Radiation Protection Issues in Clinical Research Involving X-Ray Diagnostic Radiology Procedures

Abstract

Aim: To review radiation protection issues in clinical diagnostic studies that involves the use of x-rays. The Issue: X-rays imparting low dose have some dominance in the use of ionising radiation (IR) in clinical radiological investigations. In good clinical diagnostic practice, with radiation effects anticipated to be wholly stochastic, it is simply not possible to be specific about risks to health other than to acknowledge an anticipated increase in probability with dose. Difficulties in making an assessment of risk can be further compounded given possible cumulative effects from previous exposures and from varying clinical state. Scientific Considerations: Clinically focused research involving IR and subjects (reviewed by ethics committees and other parties) necessarily involves assessment of the study protocol. In addition to the embodiment of radiation protection principles, the protocol must conform to the general ethical principles of beneficence, prudence, justice and dignity, all of which are important. The protection aspects arising from the use of radiation needs to be assessed by radiation experts, the safety of study participants needing to be weighed against the necessity for the study. This information must be fully explained to the participant as part of the process of seeking consent. In obtaining consent, the participant information sheet must be of an appropriate quality of language and possible specific risks provided in a transparent manner. Conclusion: In clinical studies that involve the use of IR, the study protocol must contain all relevant radiation protection measures. It is important that review of the protocol should involve IR experts.