The new radiation protection ordinance from the viewpoint of the researcher in nuclear medicine

After the new radiation protection ordinance has come into effect with July 20th, 2001 the approval process for application of radiation substances or ionizing radiation in medical research changed considerably with respect to the responsibility of the Federal Office for Radiation Protection as the approval authority, the participation of an approved ethic committee, the inclusion of an expert for medical physics for planning and execution of the study as well as stricter regulations for cover clause. On the contrary, existing regulations have been facilitated since the effective dose limit for volunteers has been increased from 10 to 20 mSv and a central procedure for approval of multicenter studies has been introduced. Moreover, the application of radioactive substances or ionizing radiation for research in people without or with restricted legal capacity is no more totally prohibited. At present, changes of the radiation protection ordinance and the atomic law cover clause ordinance with respect to medical research are in discussion. (orig.)