Necessity of establishing organ dose limits for healthy test persons in medical research

Posing reasonable questions while observing scientific and ethical principles in medical research may rule out the possibility that healthy volunteers under examination receive equivalent dose levels reaching the limits for occupational exposure.

In nuclear medicine, there is little probability of realistic scenarios where equivalent dose levels to volunteers could exceed the limits for occupationally exposed individuals when the effective dose limit of 20 mSv is observed. Within the scope of the X-Ray Ordinance no reasonable diagnostic indication is conceivable due to which volunteers would receive levels of equivalent dose exceeding the limits for occupationally exposed individuals. In either case, established means of control, consisting of the consent to be requested from the Ethics Commission and the approval to be obtained from the Federal Office for Radiation Protection (BfS) are sufficient to ensure

• that research projects involving unnecessarily high levels of equivalent dose are not approved within the scope of the risk-benefit-assessment, and
• that appropriate dose reduction is achieved by modifying the study design, based on the optimisation principle.

This Statement has been published in volume 67 of the series “Veröffentlichungen der Strahlenschutzkommission" (Publications of the Commission on Radiological Protection).