Use & Distribution of REACH Data & Bio-specimen Access Policy

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. For external collaborators, one REACH investigator must be listed as a sponsor/collaborator for the project.

III. Governance

A. 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 (Lotz or Ortho Vice Chair of Research as scientific head of RPMO).
- Scientific Experts: Researchers with expertise in the relevant therapeutic areas, bioinformatics, and biostatistics (BACPAC Core Directors; Lotz, Fields, O'Neill, Mehling, Peterson, Bailey).
- Data and Biosample Custodian: The individual responsible for the day-to-day management of the repository (Trisha Hue, Lucy Wu).
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.

B. Operational Body: The Repository Management Team

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. (Gina Goodrich)
- Data Manager/Bioinformatician: Responsible for maintaining the data infrastructure, quality control, and providing technical support to researchers. (Trisha Hue)
- 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 (Lucy Wu).
- Administrative Coordinator: Handles all administrative tasks, including processing access requests, managing communication, and scheduling committee meetings (Alick Shiu).

C. 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.

V. Access Review Criteria

Requests will be evaluated based on:

Alignment with BACPAC/REACH mission and ethical standards
Scientific merit and feasibility
Availability of requested data or specimens
Prioritization of internal vs external requests if resources are limited
Applicants must acknowledge that they have reviewed REACH’s current publications and approved analysis plans, and confirm that their proposed work is distinct from ongoing or completed projects.

REACH Analysis Plans

VI. How to Submit a Request

To request access to REACH data or biospecimens, please complete the Clinical Data and Biosample Repository Access Request Form.

You will be asked to provide project details, documentation, and signature.