REGI
REGI stands for Research Ethics, Governance and Integrity Team. The team manages the University of Birmingham’s sponsorship of clinical research projects, in line with the principles of good practice set out in the UK Policy Framework for Health and Social Care Research. If you are interested in UoB sponsorship for a clinical research project, see Applying for University of Birmingham Sponsorship.
You should also contact the REGI if you have any queries regarding their other areas of responsibility, as listed below.
- Reporting: throughout the duration of the research, the REGI will monitor annual report submissions to the Research Ethics Committee (REC) and if applicable, to a competent authority such as the MHRA.
- Site agreement: the REGI is responsible for establishing agreements with participating sites.
- Insurance: the REGI ensures that research projects have appropriate insurance cover.
The REGI also facilitates the University’s research ethics processes for all staff and postgraduate student research projects. The team works with the University’s Humanities and Social Sciences (HASS) and Science, Technology, Engineering and Mathematics (STEM) research ethics committees to ensure that all research projects requiring University ethics review receive this as appropriate. For more information, see Research ethics – what do I need to do?
CRCT
CRCT stands for Clinical Research Compliance Team (CRCT). The CRCT helps to ensure clinical research projects, in particular clinical trials, are conducted in line with any applicable regulations, international standards, and the university’s own standards.
The CRCT develops and maintains the UoB Quality Management System (QMS), and supports researchers in developing their own documentation. The team also provides training and support to researchers, to help them to ensure that their clinical research projects comply with applicable regulations and standards.
The CRCT is responsible for carrying out compliance reviews across the university’s clinical research portfolio. The CRCT assesses a project’s compliance against applicable regulations and standards, using either the:
- sponsor support visit (SSV) programme
- audit programme.
For further detail about SSVs and audits, see the FAQ ‘What is the difference between an SSV and an audit?’
How does an NHS trust’s R&D department fit in?
R&D stands for research and development. If a clinical research project uses NHS premises, or involves NHS participants (staff or patients), researchers will need additional approval from the relevant NHS trust’s R&D department. This approval process is automatically included as part of the Health Research Authority (HRA) approval completed via the Integrated Research Application System (IRAS). However researchers are encouraged, at an early stage, to liaise directly with the relevant trust’s R&D department to ensure that the trust is able to facilitate the proposed research project.