Pathology laboratory policies and procedures for releasing diagnostic tissue for cancer research

Yao Yuan, Alison L. van Dyke, Valentina I. Petkov, Sarah Hussey, Radim Moravec, Sean F. Altekruse, Mayra Sandoval, Rosemary D. Cress, Lloyd M. Mueller, Alan Mogi, Brenda Y. Hernandez, Freda R. Selk, Charles F. Lynch, Thomas C. Tucker, Mary Anne Lynch, Christina Lefante, Xiao Cheng Wu, Carol Sweeney, Jennifer A. Doherty, Lynne S. Penberthy

Research output: Contribution to journalArticlepeer-review

1 Scopus citations


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 ¼ 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.

Original languageEnglish
Pages (from-to)222-226
Number of pages5
JournalArchives of Pathology and Laboratory Medicine
Issue number2
StatePublished - Feb 2021

Bibliographical note

Funding Information:
This study was funded by the National Institutes of Health through contracts HHSN261201300009I, HHSN261201300013I, HHSN261201300014I, HHSN261201300016I, HHSN261201300019I, HHSN261201300020I issued to the 6 SEER cancer registries. The authors have no relevant financial interest in the products or companies described in this article.

Publisher Copyright:
© 2021 College of American Pathologists. All rights reserved.

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Medical Laboratory Technology


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