Pathology and regulation for research in the UK: An overview [version 2; peer review: 3 approved]

Driskell, O. J., Lee, J. L., Oien, K. A. , Hall, A., Verrill, C. and CM-Path QA Panel, . (2019) Pathology and regulation for research in the UK: An overview [version 2; peer review: 3 approved]. F1000Research, 8, 975. (doi: 10.12688/f1000research.19732.2) (PMID:31448108) (PMCID:PMC6694446)

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The input of pathologists is essential for the conduct of many forms of research, including clinical trials. As the custodians of patient samples, pathology departments have a duty to ensure compliance with the relevant regulations, standards and guidelines to ensure the ethical and effective use for their intended investigational analysis, including when patients are participating in a research study. The results of research studies have impacts beyond the research study itself as they may inform changes in policy and practice or support the licensing of medicines and devices. Compliance with regulations and standards provides public assurance that the rights, safety and wellbeing of research participants are protected, that the data have been collected and processed to ensure their integrity and that the research will achieve its purpose. The requirements of the regulatory environment should not be seen as a barrier to research and should not significantly impact on the work of the laboratory once established and integrated into practice. This paper highlights important regulations, policy, standards and available guidance documents that apply to research involving NHS pathology departments and academic laboratories that are contributing to research involving human subjects.

Item Type:Articles
Additional Information:The CM-Path initiative and QA Panel is supported by the National Cancer Research Institute (NCRI). OJD is funded by the National Institute for Health Research (NIHR) Clinical Research Network West Midlands and is a member of the CM-Path Clinical Trials Working Group supported by the NCRI. CV is funded by the Oxford NIHR Biomedical Research Centre.
Glasgow Author(s) Enlighten ID:Oien, Professor Karin
Authors: Driskell, O. J., Lee, J. L., Oien, K. A., Hall, A., Verrill, C., and CM-Path QA Panel, .
College/School:College of Medical Veterinary and Life Sciences > Institute of Cancer Sciences
Journal Name:F1000Research
ISSN (Online):2046-1402
Copyright Holders:Copyright © 2019 Driskell OJ et al.
First Published:First published in F1000Research 8:975
Publisher Policy:Reproduced under a creative commons licence

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