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.

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. 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.

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.

2. The law shall protect against inappropriate disclosure of any other information related to a research project that has been submitted to an ethics committee in compliance with this Protocol.

Article 26

Right to information

1. Research participants shall be entitled to know any information collected on their health in conformity with the provisions of Article 10 of the Convention.

2. Other personal information collected for a research project will be accessible to them in conformity with the law on the protection of individuals with regard to processing of personal data.

Article 27

Duty of care

If research gives rise to information of relevance to the current or future health or quality of life of research participants, this information must be offered to them. That shall be done within a framework of health care or counselling. In communication of such information, due care must be taken in order to protect confidentiality and to respect any wish of a participant not to receive such information.

Article 28

Availability of results

1. On completion of the research, a report or summary shall be submitted to the ethics committee or the competent body.

2. The conclusions of the research shall be made available to participants in reasonable time, on request.

3. The researcher shall take appropriate measures to make public the results of research in reasonable time.

Chapter IX

RESEARCH IN STATES NOT PARTIES TO THIS PROTOCOL

Article 29

Research in States not parties to this Protocol

Sponsors or researchers within the jurisdiction of a Party to this Protocol that plan to undertake or direct a research project in a State not party to this Protocol shall ensure that, without prejudice to the provisions applicable in that State, the research project complies with the principles on which the provisions of this Protocol are based. Where necessary, the Party shall take appropriate measures to that end.

Chapter X

INFRINGEMENT OF THE PROVISIONS OF THE PROTOCOL

Article 30

Infringement of the rights or principles

The Parties shall provide appropriate judicial protection to prevent or to put a stop to an unlawful infringement of the rights or principles set forth in this Protocol at short notice.

Article 31

Compensation for damage

The person who has suffered damage as a result of participation in research shall be entitled to fair compensation according to the conditions and procedures prescribed by law.

Article 32

Sanctions

Parties shall provide for appropriate sanctions to be applied in the event of infringement of the provisions contained in this Protocol.

Chapter XI

RELATION BETWEEN THIS PROTOCOL AND OTHER PROVISIONS AND RE-EXAMINATION OF THE PROTOCOL

Article 33

Relation between this Protocol and the Convention

As between the Parties, the provisions of Articles 1 to 32 of this Protocol shall be regarded as additional articles to the Convention, and all the provisions of the Convention shall apply accordingly.

Article 34

Wider protection

None of the provisions of this Protocol shall be interpreted as limiting or otherwise affecting the possibility for a Party to grant research participants a wider measure of protection than is stipulated in this Protocol.

Article 35

Re-examination of the Protocol

In order to monitor scientific developments, the present Protocol shall be examined within the Committee referred to in Article 32 of the Convention no later than five years from the entry into force of this Protocol and thereafter at such intervals as the Committee may determine.

Chapter XII

FINAL CLAUSES

Article 36

Signature and ratification

This Protocol shall be open for signature by Signatories to the Convention. It is subject to ratification, acceptance or approval. A Signatory may not ratify, accept or approve this Protocol unless it has previously or simultaneously ratified, accepted or approved the Convention. Instruments of ratification, acceptance or approval shall be deposited with the Secretary General of the Council of Europe.

Article 37

Entry into force

1. This Protocol shall enter into force on the first day of the month following the expiration of a period of three months after the date on which five States, including at least four member States of the Council of Europe, have expressed their consent to be bound by the Protocol in accordance with the provisions of Article 36.

2. In respect of any State which subsequently expresses its consent to be bound by it, the Protocol shall enter into force on the first day of the month following the expiration of a period of three months after the date of the deposit of the instrument of ratification, acceptance or approval.

Article 38

Accession

1. After the entry into force of this Protocol, any State which has acceded to the Convention may also accede to this Protocol.

2. Accession shall be effected by the deposit with the Secretary General of the Council of Europe of an instrument of accession which shall take effect on the first day of the month following the expiration of a period of three months after the date of its deposit.

Article 39

Denunciation

1. Any Party may at any time denounce this Protocol by means of a notification addressed to the Secretary General of the Council of Europe.

2. Such denunciation shall become effective on the first day of the month following the expiration of a period of three months after the date of receipt of such notification by the Secretary General.

Article 40

Notifications

The Secretary General of the Council of Europe shall notify the member States of the Council of Europe, the European Community, any Signatory, any Party and any other State which has been invited to accede to the Protocol of:

a. any signature;

b. the deposit of any instrument of ratification, acceptance, approval or accession;

c. any date of entry into force of this Protocol in accordance with Articles 37 and 38;

d. any other act, notification or communication relating to this Protocol.

In witness whereof the undersigned, being duly authorised thereto, have signed this Protocol.

Done at Strasbourg, this 25th day of January 2005, in English and in French, both texts being equally authentic, in a single copy which shall be deposited in the archives of the Council of Europe. The Secretary General of the Council of Europe shall transmit certified copies to each member State of the Council of Europe, to the non-member States which have participated in the elaboration of this Protocol, to any State invited to accede to the Convention and to the European Community.

Appendix Information to be given to the ethics committee

Information on the following items shall be provided to the ethics committee, in so far as it is relevant for the research project:

Description of the project

i. the name of the principal researcher, qualifications and experience of researchers and, where appropriate, the clinically responsible person, and funding arrangements;

ii. the aim and justification for the research based on the latest state of scientific knowledge;

iii. methods and procedures envisaged, including statistical and other analytical techniques;

iv. a comprehensive summary of the research project in lay language;

v. a statement of previous and concurrent submissions of the research project for assessment or approval and the outcome of those submissions;

Participants, consent and information

vi. justification for involving human beings in the research project;

vii. the criteria for inclusion or exclusion of the categories of persons for participation in the research project and how those persons are to be selected and recruited;

viii. reasons for the use or the absence of control groups;

ix. a description of the nature and degree of foreseeable risks that may be incurred through participating in research;

x. the nature, extent and duration of the interventions to be carried out on the research participants, and details of any burden imposed by the research project;

xi. arrangements to monitor, evaluate and react to contingencies that may have consequences for the present or future health of research participants;

xii. the timing and details of information for those persons who would participate in the research project and the means proposed for provision of this information;

xiii. documentation intended to be used to seek consent or, in the case of persons not able to consent, authorisation for participation in the research project;