What is a biological specimen?
A biological specimen (also called a biospecimen) is a biological laboratory specimen held by a biorepository for research.
What is a synonym for specimen?
Synonyms for specimen. Synonyms. being, bird, body, character, creature, customer, devil, duck, egg, face, fish, guy, head, human, human being, individual, life, man, mortal, party, person, personage, scout, sort, soul, stiff, thing, wight.
Why use human specimens in biomedical research?
The use of human specimens in biomedical research has been critical to the development of current medical care.
What is the importance of specimen collection?
Human specimens are an invaluable resource for the investigation of normal and pathological conditions.
What are considered specimens?
Patient specimens include, but are not limited to, excreta, secreta, blood, blood components, tissue, and specimens in transport media. Patient specimens considered Infectious Substances: The specimen is obtained from a patient with suspected infection. Exposure to the specimen could result in an infection.
What are the human specimens used for analysis?
Today's technologies allow testing on an impressively wide variety of samples collected from the human body. Most often, all that is required is a blood sample. However, samples of urine, saliva, sputum, feces, semen, and other bodily fluids and tissues also can be tested.
What is considered exempt human specimen?
Term: Exempt Human or Animal Specimens A human or animal sample (including, but not limited to, secreta, excreta, blood and its components, tissue and tissue fluids, and body parts) transported for routine testing not related to the diagnosis of an infectious disease.
What is specimen A in biology?
specimen. (Science: microscopy) A piece or portion of a sample selected for examination. The specimen may, or may not be representative, whereas the sample may have been selected to be representative.
Can a human be a specimen?
Specimens. A wide range of human specimens can support virological diagnosis procedures. The most common ones are whole blood, plasma, and serum.
Are cell lines considered human specimens?
A: No. Although the bacteria or virus come from a human sample they are not 'human' material and do not need to be reported.
Is a stool sample an exempt human specimen?
d. Exempt human or animal specimen means a human or animal sample (including, but not limited to, secreta, excreta, blood and its components, tissue and tissue fluids, and body parts) transported for routine testing not related to the diagnosis of an infectious disease.
What are Category B specimens?
Category B Specimens: Category B specimens are infectious substances not in a form generally capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs.
Is DNA exempt human specimen?
However, GenoMEL recommends that DNA be shipped according to the guidelines for the Exempt Human Specimen category: DNA sent in either a sealed 96 well plate or individually labelled, screw-topped Eppendorf – style tubes. Plates should be individually wrapped in Saran-wrap to prevent evaporation and leakage.
What are the examples of biological specimens?
Biological Samples means biological samples (e.g., blood, urine, tissue, saliva, etc.) obtained from Trial Subjects.
What is a female specimen?
Female. Genital tract specimens are submitted primarily for the detection of sexually transmitted pathogens (such as N. gonorrhoeae, Chlamydia trachomatis, lumphogranuloma venereum, HSV, human papillomavirus (HPV) with histological confirmation], trichomonads, group B streptococci, and Candida infections).
What is specimen Wikipedia?
Sample (material), a limited quantity of something which is intended to be similar to and represent a larger amount. Biological specimen or biospecimen, an organic specimen held by a biorepository for research. Laboratory specimen, a biological specimen taken by sampling.
What is a human biospecimen used for?
Commonly, research human biospecimens are used to: Identify and validate ways to deliver drugs or agents to specific cells. Identify how diseases vary in their development and progression. Group patients as more or less likely to respond to specific drugs or types of therapies.
What is a biospecimen?
A human biospecimen is any natural material from the human body, such as tissue, blood, and urine. Biospecimens are usually obtained during a diagnostic test or a procedure, such as surgery. Patients may give permission so that a small amount of a biospecimen (such as blood or tissue removed from a procedure) that exceeds what is needed ...
Why are biospecimens important?
Research biospecimens provide unique and essential resources for future research aimed at improving precision medicine.
What is the definition of a urine specimen?
1 : an individual, item, or part typical of a group, class, or whole. 2 : a portion or quantity of material for use in testing, examination, or study a urine specimen.
What is a urine specimen?
1 a : an individual, item, or part considered typical of a group, class, or whole. b : a portion or quantity of material for use in testing, examination, or study a urine specimen. 2 a : something that obviously belongs to a particular category but is noticed by reason of an individual distinguishing characteristic.
Measures proposed for NCI evaluation of human specimen resources
In general, the NCI expects an evaluation to answer three critical questions:
Criteria to assess the performance of a resource
Performance is by far the easiest item to evaluate. In general the factors listed below are numerical and can be easily tallied if identified in advance. As with the factors discussed below, the choice of specific evaluation factors will be made in the context of what the resource was designed to accomplish and how it was expected to operate.
Criteria to measure the impact of a resource
The impact of a resource is the most difficult characteristic to measure, although impact becomes easier to measure with time as more researchers are served. Time is required not only for a resource to become established, but also for the critical research findings resulting from use of the resource to be published and appreciated.
Criteria to measure the continuing need for a resource
To determine whether there is a continuing need for an existing resource it is important to consider the nature of the resource, its original objective and how long it has been in existence.
What is human subject research?
According to 45 CFR 46 , a human subject is "a living individual about whom an investigator (whether professional or student) conducting research: Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or.
What is a questionnaire?
The questionnaire is a tool to assist you with determining whether your project involves non-exempt human subjects research, meets the criteria for exempt human subjects research, or does not involve human subjects research.
Is a study involving human subjects considered research?
Studies involving the use of human specimens or data may or may not be considered to be research involving human subjects, depending on the details of the materials to be used.
