Abstract
Purpose:There has been no guide of authorized radiological protection system in Japan when volunteers receive radionuclide administration in clinical research or phase I — IV studies. The purpose of this report was to depict issues on institutional radiological protection system for establishing the guide.
Subjects and Methods:We accumulated full-filled questionnaires regarding institutional radiological protection system of human subjects in 82 hospitals in which clinical researches or phase I — IV studies underwent to be subjected to radionuclide administrated volunteers in recent two years. We analyzed regarding (1) research content, (2) what committee approval of research using radionuclide administrated volunteer, (3) selection of the volunteers, (4) regulatory dose of administrated radionuclide, and (5) informed consent.
Results:Normal volunteers are subjected in clinical researches as well as phase-I study and microdose study. The researches subjected to normal volunteers needed with approval of institutional ethic committee in 64(78%)hospitals, others than ethic committee in 9(10%), and unknown in 2(2%). In remaining 7(8%), both ethic and other committees were described. No one with radiological knowledge included the committees in 23 hospitals(28%),of 15 had no consultation system regarding radiological protection. In all hospitals, regulatory dose in human subjects is less than 50mSv and sufficient informed consent regarding the protection was obtained.
Conclusions:In Japan, researches subjected to radionuclide administrated volunteers are performed by authorization of institutional ethic committees. Administrated radionuclide dose in them are less than upper limits of regulatory system of ICRP, USA and England because the committees include physicians, technologists and pharmaceutics with knowledge of radiological protection. But some hospitals have no committees authorize the research because they have no idea of authorized committees or cannot establish the committees. We recommend that improvement of institutional radiological protection system in such hospitals. If necessary, approval system with outside hospital-committees may be required. Furthermore, we hope that improvement the condition which no consensus of regulatory dose to the volunteers in hospitals.
