What is the LHP Joint Research Office?
The Joint Research Office was established in October 2013 as part of the Liverpool Health Partners strategic partnership to streamline the research and development process across the Liverpool-City region. It brings together expertise from the University of Liverpool and Partner Trusts to provide practical help and support to research projects involving the University of Liverpool and at least one of the Partners.
The JRO will provide assistance in:
- Advice and knowledge base
- Study costings
- Clinical Research Governance
- Funding applications
The LHP JRO is unique as it brings together 1 university, 2 acute trusts, 5 specialist trusts, a mental health trust and a CCG working to bring and develop excellent clinically focussed research for tangible patient benefit. We will ensure that studies are set up in a timely manner with an integrated, effective approach with support available through the lifetime of the study.
Contact us and see how the JRO can work for you:
Alder Hey Children’s NHS Foundation Trust
Aintree University Hospitals NHS Foundation Trust
The Clatterbridge Cancer Centre NHS Foundation Trust
For general enquires please contact Business Manager: Mr Laurie Lomax - Laurie.Lomax@clatterbridgecc.nhs.uk
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool Women’s NHS Foundation Trust
The Royal Liverpool and Broadgreen University Hospitals NHS Trust
University of Liverpool
Web: University of Liverpool Research Support Office (Authorisation required)
The Walton Centre NHS Foundation Trust
What is an Liverpool JRO Project?
A research study can be classified as a JRO project when it involves a JRO NHS Trust and the University of Liverpool.
Involvement of an organisation can be defined as substantive employing organisation of the Chief Investigator, the lead NHS Trust for the research or an organisation where a service will be employed for work on the study such as use of a Clinical Trials Unit or laboratory.
If the proposed study fits with the definition of a JRO Project please contact the Research Office at your substantive employing organisation
If you have any queries regarding your study please contact your substantive employing organisation or the University Research Support Office for further advice.
The JRO Portal has been designed to be used by Partner R&D offices to alert other JRO colleagues of an application for research funding. This ‘early warning system’ will allow all partners concerned to include their own specific costs to the application at the earliest possible stage. Found on the JRO Homepage the JRO Portal is accessed through a password (issued to all R&D offices).
Applying for Research Funding
The LHP JRO will endeavour to assist you in gathering all the necessary information needed to submit your research funding application.
Once a funding opportunity has been identified you will need to decide which organisation will be leading the application; the University of Liverpool or an NHS Trust (some funding bodies dictate who should be the lead). The JRO will work with local Partner R&D offices and the University’s RSO as well as the local Clinical Research Network and Clinical Trials Unit (if applicable) to help create a complete application as well as identifying at an early stage the Sponsorship and legal requirements.
Liverpool Joint Research Office Sponsorship
All organisations in the Liverpool JRO are able to undertake Sponsorship responsibilities as defined in the Department of Health’s Research Governance Framework for Health and Social Care (RGF) and the Medicines for Human Use (Clinical Trials) Regulations 2004 (the Regulations) (where applicable).
Does my project require Sponsorship?
Sponsorship will be required if your project is classed as research (please see NRES Defining Research leaflet for advice) and falls under any of the following categories;
- Involvement of patients and users of the NHS including use of their data, tissue or other bodily material;
- Involvement of relatives or carers of NHS patients;
- Use of NHS premises or resources;
- Any CTIMP (please see MHRA Is it a CTIMP? algorithm for advice)
Who will Sponsor my research?
Sponsorship responsibilities usually remain with the substantive employing organisation of the Chief Investigator.
The Chief Investigator should contact the R&D Department of their substantive employee to discuss sponsorship arrangements and the process for gaining approval.
The JRO has 2 Sponsorship Committees that undertake review and provide recommendations for Sponsorship for each JRO organisation
The JRO Sponsorship Committee discusses all high risk studies, including all CTIMPs, Clinical Trials of Medical Devices and Performance Evaluations of in vitro diagnostic devices. Other studies may be discussed at this committee if it is deemed to be high risk.
The JRO Non-Interventional Sponsorship Sub Committee discussed all lower risk studies including questionnaire and qualitative based studies, studies using human tissue and studies using data only.
Both Committees meet monthly and the deadline for the Committee is 2 weeks prior to the meeting. The deadline dates can be found in the JRO Sponsorship Application Pack below.
In order for a study to be discussed at a JRO Committee the following documents are required;
- Completed JRO Sponsorship Application Form <attach form>
- Comprehensive protocol
- Copies of peer review (please see Part D of <Guidance for Completion JRO Sponsorship Application form>)
- Risk Assessment (CTIMPs only)
Post Award and Project Management
Post award administration will be the responsibility of each partner organisation who are involved in the research project.
Charities and Trusts (UK & International)
Conducting Research in the NHS
Research governance framework (RGF) for health and social care: Second edition
The RGF for Health and Social Care sets out the broad principle of good research governance and sets out the responsibilities for those involved in the management and conduct of research.
