MRC policy on UK clinical trials regulations
Key facts about the regulations
In 2001 the European Union 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 well-being 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 MRC’s 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 investigator 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 contact the MHRA directly.
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 and/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 and/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 the MRC must include the name(s) of the intended sponsor(s). The MRC expects that the Research Organisation applying for a grant will be the sponsor, or will accept an allocation of sponsorship responsibilities. If the Research Organisation does not accept a sponsorship role, we may refuse to fund the trial.
Informing the MRC about the trial sponsor
- Grant and fellowship applications: All 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.
- New trials in MRC units / institutes: Directors of MRC units / institutes must ensure that their systems identify the authorisation and sponsorship details of new trials involving their unit / institute staff (including visitors under unit / institute supervision). These should be documented so that the information is available promptly on request by MRC Head Office or others.
The MRC as a sponsor
- For trials initiated and managed by MRC units / institutes, the MRC will accept some or all of the sponsorship responsibilities under the UK Clinical Trials Regulations, providing that:
- Another organisation is not better placed to undertake the sponsor’s duties
- One or more MRC employees acts as investigator(s) and accept responsibilities for the design and/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
- The MRC unit / institute is able to exercise the sponsor’s duties
- The MRC may agree to (co-)sponsor trials under other circumstances subject to appropriate agreements and controls. However, it will not accept liability for responsibilities that properly belong elsewhere.
- Directors of MRC units / institutes are authorised to approve new clinical research projects within the framework of the unit’s / institute’s MRC-approved programme, and to accept sponsorship responsibilities on the MRC’s behalf. They are responsible for ensuring that the research is appropriately assessed and resourced, and that it is conducted to the required standards and in conformity with regulatory requirements.
Actions required for trials of medicinal products
- Actions required of the chief investigator (likely to be principal applicant):
- Review your trial with the sponsor(s) to ensure that it complies with the UK regulations
- Ensure you meet the requirements of the MHRA, Research Ethics Committees, HRA and/or NHS R&D and the MRC in relation to authorisation and sponsorship. Send details of the sponsorship arrangements to the 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 and MRC units / institutes:
- Ensure that appropriate arrangements for sponsorship are in place. Notify the MRC directly about these or authorise the chief investigator to do so
- Ensure that you can give the 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 (applies to all MRC-funded research)
- For research involving human participants, the Research Organisation must demonstrate to the MRC on request that required approvals, such as regulatory authorisations (e.g. CTA from MHRA), favourable opinion from the research ethics committee and HRA and/or NHS R&D approval(s) are in place or were in place before the trial started.
In addition, the chief investigator must notify the MRC if a regulator or a research ethics committee requires amendments that substantially affect the research question, methodology or costs to the extent that the project is no longer the same as that approved for funding by the MRC.
- The MRC does NOT require:
- Required permissions to be in place when an application for funding is submitted to the MRC.
- To be routinely sent copies of evidence of submissions, permissions and amendments.
- To be routinely notified of changes to the protocol requested by the MHRA or research ethics committees unless they substantially change the research project approved for funding by the MRC.
- In cases where the research is especially sensitive, the MRC may ask the chief investigator for evidence of required approvals before releasing funding.
Good Trials Management
- Investigators and Research Organisation’s 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, bearing in mind that:
- 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 the MHRA if in doubt about the appropriate risk management systems to adopt.
- MRC-funded trials should also comply with relevant MRC policies and guidance.
MRC Regulatory Support Centre: firstname.lastname@example.org