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Article 9 – Independent examination by an ethics committee

1 Every research project shall be submitted for independent examination of its ethical acceptability to an

ethics committee. Such projects shall be submitted to independent examination in each State in which any

research activity is to take place.

2 The purpose of the multidisciplinary examination of the ethical acceptability of the research project shall

be to protect the dignity, rights, safety and well-being of research participants. The assessment of the ethical

acceptability shall draw on an appropriate range of expertise and experience adequately reflecting professional

and lay views.

3 The ethics committee shall produce an opinion containing reasons for its conclusion.

Article 10 – Independence of the ethics committee

1 Parties to this Protocol shall take measures to assure the independence of the ethics committee. That

body shall not be subject to undue external influences.

2 Members of the ethics committee shall declare all circumstances that might lead to a conflict of interest.

Should such conflicts arise, those involved shall not participate in that review.

Article 11 – Information for the ethics committee

1 All information which is necessary for the ethical assessment of the research project shall be given in

written form to the ethics committee.

2 In particular, information on items contained in the appendix to this Protocol shall be provided, in so far as

it is relevant for the research project. The appendix may be amended by the Committee set up by Article 32 of

the Convention by a two-thirds majority of the votes cast.

Article 12 –Undue influence

The ethics committee must be satisfied that no undue influence, including that of a financial nature, will be

exerted on persons to participate in research. In this respect, particular attention must be given to vulnerable or

dependent persons.

CHAPTER IV – Information and consent

Article 13 – Information for research participants

1 The persons being asked to participate 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. Before being asked to consent to participate in a research

project, the persons concerned shall be specifically informed, according to the nature and purpose of the

research:

i of the nature, extent and duration of the procedures involved, in particular, details of any burden imposed

by the research project;

ii of available preventive, diagnostic and therapeutic procedures;

iii of the arrangements for responding to adverse events or the concerns of research participants;

iv of arrangements to ensure respect for private life and ensure the confidentiality of personal data;

v of arrangements for access to information relevant to the participant arising from the research and to its

overall results;

vi of the arrangements for fair compensation in the case of damage;

vii of any foreseen potential further uses, including commercial uses, of the research results, data or

biological materials;

viii of the source of funding of the research project.

3 In addition, the persons being asked to participate in a research project shall be informed of the rights and

safeguards prescribed by law for their protection, and specifically of their right to refuse consent or to withdraw