What is a Biospecimen?
Human biospecimens are tissue or fluid samples, or remnant portions of samples, procured, processed, annotated and distributed for research using standard protocols within a quality-controlled environment. Our specimens all come from generous patients with a cancer diagnosis who wish to further research in cancer.
Biospecimens are incredibly vital to supplying a cell source on which researchers can learn about how cancer behaves and testing possible treatments.
Unfortunately biospecimens are in short supply. A recent survey of 7,000 researchers funded by the National Cancer Institute found that "samples they needed was ‘somewhat difficult’, ‘difficult’, or ‘very difficult’ to obtain".
What is annotation data?
Each biospecimen may be accompanied by patient medical record data. Biospecimens also may be associated with information about the biospecimen itself, such as diagnostic details, cellular measurements, etc. The information that accompanies the specimen is called annotation data.
We input every biospecimen and its annotation into a secure database and private information and personal identifiers are not given out. Sometimes annotation data is as vital as the specimen itself in a study, therefore it may be given out only if the patient has consented to it and if the study has recieved IRB approval to access that information.
Consent for broad use of biospecimens and medical record data is sought of UCSD Health patients through the Biorepository at Moores Cancer Center. Patient consent is obtained by BTTSR staff with Institutional Review Board permission and oversight, is completely voluntary, and can be withdrawn at any time. A patient’s consent status is not revealed to clinical care providers, and whether or not the patient volunteers to participate in BTTSR does not affect clinical care in any way.
We uphold all regulatory and other mandates pertaining to procuring human biospecimens and annotating those biospecimens with medical record and other data, including guidance from the College of American Pathologists which accredits our clinical laboratories to meet the conditions of federal law including the Clinical Laboratory Improvement Amendments and Health Insurance Portability and Accountability Act, Institutional Review Board regulations, and hospital and departmental policies.
What is an Institutional Review Board (IRB)?
An institutional review board (IRB) is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving human subjects. IRBs conduct risk-benefit analysis to determine whether or not research should be done, and help ensure protection of the rights and welfare of human research subjects.