16 DE SETEMBRO DE 2016 19

of discrimination, in particular regarding the right to medical care. They shall be specifically informed according

to the nature and purpose of the research of the items of information listed in Article 13.

3 The information shall also be provided to the individual concerned, unless this person is not in a state to

receive the information.

Article 17 –Research with minimal risk and minimal burden

1 For the purposes of this Protocol it is deemed that the research bears a minimal risk if, having regard to

the nature and scale of the intervention, it is to be expected that it will result, at the most, in a very slight and

temporary negative impact on the health of the person concerned.

2 It is deemed that it bears a minimal burden if it is to be expected that the discomfort will be, at the most,

temporary and very slight for the person concerned. In assessing the burden for an individual, a person enjoying

the special confidence of the person concerned shall assess the burden where appropriate.

CHAPTER VI – Specific situations

Article 18 - Research during pregnancy or breastfeeding

1 Research on a pregnant woman which does not have the potential to produce results of direct benefit to

her health, or to that of her embryo, foetus or child after birth, may only be undertaken if the following additional

conditions are met:

i the research has the aim of contributing to the ultimate attainment of results capable of conferring benefit

to other women in relation to reproduction or to other embryos, foetuses or children;

ii research of comparable effectiveness cannot be carried out on women who are not pregnant;

iii the research entails only minimal risk and minimal burden.

2 Where research is undertaken on a breastfeeding woman, particular care shall be taken to avoid any

adverse impact on the health of the child.

Article 19 – Research on persons in emergency clinical situations

1 The law shall determine whether, and under which protective additional conditions, research in emergency

situations may take place when:

i a person is not in a state to give consent, and

ii because of the urgency of the situation, it is impossible to obtain in a sufficiently timely manner, authorisation

from his or her representative or an authority or a person or body which would in the absence of an emergency

situation be called upon to give authorisation.

2 The law shall include the following specific conditions:

i research of comparable effectiveness cannot be carried out on persons in non-emergency situations;

ii the research project may only be undertaken if it has been approved specifically for emergency situations

by the competent body;

iii any relevant previously expressed objections of the person known to the researcher shall be respected;

iv where the research has not the potential to produce results of direct benefit to the health of the person

concerned, it has the aim of contributing, through significant improvement in the scientific understanding of the

individual's condition, disease or disorder, to the ultimate attainment of results capable of conferring benefit to

the person concerned or to other persons in the same category or afflicted with the same disease or disorder or

having the same condition, and entails only minimal risk and minimal burden.

3 Persons participating in the emergency research project or, if applicable, their representatives shall be

provided with all the relevant information concerning their participation in the research project as soon as

possible. Consent or authorisation for continued participation shall be requested as soon as reasonably possible.