Key facts about the regulations
In 2001 the EU adopted the EU Clinical Trials Directive (2001/20/EC) as a framework for good management in trials of medicines for human use. The subsequent UK Medicines for Human Use (Clinical Trials) Regulations became law in 2004.
The regulations are intended to protect the rights, safety and wellbeing of research participants and to simplify and harmonise regulatory processes. They apply to trials designed to generate information on the efficacy or safety of medicines.
The Medical Research Council’s (MRC) policy on the UK clinical trials regulations details our requirements of MRC-funded researchers in universities or other research organisations who take on the role of chief investigator (likely to be the principal grant applicant) in a clinical trial of an investigational medicinal product (CTIMP).
If you are planning a clinical trial but are uncertain whether it falls within the scope of the regulations, please look at guidance from the Medicines and Healthcare products Regulatory Agency (MHRA). This guidance includes a link to their algorithm, and if still unsure discuss with your sponsor or contact the MHRA on clinicaltrialhelpline@mhra.gov.
For other clinical research, please see the MRC policy on the UK policy framework for health and social care research.
Summary of MRC requirements
The trial sponsor
The UK Clinical Trial Regulations define the sponsor as “an individual, company, institution or organisation which takes responsibility for the initiation, management or financing of a clinical trial.”
They do not require a single organisation or person to take on all sponsorship responsibilities, nor do all the other partners’ civil liabilities transfer to the sponsor in collaborative trials. The responsibilities of the sponsor can be accepted by:
- an investigator
- a single organisation
- a group of individuals or organisations.
They may act as either co-sponsors or joint sponsors. Co-sponsors agree how best to allocate sponsor’s legal responsibilities between partners according to whichever is best placed to accept them, and where no party accepts joint liability for responsibilities allocated to other parties. Joint sponsors agree to accept joint liability for all of the sponsor’s responsibilities.
Research organisations as sponsors
The UK Clinical Trials Regulations permit a group of individuals or organisations to name themselves as the research sponsor. For new grant-funded trials, the funding application to MRC must include the names of the intended sponsors.
MRC expects the research organisation applying for the grant to be the sponsor, or to have sponsorship arrangements with a collaborator if they are better placed. If the sponsorship role is unclear or inappropriate, we may refuse to fund the trial.
Informing MRC about the trial sponsor
All grant and fellowship applications to the MRC for funding for clinical studies that fall within the scope of the UK regulations must include the details of sponsorship arrangements made by the research organisation.
For new trials in MRC units or institutes, the directors of MRC units or institutes must ensure that their systems identify the authorisation and sponsorship details of new trials involving their unit or institute staff, including visitors under unit or institute supervision. These should be documented so that the information is available promptly on request by MRC head office or others.
The MRC as sponsor
MRC, or more accurately UKRI, will only consider accepting trial sponsor responsibilities in very limited circumstances. For UKRI to accept sponsorship, all of the following must apply:
- another organisation is not better placed to undertake the sponsor’s duties
- one or more UKRI employees will lead the trial (act as chief investigator) and accept responsibilities for the design or conduct of the trial
- the research proposal has been peer reviewed and approved for funding by the MRC or by a funder with equivalent assessment standards
- an MRC institute is able to exercise the sponsor’s duties.
UKRI may also agree to co-sponsor projects with another research organisation under certain circumstances, subject to appropriate agreements and controls, and providing that the above criteria are fulfilled.
UKRI will review whether they will accept sponsorship responsibility on a case by case basis. Please contact us to discuss.
Actions required for trials of medicinal products
Actions required of the chief investigator, likely to be principal investigator:
- review your trial with the sponsors to ensure that it complies with the UK regulations
- ensure you meet the authorisation and sponsorship requirements of the:
- MHRA
- Research Ethics Committees
- Health Research Authority
- NHS or Health and Social Care (HSC) Northern Ireland Research and Development
- MRC
- send details of the sponsorship arrangements to MRC
- ensure that your trial will be well managed and monitored in respect of any inherent risks, that the principles of good clinical practice are being applied effectively, and that your safety reporting systems are robust
- make sure that any substantial changes to your trial protocol are submitted to the MHRA and Research Ethics Committee as required.
Actions required of research organisations, including MRC institutes:
- ensure that appropriate arrangements for sponsorship are in place. Notify MRC directly about these or authorise the chief investigator to do so
- ensure that you can give MRC assurance that your institutional systems for research governance under the UK policy framework for health and social care research and the UK Clinical Trials Regulations are robust.
Approvals for research
Clinical trials involving human participants must have appropriate ethics and regulatory approvals before the trial starts.
Good trials management
Investigators and research organisations should review their systems for good clinical practice and safety reporting, based on a thorough analysis of the trial risks, the systems in place to manage the risks, and the regulatory requirements. Investigators and research managers should use MHRA guidance and refer to the Clinical Trials Tool Kit for advice on trial management and monitoring. Investigators undertaking global health trials should refer to the MRC guidance on the management of global health trials.
The MHRA is committed to taking a risk-based approach to its responsibility for inspection. Systems appropriate to one kind of trial should not be applied to other kinds of trial for which the risk profile is different. Investigators should consult MHRA if in doubt about the appropriate risk management systems to adopt.
MRC-funded trials should also comply with relevant MRC policies and guidance.
Contact for more information
For more information on the UK Clinical Trials Regulations, please see the Clinical Trials Tool Kit, or contact the MRC regulatory support centre:
Email: rsc@mrc.ukri.org