It is important to ensure you have the right people in the correct roles supporting your project.
When it comes to your project based research we would expect your research team to include the following roles, which is in line with policy and legislation;
- sponsor’s legal representative
- chief investigator
- principal investigator
- data controller.
There may be additional roles that you may need to consider depending on your type of research, such as with student research or roles that are required for research tissue banks and databases.
An 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. Any delegation of responsibilities to another party should be formally agreed and documented by the sponsor.
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. 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.
Sponsorship of CTIMPs
It is a legal requirement for any clinical trial of an investigational medicinal product (CTIMP) to be sponsored. The sponsor is responsible for ensuring that a clinical trial complies with the legislation and GCP.
If a sponsor of a CTIMP is a commercial or other non-NHS body, a copy of an insurance or indemnity certificate should normally be included with the REC application as evidence of the cover in place for the potential liability of the sponsor. This may be a certificate for a trial-specific policy or a block policy covering a number of trials conducted by the sponsor. If the certificate is not yet available, for example because proposed trial-specific cover will not be brought into effect until the trial is ready to start, the REC will require as a condition of its favourable opinion that a copy of the certificate is provided prior to the start of the trial.
Sponsor’s legal representative
Legal representatives – CTIMPs
If a sponsor(s) of a CTIMP is not established in the UK or on an approved country list (which initially includes EU / European Economic Area (EEA) countries), it is a statutory requirement to appoint a legal representative based in the UK or a country on the approved country list for the purposes of the trial. Details of the legal representative should be entered in the ‘legal representative’ section of IRAS.
The legal representative:
- may be an individual person or a representative of a corporate entity;
- does not have to be a legally qualified person;
- should be willing to act as the agent of the sponsor in the event of any legal proceedings instituted (e.g. for service of legal documents);
- should be established and contactable at an address in the UK or a country on the approved country list;
- does not assume any of the legal liabilities of the sponsor(s) for the trial by virtue of the role of legal representative and does not therefore require insurance or indemnity to meet such liabilities; but
- may in some cases enter into specific contractual arrangements to undertake some or all of the statutory duties of the sponsor in relation to the trial, in which case the legal representative would also be regarded as a co-sponsor and would then require insurance or indemnity cover.
In all cases, evidence should be provided with the application that the legal representative is willing to take on the role of legal representative and is established at an address in the UK or a country on the approved country list. For example, a copy of correspondence between the sponsor and legal representative on appropriate headed paper could be supplied, or a copy of a contract.
Where the legal representative is also a co-sponsor, this should be separately recorded on the application form and details given of the allocation of sponsorship responsibilities. Evidence of insurance or indemnity cover should be provided.
Legal representatives – studies other than CTIMPs
The UK Policy Framework, which has replaced the Research Governance Frameworks, does not require a UK legal representative of the lead sponsor (or any co-sponsor) for studies other than CTIMPs.
Clinical investigations of medical devices sponsored by the manufacturer
Under the UK Medical Devices Regulations 2002 (as amended) a manufacturer who places devices on the GB market under their own name and does not have a registered place of business in the UK must designate a UK Responsible Person.
For the purposes of placing a device on the Northern Ireland market, where a manufacturer is based outside Northern Ireland, a UK Responsible Person or Authorised Representative may be required to act on their behalf. Please see MHRA guidance for specific requirements, which will depend on the location of the manufacturer and device class.
Details of the UK Responsible Person/Authorised Representative must be notified to the MHRA when the device is registered. The name and address of the UK Responsible Person, where required, must be included on the device labelling where the device has been affixed with a UKCA mark. EU labelling rules will apply to devices placed on the market in NI.
In the case of non-UKCA/CE UKNI/CE-marked medical devices, the UK Medical Devices Regulations 2002 (as amended) do not require a manufacturer to appoint a UK Responsible Person/ Authorised Representative until the point that the device is placed on the UK market. However, the UK Responsible Person/ Authorised Representative may be appointed in advance of UKCA/CE UKNI/CE-marking at the manufacturer’s discretion.
If the manufacturer has appointed a UK Responsible Person/ Authorised Representative at the time of application to undertake research on the device, details should be included in the relevant section of IRAS.
The role of a UK Responsible Person/Authorised Representative under the UK Medical Devices Regulations 2002 (as amended) is not the same as that of a legal representative for research undertaken on the device in the UK (see previous section of this guidance). Therefore, non-UK manufacturers acting as sponsors of research in the UK would still need to appoint a legal representative established in the UK, even though they may have appointed a UK Responsible Person or Authorised Representative elsewhere in the UK for the purposes of the regulations.
Chief Investigator (CI)
An individual who is responsible for the conduct of the whole project in the UK. Our policy states that the named CI should be a researcher who is professionally based in the UK, as they will be:
- able to supervise the research effectively
- 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.
Chief Investigators of Clinical Trials of an Investigational Medicinal Product (CTIMPs)
We have produced guidance with the MHRA on who can act as the CI for CTIMPs taking place in the UK. It includes a definition of the term ‘Authorised Health Professional’ and examples of which professions this term applies to.
Principal Investigator (PI)
An individual responsible for the conduct of the research at a research site. 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.
The data controller will be the organisation responsible for the management and oversight of the data. More information on the role of data controllers and personal data in health and care research can be found in our guidance.