Scientific studies which entail intervention may not be carried out on human subjects if it is deemed likely that the same or a comparable objective can be attained without human participation.
Before a scientific study on human subjects is approved, the NBC (National Bioethics Committee) or HREC (Health Research Ethics Committee) shall evaluate potential risk and burden on the one hand, and benefits for the participants or others on the other hand. In research on the effectiveness of a new treatment, with or without placebo, it shall be ensured that patients receive recognised treatment. In that evaluation, the interest of the individual shall invariably outweigh scientific or societal interests. Should it transpire that the risk outweighs the potential benefit, the NBC or HREC will halt the study.
Special care shall be taken when recruiting individuals from vulnerable groups, i.e. individuals who for some reason are not in a position to make an informed or free decision. Studies which require the participation of children, or members of vulnerable social groups, shall be evaluated with special care. Such studies may involve, e.g., adults who, due to mental disability, disease, imprisonment or other factors are inable to grant consent. Individuals in vulnerable positions shall be involved in decision-making on participation as far as possible. Children shall be involved in decision-making in so far as their development permits, and without exception for those aged 12 years or more.
The NBC may issue further rules on participation in research by children and members of vulnerable groups.