Intramural Request for Archived Human Biological Material

Requesting Material through the Tissue Resource Committee (TRC) Program

Please provide all information requested on the Tissue Resource Committee (TRC) form to Ms. Silke Williams, Bldg. 10, Room 2S249, so that we may review the request in full.

1. TRC requests could take up to three (3) weeks to complete, depending on our clinical workload and other Archivist priorities.
2. The requester completes the TRC Request Form and returns it to the Archivist, along with the associated IRB-approved protocol number or an exemption letter from the Office of Human Subjects Research (OHSR), if necessary.
3. The Archivist assigns a TRC number to the request, creates a paper file folder for the request,and logs the request into the TRC Excel spreadsheet on the Laboratory of Pathology (LP’s) server, which is also available to the Clinical Manager.
4. The Archivist will review the request with the Clinical Manager to determine completion of requisition, OHSR / IRB compliance, and to determine if the request can be completed inhouse or if the recuts must be sent out to a reference laboratory. If the processing / recuts cannot be done inhouse, the requesting PI will be notified if his/her CAN will be billed, and the cost of the work.
5. Key requirements for intramural requests are:
   • Complete Principal Investigator (PI) information.
   • CAN number for all Non-NCI requests.
   • Complete description of resource needs and a list of cases, if appropriate.
   • Intended use and methodology. The TRC may question the technical approach of any request and may contact the requester for additional information to justify or modify the request. However, it is not the purpose of the TRC to review the scientific merit or ethics of any proposal.
   • PI must provide OHSR exemption or Institutional Review Board (IRB) approval number. Neither is required for autopsy material. Make sure proper authorization is given based on type of request (linked, anonymized, autopsy, deceased).
   • Certification or proof-of-death is required for deceased patients (non-autopsy cases).
   • The PI must sign the request.
6. If the request requires pathologist review, the Archivist will direct the TRC to the Resident on Autopsy service or Surgical Pathology Attending on service. Physician review may be required for:
   
   • Which block to use for recuts?
   • If the tissue is a small biopsy and is not requested for the specific patient protocol, does the request warrant the use of the material remaining?
   • Is the quantity of material requested acceptable / feasible?
   • If the material is in danger of being exhausted, the Pathologist and original PI for the material must be consulted to determine if the request can be fulfilled.
7. If anonymized (unlinked) material is requested, the Archivist or another LP employee will unlink the source. For example, if anonymized recuts are sent to a reference lab for cutting, a random number will be assigned to the block before the blocks are sent out. Slides will be labeled with the random number. The label will be removed from the block before it is returned to the file.
   
   • The Technologist or Archivist will order “research recuts” in the Laboratory Information System (LIS) indicating the amount of slides given for research.
   • Records of the source will not be documented in a way that the material can be linked to the patient. Any interim documentation created in organizing the request will be destroyed at the time of releasing the material or shortly thereafter.
8. The Archivist will also notify the Pathologists Assistants and/or Resident on the autopsy service, if fresh autopsy materials are requested.

Requests for Paraffin-Embedded (Whole) Tissue Blocks

LP does not routinely release whole tissue blocks. Any request for blocks must be submitted the Branch Chief / Medical Director with a justification of the need for the block(s) rather than slides. Only the Branch Chief of LP can approve the release of tissue blocks.

Requests for Research Immunohistochemistry (IHC)

• Requests for IHC stains for research is not processed through the TRC program. LP PIs requesting research Immuno tests should discuss these requests with the Experiment Pathology Lab (EPL). If the EPL is not able to perform the LP-driven IHC research tests, the LP PI must discuss the research request with the Section Head for the Clinical Immunohistochemistry Section.
• Requests for IHC from non-LP PIs:
  • LP's Archivist can provide recuts through the TRC program, but the requesting PI must coordinate sending the testing to the outside laboratory from his/her own lab.
  • Inquiries about research requests for IHC in LP’s Immunohistochemistry lab should be directed to the IHC Section Head.  Only the Immuno Section Head, or Branch Chief, can approve research IHC in the clinical lab.

Obtaining Tissues through the NCI / Walter Reed Tissue Collaboration

The NCI Laboratory of Pathology and the Walter Reed National Military Medical Center (WRNMMC) have a collaborative project in which formalin preserved and fresh frozen excess human surgical tissues and associated clinical information can be obtained for NCI and NIH investigators. PIs interested in obtaining tissues that are not available at the NIH should complete the TRC Request Form and contact Dr. David Kleiner or Dr. Joseph Chinquee to discuss this possibility.