• You will first need to confirm if your project is research – the HRA decision tool can assist with this).
• You will need to consider the research team and key roles/ responsibilities. In the first instance, contact your employing organisations Research and Development team (R&D) who will be able to provide guidance (contacts here). 
  • If your idea involves UHB staff, patients, samples, data, or facilities, the UHB Research Application Support (RAS) team offer dedicated support during grant development stages (RAS@uhb.nhs.uk).
• The NIHR Research Support Services support Investigators to navigate these early stages and can provide further guidance with protocol development and funding applications.
• Clinical Trials Units can support investigators to develop their ideas or pilot studies into full-scale projects, offering advice on study design and methodology, and help with grant applications. An expert multi-disciplinary team can support with trial designs, methodology and trial management, supporting the study through delivery and conclusion.
• The NIHR Biomedical Research Centres support with translational research.
• Public and Patient Involvement at all stages is critical is a key component that funders will look for. The above teams may be able to support you with this and more information can be found here.

The Research Team

To support development of a protocol suitable for delivery across various settings, its important to establish a well-rounded research team at an early stage who can support protocol development.  They must be established prior to the research call as their time will often need to be funded within the grant application.

• obtain stats support
• undertake PPIE

Funding

All projects need to be fully funded – the relevant R&D teams will help you determine the costs associated with research activity such as staff time, consumables, equipment and the facilities where the research will be conducted. 

You will need to identify a suitable grant funding call where your trial meets the eligibility criteria.  Some common funders include NIHR, Wellcome, MRC,

• submit grant application (gaining local approvals)

Feasibility: A feasibility review ensures a proposed study has a better chance of being successfully completed. This must be provided in your applications for national and local approvals.

Approvals: Permission is required from various authorities, such as regulatory bodies at a national level. Approval from the host organisation, the clinical department and various other areas at a local level will also be needed. Contracts and agreements may be required to clarify terms and conditions of funding or how data is shared or used. Your proposals will undergo an ethical review at this stage.

Conduct and responsibilities: All research must be conducted in line with the approved protocol, Trust policy and national frameworks. As an investigator you will have multiple responsibilities. You can always contact your Study Support Officer for clarification.

Finalising your research: Once your study has been completed, you will need to provide an end of study report and alert the Research and Innovation team of various other figures and findings.

Publicising your research: When you have finished your research and your findings are about to be published, you need to consider publicising your research. Promoting your research to a general audience is a vital part of your research.

Introduction to health and care research | NIHR

Course: GCP and Research Delivery e-Learning hub | NIHR Learn

Training (nihr.ac.uk) / CRNWM Learning & WFD (wmrtc.org)

INSIGHT West Midlands – University of Birmingham

Introduction to Clinical Research (birmingham.ac.uk)

Continuing Professional Development | University of Birmingham Online Shop (bham.ac.uk)

Research Methods: Introduction to Randomised Controlled Trials – University of Birmingham

New to research?

NIHR Learn offers training , with refresher training due every 2-3 years.

Introductory sessions on Research Practice in either Clinical Settings or Health, Care and Community Settings is available as an introduction to research.  This is suitable for those wanting to know more about research, or those supporting research, but not undertaking delegated research duties.

It is mandatory for all researchers and members of the trials team to complete Good Clinical Practice (GCP) Training, as a minimum requirement. 

For those responsible for IMP Management, there is specific GCP Training available.

Various Informed Consent training is also available for those who will bn required to obtain this from patients:

• General Informed Consent
• Informed Consent with Children
• Informed Consent with Adults lacking capacity
• Informed Consent with Different Communities
• Remote Consent

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