Who has ultimate responsibility for an investigational device at the site?

It is important to ensure you have the right people in the correct roles supporting your project.

Your research team should include the following roles in line with the UK Policy Framework for Health and Social Care Research and applicable legislation:

• sponsor
• 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.

The 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 should have a sponsor. This includes all research that involve NHS patients, their tissue or information.

Two or more organisations may agree to act as co-sponsors or joint sponsors. Co-sponsors allocate specific sponsor responsibilities between them whilst joint sponsors each accept liability for all of the sponsor’s responsibilities.

A sponsor can delegate specific tasks to any other individual or organisation that is willing and able to accept them.

Any co-sponsorship, joint sponsorship or delegation of tasks to another party should be formally agreed and documented by the sponsor(s).

The Sponsor’s responsibilities are set out in more detail in the UK Policy Framework for Health and Social Care Research.

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 does not require a UK legal representative of the lead sponsor (or any co-sponsor) for studies other than CTIMPs.

Legal representatives – clinical investigations of medical devices in Northern Ireland

Under the EU Medical Device Regulation 2017/745, clinical Investigations of Medical Devices that take place in Northern Ireland must have a legal representative of the sponsor that is based in Northern Ireland or the EU.

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.

The chief investigator is the overall lead researcher for a research project (Outside the UK the term Coordinating Investigator or Investigator may be used). In addition to their responsibilities if they are members of a research team, chief investigators are responsible for the overall conduct of a research project.

The chief Investigator’s responsibilities are set out in more detail in the UK Policy Framework for Health and Social Care Research.

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.

• MHRA and HRA position on who can act as a Chief Investigator

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.

Data controller

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.