This process is based on the IRAS application. This is a two part form. One for gaining ethical approval for the study and second is to gain NHS permission for the study to commence. Before you start the study you also have to gain R&D approval from the Trust for the project to go ahead on the Trust premises.
Check with R&D Department if an ethics approval is required for a project. Depending on the scope of the research you may only require an ethics approval from a Research Ethics Committee. Additional approvals may be needed from other organisations e.g MHRA (for medicines and medical devices) or GTAC (gene technology). The necessary forms for the submissions to these agencies can now be completed through the national Integrated Research Application System (IRAS).
All research projects undertaken at London North West Healthcare NHS Trust is logged onto the R&D database and a unique identifier is allocated to the study.
Gaining ethics approval
Before submitting to the Research Ethics Committee you should obtain guidance from the R&D Office. Please contact Sunder Chita on 020 8869 5829 or Simon Lewis on 020 8869 5173.
All research studies require a sponsor, funding and the scientific value of the research assessed by means of independent external peer review.
The sponsor of the study is the organisation who takes on the overall responsibility for the research and this could be the Trust, a charity, other trust, university or a commercial organisation.
All research studies should be appropriately sponsored and funded to cover the costs of the research procedures, researchers time and use of facilities. Further information on costing and funding can be obtained from Mita Vithlani on 020 8869 5286.
The main forms required to gain ethics approval include:
Gaining Trust R&D approval
The Research Governance Framework requires that all research undertaken in the NHS requires Trust R&D approval before it commences.
Please note that in most of the research projects a setup fee will be charged to the relevant departments. For further information on this please check with R&D finance Manager before embarking on the project.
R&D approval involves a number of elements, including:
- Assessment of the scientific quality of the proposal (if it has not already undergone peer review);
- Ensuring that the project has received a final favourable opinion from a Research Ethics Committee
- Ensuring that the financial and resource implications of the project are understood;
- Ensuring that adequate information has been obtained for registration of the project on the R&D database and, where appropriate, subsequent publication on the National Research Register
- Ensuring that all researchers have substantive or honorary contracts with the organisation hosting the research;
- Ensuring that the project has the support and approval of the management of the relevant Clinical Directorates and support departments;
- Ensuring that any formal agreements or contracts with external bodies have been finalised;
- A decision, in the case of “own account” projects (ie those with no external funding), whether the Trust will take on the role of sponsor of the project (as defined in the Research Governance Framework)
Procedures for obtaining R&D approval
Applications are reviewed on a first come first serve basis, usually within five days of arrival. If additional documents are required the person reviewing the application will request these and inform you of the next steps.
R&D approval cannot be issued until confirmation of REC favourable opinion has been received, however you may receive a conditional approval based on R&D review, final decision pending REC opinion.
When the appropriate ethics approval is in place and before the study can commence, R&D needs to undertake a governance assessment of the study to confirm that the research will be carried out safely using the hospitals facilities and in line with appropriate policies and procedures together with national and EU legislation.
All departments involved in research need to be aware of the study and are happy that there are appropriate resources in place to undertake this research. All studies are reviewed by the Health Service Research Manager (020 8869 5829) and the Governance Manager (020 8869 5173) and where applicable, other support departments, depending on the type of the study.
These approvals have been put in place to adhere to the Research Governance Framework, EU Directive and other Regulatory Frameworks. They are also vital to protect patients and their data as well as to protect the researchers and their sponsoring organisation from avoidable risks.
When ethics approval and the governance checks are complete, Trust R&D approval is issued. The study can only commence once R&D approval has been granted.
For further information on documents required for R&D approval please see document checklist in the Document Library