Research and innovation

We are passionate about research and are proud of the record. Opened in 2005 and benefiting from a recent major investment in a clinical research facility, we are one of the top recruiting centres in the country for a number of trials.

We are passionate about research and are proud of the record. Opened in 2005 and benefiting from a recent major investment in a clinical research facility, we are one of the top recruiting centres in the country for a number of trials.

Areas of research include includes oncology, haematology, stroke, cardiology, paediatrics, dermatology, diabetes, midwifery, ophthalmology, respiratory, anaesthesia, general surgery gastroenterology and orthopaedics.

Find out more:

Faster treatment for Lincolnshire prostate cancer patients thanks to United Lincolnshire Hospitals’ role in national trials

How Lincolnshire Clinical Research Facility is putting patients and the public at the heart of innovation and clinical development 

Regional recognition for United Lincolnshire Hospitals at awards celebrating excellence, innovation and inspiration

Diagnostic tool developed by United Lincolnshire Hospitals to reduce pressure ulcers attracts international interest

These are a set of aims for the best practice and conduct of staff within Lincolnshire Clinical Research Facility. Enclosed in this document is also the LCRF’s research vision, in line with the Trusts charter about the five key things we can do as staff to be patient centred and be the best we can be.

1. Work in the ULH Trust by promoting, supporting and delivering high quality clinical trials/studies enabling local patients to have access to the latest treatment options (The Handbook to the NHS Constitution 2009).
2. Promote Research and Innovation within the Trust, assisting Clinical Business Units to develop specialist clinical services and implement clinical research findings, thereby contributing to the improvement of patient care.
3. Ensure ULHT patient recruitment targets, set up in conjunction with other networks/organisations, are met.
4. Develop and strengthen external collaborative partnerships with key stakeholders to strengthen our Clinical Research Infrastructure.
5. Develop robust training and education and Quality Assurance programs, thereby attracting and retaining a high quality, motivated Research Team and delivering high quality clinical trials/studies.
6. Develop a financial strategy to generate patient benefits and cost savings to the NHS particularly to the ULH Trust.
7. Identify suitable accommodation across the Trust for LCRF & R&D Admin staff and trials patients, with sufficient space, for the fast growing LCRF team. In addition, to set up a plan for setting up dedicated space for LCRF within supporting departments (pharmacy and chemotherapy) for clinical trials.

You can ask your doctor or healthcare professional if they know of any research that you may be eligible to join.

You can also search for information on a number of websites and register your interest in taking part in research.

Be part of research

Be Part of Research is run by the National Institute for Health and Care Research (NIHR).It is an online service that helps members of the public understand what research is and what it might mean to take part. It shows what research is currently happening across the UK.

Be Part of Research makes it easy to find and take part in vital health and care research across the UK. Simply tell them which health conditions you’re interested in. They’ll match you to suitable studies and send you information on how to take part.

Clinical trials maintain your privacy and dignity. They are run to the highest ethical standards and regulatory approvals are sought at all stages to ensure compliance and adherence to the protocol for safe delivery. There are many stages to a clinical trial, in the delivery of a potential new treatment or therapy.

Testing a new medicine

All clinical trials of new medicines go through a 3series of phases to test whether they are safe and whether they work.

The medicines will usually be tested against another treatment called a control. This will either be a dummy treatment (a placebo) or a standard treatment already in use.

Phase one trials:

• A small number of people, who may be healthy volunteers, are given the medicine.
• The drug is being trialled in human volunteers for the first time.
• Researchers test for side effects and calculate what the right dose might be to use in treatment.
• Researchers start with small doses and only increase the dose if the volunteers don’t experience any side effects, or if they only experience minor side effects.

Phase two trials:

• The new medicine is tested on a larger group of people who are ill. This is to get a better idea of its effects in the short term.

Phase three trials:

• Carried out on medicines that have passed phases one and two.
• The medicine is tested in larger groups of people who are ill, and compared against an existing treatment or a placebo to see if it’s better in practice and if it has important side effects.
• Trials often last a year or more and involve several thousand patients.

Phase four trials:

• The safety, side effects and effectiveness of the medicine continue to be studied while it is being used in practice.
• Not required for every medicine.
• Only carried out on medicines that have passed all the previous stages and have been given marketing licences – a licence means the medicine can be made available on prescription.

