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. 2021 Feb 1;145(2):222-226.
doi: 10.5858/arpa.2019-0474-OA.

Pathology Laboratory Policies and Procedures for Releasing Diagnostic Tissue for Cancer Research

Yao Yuan  1 , Alison L Van Dyke  1 , Valentina I Petkov  1 , Sarah Hussey  1 , Radim Moravec  2 , Sean F Altekruse  3 , Mayra Sandoval  4 , Rosemary D Cress  4 , Lloyd M Mueller  5 , Alan Mogi  6 , Brenda Y Hernandez  6 , Freda R Selk  7 , Charles F Lynch  7 , Thomas C Tucker  8 , Mary Anne Lynch  9 , Christina Lefante  9 , Xiao-Cheng Wu  9 , Carol Sweeney  10 , Jennifer A Doherty  10   11 , Lynne S Penberthy  1
Affiliations

Pathology Laboratory Policies and Procedures for Releasing Diagnostic Tissue for Cancer Research

Yao Yuan et al. Arch Pathol Lab Med. .

Abstract

Context.—: The Surveillance, Epidemiology, and End Results (SEER) cancer registry program is currently evaluating the use of archival, diagnostic, formalin-fixed, paraffin-embedded (FFPE) tissue obtained through SEER cancer registries, functioning as honest brokers for deidentified tissue and associated data. To determine the feasibility of this potential program, laboratory policies for sharing tissue for research needed to be assessed.

Objective.—: To understand the willingness of pathology laboratories to share archival diagnostic tissue for cancer research and related policies.

Design.—: Seven SEER registries administered a 27-item questionnaire to pathology laboratories within their respective registry catchment areas. Only laboratories that processed diagnostic FFPE specimens and completed the questionnaire were included in the analysis.

Results.—: Of the 153 responding laboratories, 127 (83%) responded that they process FFPE specimens. Most (n = 88; 69%) were willing to share tissue specimens for research, which was not associated with the number of blocks processed per year by the laboratories. Most laboratories retained the specimens for at least 10 years. Institutional regulatory policies on sharing deidentified tissue varied considerably, ranging from requiring a full Institutional Review Board review to considering such use exempt from Institutional Review Board review, and 43% (55 of 127) of the laboratories did not know their terms for sharing tissue for research.

Conclusions.—: This project indicated a general willingness of pathology laboratories to participate in research by sharing FFPE tissue. Given the variability of research policies across laboratories, it is critical for each SEER registry to work with laboratories in their catchment area to understand such policies and state legislation regulating tissue retention and guardianship.

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Conflict of interest statement

The authors have no relevant financial interest in the products or companies described in this article.

Figures

Figure 1.
Figure 1.
Pathology laboratories’ current practice on sharing of biospecimens or providing other resources or services for research use (n = 127). The willingness to share different types of biospecimens for research use (A), and the willingness of providing other resources or services for research (B). Abbreviation: FNA, fine-needle aspiration.
Figure 2.
Figure 2.
Regulatory requirements for research using biospecimens among laboratories processing formalin-fixed, paraffin-embedded blocks (n = 127). A, Terms of research consent required for pathology laboratories to provide tissue specimens for research. B, Institutional Review Board (IRB) protocols required by pathology laboratories.
See this image and copyright information in PMC

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