Request for Human Biological Materials for Research

Intramural Request for Archived Human Biological MaterialReference Lab RequestsOHSRP Exempt ApplicationTRC Request FormExtramural Requests

Purpose and Guidelines 

This procedure is written under the direction of the Tissue Resource Committee (TRC). In June 2000, the Medical Executive Committee constituted a Tissue Resource Committee to formulate guidance regarding the procurement and use of human tissues for research. The committee addressed issues of human subjects protections and implementation of a documentation system for tissue acquisition and transfer in the NIH Clinical Center (CC) and to non-NIH investigators. Additionally, the committee sought to delineate the differences in handling tissue specimens obtained for clinical care as opposed to research, and to protect investigators’ access to tissues collected under protocols, while providing access of others to the archival CC specimen collection (the Archive) curated by the Laboratory of Pathology (LP). See M01-2 (rev.), “Procurement and Use of Human Biological MM01-2 (rev.), “Procurement and Use of Human Biological Materials for Research Materials for Research for the CC Medical Executive Committee policy.

Release of any patient materials from the archive (e.g., specimen, blocks, slides, or reports) for research must be approved by the TRC. 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.

All studies using materials from living patients must have proper Institutional Review Board (IRB) approval or Office of Human Subjects Research (OHSR) exemption. IRB approval is necessary if the request requires samples linked to patient identification or any study that uses patient information other than age, sex, and diagnosis (i.e., clinical outcome).

An OHSR exemption is required for non-protocol material, such as anonymized material (i.e., unlinked, with no patient identifiers and therefore cannot be correlated with patient’s clinical course or clinical outcomes, etc.). It is the responsibility of the requestor to obtain the appropriate OHSR approval before requesting resources through LP. Age, sex, diagnosis, and source may be provided for OHSR-exempted requests.

Neither IRB approval nor OHSR exemption is required for materials from deceased patients. For release of material from non-living patients, the requester must certify the expiration of the patient.

The use of tissues for controls in diagnostics tests (e.g., block used as a control for an immunoperoxidase stain) performed for diagnosis (tests performed in a CLIA- or CAP-approved laboratory) is exempted from this process.

Specimens prospectively collected for particular protocols are protected from non-protocol-specific research. General policies are listed below to provide general guidance.