Human Biomaterials Policy

The University at Buffalo (UB, university) is committed to serving the academic research community and industry partners by providing a supply of high-quality biomaterials to support basic and translational research through centralized and standardized services for the collection, processing, management, and distribution of biobanking assets. The UB Biorepository was created to establish a centralized resource of high-quality, deeply annotated biospecimens to enable research and technology development, including new diagnostic tests and therapeutics, advancing the goals of the research community and industry partners.

Principal investigators (PIs) and collaborators must meet the minimum regulatory standards outlined in the UB Biorepository Manual of Operations and in the event that those requirements cannot be met, PIs must utilize the UB Biorepository for the collection and storage of human biomaterials. All samples must be registered in the UB Biorepository Laboratory Information Management System (LIMS) irrespective of processing and storage location. PIs maintain control and use of the samples, as well as control over any data linked to the samples.

The UB Biorepository is a New York State DOH (Department of Health) Tissue Licensed laboratory that facilitates the collection, processing, and storage of many types of biomaterials performed in a regulated and compliant environment enabling the downstream use of samples for academic, government, and commercial applications.

All UB programs, studies, and departmental activities that receive university funding or have grants and/or contracts for biosample collection activities shall use the UB Biorepository for the collection and storage of biomaterials as it pertains to that grant or project, unless the PI is able to demonstrate that their lab is compliant under the same conditions and to the same standards under which the UB Biorepository operates as outlined in the UB Biorepository operations manual. All samples, regardless of storage location, must be entered into the university-wide LIMS system, managed by the UB Biorepository.

Biomaterial, Biosample, Biospecimen

Any tissue or analyte that is derived from a human biological sample or animal model.

Laboratory Information Management System (LIMS)

Comprehensive database of all UB biospecimens accessible to university investigators and collaborators upon request.

• Distribute information and educate UB faculty and staff regarding this policy.
• Perform periodic reviews of all projects, grants, and contracts that involve the collection, processing, and storage of biomaterials to determine compliance with this policy.

• Register all biological samples in the UB Biorepository LIMS.
• Utilize the UB Biorepository for the collection, storage, and distribution of biomaterials as it pertains to all projects, grants, and contracts, or demonstrate that the minimum standards as outlined in the UB Biorepository operations manual exist in their own laboratory for sample annotation, processing, and storage.

• Monitor compliance with regulations for programs that collect, analyze, and store human biological samples for basic, clinical, translational, and industrial research.
• Facilitate the regulated collection, processing, and storage of many types of biomaterials.
• Follow Good Laboratory Practice (GLP) and operate under guidelines set forth by the College of American Pathologists (CAP).
• Provide requirements ensuring all samples collected, processed, and stored meet regulatory standards.
• Provide appropriate consultative resources to implement basic requirements in individual labs, as needed:
  • Sample chain of custody from sample collection to storage
  • Standard operating procedures and protocols to maintain uniform sample quality
  • Appropriately monitored storage environments for all sample types
  • Appropriate regulatory guidelines to ensure sample integrity, quality and prevent limitation of sample use

• Provide appropriate facility and service guidelines that align with Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC) submission and approval requirements.
• Maintain a record of unsigned consent forms used to collect the sample and stated uses.
• The Quality Assurance Manager will provide annual updates on security.