NHS Research and Development approval

NHS Research and Development permission is required for clinical and social research involving NHS patients, tissue and/or data.

On this page

NHS Research and Development Management approval is required from each participating NHS organisation undertaking clinical, health and social care research and development studies involving NHS patients, their tissues and/or data or NHS Resources. Approval must be in place prior to initiation of the clinical research.

We advise researchers to contact the R&D office as early as possible to discuss and notify them of the research proposal.

NHS Tayside R&D management approval is issued following completion of local capacity and capability review and sign off of appropriate contracts and agreements, depending upon the study in question. R&D management approval ensures that the Health Board meets its legal obligations and provides insurance /indemnity under CNORIS (Clinical Negligence & Other Risks Indemnity Scheme) whilst also being a condition of the ethical favourable opinion.

We advise researchers to contact the R&D office as early as possible to discuss and notify them of the research proposal.

Applications for NHS R&D management approval should be made using the Integrated Research Application System (IRAS).

All clinical, health and social care research and development studies in Scotland require to be submitted to the the NHS Research Scotland Permissions Coordinating Centre (NRSPCC) at gram.nrspcc@nhs.scot. NRSPCC will upload multicentre studies onto the shared Scottish R&D web based database and make them available to participating Health Boards for review and approval and will ensure single centre studies are available to the relevant R&D office.

All research teams are encouraged to submit their application for NHS R&D management approval in parallel with their application for an ethics committee opinion, as this will help expedite the R&D management approval process.

Audit and Service Evaluation fall out with the remit of NHS R&D and do not require R&D management approval. You are required to contact the clinical governance team at tay.clinicalgovernanceriskdept@nhs.scot for such studies.

Site Specific Information

Organisation Information Document (OID) available through IRAS

The OID will form the agreement between the participating NHS/HSC organisation and the Sponsor for all non-commercial studies except interventional trials.
There are different templates, please use the appropriate one to create the ‘Outline Organisation Information Document(s)’ for your project
The outline Organisation Information Document should give information that will be common to all participating NHS/HSC organisations that are undertaking the same activities within the study. In some studies, some NHS/HSC organisations will undertake different activities to others. In this scenario you will need to create and submit an outline Organisation Information Document for each group of NHS/HSC organisation undertaking the same activities.

Schedule of Events (SoE)

The SoEs are to ensure that the appropriate resources are identified to support study delivery and that costs associated with site participation are correctly attributed.
This may have been completed as part of grant application as the “Schedule of Events Cost Attribution Template – SoECAT”.
Any changes since then will have to be made and be re-authorized by the NHS R&D AcoRD specialist.
One SoE/SoECAT is needed for each Outline Organisation Information Document (OID)

Caldicott Approval

Caldicott approval is required in Scotland if you propose to access or use identifiable NHS patient information without consent within one Health board or Trust.

Contact: tay.informationgovernance@nhs.scot

If you intend to access or use identifiable NHS patient information without consent from more than one Health board in Scotland you must apply to the Public Benefit and Privacy Panel (PBPP) who determine whether there is sufficient justification to access data without consent.

Further information from informationgovernance.scot.nhs.uk

In England, this role is undertaken by the Confidentiality Advisory Group (CAG) and application is undertaken through the IRAS system.

Funding – costings, grant applications, SOECAT and excess treatment costs

The TASC R&D Non-commercial Group works with research teams from the outset of grant application through to study close out. We provide advice and costings for NHS staff and resources and attribute the costs to the relevant budgets. We ask that researchers include TASC R&D in grant application discussions as early as possible to allow appropriate identification, attribution, local capability review and costings of NHS resources. A minimum of 10 working days’ notice is required for NHS costings for research and development applications.

We will facilitate completion of the Schedule of Event Cost Attribution Template (SOECAT) which many funders now require as part of their funding application. We are responsible for signing off the SOECAT as recognised UK AcoRD specialists.

