Lehtonen-DoH-Helsinki-20141111

12/11/14
1
www.helsinki.fi/yliopisto
THE IMPACT OF THE DECLARATION OF
HELSINKI ON EUROPEAN HUMAN RIGHTS
DEVELOPMENT
Prof. Lasse Lehtonen
University of Helsinki
12/11/14
WMA 11.11.2014
Lasse Lehtonen 1
www.helsinki.fi/yliopisto
Year 1964: The Declaration of
Helsinki is approved
U.S. military forces
launch attacks on North
Vietnam on the basis of
Tonkin Gulf resolution
Beatles 1st US #1,
« I Want to Hold your
Hand »
Al Oerter wins in
Tokyo Olympics the
discus for the third
time in straight
Konrad E. Bloch and
Feodor Lynen win Nobel
Prize for research on
mechanism and
regulation of cholesterol
and fatty-acid
metabolism
12/11/14
WMA 11.11.2014
Lasse Lehtonen 2
12/11/14
2
www.helsinki.fi/yliopisto
The European Convention on
Human Rights
12/11/14
WMA 11.11.2014
Lasse Lehtonen 3
www.helsinki.fi/yliopisto
This international Convention, signed by most of the European States, sets out
the fundamental principles applicable in day-to-day medicine as well as those
applicable to new technologies in human biology and medicine.
•  the additional Protocol on the Prohibition of Cloning Human Beings (adopted by the
Committee of Ministers on 6 November 1997, entry into force on 1 March 2001);
•  the additional Protocol concerning Transplantation of Organs and Tissues of Human
Origin (adopted by the Committee of Ministers on 8 November 2001, came into force
on 1 May 2006);
•  the additional Protocol on Biomedical Research (adopted by the Committee of
Ministers on 30 June 2004, entered into force on 1 September 2007); and
•  the Protocol concerning Genetic Testing for Health Purposes (adopted by the
Committee of Ministers on 7 May 2008, opened for signature on 27 November 2008).
Note: e.g. Germany, Russia and UK have not signed the Convention
Convention on Human Rights and
Biomedicine (entry into force on Dec. 1,
1999) and its additional Protocols
12/11/14
WMA 11.11.2014
Lasse Lehtonen 4
12/11/14
3
www.helsinki.fi/yliopisto
1.  the primacy of the well-being of research subject in
comparison to benefits for science and society in
different documents
2.  the requirement for independent review of the
research prior its initiation
3.  the informed concept requirements and
4.  the status of incapacitated subjects and minors in
the different documents.
Declaration of Helsinki v.
Biomedicine Convention
12/11/14
WMA 11.11.2014
Lasse Lehtonen 5
www.helsinki.fi/yliopisto
EC Convention on
Biomedicine: Art 2:
The interests and welfare
of the human being shall
prevail over the sole
interest of society or
science.
EU Regulation No
536/2014 on Clinical Trials
Art 3:
A clinical trial may be
conducted only if:
(a) the rights, safety, dignity
and well-being of subjects
are protected and prevail
over all other interests…
Primacy of the Human Being
12/11/14
WMA 11.11.2014
Lasse Lehtonen 6
DoH article 8: While the primary purpose of medical research is to
generate new knowledge, this goal can never take precedence over the
rights and interests of individual research subjects
12/11/14
4
www.helsinki.fi/yliopisto
DoH article 23:
• the research protocol must be submitted for consideration, comment, guidance and
approval to the concerned research ethics committee before the study begins
EC Convention on Biomedicine: Research on a person may only be undertaken if all the
following conditions are met
• 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
the research, and multidisciplinary review of its ethical acceptability
EU Regulation No 536/2014 on Clinical Trials
• Ethics committee’ means an independent body established in a Member State in
accordance with the law of that Member State and empowered to give opinions for the
purposes of this Regulation, taking into account the views of laypersons, in particular
patients or patients’ organisations
• A clinical trial shall be subject to scientific and ethical review and shall be authorised in
accordance with this Regulation…
.
Ethical Review of the Research
Protocol
12/11/14
WMA 11.11.2014
Lasse Lehtonen 7
www.helsinki.fi/yliopisto
The committee must be transparent in its functioning,
must be independent of the researcher, the sponsor
and any other undue influence and must be duly
qualified.
Even though the committee must take into
consideration the laws and regulations of the country
or countries in which the research is to be performed
as well as applicable international norms and
standards but these must not be allowed to reduce
or eliminate any of the protections for research
subjects set forth in this Declaration.
Independence of the Ethics
Committee
12/11/14
WMA 11.11.2014
Lasse Lehtonen 8
12/11/14
5
www.helsinki.fi/yliopisto
The Swedish Parliamentary Ombudsman brought criminal proceedings against Mr.
Gillberg, and short time later he was convicted of misuse of office. Mr. Gillberg was
given a suspended sentence and a fine of the equivalent of 4,000 euros. The
university’s vice president and the officials who had destroyed the research
material were also convicted.
Mr. Gillberg’s conviction was upheld by the Court of Appeal and leave to appeal to
the Supreme Court was refused. Short time later Mr. Gillberg lodged an application
with the Strasbourg Court of Human Rights. He complained in particular that his
criminal conviction breached his rights under Articles 8 and 10, because his
promise of confidentiality to the participants in the research was allegedly
imposed on him by the university’s ethics committee, as a precondition for
carrying out his research.
