Request from an Extramural (Outside NIH) Organization 

1. If the Laboratory of Pathology (LP) receives a request from outside the NIH, the Archivist responds with a letter and the Extramural Request for Human Biological Materials For Research Purposes (Medical Record Form # NIH-2803-2) specified in the NIH Clinical Center (CC) Medical Executive Committee policy, M01-2, “Procurement and Use of Human Biological Materials for Research". Anonymized tissue will not be released because it is not within our mission to function as a tissue bank for extramural investigators.
   
   
2. The requester must provide billing information on the request form so that the reference lab may bill for the service. Shipping will be billed to the requester’s account specified on the request.
    
3. To obtain linked material, the extramural Principal Investigator (PI) must have an Institutional Review Board (IRB)-approved protocol and consent for this acquisition. The TRC Reviewer must verify the form is complete. The patient (or guardian) signature is required.
   
   
4. Because of the Privacy Act, no personally identified (linked) samples (materials) can be shared even if the outside IRB has waived consent. The Privacy Act does not apply if the patient is deceased.
   
   
5. The extramural PI must certify this request.
   
   
6. Materials cannot be released unless sufficient diagnostic material is available for NIH archives.
   
   
7. In accord with the CC Medical Administrative Policy M01-2, these requests require approval by the PI of the protocol under which the tissue was collected or the institute Clinical Director.
   
   
8. The TRC Reviewer reviews the request and records the outcome (e.g., recuts will be sent on XX/XX/XX, denied/incomplete form, etc.) and signs the form. The Clinical Manager and Archivist will coordinate release of patient material.

Resources: NIH Office of Technology Transfer