Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research

Preamble

Considering that the aim of the Council of Europe is the achievement of greater unity between its members and that one of the methods by which this aim is pursued is the maintenance and further realisation of human rights and fundamental freedoms;

Considering that the aim of the Convention, as defined in Article 1, is to protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine;

Considering that progress in medical and biological sciences, in particular advances obtained through biomedical research, contributes to saving lives and improving quality of life;[…]

Convinced that biomedical research that is contrary to human dignity and human rights should never be carried out;

Stressing the paramount concern to be the protection of the human being participating in research;

Affirming that particular protection shall be given to human beings who may be vulnerable in the context of research;

Recognising that every person has a right to accept or refuse to undergo biomedical research and that no one should be forced to undergo such research;

Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to biomedical research, […]

CHAPTER I – Object and scope

Article 1 – Object and purpose

Parties to this Protocol shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to any research involving interventions on human beings in the field of biomedicine.

CHAPTER II – General provisions

Article 3 – Primacy of the human being

The interests and welfare of the human being participating in research shall prevail over the sole interest of society or science.

Article 4 – General rule

Research shall be carried out freely, subject to the provisions of this Protocol and the other legal provisions ensuring the protection of the human being.

Article 5 – Absence of alternatives

Research on human beings may only be undertaken if there is no alternative of comparable effectiveness.

Article 6 – Risks and benefits

1 Research shall not involve risks and burdens to the human being disproportionate to its potential benefits.

2 In addition, where the research does not have the potential to produce results of direct benefit to the health of the research participant, such research may only be undertaken if the research entails no more than acceptable risk and acceptable burden for the research participant. This shall be without prejudice to the provision contained in Article 15 paragraph 2, sub-paragraph ii for the protection of persons not able to consent to research.

Article 7 – Approval

Research may only be undertaken if the research project has been approved by the competent body after independent examination of its scientific merit, including assessment of the importance of the aim of research, and multidisciplinary review of its ethical acceptability.

Article 8 – Scientific quality

Any research must be scientifically justified, meet generally accepted criteria of scientific quality and be carried out in accordance with relevant professional obligations and standards under the supervision of an appropriately qualified researcher.

CHAPTER III – Ethics committee

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 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 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 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.

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.

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.

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.