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Barriers to the release of human tissue for clinical trials research in the UK: a national survey of cellular pathology laboratories on behalf of the National Cancer Research Institute’s Cellular Molecular Pathology (CM-Path) initiative
  1. Philip S Macklin1,
  2. Andrew Hall2,
  3. Jessica Lee3,
  4. Jane Hair4,
  5. Valerie Speirs5,6,
  6. Gareth J Thomas7,
  7. Karin A Oien8,
  8. Clare Verrill1,9
  1. 1 Department of Cellular Pathology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
  2. 2 Northern Institute for Cancer Research, Newcastle University, Newcastle upon Tyne, UK
  3. 3 Strategy and Initiatives, National Cancer Research Institute, London, UK
  4. 4 Greater Glasgow and Clyde Bio-repository, Department of Pathology, Queen Elizabeth University Hospital, Glasgow, UK
  5. 5 Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK
  6. 6 Institute of Medical Sciences, University of Aberdeen, Aberdeen, UK
  7. 7 Cancer Sciences Unit, University of Southampton, Southampton, UK
  8. 8 Department of Pathology, Southern General Hospital, Glasgow, UK
  9. 9 Nuffield Department of Surgical Sciences and NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK
  1. Correspondence to Dr Philip S Macklin, Department of Cellular Pathology, Oxford University Hospitals NHS Foundation Trust, Oxford, OX3 9DU, UK; philip.macklin{at}ouh.nhs.uk

Abstract

Aim To survey UK cellular pathology departments regarding their attitudes and practices relating to release of human tissue from their diagnostic archives for use in clinical trial research.

Methods A 30-item questionnaire was circulated to the National Cancer Research Institute’s Cellular Molecular Pathology initiative and Confederation of Cancer Biobanks mailing lists. Responses were collected over a 10-month period from November 2016 to August 2017.

Results 38 departments responded to the survey, the majority of which regularly receive requests for tissue for research purposes. Most requests come from academia and financial support to facilitate tissue release comes from a variety of sources. A range of practices were reported in relation to selection of the most appropriate sample to release, consent checking, costing and governance frameworks.

Conclusions This survey demonstrates wide variation in practice across the UK and identifies barriers to release of human tissue for clinical trial research. Until we can overcome these obstacles, patient samples will remain inaccessible to research. Therefore, this study highlights the urgent need for clear and coordinated national guidance on this issue.

  • cancer
  • cancer research
  • laboratory management

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Footnotes

  • Handling editor Runjan Chetty.

  • Contributors Conceptualisation: PSM, AH, JH, VS, GJT, KAO, CV. Methodology: PSM, AH, JH, VS, GJT, KAO, CV. Investigation: PSM, JL. Formal analysis: PSM, CV. Resources: PSM, JL. Data curation: PSM, JL. Writing—original draft: PSM, CV. Writing—review and editing: PSM, AH, JL, JH, VS, GJT, KAO, CV. Visualisation: PSM. Supervision: CV. Project administration: JL. Funding acquisition: not applicable.

  • Funding The NCRI’s CM-Path initiative was established in 2016 with the aim of reinvigorating academic pathology. It is funded as a collaborative venture between 10 of the NCRI partner organisations: Bloodwise, Breast Cancer Now, Cancer Research UK, the Chief Scientist Office (Scotland), the Department of Health and Social Care (England), Health and Care Research Wales, Health and Social Care (Northern Ireland), the Medical Research Council, Prostate Cancer UK and Tenovus Cancer Care. These organisations did not participate in study design; collection, analysis and interpretation of data; writing the report or the decision to submit the paper for publication.

  • Competing interests KAO reports grants from the National Cancer Research Institute during the conduct of the study; grants from Leica Biosystems, grants from Qiagen, non-financial support from ThermoFisher, non-financial support from Illumina, non-financial support from Aridhia, non-financial support from Sistemic, non-financial support from BioClavis, non-financial support from Biotheranostics, outside the submitted work. CV reports other from National Cancer Research Institute CM-Path, other from NIHR Oxford Biomedical Research Centre (BRC), other from CRUK Oxford Cancer Centre, during the conduct of the study. PSM, AH, JL, JH, VS and GJT have nothing to disclose.

  • Patient consent Not required.

  • Provenance and peer review Not commissioned; internally peer reviewed.

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