I. Purpose
The purpose of this policy is to outline the procedures and requirements for access to data
and biospecimens collected by the UCSF Core Center for Patient‑centric, Mechanistic
Phenotyping in Chronic Low Back Pain (REACH). This ensures responsible use of resources,
compliance with participant consent, and alignment with REACH’s scientific mission. Before
submitting a request, please read sections I-V below.
II. Scope
This policy applies to all REACH data and biospecimens, including but not limited to:
Clinical and demographic data
Psychosocial and behavioral assessments
Biological specimens (blood, saliva, tissue, etc.)
Imaging, biomechanical, and omics data
Access may be requested by internal UCSF investigators
III. Governance
Governing Body: The Repository Oversight Committee (ROC)
This high-level committee provides strategic direction and ultimate authority over the repository.
Composition:
Chair: A senior institutional leader
Scientific Experts: Researchers with expertise in the relevant therapeutic areas, bioinformatics, and
biostatistics ).
Data and Biosample Custodian: The individual responsible for the day-to-day management of the repository
Responsibilities:
Establish and approve repository policies (e.g., data sharing, fee structure, intellectual property).
Review and approve complex or high-stakes data and sample access requests.
Oversee repository finances and sustainability planning.
Ensure compliance with all relevant regulations.(e.g., HIPAA, GINA, Common Rule).
Conduct periodic audits of repository operations.
Operational Body:
This team is responsible for the day-to-day operations and serves as the primary point of contact for researchers.
Key Roles:
Repository Director/Manager: The lead individual responsible for operational oversight. Manages staff, budget, and implements ROC policies. Serves as the first point of contact for all access requests.
Data Manager/Bioinformatician: Responsible for maintaining the data infrastructure, quality control, and providing technical support to researchers.
Biosample Manager: Oversees the physical handling, storage, and inventory of the biosamples at Oyster Point. Ensures samples are handled in accordance with best practices and standard operating procedures (SOPs) and is the main point of contact for Oyster Point staff
Administrative Coordinator: Handles all administrative tasks, including processing access requests, managing communication, and scheduling committee meetings
Scientific Review Panel (SRP)
For scientific merit review of complex or burdensome access requests, an ad-hoc or standing panel of scientific experts can be convened.
Composition:
Members are drawn from the ROC and Department Research Committee.
Members should be selected based on their expertise related to the specific research proposal being reviewed.
Responsibilities:
Review the scientific rationale and feasibility (scientific and financial) of each access request.
Provide a recommendation to the Repository Manager for approval or denial, or request revisions.
IV. Agreements
Data/Biosample Use Agreement (DBUA):
I acknowledge that I must sign a Data/Biosample Use Agreement with [Your Institution Name] before access can be granted.
I agree to use the data and samples solely for the research described in this application.
Publication and Acknowledgment:
I agree to acknowledge [Your Institution Name] and the original NIH grant (U19AR076737) in all publications and presentations resulting from this research.
I agree to provide a copy of any publications to the Repository Management Team.
Submit all requests to the form here. Please make sure to select REACH Data Access.