What can biospecimens be used for in the future?
If the investigator envisions future unspecified research using the biospecimens, that possibility must be clearly stated. Biospecimens are often stored in repositories for future research uses, including unspecified future research.
What kind of material is a biospecimen?
A human biospecimen is any natural material from the human body, such as tissue, blood, and urine.
When do you need a biospecimen consent form?
If the consent form describes uses of the specimens that are limited to a specific purpose or type of research, any future use of the biospecimens must be limited to research of that type or purpose. If the investigator envisions future unspecified research using the biospecimens, that possibility must be clearly stated.
What is the definition of a biological specimen?
Jump to navigation Jump to search. A biological specimen (also called a biospecimen) is a biological laboratory specimen held by a biorepository for research. Such a specimen would be taken by sampling so as to be representative of any other specimen taken from the source of the specimen.
Can a research project be carried out without biospecimens?
If the research involves identifiable information or identifiable biospecimens, the research could not practicably be carried out without identifiers. Waiving the informed consent requirement will not adversely affect rights and welfare of subjects. When appropriate, subjects will be provided additional pertinent information about the research.
Why do we need a biospecimen resource program?
Biospecimens can provide a bridge between emerging molecular information and clinical information to diagnose and treat disease in new and more effective ways. Research biospecimens provide unique and essential resources for future research aimed at improving precision medicine.
How are biospecimen levels affected by other factors?
Research has demonstrated that analyte levels may be affected by a variety of factors such as the overall health of the human research participant, the type of anesthesia used, food and beverages consumed prior to biospecimen collection, the medication status of the patient, and the time of day at which the biospecimen was collected [ 33, 34 ].