Ethical aspects of using radiolabelling in aerosol research

Radiolabelled pulmonary deposition studies in children can be undertaken using very low doses carrying apparently very low risk. For studies using solutions delivered by nebulisers, they are relatively simple and straightforward to undertake, making them attractive for researchers. However, before resorting to such studies the question to be answered should be carefully formulated. It should be clear that it cannot be answered effectively in other ways and that the study has been designed by a team who understand the strengths and limitations of the various possible approaches to assessing inhaled devices and which include radiation protection expertise. These studies do not replace the need for careful clinical trials since they cannot answer questions regarding safety and efficacy.