What is NWBioSpecimen?
NWBioSpecimen is a collaborative effort between the University of Washington, Fred Hutchinson Cancer Research Center, and Seattle Cancer Care Alliance to facilitate Consortium access to well-characterized research biospecimens to innovative research projects aimed at improving the prevention, diagnosis, and treatment of human disease.
The mission of NWBioSpecimen is to provide investigators with broad access to high-quality biospecimens and annotation data including medical record data. Services may be customized to the specific needs of each research project, in a manner that is cost effective for investigators and aims to be self-sustaining for our institutions.
What is a biospecimen?
We define human biospecimens as tissue or fluid samples, or remnant portions of samples, procured, processed, annotated and distributed for research using standard protocols within a quality-controlled environment1.
For many scientific studies an ample supply of high-quality biospecimens is essential to allow researchers to frame questions that can be answered only by examining hundreds or thousands of patient biospecimens3.
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” 4.
What is annotation data?
Each biospecimen may be accompanied by patient medical record data, from data generated in clinical trials that patients may have volunteered to join, or other patient information. Biospecimens also may be associated with information about the biospecimen itself, such as diagnostic details, cellular measurements, etc. This information that accompanies biospecimens is known as annotation data. Annotation data is often as scientifically important as the biospecimens themselves2.
Honoring the Patient
Consent for broad use of biospecimens and medical record data is sought of UW Medicine and Seattle Cancer Care Alliance (SCCA) patients through NW BioTrust. Patient consent is obtained by NW BioTrust staff with Institutional Review Board permission and oversight, is completely voluntary, and can be withdrawn at any time.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 NW BioTrust 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 Joint Commission which accredits our hospitals, 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?
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.
- Biospecimen procurement
- Annotation data associated with study participants and their biospecimens
- Distribution of materials for research
- Dash, R. C. et al. Biospecimens and biorepositories for the community pathologist. Archives of pathology & laboratory medicine 136, 668-678 (2012).
- Donating Tissue for Cancer Research: Biospecimens and Biorepositories, National Cancer Institute. http://www.cancer.gov/cancertopics/factsheet/clinicaltrials/donating-tissue-research
- Why are biospecimens important in cancer research? National Cancer Institute. http://www.cancer.gov/cancertopics/factsheet/clinicaltrials/donating-tissue-research#q3
- Carlson, Robert H. Unreliable biospecimens threaten research. Oncology Times UK: November 2010 - Volume 7 - Issue 11 - p 12.