Trust (R&D) Confirmation Process at The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

If you are hoping to start a research project in the NHS, there are a number of procedures to go through. We are able to offer you assistance through the process and paperwork and we are able to direct you to the appropriate support personnel for help with other aspects of your work. If you are new to the process and need to know where to start, or if you are already an experienced researcher, or are partially through the system, The Clinical Trials Toolkit has a wealth of information to answer your specific queries, follow the links to the areas which concern you.

Applications for ethical approval and for other approvals necessary for a project can be made online via the Integrated Research Application System (IRAS), which can be accessed at: This system streamlines the process for seeking relevant approvals by ensuring that, as far as possible, details only need to be entered once for a single project and much of the form is then self-populated.

For anyone considering starting a research project, we recommend contacting us as soon as possible to discuss your project requirements and guide you through the process.

Application for Trust (R&D) Confirmation

‘R&D Confirmation’ relates to the process of reviewing and checking applications for research to take place within an individual NHS organisation, prior to giving written permission. More recently, it is also frequently referred to as NHS Permission and previously would have been known as Trust (R&D) Approval.

In most NHS organisations, an R&D office is responsible for carrying out these checks before permission is given by the research director or a delegated senior person.

The R&D office provides a single point of entry and contact for all applications for Trust (R&D) approval.

We continue to use the online Integrated Research Application System in the new system of HRA Approvals. It is worth noting that SSI forms will no longer be used in the new system with the exception of devolved nation's studies, i.e. where the CI (chief investigator) is based in Scotland, Wales or Northern Ireland.

All applications for R&D confirmation must be accompanied by the completed R&D Confirmation Checklist, guidance for which can be found here: R&D confirmation Checklist Guidance

Individual Trusts are no longer required to issue local approval before a study can proceed at their site. Instead all applications are made to the central Health Research Authority (HRA) who work in partnership with the Research Ethics Committees and will refer the project for ethical review (if necessary), and consider all elements of the study before issuing a central HRA Approval document which can then be used in all relevant organisations within England. The theory is then that local trusts will only need to perform their individual feasibility and capability exercises before a study can be adopted locally. Local R&D offices will require the HRA Approval document before they can issue local confirmation a study can proceed, with the exception of some low risk survey based studies that the HRA will issue without the need for any central approval. The HRA will continue to review and develop HRA Approval and feedback is encouraged to

I received REC approval before HRA approval, what do I do?

Studies which have already applied for REC review but have not applied for R&D review, or need to add new NHS sites in England, or have new amendments, should follow the specific HRA Approval processes for these situations, so that NHS sites can work with sponsors in the new way.

My research is taking place across the UK, what approvals will I need?

HRA Approval applies only to the NHS in England. Studies with sites in Northern Ireland, Scotland or Wales will be supported through existing UK-wide compatibility systems, by which each country accepts the centralised assurances, as far as they apply, from national coordinating functions without unnecessary duplication.

- See more at: #WhatIsHRApproval

The R&D confirmation process, including review of the agreement and budget, will not commence until a valid document pack is received from the local investigator. For more information about what makes a valid document pack, please see our R&D Confirmation Checklist

Why is Trust Confirmation Required?

In order to remain a research active organisation, and protect the funding provided by the Department of Health to host research, all Trusts must comply with national Research Governance standards set out by the Department of Health. Therefore, we ensure that all research that takes place within the Trust has received local confirmation. The R&D Confirmation process is a capability and capacity assessment performed from a local perspective and is separate from issues addressed by the HRA.

As a general rule, R&D confirmation will always be required if ethical approval is required. There may also be occasions where R&D confirmation is required when ethical approval is not required (e.g. laboratory research on NHS premises, and studies interviewing NHS employees).

For information regarding the booking of REC reviews, including telephone numbers and the location of your local REC, please see how to book your REC review.

When is Confirmation Needed?

Confirmation is required for proposed research that involves any of the following within the Trust:

  • Data
  • Equipment
  • Facilities
  • Organs
  • Patients
  • Staff
  • Tissue

What does the process involve?

The Research Governance Framework (DH 2005) (RGF) requires NHS organisations to ensure that before any research involving human participants, their organs, tissue or data commences:

There are adequate arrangements and resources (finance, staff and facilities capacity) to meet the standards set out in the RGF through to project completion.
An identified sponsor has taken on responsibility for the project.
The project has received ethical approval (where required).
There is a ‘Clinical Trial Authorisation’ (CTA) in place for a clinical trial of a medicine.
A ‘Declaration of No Objection’ has been received for a clinical investigation of a medical device.
Other regulatory approvals are in place depending on the nature of the research.
The allocation of responsibilities is agreed and documented.
Appropriate contractual arrangements are in place.
Legislation relating to the research is followed within the organisation.

Financial Considerations of Research

Definition of Costs

The costs of externally funded non-commercial R&D can be split into 3 categories:

R&D costs are the costs of the R&D itself and are met by the research funder. They include the costs of data collection and analysis and other activities needed to answer the questions that a piece of R&D is addressing. They can include pay and indirect costs of staff employed to carry out the R&D.
Service Support Costs are the additional patient care costs associated with the research, which would end once the R&D activity in question had stopped, even if the same patient care service continued to be provided. This might cover things like extra blood tests, extra in-patient days, extra nursing attention.
Treatment costs are the patient care costs which would continue to be incurred if the patient care service in question continued to be provided after the R&D activity had stopped. Where patient care is being provided which differs from the normal, standard, treatment for that condition (either an experimental treatment or a service in a different location from where it would normally be given) the difference between the total Treatment Costs and the costs of the "standard alternative" (if any) can be termed the Excess Element of Treatment Costs (or just "Excess Treatment Costs"), but is nonetheless part of the Treatment Cost, not a Service Support or R&D cost.

The boundary between NHS costs and R&D costs

R&D costs are met by the research funder. Service support and treatment costs are met by the NHS. Treatment costs are met through normal commissioning arrangements for patient care. Further guidance on the distinction between research costs, NHS support costs and treatments costs can be found at the following link: Attributing the costs of health and social care Research & Development (AcoRD)