Running a Research Study in your Service
The National Institute for Health and Care Research (NIHR) works across the health and social care sector to deliver research in the East Midlands.
This short overview of our work is intended to support people and organisations that have had an initial introduction to research, and are interested in delivering a research study.
Increasing opportunities for people to take part in research in different settings is a key part of our work. We aim to encourage and empower organisations within social care and would welcome the opportunity to explore how we can support you.
Research terms, roles and responsibilities
Within research you may come across some acronyms. A helpful glossary of terms can be found via the NIHR website. Here are some of the key terms you may encounter:
Chief Investigator (CI): the person who takes overall responsibility for the design, conduct and reporting of a study.
Principal investigator (PI): may be the chief investigator, or where the research is taking place across more than one site, the principal investigator is the person at each site who is responsible for the day to day running of the research project.
Sponsor: The sponsor is the individual, organisation or partnership that takes on overall responsibility for proportionate, effective arrangements being in place to set up, run and report a research project. All health and social care research has a sponsor. The sponsor is normally expected to be the employer of the chief investigator and has overall responsibility for the research
Research site: Research sites are the organisations with day-to-day responsibility for the locations where a research project is carried out. In health and social care research, they are often providers of health or social care and/or the employer of members of the research team.
Participant Identification Centres (PICs): A site that identifies potential research participants but does not undertake any further research activity for that study ( i.e. the identified potential participant is referred elsewhere).
Research nurse and Clinical Research Practitioner: Professionals working in research delivery roles that involve direct contact with patients or other study participants.
Further information regarding responsibilities can be found within the UK policy framework for Health and Social Care research.
Research funding
A non-commercial research study is typically funded by a non-commercial organisation e.g. a charity or government grant and sponsored by for example a University or NHS organisation. For non-commercial research, costs of delivering the study are split into different types:
Research Costs are the costs of the research itself that end when the research ends. They relate to activities that are being undertaken to answer the research questions. These costs are met by the research funder (for example a charity or government grant).
Service Support Costs are the additional participant costs associated with the research, which would end once the study in question had stopped, even if the participant care involved continued to be provided. This cost will be determined on a study by study basis. In the UK, Service Support Costs are met by the Department of Health and Social Care and paid via the Clinical Research Network.
If you would like to find out more, or have a question about research funding, please contact supportmystudyeastmidlands@nihr.ac.uk
Optional research training available to you
Good Clinical Practice (GCP)
GCP is the international ethical, scientific and practical standard to which all clinical research is conducted. Training can be completed online, for free, via the NIHR Learn platform. Depending on the study you support within your service, you may be asked to complete GCP training.
Informed consent
This covers the history and principles of consent in research, including when working with vulnerable adults and with children and young people. Informed consent training can be accessed via the NIHR Learn platform.
Study specific training
Some studies may require study specific training, for example related to documentation management or participant assessments. In such cases, training support will be provided.
Further training which may be of interest can be found on the NIHR CRN East Midlands Workforce Development website.
Contracts/agreements
Before getting started, your site will need to assess whether you are in a position to support a specific study. You may hear this referred to as Assess, Arrange and Confirm:
Assess: Consider what is required to support delivery of this study at your site. For example, does the service have capacity to take the study on; does your service have the relevant participants; is support required from a member of staff who needs specific training (if so, how will the training be provided);
Arrange: If the outcome of the assess phase shows that an element is missing, can arrangements be made to put this in place?
Confirm: Once arrangements have been put in place, confirm to the study Sponsor (usually via email) that the site has capacity and capability. This will progress the set up of the research at your site.
We recognise there may be occasions where you complete the assess phase and find that this may not be the right study for your site. That is a valid outcome and other studies which better meet the capacity and capability of your service may be open to recruitment.
If a study does progress at your site, there will normally be an expectation to sign an agreement or contract with the study Sponsor. Contracts may include information regarding GDPR and information governance arrangements, insurance, payments, etc. If you have any queries regarding contracting (that can’t be resolved by the study Sponsor), please contact supportmystudyeastmidlands@nihr.ac.uk.