Research "Excellence" Awards Nomination Form

Nursing, Midwifery and Allied Health Professionals (AHPs)

Research improves our understanding of health and disease, it is vital to improving patient care and outcomes. Health professionals need evidence from research to know which treatments are most effective. Our dedicated research department manage the review, set up and delivery of a range of research projects across the Trust.

We are research active in several clinical areas delivering a range of different projects from clinical trials of new drugs or interventions to studies involving questionnaires and data collection. Some research is simply collecting information about diseases, some people help us by telling us their opinion or experience and some people are involved in creating and testing new products. There are many ways to be involved. If you would like to discuss opportunities to get involved with research please contact a member of the team.

Meet the Team
Claire Livingstone

Head of Research
Email: claire.livingstone5@nhs.net

Deepali Varma

Director of Research
Email: deepali.varma1@nhs.net

Carly Brown

Lead Research Nurse
Email: carly.brown8@nhs.net
Phone: 0191 404 1000 ex 2260

Fiona Wakinshaw

R&D Manager
E-mail: fiona.wakinshaw@nhs.net
Phone: 0191 404 1000 Ext 2260

PRES (Patient Research Experience Survey)

As many of you are aware we are trying to increase our efforts in distributing PRES (Patient  Research Experience Survey) to research participants.

To aid this the following documents have been put together outlining the methods that research teams across the trust can use  to aid research in using PRES. A number of iPads have been taken back to IT to be reconfigured to help staff access PRES. These iPads should become available to staff within the next few days. As well PRES cards have been delivered and will be distributed out to research teams in the coming days.

Pres User Guide

Ways to access PRES

Pres Patient Email

Below are links to the NIHR website which has more information on what PRES is about and how to use it.

https://local.nihr.ac.uk/documents/crn-north-east-and-north-cumbria-pres-standard-operating-procedure/27951

https://local.nihr.ac.uk/documents/crn-north-east-and-north-cumbria-pres-toolkit/28635

https://local.nihr.ac.uk/documents/crn-north-east-and-north-cumbria-pres-questions-202122/28499

There is a link below to an instructional video on how to use PRES and a user guide attached for using the myresearchexperience.com website. Both links are also included in the guidance document along with a FAQ section on PRES from the NIHR website which may answer and questions or queries you may have.

https://www.youtube.com/watch?v=-5z-VwkXu0A&t=4s

Here is the link to the site that monitors and records the PRES responses for the trust for to access to see the feedback received.

https://datastudio.google.com/reporting/397f0a39-ea71-4a5b-ba96-3824757f02aa/page/IAmSB

Over time the methods available in using PRES may expand and if new methods become available new guidance will be distributed. The trust SOP on emailing patients is also attached and must be followed if using option 3 in the guidance document.

Please use whichever method/s you feel the most comfortable with and should you need any resources or have any questions or queries please contact James Kitchen via email jameskitchen@nhs.net or extension 42143.

Patient Research Ambassadors

We believe strongly that Patients and Public should have the opportunity to give feedback and be involved in shaping the future of research. We have a group of Patient Research Ambassadors who help by giving us their perspective and by talking to patients about their experience of participating in research.

 

“I am a retired deputy head teacher who was treated for throat cancer in 2009. I am free of cancer now but have other problems as a result of the treatment.

Until I was introduced to research by my speech therapist I didn’t realise anyone could get involved and in so many different ways.

Since then I have taken part in many different areas of research and promoting research. I have been involved in a randomised controlled trial, in patient workshops as part of a qualitative study, in organising research days for patients and staff and other work such as patient panels. This led to me being invited to become a patient research ambassador (PRA) I decided to become a PRA to try and spread the word that research is happening in our hospitals and encourage other patients and carers to get involved.

I feel it’s extremely important that as many people as possible get involved in research. It helps the NHS find out what works and what doesn’t work but most of all it gives us, the patients, carers and local public a voice in our future treatment and care.

Please come and join us!”

