TY - JOUR
T1 - Pathology laboratory policies and procedures for releasing diagnostic tissue for cancer research
AU - Yuan, Yao
AU - van Dyke, Alison L.
AU - Petkov, Valentina I.
AU - Hussey, Sarah
AU - Moravec, Radim
AU - Altekruse, Sean F.
AU - Sandoval, Mayra
AU - Cress, Rosemary D.
AU - Mueller, Lloyd M.
AU - Mogi, Alan
AU - Hernandez, Brenda Y.
AU - Selk, Freda R.
AU - Lynch, Charles F.
AU - Tucker, Thomas C.
AU - Lynch, Mary Anne
AU - Lefante, Christina
AU - Wu, Xiao Cheng
AU - Sweeney, Carol
AU - Doherty, Jennifer A.
AU - Penberthy, Lynne S.
N1 - Publisher Copyright:
© 2021 College of American Pathologists. All rights reserved.
PY - 2021/2
Y1 - 2021/2
N2 - 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.
AB - 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.
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U2 - 10.5858/arpa.2019-0474-OA
DO - 10.5858/arpa.2019-0474-OA
M3 - Article
C2 - 33501497
AN - SCOPUS:85100485732
SN - 0003-9985
VL - 145
SP - 222
EP - 226
JO - Archives of Pathology and Laboratory Medicine
JF - Archives of Pathology and Laboratory Medicine
IS - 2
ER -