Is your study clinical research?
If you are unsure if your research falls under the UK Framework for Health and Social Care Research use the HRA Decision Tool to help you. If you are still unsure, contact the Clinical Trials team.
Study Classification
What type of clinical research are you doing?
accordion
A Clinical Trial of an Investigational Medicinal Product is a study that looks at the safety or efficacy of a medicine/foodstuff/placebo in humans, as defined by the Medicines for Human Use (Clinical Trials) Regulations 2004 The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.
Use the algorithm developed by the MHRA to help you decide if your research is classified as a CTIMP.
The term ‘medical devices' includes:
- in vitro diagnostic medical devices (devices used in vitro for the examination of a specimen derived from the human body, including reagents, instruments and specimen receptacles)
- active implantable medical devices (e.g. implantable cardiac pacemakers, cochlear implants, implantable active drug administration devices etc)
- as well as a wide range of other devices (from dressings and tongue depressors to heart valves and X-ray equipment)
For studies involving:
- CE marked devices that are being used outside their intended purpose,
- Non-CE marked devices
Under the Medical Devices Regulations 2002, ethical approval is required for a clinical investigation undertaken by, or with the support of, the manufacturer or another commercial company in order to demonstrate the safety and performance of a non-CE marked medical device, or a CE-marked device that has been modified or is to be used for a new purpose.
ALL research involving human participants (e.g. staff, relatives, members of the public or patients), human tissue or human data (unless the data is previously collected, fully anonymised and cannot be traced back to an individual) requires approval from a NHS Research Ethics Committee (REC) prior to any study procedures taking place. Furthermore, to comply with the Department of Health’s Research Governance Framework all such research activities must be formally approved by the Clinical Trials Sponsorship Committee.
Please note that if the research is being conducted within the NHS in England permission through HRA is needed.