Elmar_Doppelfeld
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Expert Conference on the Revision
of the Declaration of Helsinki
28 February – 1 March 2013,Tokyo
Protective Provisions for Research Participants
– Council of Europe –
Prof. Elmar Doppelfeld, MD
Chair of the Working Group “Biomedical Research”
Committee on Bioethics (DH-BIO)
Chair (2005-2007) of the “Steering Committee on Bioethics (CDBI)”
Council of Europe
Chair (1994 – 2012) of the Permanent Working Party of
Research Ethics Committees
in Germany
Council of Europe
E.Doppelfeld,
WMA
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Conference,
26.February-‐1
March
2013,
Tokyo
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• Established in 1949 – “Intergovernmental body”
• 47 Member States (Population: ± 800 Mio)
• 5 Observer States (Canada, Holy See, Japan, Mexiko, USA)
• „Human Rights, Democracy“
• Harmonization of European legislation
• Conventions and additional Protocols: treaties!
Ø Signature and ratification: decision of the Member States
v Convention for the Protection of Human Rights
and Fundamental Freedoms
of 4 November 1950
Common Basis of all Provisions
Goods of protection
Human dignity
Autonomy
Beneficence
Justice
E.Doppelfeld,
WMA
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Conference,
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2013,
Tokyo
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Classification of Provisions
Legal Instruments
o Treaties
- Oviedo Convention and
additional Protocols,
Council of Europe,1997
- Directive 2001/20/EC,*
European Union, 2001
o National Law
* Applicable only for drug trials
Other Provisions* („soft law“)
o Declaration of Helsinki, WMA 1964 – 2008
o International Guidelines, CIOMS 2002
o Universal Declaration on Bioethics and
Human Rights, UNESCO 2005
o National Codes of Deontology
o Professional Codes
* The number of „other provisions“ is not known
N.B. „soft law“ may enter into legal force by implementation into
national law on decision of a State
E.Doppelfeld,
WMA
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Conference,
26.February-‐1
March
2013,
Tokyo
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Reasons for legal Instruments
v Adoption of ethical principles into law of States
Ø e.g. free and informed consent to protect autonomy required by German
law for medical interventions since 1887,for research since 1900
v Main responsibilty of States to protect human rights and
fundamental freedoms
v Obligation to regulate fields in direct relation to these rights
v Law as instrument for harmonization of the interests of
different groups in a society
² Legal instruments are binding for all groups concerned
² Framework for the application of „soft law“
E.Doppelfeld,
WMA
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Conference,
26.February-‐1
March
2013,
Tokyo
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Legal Instruments and other Texts- Council of Europe –
• Convention for the Protection of Human Rights and Dignity of the
Human Being with regard to the Application of Biology and
Medicine: Convention on Human Rights and Biomedicine,
Oviedo, 4.IV.1997, European Treaty Series – No. 164, ratified by 29 States
• Additional Protocol to the Convention on Human Rights and
Biomedicine concerning Biomedical Research,
Strasbourg, 25.I.2005, Council of Europe Treaty Series – No. 195
Ø Both are treaties and binding for States only by ratification
² Other provisions
- Recommendation Rec(2006)4 of the Committee of Ministers to
member states on research on biological materials of human origin
(Adopted by the Committee of Ministers on 15 March 2006)
- Guide for Members of Research Ethics Committees (Adopted by the
Steering Committee on Bioethics on 3 December 2010)
E.Doppelfeld,
WMA
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Conference,
26.February-‐1
March
2013,
Tokyo
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Primacy of the Human Being
„The interests and welfare of the
human being shall prevail over the
sole interest of society or science.“
(Article 2, Oviedo Convention)
E.Doppelfeld,
WMA
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Conference,
26.February-‐1
March
2013,
Tokyo
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Freedom of Research
“Scientific research in the field of biology and
medicine shall be carried out freely, subject to
the provisions of this Convention and the other
legal provisions ensuring the protection of the
human being.“
(Article 15, Oviedo Convention)
E.Doppelfeld,
WMA
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Conference,
26.February-‐1
March
2013,
Tokyo
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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.“ (Article 8, Research Protocol)
E.Doppelfeld,
WMA
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Conference,
26.February-‐1
March
2013,
Tokyo
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Risks and Benefits
„No risks and and burdens to the participant
disproportionate to its potential benefits“
o Research without a potential direct benefit for the participant
- no more than acceptable risk and acceptable burden
o Research with a potential direct benefit for the participant
- Risk not disproportionate to the expected benefit
² Research on persons not able to consent
- with a potential direct benefit: proportion risk/benefit
- without a potential direct benefit: only minimal risk and minimal burden*
* These conditions have been introduced by the Oviedo Convention 1997
and have been adopted by national law or „soft law“
Sources: Articles 16,17, Oviedo Convention, Article 6, Research Protocol
E.Doppelfeld,
WMA
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Conference,
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March
2013,
Tokyo
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Key condition for participation in research
o Full information in understandable language
o Consent or refusal without any undue influence
o No discrimination in case of refusal
o Specific attention for vulnerable persons
v Responsibility of ethics committees!
