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Study set-up

If your study is taking place in Primary Care in Norfolk, Suffolk or North-East Essex, Norfolk Community Health and Care NHS Trust (NCH&C) or East Coast Community Healthcare CIC (ECCH) you can contact us on NWICB.RandDoffice@nhs.net and we can provide advice and guidance on the steps you need to take to set up and deliver your study and support you through the process.

What do we do?

We provide guidance and support for research undertaken in GP practices within the East of England Region, Norfolk Community Health and Care NHS Trust (NCH&C) and East Coast Community Healthcare CIC (ECCH).
We work in partnership with the Cambridgeshire and Peterborough Primary & Community Care Research Office and the NIHR Clinical Research Network East of England to provide a central point of coordination and management for research in primary care and wider community settings across CRN East of England region for NIHR Portfolio Studies.
We confirm capacity and capability on behalf of Norfolk Community Health and Care NHS Trust and East Coast Community Healthcare CIC.

For further information, please contact NWICB.RandDoffice@nhs.net.

Is my study research?

The UK Policy Framework for Health and Social Care sets out principles of good practice in the management and conduct of health and social care research in the UK. This applies to all health and social care research involving patients, services users, their relatives and carers or their data. All activities meeting the definition of research under this framework is expected to be managed in accordance with this framework.

To help you decide whether or not your study is research, the Health Research Authority (HRA) have produced a decision tool - Is my study research?

If you are still unsure as to whether your study is research then please contact the team for more guidance at NWICB.RandDoffice@nhs.net

Please also see our Evidence and Evaluation Hub for information on undertaking service evaluations.

What approvals do I need?

To undertake research in the NHS in England or Wales, which means either recruiting patients or staff through their role in the NHS, or using patient or staff data, or taking place on NHS premises, you need to obtain Health Research Authority (HRA) and/or Health and Care Research Wales (HCRW) Approval. Separate approvals are necessary in Scotland and Northern Ireland, you can find further information here: NHS/HSC R&D Permissions

HRA/HCRW Approval brings together the assessment of governance and legal compliance, undertaken by dedicated HRA staff, and independent ethical opinion (where required) by a Research Ethics Committee (REC).

Do I need NHS REC approval? – Not all research conducted within the UK requires approval from an NHS Research Ethics Committee (REC). This decision tool will help you to determine if your study requires this type of approval. If you remain unsure and you are running your project within primary or community care in Norfolk and Suffolk, please submit a draft proposal to the research office. We will review your proposal and can provide you with advice.

If REC approval is required this toolkit can help you to determine whether you can apply for proportional review by REC.

If you are not sure what approvals you need then please contact us for more guidance

Applying for HRA/HCRW approval

For most studies, you will need to apply via the Integrated Research Application System IRAS. For a guide to using IRAS please click here.
All Clinical Trials of Investigational Medicinal Products (CTIMPs) and Combined trials of an investigational medicinal product and an investigational medical device (IMP/Device trials) need to apply using the combined review service, which can be accessed using the New part of IRAS. Please use the guidance on the HRA website for instructions on how to apply for combined review.

Local confirmation of Capacity and Capability (C&C)

Depending on the study, following HRA/HCRW Approval, the local organisation(s) undertaking your study (i.e. the site(s)) may need to confirm capability and capacity to undertake your research. You cannot start your study at a site if C&C is required and its confirmation is pending.
In order to confirm C&C a copy of your Local Information Pack needs to be provided. We will assist with C&C and advise on study specific requirements, including laboratory analysis, IT arrangements and liaise with local Trusts, GP Practices and ICBs to secure relevant arrangements. We prepare an assurance e-mail for the Sponsor to share with local sites, confirming that arrangements are in place.
We will confirm capacity and capability on behalf of NCH&C and ECCH.
For primary care, depending on the study, assurance is confirmed on a per practice, locality or regional basis, however individual GP practices will need to provide confirmation of capacity and capability for their practice.

Study amendments

Any study amendments that are submitted after the original HRA/REC Approvals are obtained, the NWICB R&D Office will also review each subsequent amendment and liaise with the research site to ensure continued capacity and capability.

Commercial research in primary care

We can support practices taking part in commercial research with:

Contract review
Budget review
Study approvals
General study set-up queries

Our team are available for a discussion around commercial research, its challenges, and the potential ways to overcome those challenges. Please contact us on nwicb.randdoffice@nhs.net.

A number of our practices have signed up to the National Contract Value Review (NCVR) process, which is currently voluntary for practices. Practice can sign up here.

Research in the wider community non-NHS settings

HRA approval does not currently cover non-NHS organisations, however, non-NHS organisations can consider the assurances provided by the HRA for studies which also include NHS organisations and where HRA approval has been granted.
This R&D office will undertake a local review of studies that do not require HRA approval to ensure they meet key requirements of the UK Policy Framework for Health and Social Care Research. Please share your study documentation with us via e-mail: nwicb.RandDoffice@nhs.net
We work in partnership with NIHR CRN EoE Agile team who supports the delivery of health and social care research in the wider community settings. You can contact the team via e-mail researcheoe@nihr.ac.uk .

Student research

Guidance on criteria for student research and approvals can be found on the HRA website. For student research below doctorate level, it is very important to complete the Student Research Toolkit before proceeding with your application form.

Letters of Access and Honorary Contracts for research

Research within the NHS is often undertaken by NHS staff not directly employed by the host NHS organisation, or by non-NHS staff, particularly researchers employed by or studying at universities. This raises issues about responsibility, accountability, patient safety and duty of care. The Research in the NHS: HR Good Practice Resource Pack describes the process for handling HR arrangements for researchers and provides a streamlined approach for confirming details of the pre-engagement checks they have undergone with the NHS.

Do I need a research passport?

A research passport is the mechanism for non-NHS staff to obtain an Honorary Research Contract (HRC) or Letter of Access (LOA) when they propose to carry out research in the NHS.

The research passport algorithm will help you assess whether you need an LOA or HRC. If your study involves contact with patients in a care setting or using identifiable data then it is likely you will need an LOA. If your study involves providing health care, or is likely to have a direct bearing on the quality of care, an HRC may be required.

Applying for an LOA or HRC

We facilitate appropriate access for research at GP practices across CRN East of England, the Norfolk Community Health and Care NHS Trust (NCH&C) and East Coast Community Healthcare CIC (ECCH).

Please contact us at NWICB.RandDoffice@nhs.net with the following documents:

Valid research passport or NHS to NHS confirmation of engagement checks as appropriate (see above);
A copy of a current CV (see template);
Certificates for Criminal Record Disclosure and Occupational Health Checks may be required, depending on the research activity involved (see the Research Passport Algorithm -Table 1). Please provide copies (when required), unless your Research Passport has already been validated by another NHS organisation.

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