Step 1 - Obtain advice
You can get advice about your proposed research from the R&D Office. You may also find it helpful to discuss the proposed research with the appropriate AWP specialty or locality R&D representative.
Undergraduate and postgraduate students should seek advice from their university and supervisor.
The South West Research Design Service provides advice and support with preparing your research proposal if you are applying via the NIHR funding scheme, or to national, peer reviewed funding competitions for applied health or social care research.
Step 2 - Write a research protocol
A protocol is needed both for review by the research ethics committee and for R&D permission. A research protocol should cover the following:
- Summary of design and methods
- Principal research question
- Aims and objectives
- Sample group description
- Sample size
- Brief scientific background
- Summary of proposed data analysis
- Outcome measures
- Study setting
- Potential benefit and/or impact of R&D
- University links and collaborations
- Project management
- Version and date
Step 3 - Obtain a sponsor's agreement
The Department of Health's Research Governance Framework requires all research to have a formal (research governance) Sponsor. A key responsibility for the Sponsor is to ensure that the research protocol is of the appropriate standard.
- External Sponsor (non AWP) - You will need to get written confirmation from your Sponsor that they have peer reviewed your protocol and will act as sponsor, unless the Sponsor is a formal partner of the NHS (MRC, DH, Wellcome Trust).
- AWP as Sponsor - Peer review is an essential part of AWP acting as sponsor and is required before an application for ethics review can be made. You will need to contact the R&D office for further information to request sponsorship.
- Student studies - These require the protocol to be approved by the academic supervisor, who is therefore the sponsor.
- Commercial studies - AWP will need to satisfy itself of the level of independent review undertaken.
- Clinical trial of a medicinal product - For arrangements for sponsorship for medicinal product trials, please see the ponsorship page.
If you are in any doubt about whether your protocol needs further review, please contact the R&D Office at an early stage to avoid delays.
Step 4 - Gain an ethics opinion
Research ethics review is needed for all research that involves any of the following:
- Patients, clients or service users of the NHS, or participants recruited by virtue of the patient or service user's past or present treatment.
- Participants identified due to their status as relatives or carers of the above.
- Access to data/records or organs.
- Access to NHS premises.
If your research study does not need NHS Research Ethics Committee (REC) review, please contact the R&D Office to discuss what information is required to start your study.
To make an application, you will need to use the online Integrated Research Application System (IRAS).
For research that falls within the following categories Research Ethics Form (REC): need to be submitted.
- Clinical trials of investigational medicinal products (CTIMPs) apart from Phase 1 CTIMPs in healthy volunteers only (CAS will provide an agenda identification service for NHS Type 1 RECs which can review Phase 1 CTIMPs in healthy volunteers)
- Research involving medical devices
- Research involving prisoners
- Research involving adults lacking capacity
The REC form should be submitted via IRAS.
Social Care Research Ethics Committee
The Social Care Research Ethics Committee is now also reviewing studies taking place in NHS settings with NHS staff and patients where the approach to data collection uses social science or qualitative methods, provided that the research does not involve any change in treatment or clinical practice.
A study collecting patients' views of care and treatment through structured questionnaires or qualitative interviews would be an example of this type of study. It meets in London. The opinion given by the Social Care REC is equivalent to that of any other NRES REC.
Step 5 - Gain AWP permission
In R&D, we pride ourselves on a fast and efficient permission process to help research can get underway as quickly as possible.
R&D Permission is required for all studies that involve our service users, carers or staff. We need to do this to ensure we are complying with the Research Governance Framework and to make sure service user (or staff) rights and wellbeing are protected at all times.
This permission will also include making sure there are services within the Trust able to support you in completing your research in the Trust. Please let the R&D department know whether you have already identified someone in the Trust who will be assisting you. If you haven't, then R&D can help you find someone.
AWP R&D Permission must be sought even if there is no local Principal Investigator or local collaborator in AWP, but you wish to carry out your research with staff, service users or carers who use AWP services.
If your study does not need NHS Research Ethics Committee (REC) review, please contact the AWP R&D Office for a specific application for R&D permission.
If you have any queries or questions please do not hesitate to contact us. We will be more than happy to help.