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II SÉRIE-A — NÚMERO 2 20

Article 20 – Research on persons deprived of liberty

Where the law allows research on persons deprived of liberty, such persons may participate in a research

project in which the results do not have the potential to produce direct benefit to their health only if the following

additional conditions are met:

i research of comparable effectiveness cannot be carried out without the participation of persons deprived

of liberty;

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

to persons deprived of liberty;

iii the research entails only minimal risk and minimal burden.

CHAPTER VII – Safety and supervision

Article 21 – Minimisation of risk and burden

1 All reasonable measures shall be taken to ensure safety and to minimise risk and burden for the research

participants.

2 Research may only be carried out under the supervision of a clinical professional who possesses the

necessary qualifications and experience.

Article 22 – Assessment of health status

1 The researcher shall take all necessary steps to assess the state of health of human beings prior to their

inclusion in research, to ensure that those at increased risk in relation to participation in a specific project be

excluded.

2 Where research is undertaken on persons in the reproductive stage of their lives, particular consideration

shall be given to the possible adverse impact on a current or future pregnancy and the health of an embryo,

foetus or child.

Article 23 – Non-interference with necessary clinical interventions

1 Research shall not delay nor deprive participants of medically necessary preventive, diagnostic or

therapeutic procedures.

2 In research associated with prevention, diagnosis or treatment, participants assigned to control groups

shall be assured of proven methods of prevention, diagnosis or treatment.

3 The use of placebo is permissible where there are no methods of proven effectiveness, or where

withdrawal or withholding of such methods does not present an unacceptable risk or burden.

Article 24 – New developments

1 Parties to this Protocol shall take measures to ensure that the research project is re-examined if this is

justified in the light of scientific developments or events arising in the course of the research.

2 The purpose of the re-examination is to establish whether:

i the research needs to be discontinued or if changes to the research project are necessary for the research

to continue;

ii research participants, or if applicable their representatives, need to be informed of the developments or

events;

iii additional consent or authorisation for participation is required.

3 Any new information relevant to their participation shall be conveyed to the research participants, or, if

applicable, to their representatives, in a timely manner.

4 The competent body shall be informed of the reasons for any premature termination of a research project.

CHAPTER VIII – Confidentiality and right to information

Article 25 – Confidentiality

1 Any information of a personal nature collected during biomedical research shall be considered as

confidential and treated according to the rules relating to the protection of private life.