Ethics and confidentiality issues
The study aims to elucidate the association between CT exposure in childhood and the risk of childhood leukaemia. Although the individuals involved in the study may not directly benefit from the results of the study, no additional risk or burden is related to those participating in the main project which is purely observational. Moreover, results of the study will be used for educating health professionals (paediatricians and radiologists) how to optimize the use of CT in paediatric patients.
In majority of the participating countries the main part of the project will be based on record linkages with subsequent anonymization of data files before analyses are conducted. Information from radiology departments will be downloaded to the secure server and will include patient's ID, reason for CT scan, age, gender and technical parameters required for dose reconstruction. All personal information and material collected during this project will be anonymised and kept confidential and all study subjects will be assigned a study-specific personal identification number. No result will be presented that allows the identification of specific study subjects. Encrypted information will be linked to the Cancer registries and/or National Health Insurance database to obtain information on the outcomes to be studied. Ethical clearance has been already obtained in all countries where national studies are underway and the study protocols have been adapted following recommendations of the national committees. If necessary, a request for ethical clearance of extended ongoing studies will be also submitted. Approval will be sought from national or local ethical committees in all participating countries where cohorts of paediatric patients will be established to secure that ethical and legal standards are kept.
When biological material is required, this will be based on informed consent, which will be asked from a parent/care giver for children below the certain age who were sampled for obtaining a blood or saliva sample for pilot testing of biological markers of CT-irradiation effects. In the case of identification of susceptible groups, plans will be made with appropriate experts for a coherent dissemination of information about risks to appropriate population groups and for better awareness and wider dissemination of knowledge resulting from the project.
No contact with potential study subjects will be made until all ethical approvals are obtained in a given country. The partners will seek the necessary permissions from national ethics committees and/or organizations for protection of privacy to ensure that all data is collected in accordance to the rules and regulations, and to ensure that the data can be kept also for future research on the relationship between low-dose exposures and cancer incidence or other health problems.