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Radiation Protection

Research involving Ionising Radiation, IRMER Compliance

All radiation exposures carried out as part of research studies must comply with the Ionising Radiation (Medical Exposures) Regulations 2000 (IRMER). This applies regardless of whether the Trust is the lead site or a participating site in a multi-centre study, or the study is confined to one site

Regardless of whether a study is a multicentre or confined only to Addenbrooke’s, 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:

or

For detailed information please download the document below from the National Research Ethics Service:

The National Research Ethics Service (NRES) guidance states that:

“a research exposure is any exposure required by the research protocol following initial consent from the participant. It includes all exposures carried out on the patient determined by the protocol including those which would otherwise be part of routine clinical care for those treated outside the research setting.” Also “Research exposures include any exposure required by the screening procedures for the research”

 

IRMER requires that all radiation exposures are justified and optimised (i.e. achieve the required clinical objective with the lowest possible radiation dose) To achieve these aims there must be a referrer, practitioner and operator for each individual exposure. Where no benefit is expected for the individual irradiated a dose constraint must be set, where there is an individual benefit, a target dose should be set. In both cases the employer is required to ensure these doses are not exceeded, therefore volunteer records must include radiation dose information.

Signatures required

For a multicentre study the SSI form should be signed by

• the Radiation Protection Adviser (RPA) to show that all radiation legislative matters have been taken into account and

• the Department(s) undertaking the radiation exposure, e.g. radiology, nuclear medicine, to show that exposures comply with local clinical practice and adequate resources are available.

These are in addition to the radiation signatures obtained for part B of the ethics form.

Where Addenbrooke’s is the lead and only site involved, the signatures on part B are sufficient for R&D purposes.