The Court considered itself only being in a position to examine whether Mr.
Gillberg’s criminal conviction for refusing to execute a court order granting access
to official documents was compatible with the Convention. The conviction of
professor for refusal to grant access to sensitive research data was not in
breach of ECHR
ECHR 2012: Case of Gillberg v.
Sweden
12/11/14
WMA 11.11.2014
Lasse Lehtonen 9
www.helsinki.fi/yliopisto
DoH article 26: In medical research involving human subjects capable of giving informed
consent, each potential subject must be adequately informed of the aims, methods, sources
of funding, any possible conflicts of interest, institutional affiliations of the researcher, the
anticipated benefits and potential risks of the study and the discomfort it may entail, post-
study provisions and any other relevant aspects of the study. The potential subject must be
informed of the right to refuse to participate in the study or to withdraw consent to participate
at any time without reprisal.
EC Convention on Biomedicine: Research on a person may only be undertaken … if
• the persons undergoing research have been informed of their rights and the safeguards
prescribed by law for their protection;
• the necessary consent as provided for under Article 5 has been given expressly, specifically
and is documented. Such consent may be freely withdrawn at any time.
EU Regulation No 536/2014 on Clinical Trials: A clinical trial may be conducted only
where all of the following conditions are met…:
• the subjects, or where a subject is not able to give informed consent, his or her legally
designated representative, have been informed in accordance…
Informed Consent
12/11/14
WMA 11.11.2014
Lasse Lehtonen 10
12/11/14
6
www.helsinki.fi/yliopisto
Information given to the subject or, where the subject is not able to give informed consent, his
or her legally designated representative for the purposes of obtaining his or her informed
consent shall:
(a) enable the subject or his or her legally designated representative to understand:
i. the nature, objectives, benefits, implications, risks and inconveniences of the clinical trial;
ii. the subject’s rights and guarantees regarding his or her protection, in particular his or her
right to refuse to participate and the right to withdraw from the clinical trial at any time without
any resulting detriment and without having to provide any justification;
iii. the conditions under which the clinical trial is to be conducted, including the expected
duration of the subject’s participation in the clinical trial; and
iv. the possible treatment alternatives, including the follow-up measures if the participation of
the subject in the clinical trial is discontinued;
(b) be kept comprehensive, concise, clear, relevant, and understandable to a layperson;
(c) be provided in a prior interview with a member of the investigating team who is
appropriately qualified according to the law of the Member State concerned;
(d) include information about the applicable damage compensation system
(e) include the EU trial number and information about the availability of the clinical trial results
Information for the Research
subjects in Clinical Trials with
Medicinal Products (article 29)
12/11/14
WMA 11.11.2014
Lasse Lehtonen 11
www.helsinki.fi/yliopisto
DoH article 20: Medical research with a vulnerable group is only justified
if the research is responsive to the health needs or priorities of this
group and the research cannot be carried out in a non-vulnerable group.
In addition, this group should stand to benefit from the knowledge,
practices or interventions that result from the research.
DoH article 28: For a potential research subject who is incapable of
giving informed consent, the physician must seek informed consent
from the legally authorised representative. These individuals must not
be included in a research study that has no likelihood of benefit for them
unless it is intended to promote the health of the group represented by
the potential subject, the research cannot instead be performed with
persons capable of providing informed consent, and the research entails
only minimal risk and minimal burden
Protection of Persons not able to
Consent
12/11/14
WMA 11.11.2014
Lasse Lehtonen 12
12/11/14
7
www.helsinki.fi/yliopisto
In the case of incapacitated subjects, a clinical trial may be conducted only where all of the following
conditions are met:
a) the informed consent of their legally designated representative has been obtained;
b) the incapacitated subjects have received the information referred to in Article 29(2) in a way that is adequate in view of their
capacity to understand it;
c) the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing the information referred to
in Article 29(2) to refuse participation in, or to withdraw from, the clinical trial at any time, is respected by the investigator;
d) (no incentives or financial inducements are given to the subjects or their legally designated representatives, except for
compensation for expenses and loss of earnings directly related to the participation in the clinical trial;
e) the clinical trial is essential with respect to incapacitated subjects and data of comparable validity cannot be obtained in
clinical trials on persons able to give informed consent, or by other research methods;
f) the clinical trial relates directly to a medical condition from which the subject suffers;
g) there are scientific grounds for expecting that participation in the clinical trial will produce:
i.  a direct benefit to the incapacitated subject outweighing the risks and burdens involved; or
ii.  some benefit for the population represented by the incapacitated subject concerned when the clinical trial relates
directly to the life-threatening or debilitating medical condition from which the subject suffers and such trial will pose
only minimal risk to, and will impose minimal burden in comparison with the standard treatment
Clinical trials on incapacitated
subjects (article 31)
12/11/14
WMA 11.11.2014
Lasse Lehtonen 13
www.helsinki.fi/yliopisto
•  Both the Convention on
Biomedicine of the Council of
Europe and EU regulation on
clinical trials follow the
principles that have their origin
in the Declaration of Helsinki.
•  New issues, however, may rise
when IT-technology (e.g. big
data analysis) and whole-
genome sequencing are
becoming widely used
research methods
•  The compliance of research
methodology with the
principles of the Declaration
has to be constantly monitored
Conclusions
12/11/14
WMA 11.11.2014
Lasse Lehtonen 14