 

Val, Patient Research Ambassador for South Tyneside and Sunderland NHS Foundation Trust

To find out more about how you could shape the future of research please contact: PatientResearch@chsft.nhs.uk

Information for Researchers

Before you can begin your research you must have the necessary permissions from the various regulatory bodies.  The research department is dedicated to supporting research across the Trust.  If you are a researcher wanting to conduct research with us we are happy to guide you through the process. 

Useful links for information and support for conducting research can be found in the links below:

Our Performance

The government want to see a dramatic and sustained improvement in the performance of all NHS providers undertaking clinical research.

The aim is to increase the number of patients given the opportunity to participate in research and to ensure research is set up efficiently.  From October 2014 all NHS Trusts have been required to publish their performance against two targets.

To see our trust's PID submission please click on the links below

Performance for Research 

Initiating Clinical Research (70 day benchmark from submission of valid application to recruitment of 1st patient

Delivering Clinical Research (time to target for commercial research)

Funding Opportunities

Are you looking to develop your research skills to act as a Principal Investigator?

This is a great scheme to support you in developing in the PI role, locally leading on an existing NIHR portfolio study.

Take a look at the below/ attached for more information.

Nb. As per ICH GCP a Principal Investigator is, 'A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.'

If you would like to discuss this in more detail please get in touch with carly.brown8@nhs.net  or claire.livingstone5@nhs.net

Green Shoots Information 2022-2023

Green Shoots Application Guidance 2022 2023

Training Opportunities

 

CRN Training Brouchure

The NENC Clinical Research Network has recently published a new brouchure of learning and development courses in health and social care research, including dates for Good Clinical Practice (GCP) Training. Please visit link below for more information. 

CRN L&D Courses 2023

 

NHS HRA Student Research Toolkit

Are you a life sciences research student? Or do you supervise students who undertake research in a UK health or social care setting? NHS HRA guidance and resources can help you to decide if the research is eligible and what approvals you need/ 

Student Research Toolkit

 

 

Research Governance

Study Setup and Capability & Capacity Guidance Video

 

Governance Team:-

Fiona Wakinshaw – Research Governance Manager, Email – Fiona.Wakinshaw@nhs.net

Paula Madgwick – Research Governance Facilitator, Email - Paula.Madgwick1@nhs.net

Alison Atkinson – Research Governance Facilitator, Email – Alison.Atkinson4@nhs.net

Generic Email Address – stsft.research@nhs.net

 

Telephone Contacts : -

Research Governance Manager: 0191 4041000 Ext.  

Research Governance Office 0191 4041000 Ext. 2700/3576/3088

 

All research trials taking place in the UK are required to apply for permissions and approvals via IRAS – Integrated Research Application System.  This is a single system for applying for the permissions and approvals for health and social care/ community care research in the UK. Please click on link below for further information, guidance on IRAS click here

 

In March 2016, HRA Approval was introduced as the process for applying for approvals for all project-based research in the NHS led from England. From 16 April 2018 this was extended to include all project-based research in the NHS in England or Wales, and is referred to as "HRA and HCRW Approval"

HRA and Health and Care Research Wales (HCRW) Approval is the process for the NHS in England and Wales that brings together the assessment of governance and legal compliance, undertaken by dedicated HRA and HCRW staff, with the independent REC opinion provided through the UK Research Ethics Service. It replaces the need for local checks of legal compliance and related matters by each participating organisation in England and Wales. This allows participating organisations to focus their resources on assessing, arranging and confirming their capacity and capability to deliver the study.  Further information and guidance on HRA click here

 

Commercial Trials - costings

It is anticipated that any commercial trials submitted for approval are costed in accordance with the NIHR Commercial Costing Template accessed via the iCT which is a web-based interactive Costing Tool (iCT) which provides a framework for transparent cost display and calculation to support swift local site budget negotiations when planning commercial trials in the NHS.

The tool is available as a module within the NIHR Central Portfolio Management System (CPMS) and includes a number of major improvements.  Further information and guidance and be found here

Site Set-up

 

All research studies conducted across South Tyneside & Sunderland NHS Foundation Trust require organisational research aproval, referred to as confirmation of capacity and confirmation (C&C) before they can start. This approval process is managed by the Research Governance Team.  Study Sponsors are required to submit a Full Document Pack to participating sites for review before Capacity and Capability Approval is issued.

