Key concepts, people and organisations

The concepts, people and organisations outlined here are things you will hear people refer to regularly in your day to day job. They are also referred to throughout this resource. You may want to bookmark this page so you can easily refer to it in the future. 

The protocol is the study ‘manual’. It is a written document which sets out the what, why, when, how and who of a clinical research study. It provides information on the background and rationale for conducting the study, and details how every element of the study should be conducted. The plan must be carefully designed to safeguard the health and safety of the participants, as well as answer the specific research question. 

Research participants are central to the clinical research process. Without people willing to participate in clinical research, no studies would happen. It is a central ethical principle of clinical research that participation is voluntary, because we don’t yet know what the outcome of the treatment they receive will be. 

Research participants in studies supported by the NIHR CRN are usually patients who have the condition or disease being studied, or fall into a particular demographic group in which it is more common. 

Visit our website to listen to patients describing why they chose to participate and how research has changed their lives. 

The Chief Investigator (CI) takes primary responsibility for the conduct of the study.

The CI works with a wider team of people to design, manage and oversee their study. The management and oversight of a study is often carried out in conjunction with a Contract Research Organisation or Clinical Trials Unit. The design and planning of studies sponsored by NHS organisations and universities may be prepared with the assistance of a statistician, a Clinical Trials Unit or the NIHR Research Support Service. 

We often refer to the Chief Investigator and their wider team as ‘the researcher’. 

In many studies, the research needs to be conducted in several locations in order to involve enough participants for the results to be meaningful, and to reduce any bias that might come from being located in a single area. 

Each individual organisation that conducts the study is called a Research Site. Research sites deliver the research - that is, they find the people to participate in the study and carry out the activities described in the protocol. 

A Principal Investigator (PI) takes responsibility for the initiation and conduct of the study at each research site. They are responsible for the conduct of the study at their site, ensuring the study is conducted in line with the protocol and to ethical and practical standards and ensuring the right people, equipment and other resources are in place to complete all the activities required. 

A wide range of people may make up the local research site team. Every organisation and the requirements of every study are different, but it is common for the PI to be supported by clinical research nurses, clinical research practitioners, doctors and other medical professionals, and pharmacy, laboratories and imaging staff. 

Most organisations that act as research sites have a dedicated research and development (R&D) or research and innovation (R&I) department. Many NHS organisations will be delivering several studies, sometimes hundreds at the same time. To support all the PIs and teams delivering studies, R&D or R&I departments provide organisation-wide policies and procedures, make sure contracts and financial arrangements are in order, and have an overview of all the research activity taking place in their organisation. 

Before a study can be conducted, regulatory and governance approvals must be in place to ensure the research meets legal and ethical standards. The Health Research Authority (HRA) coordinates all research approvals for studies taking place in the NHS in England, ensuring necessary approvals from all regulatory bodies are in place. 

Life sciences is a branch of science that deals with living organisms and life processes, including, for example, biology, medicine and healthcare technology. The Life Sciences Industry is the collective term for commercial organisations that design, deliver and support life sciences research, for example, pharmaceutical and medical technology companies. 

The Life Sciences Industry contributes significantly to the UK economy, creating jobs and providing investment. Find out how more about NIHR support for the Life Sciences Industry. 

The NIHR is the largest non-commercial funder of clinical research in the UK. Other non-commercial funders include the Medical Research Council (MRC) and medical and health research charities, such as Cancer Research UK and the British Heart Foundation. 

Collectively, non-commercial funders invest over £1bn a year in clinical research in the UK. 

Find out more about how we partner with charities and industry  

These are studies delivered in partnership with multiple funders or organisations. For example, a Life Sciences company may apply for funding either as a lead organisation or as co-applicants with NHS or academic partners. The company's involvement could range from the provision of the treatment being investigated free of charge, to funding for specific staff or activities.

The NIHR encourages applications for funding from Small to Medium Enterprises (SMEs). To date, the NIHR has funded over 200 projects involving SMEs as either lead or co-applicants.

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