Control groups, randomisation and blinding

If you take part in a clinical trial, you will usually be randomly assigned to either the:

• treatment group– where you’ll be given the treatment being assessed, or
• control group– where you’ll be given an existing standard treatment, or a placebo if no proven standard treatment exists

While the treatments are different in the two groups, researchers try to keep as many of the other conditions the same as possible.

For example, both groups should have people of a similar age, with a similar proportion of men and women, who are in similar overall health.

In most trials, a computer will be used to randomly decide which group each patient will be allocated to.

Many trials are set up so nobody knows who’s been allocated to receive which treatment. This is known as blinding, and it helps reduce the effects of bias when comparing the outcomes of the treatments.

The Research and Innovation team support and facilitate high-quality research in ULHT by ensuring principles of good practice in the management and conduct of research that take account of legal requirements and other standards.

Research Governance is the process of approval for a clinical trial to occur within an NHS trust. The UK Policy Framework for Health and Social Care Research sets out principles of good practice in the management and conduct of health and social care research in the UK.

These principles protect and promote the interests of patients, service users and the public in health and social care research, by describing ethical conduct and proportionate, assurance-based management of health and social care research, so as to support and facilitate high-quality research in the UK that has the confidence of patients, service users and the public.

Find out more about the Framework and role of other organisations that work together in the UK to regulate and approve different aspects of health and social care research within the NHS Health Research Authority (HRA) webpages.

Detailed information, produced by the Health Research Authority, about how patient information is used in Health and Care Research is available on the Health Research Authority website.

How we process and share personal data as a participating organisation in Research Studies

In addition to the general information outlined in the link above, we have published a list of research studies that the United Lincolnshire Hospitals NHS Trust are involved in (as “Data Processors”), that are co-ordinated by other organisations (research “Sponsors” – The “Data Controller”) which will enable you to find our more detail about how data is processed and shared for specific research studies.

If you are a participant in a study and/or wish to find out more information about a how a Sponsoring organisation manages the personal data it holds for a particular study, you can find out by contacting the sponsoring organisation.

Find out the name of a study sponsor in this report.

You can then find sponsor contact details and further information about a particular study by searching the Clinical Trials Gateway webpages.

If you are unable to find the information you are looking for, or have any queries, please contact the Research & Innovation team at R&[email protected]

How we manage data as the sponsoring organisation (“data controller”) of research studies

As a NHS organisation we use personally-identifiable information to conduct research to improve health, care and services. As a publicly-funded organisation, we have to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research. This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

Health and care research should serve the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research.

If you wish to raise a complaint on how we have handled your personal data, you can contact our Data Protection Officer who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO).

Please contact R&[email protected] if you have any queries about  research projects we currently sponsor (and act as Data Controller for).

Performance in initiating and delivering clinical research

The government aims to increase the number of patients who have the opportunity to participate in research and see a dramatic and sustained increase in the performance of providers of NHS services in initiating and delivering clinical trials.

As a provider of NHS clinical research services we are required to publish our performance metrics relating to recruitment and delivery to clinical trials for the previous 12 months. These are reported quarterly under the following categories:

• Performance in initiating (PI) – reporting information for every clinical trial where the Date Site Selected (DSS) falls within the previous 12 months
• Performance in delivering (PID) – reporting information for commercial clinical trials hosted by the Trust which have closed to recruitment in the previous 12 months

Our performance

For documents relating to the performance of our clinical research please see the National Institute for Health Research website.

1.  Have you been involved in, or are interested in, medical research as a
   patient or carer?
2.  Would you like to share your views & experiences?
3. How about having the opportunity to influence future decisions for the direction of clinical research?

If you answered yes to these questions, please continue to find out more.

If you answered yes to the questions over the page, then why not join the Lincolnshire Research Patient and Public Forum (LRPPF)?
The LRPPF is a new pan-county venture initiated by the Lincolnshire Clinical Research Facility (LCRF), part of United Lincolnshire Teaching Hospitals NHS Trust.

The conduct of clinical trials is strictly regulated, controlled and monitored and embedded in legislation. Patient and Public involvement in preparing research projects provides insight into making health research more relevant to the needs of patients, carers and service users.

