If your research involves an intervention or actions expected to result in change, such as providing your participants with a drug treatment, a surgery or different surgical technique or approach, altering diet, exercise, or some other lifestyle aspect, then MRC has the following additional expectations:
- you should consider how to involve people with lived experience in appropriate aspects of your study, considering study design, management, conduct and dissemination
- trial registration and dissemination requirements
- adequate information should be included in each proposal to enable MRC to evaluate any physical or psychological hazard to which participants may be exposed. Each proposal should specify the number, sex, age range and state of health of the human participants
- you should indicate whether participants are patients, healthy volunteers or individuals in a control cohort and how consent will be obtained
- you can pay participants to take part in your research, provided that the payment is to reimburse expenses or compensate for time and inconvenience. Payments should not be at a level that would constitute an inducement to take part.
5.4.1 Clinical trials of investigational medicinal products, including advanced therapies
These interventional trials test the safety and efficacy of medicinal products and include trials of advanced therapies, which are governed by the clinical trials regulations.
You can find further guidance on the regulatory requirements of these trials in:
- clinical trials regulations for MRC’s expectations on the sponsorship of these trials
- clinical trials of medicines and advanced therapies, which signposts Medicines and Healthcare products Regulatory Agency (MHRA) guidance
- National Institute for Health and Care Research’s Clinical Trials Toolkit for practical guidance on running a clinical trial in the UK.
If you are proposing a clinical trial of an investigational medicinal product, you will need to apply for combined review from the NHS Research Ethics Committee (REC) and MHRA, using a new part of the Integrated Research Application System.
5.4.2 Ionising radiation in human participants
If your proposal involves ionising radiation, which includes, but is not limited to:
- x-rays, computerised tomography (CT) scans and bone density scans
- radiotherapy (including brachytherapy and therapy using unsealed sources)
- radionucleotide imaging
- administration of radioactive substances (for example, nuclear medicine and positron emission tomography or CT).
Neither magnetic resonance imaging nor ultrasound involve ionising radiation.
There is a legal and ethical need to justify the use of ionising radiation in your proposal. Be aware that the Ionising Radiation (Medical Exposure) Regulations relate to any research exposure, not only to those additional to routine clinical care. Guidance is given on this, and other relevant legal frameworks in the Health Research Authority website.
Where research involves the administration of radioactive substances, this must also be approved by the Administration of Radioactive Substances Advisory Committee.
All imaging technologies have the potential to uncover previously unknown pathology. You should always consider how likely such a discovery may be and if appropriate, describe how you would handle such discoveries within your application.
For further guidance, please see the MRC and Wellcome Trust framework on the feedback of health-related findings in research.
5.4.3 Testing a medical device or an in vitro diagnostic
Testing a medical device, including software products, may be regulated under the Medical Device Regulations depending on the purpose of the device, commercial intent and whether an exemption applies.
Please discuss with your sponsor’s office, as local interpretation of the exemption differs. If you are within scope of the medical devices regulations, you may be conducting a clinical investigation that requires an application to MHRA and NHS REC.
For in vitro diagnostics, you may be conducting a performance evaluation, which you will need to register with MHRA.
Learn more about the regulation of Medical Devices and in vitro diagnostics.