Pathology and regulation for research in the UK: an overview

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.

Contribution of Pathologists in Leading Clinical Cancer Research Through Interdisciplinary Collaboration in Saudi Arabia

“…The involvement of pathologists is essential in preclinical, as well as in clinical cancer research [ 5 , 12 ]. In Saudi Arabia, most of the clinical cancer research was led by pathologists [ 8 ].…”

“…While clinical cancer research is often led by oncologists, there are important aspects that require the integration of laboratory-based and preclinical knowledge. This is achieved through interdisciplinary collaboration between oncologists, pathologists, and laboratory scientists [ 5 - 6 ]. Such collaboration is required to advance research, especially in the era of “big data” [ 7 ].…”

The important role of the histopathologist in clinical trials: challenges and approaches to tackle them

“…Histopathology staff providing support activity to a clinical trial must be adequately qualified, trained and experienced to assume clinical research responsibilities 15 . The research regulations, standards and guidelines that apply to pathology departments in the United Kingdom have been reviewed in recent papers from CM‐Path 16,17 . Clinical trials regulations and professional standards require staff to be trained commensurate with their roles, and staff should be able to provide up‐to‐date training records and/or curriculum vitae.…”