Pathology and regulation for research in the UK: an overview.

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ID: 18649
2019
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Abstract
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. This includes where 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.
Reference Key
driskell2019pathologyf1000research Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors Driskell, Owen John;Lee, Jessica;Oien, Karin;Hall, Andy;Verrill, Clare;, ;
Journal F1000Research
Year 2019
DOI
10.12688/f1000research.19732.1
URL
Keywords Keywords not found

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