All research carried out in the NHS needs to have research governance approval. This involves all projects which recruit NHS patients and/or staff or which use NHS facilities.
The R&D approvals process has been put in place to protect both the participants and the investigators. It therefore needs to be a robust process and this is why we require lots of information.
NUH will provide a framework for research which complies with good clinical practice, without restricting the freedom of individual researchers to develop ideas which can improve clinical care.
An expert team of professional governance staff, with direct research experience, will engage with investigators in the Trust to develop a culture of support and mentorship. A structured risk assessment approach will be adopted in order to identify key issues very early in the project lifecycle in order to minimise bureaucratic delays. As part of the approvals of research submissions procedure, all projects will be processed within a median period of 30 days of their valid submission and we will conduct regular audit of each stage of the research approval process.
There are two parts to gaining the required approval for studies to begin recruiting at NUH, the Research Ethics Committee Process and the local NUH process.
For a step by step process of applying to REC and completing IRAS, and the NUH submissions process please see the pdf documents below.
ATTENDING A REC COMMITTEE
Between 7 and 18 members of the Research Ethics Committee (REC) will be present, together with the coordinator. It is a formal meeting but the REC aim to make this a positive and helpful experience. The REC will be unable to let you know their decision on the day of the meeting.
You should be ready to clarify any ethical issues that REC may raise so it is important that you are prepared, with hard copies of your documents.
The REC’s decision with be sent to you in writing within 10 days of the meeting, The letter will contain details of any revisions or clarifications that the REC required and may also offer suggestions on your research. A REC is required to give an ethical opinion on an application within 60 calendar days of the receipt of valid application. Where REC considers that further information is required in order to give an opinion, it may make a request in writing for further information. The period of 60 days will be suspended pending receipt of this information