Local Document Packs and any Amendments packs for any existing studies should be submitted to the following email address:-

stsft.research@nhs.net

A Full document pack should contain the following:-

  • Copy of IRAS Form as submitted Protocol and amendments;
  • Participant Information and Consent Documents (without local logos/headers)
  • Relevant model agreement;
  • Localised Organisation Delegation log (where applicable, including known research team names but not signatures, or indicate when this will be shared);
  • Localised Organisation Information Document (OID);
  • Commercial studies only – NIHR Costing template (validated);
  • Non-commercial studies only – Schedule of Event or Schedule of Event Cost attribution Tool;
  • Any other documents that the sponsor wishes to provide to the site to support the set up and delivery of the study;
  • Copy of initial assessment letter (if one issued) and (when issued) HRA Approval Letter and final documents.

   

Process of a Review at Site:-

See flow chart below for governance process.

 

Template Documents which may be required for study set up at site:

Caldicott Approval Form Rev 9   

Caldicott Process 2022    

Data Flow Review Questionnaire        

Seeking Pathology Approval for Clinical Research Support       

Information Governance

Where any identifiable data of a participant taking part in research is leaving the Trust the research delivery team are required to complete a Caldicott Form, where data leaving the trust of a participant taking part in research is psuedononymised/anonymised delivery teams are required to complete a Data Flow.  The Governance team will liaise with the Information Governance Team regarding Caldicott/Data Flow and advise delivery teams what form to complete, they will also arrange for documents to be authorised by the Information Governance Team/Caldicott Guardian

 

Support Departments

 

Pharmacy:

For any CTIMP Trials it is the responsibility of the delivery team to inform Pharmacy of the trial and forward any necessary study documentation, the Governance team will liaise with the pharmacy team to obtain their support approval.

 

Pathology:

For any studies that require Pathology Support it is the responsibility of the delivery teams to liaise with Pathology, complete a Pathology Review Approval Form (attached above) forward to pathology for their review to enable support approval to be issued.  The governance team require this approval prior to Capacity and Capability approval being issued.

 

Radiology/IMER assessment:

For any studies where there is radiology involvement/IRMER assessment required delivery teams should contact Christopher Reay at Regional Medical Physics, Newcastle, email christopher.reay@nhs.net.

Please also cc. the generic email nuth.nmpce-ethics@nhs.net

 

Medical Devices:

For any medical device studies support approval will be required from the Clinical Engineering Department, the Governance team will liaise with Department initially and direct any necessary documents for completion/queries to the delivery team to action.

 

GCP Training:

Further information regarding GCP training can be found in Good Clinical Practice SOP.

 

Good Clinical Practice SOP

 

 

Research Passports

All Research Passports/Letters of Access applications of Researchers who are to conduct Research in the Trust must be submitted to the Research Office in the first instance, documents will be reviewed and sent to HR to process.

Applying to Conduct Research if you already have a contract with any NHS Trust

Researchers with a contractual relationship with any NHS Trust who require an Honorary Research Contract (HRC) or Letter of Access (LOA) need to complete the NHS to NHS letter of access proforma (please see Figure 1) which needs to be signed by their HR department.

A LOA is requested unless the Researcher is going to provide health care to an adult and/or child under the direction or supervision of health care professional in which case they would request an HRC.  Once the proforma has been completed it must be submitted to the Research office along with their CV signed and dated within 6 months.

NHS to NHS Proforma - Letter of Access

Applying to Conduct Research with no contract with any NHS Trust (e.g University applicants)

If the Researcher does not have a Research Passport, they must complete the Research Passport Form (Figure 2), the individual’s substantive employer (HR Department) must have completed section 5 – this section confirms that as the employer they have conducted pre-employment checks.