We believe the Forum will be fundamental in providing informed choices and advice to the Trust from the all too important patient’s perspective whilst embedding a research culture within the organisation.

We envisage the Forum will be there to provide support and unbiased advice to potential new clinical trials patients. The Forum works independently from medical advice and opinion.
If you would like to talk to someone regarding the forum or call for some unbiased advice or support, please contact, Rose Brown, Chairperson, via Simone Seychell, in the first instance: email [email protected] or call 01522 512512 ext 582059.

We meet regularly, so contact Simone for further details of the next meeting.

We look forward to hearing from you!

Safety

Clinical Research aims to inform safer,

effective treatments to enhance patient care. Research will be conducted by trained experienced staff guided by UK Policy Framework for Health and Social Care Research (2017), Good Clinical Practice and Medicines for Human Use (Clinical Trials) Regulations 2004.

We aim to enhance our quality governance systems and continue to develop our working processes to provide systematic and streamlined delivery of clinical trials.

Respect

Research respects people’s rights and wishes and should never be coercive.

Patients will be provided with comprehensive information about Research and given time to ask questions and make informed choices about their participation. The patient decision will always be respected.

Staff involved in research have a duty to respect trial participants’ rights, dignity and beliefs.

Patient centred

Research is continually improving and changing healthcare systems and processes. We will work towards implementing the 2021 Research & Innovation Strategy leading quality and innovation in patient-centred healthcare services.

We aim to ensure that all patients are informed about and offered the opportunity to take part in research that is relevant to them.

Excellence in Rural Health

We will promote the opportunities to deliver and disseminate Research across Lincolnshire as we work in collaboration with different healthcare providers.

The people of Lincolnshire will have the opportunity to participate and invest in the future of their healthcare providing long term benefits to the wider community.

Compassion

Patients are at the heart of research and we pledge to deliver research holistically, involving patients in research as part of their healthcare journey.

We will ensure that we listen to research participants and value their contributions and participation in clinical research to improve healthcare in the future.

Membership
Membership is open to all members of ULHT Trust patient and carers, whom are involved in or interested in clinical or medical research.
Associate Membership is open to all researchers, research administrators and other health professionals with an interest in medical research.

Sponsorship and reporting
The Lincolnshire Research Patient and Public Forum is sponsored by the Director of LCRF.
The Chairperson will also be a member of the Trust Research and Innovation Committee.

Management of the forum
The Chairperson is Mrs Rosemary Brown, a retired stroke research nurse and research manager. Rose has extensive research experience and current patient and public involvement with East Midlands. Administrative and support facilities will be provided by the LCRF. Minutes will be produced for every formal meeting.

Meetings
Formal meetings will be held every three months at Lincoln site. Additional meetings may be held as and when required.
Quorum for meetings is 5 members including the chair. Meetings must be chaired by the Chairperson or elected member.
Members shall be given at least two weeks’ notice of a meeting; emergency meetings may be called at the Chairperson’s discretion.
Members are expected to attend/contribute to a minimum of 2 of the quarterly meetings per year.
Meetings will last a maximum of 2 hours. Members will respect patient, carer and other members confidentiality outside the meeting room

Expenses
Legitimate travel expenses may be claimed to attend meetings on completion of a ULHT Travel Claim Form. A preferential mileage rate for LRPPF business has been agreed at 40p a mile.
Any other expenses (attendance at training events etc.) MUST have the prior approval from the chair.

Terms of reference

1. To improve people’s experience, knowledge and acceptance of clinical research.
2.  To provide advice on research proposals from a patient/carer perspective thus ensuring Trust clinical research has a patient/carer focus.
3. Embed research into the heart of NHS core delivery as per the pledges set out in the NHS Constitution (2015)
4. To support shared decision making between NHS patients and health professionals.
5. To advise the Lincolnshire Clinical Research Facility and Research and Innovation on the direction of high quality clinical research and research training.
6. To promote the research culture in ULHT Trust, by being involved in research events.
7. To work towards the Lincolnshire Sustainability and Transformation Plan, ensuring innovative research for our evolving healthcare services.
8. Work as patient ambassadors, striving to promote health research. (NIHR, Research Ambassador)
9. To increase public understanding of research, through relevant media outlet, publications, and communications.