the analysis is initially performed on a single subset, while the other subsets are retained for subsequent use in confirming and validating the initial analysis (NCI Thesaurus).

Virtual Collections

Collections of virtual representations of specimens (e.g., digital pathology images, H&E stained slides, slides of tissue prepared for immunohistochemical analysis, digital images of specimens, molecular data) that are housed and analyzed elsewhere, or represent catalogs of specimens stored elsewhere. (ISBER, 2018)

Vital signs

Signs of life — specifically, a person's heart rate (pulse), breathing rate, body temperature and blood pressure. They show doctors how well a person's body is functioning.

Vitrification

(see also Glass Transition) Refers to the transformation of a glass-forming liquid into a glass, which usually occurs upon rapid cooling. It is a dynamic phenomenon occurring between two distinct states of matter (liquid and glass), each with different physical properties. (ISBER, 2018)

W

Warm Ischemia

The amount of time that an organ remains at body temperature after its blood supply has been stopped or reduced. (ISBER, 2018)