If you are a researcher who needs to explain the risks of ionising radiation to your study participants, then we have produced some generic statements to help you.
We have worked with patients and radiation experts to create these statements, which describe what ionising radiation is in plain English to ensure your participants are clear about the risks involved.
They have been designed to meet the requirements of most studies and to ensure that information is provided to Research Ethics Committees (RECs) and trial participants in a consistent manner.
Statements have also been provided for use by Medical Physics Experts (MPEs) and Clinical Radiation Experts (CREs) for their reviews in the IRAS form.
HRA Senior Technical Assurances Officer, Sarah Grimshaw, said: “When developing radiation assurance, which will eventually become part of HRA Approval, experts noted that there was considerable variation in the way that risk of exposure to ionising radiation is described to participants in patient information sheets, and ethics committees.
“This can be anything from how far you need to fly to experience the same amount of radiation, to how long you might need to be in Cornwall to how many bananas you would need to eat!
“This new guidance for sponsors, MPEs and CREs on describing the exposure risk has been produced with the aid of a patient and public involvement group – the Northern Ireland Cancer Research Consumer Forum – the National Research Ethics Advisory Panel (NREAP) and REC Chairs.”
“We hope that use of these generic statements will mean that participants can more easily understand the risks of participation and compare the risks between different studies.
“Additionally, sponsors, MPEs and CREs can also take assurance that the information they are providing is appropriate for the audience they are trying to reach.”
This guidance is now available as a consultation-in-use document and can be found within our online consent and participant information sheet pages.
The initial consultation-in-use period is open until 31 August 2017.
We are seeking feedback from a range of stakeholders about the usability of the statements, which will inform whether we need to make any changes to the information provided.
Feedback from staff and stakeholders should be sent to firstname.lastname@example.org.