We will work with you, the researchers, to identify and attribute the Excess Treatment Costs (ETC) associated with the research and where appropriate to complete and submit the Excess Treatment cost bids to the Chief Scientist Office for ETC funding.

To facilitate and expedite review and costings please provide: -

a copy of the research proposal/outline
Name and contact details of the Chief Investigator/applicant
Name of funding body being applied to
Deadline of funder
Clarification on number of participating Health Boards/Trusts (single or multi-centre research)

Please contact: tay.tasc@nhs.scot for all health and social care research applications.

Feasibilities and expressions of interest

The facilitators will work with the local teams to confirm local interest and identify a Principal Investigator (PI) or local collaborator where appropriate.

Once a PI or local collaborator has been confirmed the facilitators will work with the Research & Development team and a lead reviewer will be assigned to the study.

Research Passports, Honorary research contracts and Letters of Access

The TASC Non-Commercial team can advise and assist researchers on requirements for Research Passports, Honorary NHS research contracts, and Letters of Access for NHS research. Please contact tay.tasc@nhs.scot for further information.

The HR Good Practice Resource Pack (HRGP RP) and Research passport application form can be found on the IRAS website.

NRS Permissions Coordinating Centre (NRSPCC)

NHS R&D permission is required from all Health Boards/Trusts where the research is intended to take place.

NRSPCC is the single point of contact that facilitates the sharing of the study document set across all the proposed participating Health Boards in Scotland thus removing the need for duplication. With direct links to their equivalent co-ordinating centres in England, Wales and Northern Ireland they facilitate the dissemination of information to the necessary Sites.

Email gram.nrspcc@nhs.scot

Local Information Pack (LIP)

The 'Local Information Pack (LIP)' is the UK-wide agreed document set for enabling the setup of participating NHS and Social Care organisations in health and social care research.

The Organisation Information Document (OID) is a key component of the LIP and is used for both commercial and non-commercially sponsored research. There are a number of different templates of the OID, depending upon the study type and all are available on the IRAS website.

Single centre research, where the NHS organisation is acting as both the Sponsor and the sole participating site for the study, does not require a LIP or an OID.

The outline OID gives information that is common to all participating NHS/HSC organisations that are undertaking the same activities within the study. In the case where NHS/HSC organisations will undertake different activities to others, separate outline OIDs are required.

The outline OID(s) must be electronically submitted as part of the IRAS Form application. This means it must be attached to the IRAS Form checklist prior to e-submission of the application.

It is important to ensure that the outline OID is localised and shared with participating NHS/HSC organisations.

The Sponsor, or authorised delegate, is responsible for sharing the UK LIP with participating NHS organisations and controls when this occurs.

UK Local Information Pack

Participant Identification Centre (PIC)

A PIC is where an organisation:

identifies participants, largely (but not exclusively) through patient records; for possible participation in studies
provides information about / or informs patients directly about a study; for example, a clinician speaks directly to a patient
advertises the opportunities to participate in a specific study; for example, via posters in waiting rooms and where the research is taking place elsewhere.

Organisations still need to be alerted an agree to be a PIC. Researchers MUST contact the Site through their NHS R&D Office to arrange this.

An organisation is not acting as a PIC when it is responsible for:

any protocol-specified assessment to determine participant eligibility for a study, eg a screening blood test or x-ray
the recruitment (informed consent) of participants into a research study
the delivery of research procedures specified in the research protocol

Facilitation of site set-up – hosted studies

External researchers wishing to include Tayside as a host/participating site or a Participant Identification Centre (PIC) in health and social care research should contact tascfeasibility.tayside@nhs.scot in the first instance and submit a feasibility or Expression of Interest form alongside a protocol/study proposal. The facilitators will work with the local teams to confirm local interest and identify a Principal Investigator (PI) or local collaborator where appropriate. Once a PI or local collaborator has been confirmed the facilitators will work with the Research & Development team and a lead reviewer will be assigned to the study.