Where, in the course of a clinical investigation, harm caused to a subject leads to the civil or criminal liability of the investigator or the sponsor being invoked, the conditions for liability in such cases, including issues of causality and the level of damages and sanctions, should remain governed by national law.
Más rud é, le linn imscrúduithe cliniciúla, go n-agraítear dliteanas sibhialta nó coiriúil an imscrúdaitheora nó an urraitheora mar thoradh ar dhochar a rinneadh d'ábhar, ba cheart na coinníollacha maidir le dliteanas i gcásanna den sórt sin, lena n-áirítear saincheisteanna cúisíochta agus leibhéal na ndamáistí agus na smachtbhannaí fanacht faoi rialú an dlí náisiúnta.