[Medical scientific research with people: what the law does not regulate]

Abstract

The 'Bill on Medical Scientific Research with Humans' fail to state clearly which research may and which research may not be carried out without previous approval from a review committee. This is a problem especially with regard to studies using human body material and studies involving questioning people to collect study data. For the sake of clarity in practice it would be advisable if researchers and review committees would observe the following rules: every planned research project which involves patients or other persons having to do or to undergo something for the special purpose of the study must be submitted by the researchers to a review committee. However, actual reviewing is only necessary in the case of studies which, in the review committee's opinion, entail a real health risk or cause significant physical inconvenience or mental stress. Research involving persons who are vulnerable with respect to self-determination, such as the mentally incompetent, should always be reviewed, even if it does not seriously threaten the subjects' physical or mental well-being.