II SÉRIE-A — NÚMERO 2 18

consent at any time without being subject to any form of discrimination, in particular regarding the right to medical

care.

Article 14 – Consent

1 No research on a person may be carried out, subject to the provisions of both Chapter V and Article 19,

without the informed, free, express, specific and documented consent of the person. Such consent may be freely

withdrawn by the person at any phase of the research.

2 Refusal to give consent or the withdrawal of consent to participation in research shall not lead to any form

of discrimination against the person concerned, in particular regarding the right to medical care.

3 Where the capacity of the person to give informed consent is in doubt, arrangements shall be in place to

verify whether or not the person has such capacity.

CHAPTER V – Protection of persons not able to consent to research

Article 15 –Protection of persons not able to consent to research

1 Research on a person without the capacity to consent to research may be undertaken only if all the

following specific conditions are met:

i the results of the research have the potential to produce real and direct benefit to his or her health;

ii research of comparable effectiveness cannot be carried out on individuals capable of giving consent;

iii the person undergoing research has been informed of his or her rights and the safeguards prescribed by

law for his or her protection, unless this person is not in a state to receive the information;

iv the necessary authorisation has been given specifically and in writing by the legal representative or an

authority, person or body provided for by law, and after having received the information required by Article 16,

taking into account the person’s previously expressed wishes or objections. An adult not able to consent shall as

far as possible take part in the authorisation procedure. The opinion of a minor shall be taken into consideration

as an increasingly determining factor in proportion to age and degree of maturity;

v the person concerned does not object.

2 Exceptionally and under the protective conditions prescribed by law, where the research has not the

potential to produce results of direct benefit to the health of the person concerned, such research may be

authorised subject to the conditions laid down in paragraph 1, sub-paragraphs ii, iii, iv, and v above, and to the

following additional conditions:

i the research 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 age category or afflicted with the same disease or

disorder or having the same condition;

ii the research entails only minimal risk and minimal burden for the individual concerned; and any

consideration of additional potential benefits of the research shall not be used to justify an increased level of risk

or burden.

3 Objection to participation, refusal to give authorisation or the withdrawal of authorisation to participate in

research shall not lead to any form of discrimination against the person concerned, in particular regarding the

right to medical care.

Article 16 – Information prior to authorisation

1 Those being asked to authorise participation of a person in a research project shall be given adequate

information in a comprehensible form. This information shall be documented.

2 The information shall cover the purpose, the overall plan and the possible risks and benefits of the research

project, and include the opinion of the ethics committee. They shall further be informed of the rights and

safeguards prescribed by law for the protection of those not able to consent to research and specifically of the

right to refuse or to withdraw authorisation at any time, without the person concerned being subject to any form