Types of Human Biological Specimens
Most human biological specimens come from samples collected for diagnostic or therapeutic procedures, but other sources can include autopsies, volunteer donors, or materials collected and shared by other researchers.
- The term "biospecimen" is used widely and encompasses a full range of human specimen types including:
- Sub-cellular components such as DNA or RNA
- Cells or tissues from any part of the human body
- Organs such as liver, bladder, kidney, heart, placenta, etc.
- Gametes (ova and sperm)
- Embryos and fetal tissues
- Breast milk
- Exhaled air
- Bodily products such as teeth, hair, nail clippings, sweat, urine, feces
- Blood and blood fractions: plasma, serum, buffy coat, red blood cells
- Saliva and buccal cells
- Exceptions: Organisms, such as bacteria and viruses, isolated from human specimens are not human biological specimens.
Tissue Banks and Repositories
Various terms are used to designate the storage sites for human biological collections. The most common are defined below.
- Repository is a term usually applied to large formal collections of specimens and/or data. Examples include:
- The National Pathology Repository
- The Cooperative Human Tissue Network
- Tissue bank generally refers to smaller collections of specimens, which may be specific to an institution, disease, or even to specimens in a researcher's freezer.
Approvals Needed to Collect and/or Bank Human Specimens
If you are involved in collecting specimens from research subjects or intend to receive specimens from clinicians for banking purposes, you will need to obtain protocol approval from the IRB.
- Federally funded or cooperative group banks usually have well-defined prioritization and distribution methods. Be prepared to provide a Letter of Intent (LOI) or a study protocol describing your research plan. Applications are generally reviewed by an oversight committee and judged on scientific merit, statistical validity, the investigator's ability to conduct the proposed research, and the appropriateness of the sample size requested to accomplish the research goals.
- Departmental/Division banks and investigator-maintained collections may not have well-established application or distribution policies and may not be obligated to share specimen resources at all. Contact the tissue bank's administrator to find out how to obtain specimens.
- Commercial Tissue Banks: Specimens may be available for purchase from commercial sources.
- Private Collections: Individual researchers who are collecting specimens in your area of research may be willing to provide them. Contact the researcher directly to find out if collaboration is an option and the conditions for transferring or sharing specimens.
Informed Consent Issues
The informed consent form for the collection of biological specimens should ask subjects whether:
- the tissue may be kept for use in research to learn about, prevent, treat or cure a particular disease;
- the tissue may be kept for research about other health problems and
- if someone from UVa may contact the subject in the future to ask him/her to take part in more research.
The consent should also obtain a description of:
- whether tissue specimens will be stored for future research, maintained in a repository or used to establish a cell line, or otherwise how the DNA information from tissue specimens will be utilized in this study.
- where the tissue specimens will be stored; specify the location within the hospital or outside of the hospital.
- the purpose of storing the tissue
- what types of research you or others might use these specimens for in the future.
- who will have access to the DNA information from tissue specimens collected
- who will control distribution of the tissue
- what will happen to stored specimens if the Principal Investigator leaves the present institution.
- an explanation of whether or not personal identifiers will be maintained with the tissue or DNA specimens or not, recorded as part of the study records, or if links to personal identifiers will be maintained in a master list.
- what personal identifiers will be recorded, such as name, medical record number, social security number or other code.
- whether or not a subject would be re-contacted and given information from the banked specimens. If so, under what circumstances.
- what will be done with the study specimens at any point during the study in the event of a subject's withdrawal ( e.g., the entire specimen/cell line could be removed from the study, identifiers could be removed, or information from the aggregate of study data already generated by a particular specimen could be removed).
PRIM&R White Paper: Tissue Banking
*Taken from UVa IRB-HSR Research Guidance