What does ‘Governance’ mean?
In the context of clinical research, it refers to the process of approval for a clinical trial to occur within an NHS trust.
In 2005 the Department of Health (DH) issued guidance which outlined that all organisations providing care must be aware of all research that it is hosting or any research activity involving participants, organs tissue or data, which is obtained through that organisation.
How does it work in Leicester’s Hospitals?
In Leicester, all research activity which involve NHS staff, patients, patient samples, patient records or facilities should be registered with our Research and Innovation team and may require approval from both the Trust and the relevant Research Ethics Committee (REC).
Are the processes the same for all research?
There are many different types of research, some of which require further complex approvals. This could be from (but not limited to):
- Medicines for Healthcare Regulatory Authority (MHRA)
- Gene Therapy Advisory Committee (GTAC)
- National Information Governance Board.
Many research applications will also be required to adhere to UK legislation, such as:
Who do I need to speak to about this?
Currently at Leicester’s Hospitals, there are separate offices for managing research. Studies adopted onto the National Institute for Health Research Portfolio are managed through the Clinical Research Network: East Midlands. Studies that are not on the NIHR Portfolio are managed through the Trust approvals process within the Research and Innovation team.
It is essential that you contact a member of staff in the Research and Innovation team as soon as possible. Early contact with the office can help enormously with the speed of approval. We deal with the Regulatory framework on a daily basis and can help you to navigate through the process.
What else should I know?
Owing to upcoming changes to the HRA process, our current structure and approvals process are likely to change within 2015/16. We will keep this page updated as to how that may affect you when the changes are implemented.
If you have any further queries or would like to speak to a member of our team, please complete the form below: