An international survey of radiological protection in medical research programmes involving human volunteers.

BACKGROUND

The International Commission on Radiological Protection (ICRP) Publication 62 provides radiological protection (RP) recommendations for medical research with human volunteers. A survey has been performed to understand the implementation of this guidance and other existing practices, requirements and oversights in these programmes across multiple continents and institutions.

METHODS

A 14-item online questionnaire was developed. The target audience included RP experts and associated professionals experienced in research studies from medical centres, research institutions and government agencies. Questionnaires were distributed over a four-month period through RP associations and networks. Descriptive statistics were used for a quantitative data analysis.

MAIN FINDINGS: A total of 274 questionnaire responses were collected from fifty-five countries on six continents and divided into six geographical groups (46 ± 13 questionnaires/group). Adherence to RP regulatory frameworks, institutional guidelinesor guidelines from professional bodies were reported by 98% of respondents. Few (2%) indicated frameworks are not followed or established. Regulations or guidelines providing levels of doses with justificationfor research were used by 75%. 35% stated that research staff undergo regular research ethics training and 19% indicated the absence of RP experts on Ethics Review Committees. There were variations in theapplication of volunteer-specific dose constraints on medical research exposures.

CONCLUSIONS

Variations were found in RP practices in human medical research programmes across the geographical groups. Further analysis is needed to better understand the current regulatory and training structures in place and the significance of the heterogeneities detected.