Broadly speaking, a research project will require review by an NHS Research Ethics Committee (NHS REC) if you will be working with individuals, or the data of individuals, identified as a result of their use of an NHS service. This usually means patients but also extends to other 'service users' such as carers and family members.
The University of Bristol requires that any research involving relevant material, as defined by the Human Tissue Act, be conducted under NHS REC approval.
The laws and guidance covering the need for NHS REC review can be complicated and vary between the devolved nations. If you are unsure whether you require review, it is best to refer to the NHS REC Decision Tool. If you are unsure whether your project is Research, from an NHS perspective, start with the Research Decision Tool.
If your project does not require review by an NHS REC but does involve human participants or their data, it will require review by a Univerisity of Bristol Research Ethics Committee.
Projects should generally only be reviewed by a single REC, so if you apply to NHS REC review you will not need any other Research Ethics review (other than in exceptional circumstances, such as a funder requiring review according to their own process).
If your project does need NHS REC approval, you will need a Sponsor and will need to apply via IRAS. Once the IRAS form is drafted, and has been approved by your Sponsor, you will need to request an appointment with a Committee, via the Online Booking Service.
Depending on the specifics of your study, you may be offered a place with a committee 'flagged' for a specialist area involved or you may simply be offered a choice of times with the next committees who have capacity.
It is generally expected that the Chief Investigator will be available to attend the meeting and answer any questions that the committee may have. This will always be remotely – by phone or video conference – so the location of the committee is not important.
Research in social care settings will require NHS REC review if:
There are currently three committees 'flagged' to review research in Social Care settings.
This will vary considerably depending upon the nature and complexity of the study, but you should allow for up to four weeks for review and revisions, once all relevant documents (IRAS, Protocol, PIS, Consent Forms, OID etc.) have been provided to Research Governance.
A REC is required to give an ethical opinion on an application within 60 calendar days of the receipt of a valid application.
If you chose not to attend the first meeting available, the 60 calendar days will start from the cut-off date for the meeting (which is 14 calendar days before the meeting date). Where the REC considers that further information is required in order to give an opinion, it may make one request in writing for further information. The period of 60 days will be suspended pending receipt of this information.
