The key to starting a research career is to develop the skills and networks in research and build knowledge around your area of interest. There is no one path that fits all and many experience changes of direction along the journey. Chapter 1 in this section provides guidance on writing a research protocol. Information and the process for applying for the requisite approvals and permissions for the study, attributing costs for the study and applying for funding are detailed in Chapter 2. The final chapter on training and development outlines the NIHR clinical research academic pathways and programmes available for researchers. A link to the mentorship registry is provided in this section.
Chapter 1
Journey from idea to writing a research protocol
Research ideas generally come from previous experience and knowledge or identified gaps within services or care. Being inquisitive, challenging accepted practice, reviewing existing literature are all ways in which ideas are formed. Once you have your research idea it is important to identify your research question, initially this may be very broad and will require some shaping. Often beginning at the end, the conclusion you hope to achieve is a good way to start to shape your idea.
You will find discussing your ideas with colleagues and gaining support from a mentor who has been through this process already valuable in helping you navigate your way through the process. It is equally important to recognise that this is a lengthy process and each stage will take time to develop.
The Research Design Service (RDS) will help guide you through the process of writing a research proposal which may seem daunting when you are starting. They can provide guidance on a variety of different aspects of a research proposal including:
When embarking on a research project it is important to get early access to the right support to guide you through the process.
Your local research and innovation / research and development department is a good place to start, and early involvement will ensure all the right processes are followed for approval of the delivery of your study. Your Local Clinical Research Network (LCRN) Study Support Service (SSS) will also help guide you through the various steps of planning your research proposal..
The clinical trials toolkit is an interactive colour coded route-map designed to help you navigate through the legal and best practice guidance setting up and managing your study.
By clicking on each station of the toolkit, you will be provided with further information of that specific process, for example by clicking on Trial Planning & Design will open up into further information.
Writing your research protocol is the next step in developing your idea into a research plan.
A protocol is defined as “a document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical trial” The Medicines for Clinical Use Regulations 2004.
The NHS Health Research Authority (HRA) offers guidance and templates to support your protocol development
Within the design of your research proposal you will need to consider the costs that are involved in the activities within your study. These generally fall into three categories:
Research costs - the costs of the research activities that stop when the research ends.
Service support costs - the additional patient care costs associated with the research.
Treatment costs - the patient care costs that would continue even when the research had stopped.
When embarking on a research project it is important to get early access to the right support to guide you through the process.
Your local research and innovation / research and development department is a good place to start, along with your Local Clinical Research Network (LCRN) Study Support Service (SSS).
For more information contact crnkss.studysupport@nihr.ac.uk
Applying for funding
Applying and securing funding for your research can be a lengthy process and it is advisable to start this process
in parallel with your protocol development. Further guidance can be found within the Clinical Trial Toolkit -
There is a wide variety of funding available for health and social care research and the
RDS
can help support you to decide the most appropriate funder for your particular research.
Listed below are the different NIHR funding streams, but funding can also be sought from charities,
research councils and other national peer reviewed funding programmes.
Chapter 2
Permissions and approvals
Once you have your final research protocol, peer review and funding secured you can apply for
the necessary permissions and approvals to start your research.
On 31 March 2016, Health Research Authority (HRA) Approval became the route for applying for approval to
conduct research in the NHS in England. HRA Approval brings together the assessment of governance and legal compliance,
undertaken by dedicated HRA staff, with the independent Research Ethics Committee (REC) opinion provided through the UK research ethics service.
All applications are submitted through the Integrated Research Application System
(IRAS)
Users of the system must have an IRAS account. On-screen instructions provide guidance on opening an IRAS account.
IRAS provides extensive guidance in the Help section and via Question Specific Guidance that can be accessed as the form is completed by clicking the green “i" buttons. IRAS also provides an e-learning module that is free to use and does not require registration. This module provides a simple overview of the system and its functionality.
CRN Portfolio - it is important to consider if your study is eligible for the NIHR CRN Portfolio.It is important to state this within the IRAS form by selecting YES to question 5b of the IRAS filter. If your study is eligible for the portfolio then your local CRN will support you in setting up and delivering your study.
For more information visit www.nihr.ac.uk/researchers/collaborations-services-and-support-for-your-research/run-your-study/crn-portfolio.htm Once the relevant HRA approvals are in place the recruiting site(s) can then begin their process of establishing and issuing capacity and capability to participate in the research.
It is the responsibility of the Chief Investigator (CI) along with the sponsor to ensure that all trial documentation has been prepared and version controlled. For multiple site trials it is the CI’s responsibility to ensure each Principle Investigator (PI) is provided with all the necessary documentation and any training required to deliver the study.
A Trial Master File (TMF) should be set up at the beginning of a trial where all essential documentation is stored. A well-kept TMF can help with efficient trial management and can facilitate the reconstruction of the conduct of the trial during the audit/inspection process.
The TMF should be held at the coordinating site (usually the Chief Investigator’s office or Coordinating Centre) and for multi-site trials, copies of relevant documents should be kept at each participating site in an Investigator Site File (ISF). Most sponsors will provide guidance on the content and set up of the TMF/ISF based on their local policies/procedures.
The TMF/ISF should be maintained throughout the course of the trial and it should be clear who has been given the task of maintaining it, for example by indicating this role on the trial delegation log.
Once all of the relevant approvals are in place, all documentation has been finalised, and all participating sites have the information they need, the trial can begin and the first participant can be recruited.
For further guidance on delivery of your research please refer to the relevant sections of the Clinical Trial Toolkit
www.ct-toolkit.ac.uk/routemap/
Central Portfolio Management System / Local Portfolio Management Systems
NIHR research data is stored in the Central Portfolio Management System (CPMS). This system holds top level study data as well as participant recruitment data with access granted to study chief investigators, study coordinators and a research activity coordinator nominated by the chief investigator.
Participant recruitment data for the majority of NIHR portfolio studies is collected by sites and uploaded to appropriate Local Portfolio Management Systems (LPMS). In Kent, Surrey and Sussex, the LPMS of choice is Edge https://edgeclinical.com/
CPMS and LPMS systems are linked by APIs to
allow study level data to be sent to the local systems, while recruitment and site level data is sent from LPMS to CPMS automatically every day.
Chapter 3
Research Training and Career Development
A skilled research workforce is essential to supporting the delivery of research within health and social care. The NIHR aims to support and develop this workforce.
To find out more visit www.nihr.ac.uk/health-and-care-professionals/career-development/ and click on the link that matches your role.
The NIHR Academy offers a wide range of NIHR training and career development awards available at different levels and accessible by different professional backgrounds as detailed below:
