NHS Research Scotland definition
Research Governance concerns setting standards to improve research quality and safeguard the public. It involves enhancing ethical and scientific quality, promoting good practice, reducing adverse incidents, ensuring lessons are learned and preventing poor performance and misconduct.
A broad range of regulations, principles and standards of good practice exist to achieve, and continuously improve, research quality across all aspects of healthcare in the UK and worldwide.
Research governance applies to everyone connected to healthcare research including Chief investigators, health care professionals, researchers, and support staff.
Introduction
Research Governance is essential for the conduct of research on humans and encompasses regulations, good practices, and world- wide collaboration to create an environment ensuring safety of the participants while conducting the studies and trials and the collection and analysis of data to quality standards.
The Research Governance team at NHS Greater Glasgow and Clyde is a support department to researchers and teams and is made up a range of highly qualified individuals such as PhD level scientists with research and Industrial experience, an engineer, auditors and monitors with key skills in QA, clinical trials, Industry, medical devices, drug development, Intellectual property and safety.
The team provide Sponsor support starting from the grant stage of a study, to protocol development, to assessing vendors, to identifying and managing risk and overseeing the conduct of the study, to managing non-compliances, protocol deviations and serious breaches of GCP. This activity covers hundreds of sites across the UK and internationally as NHS GG&C and Glasgow University researchers lead on worldwide research.
The QA team carry out GCP audits, a requirement of the Clinical Trial Regulations, engage with third parties to audit our own activities and provide a Quality system for the production and maintenance of SOPS incorporating all of the departments involved in research e.g. Imaging, safehaven, Bio repository.
The team activity is inspected by the MHRA during Regulatory Sponsor inspections. The Governance manager is a lead for these inspections involving all departments and other organisations. Together with the QA manager they manage the outcomes of inspections and ensure that the findings are addressed.
The Team are also responsible for the oversight of other studies such as surgical, medical devices and hosted studies including commercial and other academic led studies. Due to limited resources this is managed by assessing risk and focusing on areas which may potentially pose safety or quality issues.
During the 2020 COVID-19 pandemic the team led the development and implementation of a process to oversee safety of research participants still taking part in sponsored clinical research led by NHSGGC and its partners.