All project based health research in the UK must have:
This is the individual, company, institution, organisation or group of organisations that takes on responsibility for initiation, management and financing (or arranging the financing) of the research.
A sponsor can delegate specific responsibilities to any other individual or organisation that is willing and able to accept them. However, the sponsor should ensure that the delegation of responsibilities to another party is formally agreed and documented.
All research falling under the remit of the Secretary of State for Health must have a formal sponsor. This includes all research in health and social care that involve NHS patients, their tissue or information, etc. There are similar requirements for research involving social care practitioners, clients and resources, where this falls under the Secretary of State for Health’s remit.
Any research outside the NHS should also have a sponsor to take on the specific responsibilities of the role.
If the study is run from outside the UK please see the advice on identifying a legal representative.
This is the individual who is responsible for the conduct of the whole project in the UK. HRA policy is that the named CI should normally be a researcher who is professionally based in the UK. This will mean that he / she is able to supervise the research effectively in the UK setting and is readily available to communicate with the Research Ethics Committee (REC) and other review bodies during the application process and where necessary during the conduct of the research.
This is the individual who is responsible for the conduct of the research at a research site. Therefore there should be one PI for each research site. In the case of a single-site study, the chief investigator and the PI will normally be the same person.
Specific research activities such as research tissue banks, or research involving radiation involve additional roles. For more information see the Resources.