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Consent and Biospecimen Collection in Human Research
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The UC Davis Biorepositories Core Resource (BCR) is a shared service that develops and delivers educational, operational and research tools for researchers and biobankers who collect, store, or study biospecimens at UC Davis.
The BCR’s goal is to enhance the quality and reproducibility of biospecimen research promoting biobank education and adoption of “best practices” standards for new and existing biobanks at UC Davis.
The BCR will also serve as a cornerstone for continuous development and implementation of enterprise-wide biorepository related infrastructure. This infrastructure will facilitate the ability of UC Davis researchers to procure, process and utilize biospecimens in the most cost as well as time effective manner.
- Institutional Review Board (IRB) and Regulatory Compliance policies concerning human biospecimen procurement (integrated with established UC Davis IRB training).
- Overview: Fundamentals of creating biospecimen collection protocols and consent forms.
- Identification of established BCR infrastructure and implementation of available services.
- External web-based biobank and biorepositories specific training programs.
- Customized training to suit need of faculty, staff and/or students (upon request).
- Web Resources (e.g. Biological MTA, Handbook of Human Tissue Sources, ethical best practices).
- International Society of Biological and Environmental Repositories (ISBER) guidelines for best practices of biospecimen procurement and storage.
- National Cancer Institute–Biorepositories and Biospecimen Research Branch (BBRB) best practices.
- College of American Pathologists (CAP) Biorepository Accreditation guidelines.
- Internal: Biorepository Core Resource (BCR) services and practices to UC Davis stakeholders.
- External: Community engagement (public/private) sharing UC Davis policies of biospecimen donation and stewardship.
- Federal, state, local and University policies for human biospecimen management.
- Distribution of relevant publications, news and events in the field of biobanking to UC Davis stakeholders.
- Biorepositories Core Resource—“Learn at Lunch” noontime education series
The BCR is developing multiple enterprise-wide tools to assist researchers. Examples:
- BCR website as a centralized biospecimen and biobanking data resource for all UC Davis faculty, staff and students.
- Virtual Biospecimen Database (VBD)—organization-wide biospecimen inventory system. The BCR will develop a Virtual Biospecimen Database (VBD) among established biorepositories and/or biospecimen collections. The VBD is meant to provide a web interface for identifying stored biospecimens across existing UC Davis repositories (retrospective inventory). Investigators and their collaborators will have the ability to identify potential samples and/or create collaborations with existing biobanks or biospecimen collections for their research. The VBD is expected to become a robust conduit allowing UC Davis researchers to participate in internal and external biobanking networks in the future.
- EMR-Computerized Physician Order Entry (CPOE): Use of CPOE allows personnel (e.g. clinician, nurse, CRC) to order research-specific blood (i.e. serum, plasma, whole blood, DNA) via the EMR alone or in conjunction with clinical blood orders. This will leverage use of already established departmental and institutional resources and can reduce duplication of effort for research.
- “Broad Consent” for UC Davis Health members participating in research. Broad consent is one type of consenting approach that allows for an unspecified range of future research studies to be permitted. It is less specific than obtaining consent for each individual research study, but narrower than the open-ended permission with no limitations (i.e., “blanket consent”). The BCR will collaborate with key stakeholders within UC Davis to create a brief standard consent form approach that agrees to a general permit for future research.
Anyone (faculty, staff or students) can request a consultation to discuss their biospecimen or biorepository-related projects by calling 916-734-3475.
Once the Virtual Biospecimen Database (VBD) is developed and implemented, samples can be located from stored biospecimen inventories across UC Davis. The VBD will identify which biobanks may contain your identified samples. The requestor would contact the established biobanks to further clarify requests and ensure that investigators are in compliance with IRB regulations.
Dr. Nicholas Anderson is the BCR Director and Leslie Solis is the Biobank Operations Specialist (see “About Us” for their biographies). The BCR administrative office is located within the Clinical and Translational Science Center (CTSC, 2921 Stockton Blvd., UC Davis Medical Center).