Additional approvals

 

Additional internal approvals are required for projects involving ionising radiation, devices, drugs, or human tissue.

Approval from the Medicines and Healthcare Regulatory Agency (MHRA) is required for studies that are investigating the efficacy or safety of medicines, research involving medical devices that are not CE (Conformité Européene) marked, or when devices are used outside their intended purpose.

In this section you will find the following information:

• Projects involving medicines
• Projects involving medical devices
• What is a medical device?
• Projects involving ionising radiation
• Projects involving medicines
• Projects involving radiology including guidance notes on Ionising Radiation
• Projects involving patient data

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Projects involving medicines

Does your study involve a medicine? You may need to submit it to the MHRA. It is best to consult the Cambridge Clinical Trials Unit if you are designing a study that involves a drug.

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Projects involving medical devices

Research involving devices that are not CE marked or devices that are used outside their intended purpose require review by the MHRA when commercialisation is intended. All studies involving medical devices need review by the Clinical Engineering Department. The Research Governance Coordinators can assist with this.

What is a medical device?

DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 September 2007, which amended the COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices, defines a ‘medical device’ as:

any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
• investigation, replacement or modification of the anatomy or of a physiological process,
• control of conception

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

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Projects involving ionising radiation

Research involving radioactive materials (for example PET CT or MUGA) or radiation (for example X-rays) require approval by the Radiation Protection team. They can be contacted via cuh.radiation.approvals@nhs.net.

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Projects involving radiology

Please contact the Radiology department as soon as possible in the project planning process to discuss any specific requirements and to ensure that the department can accommodate the study. Before R&D approval can be granted, any project involving the department will need authorization from the Clinical Director of Radiology; contact Wendy Phillips, Clinical Trials Administrator, to arrange this:

• Tel 01223 256419
• Email wendy.phillips19@nhs.net

If your project will involve ionising radiation please read the guidance note below.

Guidance note – Ionising Radiation

All radiation exposures carried out as part of research studies must comply with the Ionising Radiation (Medical Exposures) Regulations 2000 (IRMER). This applies to all studies including those where Cambridge University Hospitals is:

• the lead site
• a participating site in a multi-centre study
• the only site (the study is confined to one site).

Researchers are strongly advised to contact the East Anglian Regional Radiation Protection Service at an early stage in planning their study to discuss local compliance with IRMER and avoid unnecessary delays in obtaining signatures on ethics application forms.

Please contact: cuh.clinicalengineering@nhs.net

If your project will involve the administration of a radioactive substance then you will need an ARSAC (Administration of Radioactive Substances Advisory Committee) licence. In the first instance please contact the Nuclear Medicine Department who can advise on this:

• Dr H K Cheow 01223 586671

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Projects involving patient data

All studies involving the use of patient data must be reviewed and approved by the Trust’s Information Governance team. This review is usually arranged by the Research Governance Coordinators.