The Medicines for Human Use (Clinical Trials) Regulations 2004
These set out the regulations that must be followed when conducting or managing a Clinical Trial of an Investigational Medicinal Product
NIHR Clinical Research Network Portfolio (NIHR CRN)
NIHR CRN Portfolio is a database of high-quality clinical research studies that are eligible for support from the NIHR Clinical Research Network in England.
NIHR Research Design Service (RDS)
The NIHR Research Design Service (RDS) supports researchers to develop and design high quality research proposals for submission to NIHR and other national, peer-reviewed funding competitions for applied health or social care research.
INVOLVE is a national advisory group that supports greater public involvement in NHS, public health and social care research. INVOLVE is funded by and part of the NIHR. They share knowledge and learning on public involvement in research.
Good Clinical Practice (GCP)
Everyone involved in the conduct of clinical research must have training to ensure they are best prepared to carry out their duties. This is laid down in the Research Governance Framework for Health and Social Care 2005, covering all research in the NHS in England, and in law for those people working on clinical trials.
ICH provides guidance for ensuring good clinical practice;
You can complete a GCP training course through the NIHR.
Clinical Trials Toolkit
The Clinical Trials Toolkit provides practical advice to researchers in designing and conducting publicly funded clinical trials in the UK. Through the use of an interactive routemap, this site provides information on best practice and outlines the current legal and practical requirements for conducting clinical trials.
The Toolkit is primarily focused on Clinical Trials of Investigational Medicinal Products (CTIMPs) and the regulatory environment and requirements associated with these. However researchers and R&D staff working on trials in other areas will also find useful information and guidance of relevance to the wider trials environment.
Human Tissue Act 2004
All research involving the use of ‘relevant material’ (any tissue that consists of or contains human cells) falls under the remit of the Human Tissue Act 2004. The Act ensures that human tissue is used and stored correctly.
Human Tissue Authority (HTA)
The HTA are responsible for regulating organisations and institutes that store human tissue for research and they ensure that tissue is removed and stored in an appropriate and well managed way.
This can only take place at organisations or institutes that hold a HTA license.
A list of licensed premises is available at http://www.hta.gov.uk/_db/_documents/Licensing_Reports_-_R_201302011252.pdf.
Data Protection Act 1998
All research must take place within the law of the Data Protection Act. This ensures that all participants data is accessed with full consent, anonymised and stored correctly.
Mental Capacity Act 2005
If you intend to recruit participants that lack capacity to consent arrangements must be made to ensure compliance with the Mental Capacity Act 2005.IUnder the Act it is unlawful to carry out intrusive research on a person who lacks capacity without prior regulatory approvals and also research that would be unlawful if it was carried out on an individual with capacity to consent but consent was not gained.
Integrated Research Application System (IRAS)
IRAS is a single system for applying for the permissions and approvals for health and social care / community care research in the UK. It enables applications to be made to all of the regulatory bodies listed below, as well individual R&D departments and the NIHR Portfolio.
National Research Ethics Service Research Ethics Committee (NRES REC)
All research that takes place within the NHS requires review by NRES REC.
Medicines and Healthcare products Regulatory Agency (MHRA)
If your research is a clinical trial of an investigational medicinal product (CTIMP), Clinical trial authorisation is required from the licensing authority (MHRA) is required for any to be conducted in the UK.
Social Care Research Ethics Committee (REC)
If your research involves adult social care you may require review from the Social Care REC.
Gene Therapy Advisory Committee (GTAC)
If your research involves the use of any gene therapy medicinal products it will require review by GTAC. As of 30th November 2012 the Gene Therapy Advisory Committee was closed and now no longer operates as a standalone department. The West London NRES Committee is now the Gene Therapy Advisory Committee. They are now also the flagged committee for research involving Advanced Therapy Medicinal Products (ATMPs), stem cell therapy, vaccines involving recombinant vectors or vectors with potentially immuno-regulatory mediator molecules, first in human trials of vaccine vectors (or variants of vectors in use) or of engineered antigen molecules and any other gene therapy research.
National Information Governance Board for Health and Social Care (NIGB)
You should apply to the NIGB if you need to access:
- Identifiable patient information relating to people living in, or receiving healthcare in, England and Wales without explicit consent, prior to the disclosure of confidential information or
- Central Register (formerly NHSCR) information (either with or without consent), or
- Hospital Episode Statistics / Secondary Uses Service (HES/SUS) for either identifiable or sensitive data (either with or without consent).
Ministry of Justice (MoJ)
Projects taking place within HM Prison Service, HM Probation Service, HM Courts Service or any other agency within the responsibility of the Ministry of Justice for England and Wales and that meet any of the following criteria are subject to the Research Quality Assurance (RQA) process within the Ministry of Justice.
- National in scope;
- Intended to be published;
- Results to be sent to Ministers; or
- A study of outcomes of policy or operational changes.
For advice on applications to the Ministry of Justice, please email email@example.com
National Offender Management Service (NOMS) (Prisons & Probation)
Research projects taking place within the National Offender Management Service (NOMS) that wish to undertake the project with Prisons or Probation Trusts are required to have approval from NOMS
For advice on applications to NOMS, please contact the National Research Committee (NRC) at firstname.lastname@example.org.