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, 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.

Keywords: CTIMP; Clinical Trial; GCP; HTA; MHRA; Quality Management; Research governance; Research regulation.

Figure 1.. Involvement of pathology along the research study pathway.

The pathology laboratory has different potential functions along the study pathway. Pathologists may be leading the Research Generation (green), e.g. coming up with the research question, applying for funding, writing up the research or providing pathology expertise to these activities as part of a multidisciplinary team. Pathologists may also be responsible for providing supporting Research Delivery activities (blue) for studies from outside researchers, e.g. assessing research protocols for local delivery and providing service activities such as reporting on or arranging the release of diagnostic tissue to research centres.