Research Passport Form

When submitting the Research Passport Form to the Research Office the individual must also include:

  • Original copy of their DBS disclosure - this disclosure should be no more than 6 months old
  • Evidence of occupational health screening/clearance
  • Copy of their CV signed and dated within the last 6 months

 

If the application does not contain these documents it cannot be forwarded to the HR Department to process.  Should an individual not have occupational health and/or CRB clearance and the Trust are required to conduct this, the Trust will conduct these clearances for which the substantive employer will be charged.

If any additional checks are carried out by the Trust, they will be recorded on the research passport by the Trust’s HR Department.

If the Researcher’s Research Passport has been signed off by another Trust (section 8 would be completed by that Trust) an Honorary Research Contract (HRC) will have been provided/requested in all instances.

If the Researcher’s Research Passport has been signed off by another Trust the Researcher can then request an HRC or LOA.

A LOA can only be requested if the Researcher has indirect contact with patients or service users but is not providing healthcare or other types of regulated activity and has no direct bearing on the quality of care, otherwise a HRC is requested.

An HRC would be requested if the Researcher is going to provide health care to an adult and/or child under the direction or supervision of health care professional in which case they would request an HRC.

Researcher’s First Day at the Trust

The Researcher will be requested to attend the HR Department on their first day in the Trust, they will be required to bring photographic identification (passport or driving license) along with their confirmation letter.  Researchers will be issued with an ID badge once identification has been provided.

 

ALL REQUESTED SHOULD BE SUBMITTED TO THE GENERIC IN BOX stsft.recruitmentservicesofficers@nhs.net ONE OF THE FOLLOWING MEMBERS OF STAFF WILL PROCESS.

Emma Stokoe and Karin Grant - Corporate/Estates and Facilities/Choice

Vicky Leddy/Judith Hogg - Medicine/Emergency Care/Family Care

Melanie Broughton/Sarah Paterson - Theatres/Clinical Support-

Lauren French/Natalie Baldassarra - Surgery/Community/Haven Court-

 

Useful links:

https://www.nihr.ac.uk/

Health Research Authority (hra.nhs.uk)

Combined review - Health Research Authority (hra.nhs.uk)

Integrated Research Application System (myresearchproject.org.uk)

 

Post Approval:

Following C&C Approval Research Trials are added to the Local Portfolio Management System (LPMS-Reda).  LPMS is a system used by the Local Research Network and partner organisations to manage local research delivery and associated processes.  Delivery teams are required to add study recruitment to this system as and when recruitment takes place.  Where additional sites are added to a study following C&C Approval delivery teams should contact the Research Governance team to enable these sites to be added to the LPMS system. 

Delivery staff who requires a LPMS account should contact the Research Governance Team to arrange access.

 

Reporting Trial Related Incidents

Further details on reporting trial related incidents can be found in SAE SOP which can be found on the STSFT Research Intranet page.

Research Related Incident Reporting SOP

 

AMENDMENT PROCESS

 

Governance Process Document

 

Research Results and Outcomes

Research is vital to improving patient care, we are proud to lead and support the delivery of a wide portfolio of research studies. To learn more about the impact of research we have been involved in please refer to the papers/articles below:

Certificate

A key objective of the R&I Strategy is embedding a culture of R&I across the organisation.  The Research Team are supporting and developing a number of initiatives to fulfil this aim. 

An important part of embedding a research culture is acknowledging the contribution that all staff make to research.  Currently a number of junior Drs get involved in research and we wanted to formally recognize their involvement and provide evidence of involvement in research for their portfolio, to support their journey to becoming Principal Investigators of the future.  This can also be used to recognise the research contribution of any member of the multi-disciplinary team. 

It is envisaged that PIs can complete the survey outlining how staff were involved in research and this can be signed off to provide evidence of their involvement.   The certificate is available via our intranet research website for downloading http://stsft-intranet.franktesting.co.uk/download_file/view/11177/3511/3511

Once the certificate is completed and handed to the recipient, we would be grateful if a scanned copy could be sent to the R&I team at  stsft.research@nhs.net for our records.

Certificate for Involvement in Research

 

 

Research Conferences

2023

 

More events coming soon!

2022

 

International Clinical Trials Day 

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