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Pathology Laboratory Policies and Procedures for Releasing Diagnostic Tissue for Cancer Research
Yao Yuan1, Alison L Van Dyke1, Valentina I Petkov1
1The Surveillance Research Program, Division of Cancer Control and Population Sciences (Yuan, Van Dyke, Petkov, Hussey, Penberthy), National Cancer Institute, National Institutes of Health, Rockville, Maryland.
Archives of Pathology & Laboratory Medicine
|January 27, 2021
Summary
Pathology labs are willing to share formalin-fixed, paraffin-embedded (FFPE) tissue for cancer research. However, understanding and standardizing institutional policies for sharing deidentified tissue is crucial for program feasibility.
Area of Science:
- Oncology
- Pathology
- Public Health Surveillance
Background:
- The Surveillance, Epidemiology, and End Results (SEER) program is exploring the use of archival formalin-fixed, paraffin-embedded (FFPE) tissue for cancer research.
- Assessing laboratory policies for tissue sharing is vital for the feasibility of this initiative.
Purpose of the Study:
- To determine pathology laboratories' willingness to share archival diagnostic tissue for cancer research.
- To understand the policies governing the sharing of FFPE tissue specimens.
Main Methods:
- A 27-item questionnaire was administered to pathology laboratories within seven SEER registry catchment areas.
- Analysis included only laboratories processing diagnostic FFPE specimens and completing the survey.
Main Results:
- 83% of responding laboratories process FFPE specimens.
- 69% of laboratories are willing to share tissue for research, irrespective of processing volume.
- Most laboratories retain specimens for at least 10 years, but institutional policies on sharing deidentified tissue vary significantly, with 43% unaware of their terms.
Conclusions:
- Pathology laboratories show a general willingness to contribute FFPE tissue for research purposes.
- Significant variability in institutional policies and lack of awareness regarding tissue sharing terms necessitate closer collaboration between SEER registries and laboratories.
- Understanding and harmonizing policies and state legislation on tissue retention and guardianship are critical for successful research tissue programs.
