Liver Tissue Distribution System

LTDS is to serve as a resource for investigators to obtain human liver tissue for scientific investigation. This liver tissue system:

1. Collects portions of liver removed from liver transplant recipients at surgery
2. Collects and provides normal liver tissue to investigators if the tissue from organ donations cannot be used for the recipient because of size, state of anoxia, etc. (a very rare event).
3. Develops and maintains the capacity to retrieve, preserve, and deliver available tissues in such condition as will be useful to investigators conducting biomedical research projects at institutions throughout the United States.
4. Provides normal human hepatocytes in culture.

A review mechanism has been established and operates to ensure each application received is reviewed for completeness and feasibility. Consultants may be used as necessary. Complete protocols for preservation and shipping must be negotiated in advance of obtaining tissue for each request. A review mechanism has been established to prioritize applications according to scientific merit and relevance. Investigators wishing to receive tissue to be used in NIH-funded projects shall receive highest priority under normal circumstances.

The contractor, in conjunction with the Tissue Collection Centers, shall establish a set of fees to be charged to and collected from investigators for shipping and handling of tissues. Investigators will not be obligated to pay these fees if tissues cannot be used due to damage.

To the extent possible, the contractor shall coordinate the efforts of participating Tissue Collection Centers in the formulation of standards for assessing the viability of tissue to be used for various research purposes. Such standards would then guide the development and use of standardized retrieval, preservation, and transportation protocols.

An information storage and management system has been established to ensure that tissues are procured from appropriate Tissue Collection Centers in response to investigators' requests, processed according to pre-established protocols, and delivered in a timely way. The system also ensures that a high degree of quality control is maintained. We have the capability to store and retrieve complete data regarding tissue availability, donor information, requirements of the investigator, protocols for retrieval, preservation and transportation, and written feedback from investigators regarding viability of received tissue and summaries of the research in which the tissue was used.

LTDS will provide synopsis of the medical history of a tissue donor, together with available laboratory data, to the investigator receiving the liver tissue when it is requested in the original proposal. A diagnostic slide will be prepared for each sample for confirmation of liver pathology when requested.

A Coordinating Committee has been established to review the proposed operating procedures, quality control procedures, tissue processing procedures, information storage and management procedures, and other operating policies as required to ensure equitable access to the system. It is the collective responsibility of the contractor and the NIDDK to form the membership of the Coordinating Committee and for that committee to appoint a chairperson.