Before a research project can begin, the Trust has to ensure that the project is compliant with applicable research legislations including the DH Research Governance Framework (RGF), that necessary approvals have been obtained and, if appropriate, contractual agreements with third parties put in place. The Trust’s processes and responsibilities for ensuring compliance with the RGF are set out in its research governance policy.
Our research approval process is supplemented by a comprehensive suite of policies, procedures and guidance documents to assist researchers through these processes. In addition and to support the timely set-up and delivery of research studies, the Research Office has produced a guidance document on increasing recruitment and delivery of clinical research which provides additional practical help and issues to consider prior to initiating research studies at the Trust.
It can sometimes be unclear whether a project should be classified as research, audit or service evaluation. The Research Office and Quality and Safety Department has developed a guidance document to assist and provide advice on these distinctions
The research approval process
All research projects conducted within the Trust must be formally approved by the Research Office, through the local NHS Permissions Process (previously known as R&D approval). RB&HFT NHS Permission must be obtained before the study can start.
NHS permission ensures that:
study processes to support the delivery of the study are agreed and documented
RB&HFT is aware of the potential impact of the research in terms of risks, resources, financial and legal implications and has made the necessary arrangements to support the activity
appropriate insurance arrangements are in place in case of clinical negligence claims arising during the course of the research.
RB&HFT NHS permission may require several other checks and approvals, undertaken in parallel, but which must be in place before NHS permission can be granted. These include:
In addition, the Research Office will also assess whether contractual agreements with external third parties are required in order to protect the interests of the Trust and its patients prior to Trust NHS Permission.
Patient and public involvement and engagement
Patient and public involvement and engagement (PPI) is an important part of research and all researchers are actively encouraged to include PPI in their research.
The Trust PPI leads have produced PPI guidance and resources which provide help and advice on carrying out PPI for your study.