E.Doppelfeld,
WMA
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Conference,
26.February-‐1
March
2013,
Tokyo
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Free and Informed Consent
Protection of Persons undergoing Research
o No alternative of comparable effectiveness to research on humans
o Acceptable risk/benefit proportion
o Approval by the competent body after independent examination of the
scientific merit, including assessment of the importance of the aim of
the research, and multidisciplinary review of the ethical acceptability
o Information of the participants of research of their rights and the
safeguards prescribed by law for their protection
o Consent or, in case of research on persons not able to consent,
authorization by the legal representative expressly, specifically
and documented. Free withdrawal of consent or authorization at
any time.
Source: Article 16, Oviedo Convention
E.Doppelfeld,
WMA
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Conference,
26.February-‐1
March
2013,
Tokyo
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Research on Persons unable to
consent
• All conditions to meet scientific quality
• Justification for research on persons unable to consent
• Risks and benefits:
- Potential direct benefit for the research participant:
risks in relation to the expected benefit
- No potential direct benefit for the research participant:
protective provisions prescribed by law,only minimal risk and minimal
burden!
• Authorization by the legal representative according to national law
- Full information on the research project for the legal representative
- Best interest of the represented person
- Refusal or withdrawal of the authorisation at any time without any form of
discrimination against the represented person
² No financial or other interest of the legal representative
Sources: Article 17, Oviedo Convention, Chapter V, Research Protocol
E.Doppelfeld,
WMA
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Conference,
26.February-‐1
March
2013,
Tokyo
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Specific Situations
Research during pregnancy or breastfeeding
Research without a potential direct benefit for the pregnant woman,
or for her embryo, foetus or child after birth, only
- contribution to the benefit of that group
- no comparable research on women who are not pregnant
- only minimal risk and only minimal burden
Research on persons deprived of liberty
Permission of research on this persons by law!
Research without a potential direct benefit only
- no comparable research on persons not deprived of liberty
- contribution to the benefit of that group
- only minimal risk and only minimal burden
Sources: Articles 18 and 20, Research Protocol
E.Doppelfeld,
WMA
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Conference,
26.February-‐1
March
2013,
Tokyo
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Research in Emergency clinical Situations
Permission and determination of protective additional conditions for
research in emergency situations by law when:
- a person is not in a state to give consent, and
- because of the urgency of the situation, it is impossible to obtain in a
sufficiently timely manner, authorisation from the legal representative or an
authority or a person or a body to be called upon to give authorization
- research of comparable effectiveness cannot be carried out on persons in
non-emergency situations;
Specific provisions
Ø approval for research in emergency situations by the competent body
Ø respect of expressed objections if known
Ø research project without a potential direct benefit for the participant: only
minimal risk and only minimal burden
Ø Information as soon as possible of the participant or of the legal representative
to ask for consent or authorization for continued participation
² Postponed consent/authorization, no waver of consent/authorization!
Source: Article 19, Research Protocol
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WMA
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Conference,
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2013,
Tokyo
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Responsibility of Ethics Committee
Independent examination of research projects (REC)
- Submission of every research project for independent examination of its ethical
acceptability to a REC; transnational project: submission in each State in which the
project or parts of it are performed
Ø In some States are RECs entitled to examine in addition the scientific quality and legal aspects
- Purpose of the examination: protection of the dignity, rights, safety and well-being of
research participants.
- Appropriate range of expertise and experience adequately reflecting professional and
lay views.
- The independence of the REC must be guaranteed
- Harmonization of information for the REC: List of items in the Appendix to the
Research Protocol
v Approval of a research project by an authority, if required by national law
only after the examination by a REC!
Sources: Article 16,Oviedo Convention, Chapter III,Research Protocol
E.Doppelfeld,
WMA
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Conference,
26.February-‐1
March
2013,
Tokyo
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Safety and Supervision
o Minimisation of risk and burden, supervision by a qualified clinical professional
o Assessment of health status prior to inclusion in research, particular considerations
on participants in the reproductive stage of life
o Non-interference with necessary clinical interventions
- no delay nor deprivation of medically necessary preventive, diagnostic or therapeutic procedures.
- control groups shall be assured of proven methods of prevention, diagnosis or treatment.
- use of placebo: no methods of proven effectiveness or withdrawal or withholding of such methods
does not present an unacceptable risk or burden
o New developments
- re-examination of a project if justified in the light of scientific developments or events arising in the course of
the research.
- need to discontinue or to change the research project
- need to inform research participants, or their representatives of the developments or events;
- additional consent or authorisation for participation?
o Information of the competent body of the reasons for any premature
termination of a research project.
Source: Chapter VII, Research Protocol
E.Doppelfeld,
WMA
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Conference,
26.February-‐1
March
2013,
Tokyo
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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 27, Research Protocol)
E.Doppelfeld,
WMA
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Conference,
26.February-‐1
March
2013,
Tokyo
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Confidentiality and Right to Information
Confidentiality
Protection of personal data collected during biomedical research
Legal provisions to prohibit inappropriate disclosure of information submitted to
an ethics committee
Right to information
- Right to know any information on health collected in the research project, right
not to know (Article 10 of the Oviedo Convention)
- Accessibility to other personal information in conformity with the law on data
protection
Availability of results
- Submission of a report or summary to the ethics committee or the competent
body after termination of the project
- Availability of the conclusions of the research to participants in reasonable time,
on request
- Appropriate measures of the researcher to make public the results of research
in reasonable time
Source: Chapter VIII ,Research Protocol
E.Doppelfeld,
WMA
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Conference,
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2013,
Tokyo
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