NWBioSpecimen Services
Annotation data associated with study participants and their biospecimens
NWBioSpecimen provides patient-level and biospecimen-level annotation services.
Patient-level information may be extracted from medical record data by NWBioSpecimen staff under their honest broker role. Additional detailed annotation data may be extracted from medical record data using Institute of Translational Health Sciences bioinformatics services.
Biospecimen-level annotations may include pathology status and diagnostic information, redacted pathology reports, detailed histologic analysis by consulting pathologists, and quantification of histologic details using digital pathology measurements.
Patient Consent
NWBioSpecimen releases data and biospecimens per Institutional Review Board (IRB) approved processes. IRB approvals may require study-specific consents or the broad-based NW BioTrust consent.
NW BioTrust Consents
Consent for broad use of biospecimens and medical record data is sought of UW Medicine and Fred Hutch Cancer Center (FHCC) patients through NW BioTrust.
Patient consent may be obtained through a “front desk” electronic system integrated into clinic settings at UW Medicine and FHCC. This system uses a customized registration module within Epic to record patient consents for the use of remnant portions of clinical samples and existing medical record data, and willingness to be contacted in the future for clinical trials.
Alternatively, paper-based consents may be administered by NW BioTrust staff or other study coordinators for use of remnant portions of clinical samples and existing medical record data, and for additional research-only biospecimens such as blood drawn or saliva obtained specifically for a study.
Study-Specific Consents
The IRB approved study protocol for which NWBioSpecimen services are requested may require a study-specific consent. If so, the signed consent must be available to NWBioSpecimen prior to biospecimen or data release.
Waivers of Consent and HIPAA authorization, and Not Human Subjects determinations
Under current regulatory rules, patient consent is not always required for the release of remnant portions of clinical samples and annotation data. In some cases, an IRB may authorize use with waiver of patient consent and waiver of patient HIPAA authorization. In other cases, use of coded/de-identified specimens and data may be determined to be Not Human Subjects research, since under current regulations de-identified materials may not be considered to include “human subjects”. However, NWBioSpecimen does not release biospecimens or data from patients who have said “No” during the NW BioTrust consenting process, unless there is a study-specific patient authorization in place to do so (such as for a clinical trial).
Links
Prospective Biospecimen Procurement
NWBioSpecimen prospective tissue procurement services include:
- Screening for visiting patients matching your study's requirements.
- Obtaining patient consent using the NW BioTrust General Consent (see above).
- Collecting, stabilizing, and processing research biospecimens sourced from surgically remnant tissue, research only biopsies, blood draws or other body fluids, and frozen banked tissue.
- Note: Study teams may also screen for patients and obtain patient consent, then utilize NWBioSpecimen tissue procurement services to obtain research biospeicmens for their study.
NWBioSpecimen tissue procurement occurs either in Anatomic Pathology laboratories (frozen section room, gross room, and other laboratories), Laboratory Medicine (Clinical Pathology) facilities (for remnant portions of blood and other biospecimens), and other sites such as Radiology procedure suites and Fred Hutch Cancer Center clinics.
Retrospective/Archival Biospecimen Procurement
NWBioSpecimen coordinates the collection and authorization of research biospecimens obtained from Department of Laboratory Medicine & Pathology's CLIA repository of archival pathology specimens (FFPE blocks and slides from pathology cases).
Services include:
- Pulling archival pathology case materials from on-site libraries and requesting materials from off-site storage facilities.
- Coordinating pathologist review and selection of pathology case materials best meeting your study's requirements.
- Obtaining authorization and documentation to obtain research samples from the archival CLIA materials.
- Coordinating anatomic pathology laboratory services (e.g. histology lab) to create new research samples (e.g. FFPE slide sections) from the authorized materials.
- Coordinating the collection of remnant/discarded blood and cytofluid specimens.
- Tissue Microarray (TMA) creation. Tissue microarrays are formalin fixed paraffin-embedded (FFPE) tissue blocks composed of tissue cores taken from regions of interest in multiple donor FFPE tissue blocks. This service provides a simple way for researchers to inquire about TMA construction, request work, and receive a finished TMA product. In addition to TMA construction, we also have the ability to punch blocks for tissue cores with high tumor cellularity (or other regions of interest) for downstream molecular analyses such as DNA sequencing.
Pathology Lab Services
NWBioSpecimen coordinates services from Department of Laboratory Medicine & Pathology's CAP accredited anatomic pathology laboratories to process and provide testing of research biospecimens procured from prospective and retrospective/archival pathways.
Histology
Most histology functions are purchased from consulting laboratories including the UW Medical Center-Montlake (UWMC-MT) and Harborview Medical Center (HMC) hospital pathology laboratories. The primary techniques offered include formalin fixation or tissue freezing, processing, embedding for routine histology and electron microscopy, and tissue sectioning. Slide sections may be stained with hematoxylin & eosin (H&E) or a variety of special processes such as immunohistochemistry (IHC), in situ hybridization, and immunofluorescence.
Immunohistochemistry
Immunohistochemical slide staining. See the antibodies list on the DLMP website.
Cytology
The Cytology laboratory is responsible for the processing and interpretation of gynecologic and non-gynecologic specimens including: effusions, cerebrospinal fluids, urines, and bronchoalveolar samples. They, in collaboration with the Molecular Diagnostics Lab, provide testing such as HPV (high risk and genotyping).
Molecular Diagnostics
The Molecular Diagnostics laboratory offers HPV (high risk and genotyping) utilizing Roche and Luminex instruments.
Cytogenetics
FISH testing, cell cultures, karyotype analysis
Electron Microscopy
EM slide sections, scoping, and analysis
Digital Imaging
Digital whole slide scanning, deidentification of images
Distribution of materials for research
NWBioSpecimen releases biospecimens and annotation data either coded/de-identified or identified, depending on each recipient researcher's permissions under their Institutional Review Board documentation. Documented Institutional Review Board authorization is required for receipt of biospecimens and annotation data