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 Seattle Cancer Care Alliance (SCCA) patients through NW BioTrust. Patient consent may be obtained through a “front desk” electronic system integrated into clinic settings at UW Medicine and SCCA. 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.
Annotation data may include medical record data, and data about individual biospecimens such as diagnostic information and other detailed analyses such as digital pathology measurements.
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).
NWBioSpecimen tissue procurement occurs either in Pathology laboratories (frozen section room, gross room, and other laboratories), Laboratory Medicine facilities (for remnant portions of blood and other biospecimens), and other sites such as Radiology procedure suites and Seattle Cancer Center Alliance clinics.
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 reports, detailed histologic analysis by pathologists, and quantification of histologic details using digital pathology techniques using the Pathology Digital Imaging Core Facility.
Distribution of materials for research
Documented Institutional Review Board authorization is required for receipt of biospecimens and annotation data. 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.