{"id":3930,"date":"2017-01-20T13:45:18","date_gmt":"2017-01-20T13:45:18","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Lehtonen-DoH-Helsinki-20141111.pdf"},"modified":"2017-01-20T13:45:18","modified_gmt":"2017-01-20T13:45:18","slug":"lehtonen-doh-helsinki-20141111-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/lehtonen-doh-helsinki-20141111-2\/","title":{"rendered":"Lehtonen-DoH-Helsinki-20141111"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

Lehtonen-DoH-Helsinki-20141111<\/a><\/p>\n

12\/11\/14
\n1
\nwww.helsinki.fi\/yliopisto
\nTHE IMPACT OF THE DECLARATION OF
\nHELSINKI ON EUROPEAN HUMAN RIGHTS
\nDEVELOPMENT
\nProf. Lasse Lehtonen
\nUniversity of Helsinki
\n12\/11\/14
\nWMA 11.11.2014
\nLasse Lehtonen 1
\nwww.helsinki.fi\/yliopisto
\nYear 1964: The Declaration of
\nHelsinki is approved
\nU.S. military forces
\nlaunch attacks on North
\nVietnam on the basis of
\nTonkin Gulf resolution
\nBeatles 1st US #1,
\n\u00abI Want to Hold your
\nHand\u00bb
\nAl Oerter wins in
\nTokyo Olympics the
\ndiscus for the third
\ntime in straight
\nKonrad E. Bloch and
\nFeodor Lynen win Nobel
\nPrize for research on
\nmechanism and
\nregulation of cholesterol
\nand fatty-acid
\nmetabolism
\n12\/11\/14
\nWMA 11.11.2014
\nLasse Lehtonen 2
\n12\/11\/14
\n2
\nwww.helsinki.fi\/yliopisto
\nThe European Convention on
\nHuman Rights
\n12\/11\/14
\nWMA 11.11.2014
\nLasse Lehtonen 3
\nwww.helsinki.fi\/yliopisto
\nThis international Convention, signed by most of the European States, sets out
\nthe fundamental principles applicable in day-to-day medicine as well as those
\napplicable to new technologies in human biology and medicine.
\n\u2022\u202f the additional Protocol on the Prohibition of Cloning Human Beings (adopted by the
\nCommittee of Ministers on 6 November 1997, entry into force on 1 March 2001);
\n\u2022\u202f the additional Protocol concerning Transplantation of Organs and Tissues of Human
\nOrigin (adopted by the Committee of Ministers on 8 November 2001, came into force
\non 1 May 2006);
\n\u2022\u202f the additional Protocol on Biomedical Research (adopted by the Committee of
\nMinisters on 30 June 2004, entered into force on 1 September 2007); and
\n\u2022\u202f the Protocol concerning Genetic Testing for Health Purposes (adopted by the
\nCommittee of Ministers on 7 May 2008, opened for signature on 27 November 2008).
\nNote: e.g. Germany, Russia and UK have not signed the Convention
\nConvention on Human Rights and
\nBiomedicine (entry into force on Dec. 1,
\n1999) and its additional Protocols
\n12\/11\/14
\nWMA 11.11.2014
\nLasse Lehtonen 4
\n12\/11\/14
\n3
\nwww.helsinki.fi\/yliopisto
\n1.\u202f the primacy of the well-being of research subject in
\ncomparison to benefits for science and society in
\ndifferent documents
\n2.\u202f the requirement for independent review of the
\nresearch prior its initiation
\n3.\u202f the informed concept requirements and
\n4.\u202f the status of incapacitated subjects and minors in
\nthe different documents.
\nDeclaration of Helsinki v.
\nBiomedicine Convention
\n12\/11\/14
\nWMA 11.11.2014
\nLasse Lehtonen 5
\nwww.helsinki.fi\/yliopisto
\nEC Convention on
\nBiomedicine: Art 2:
\nThe interests and welfare
\nof the human being shall
\nprevail over the sole
\ninterest of society or
\nscience.
\nEU Regulation No
\n536\/2014 on Clinical Trials
\nArt 3:
\nA clinical trial may be
\nconducted only if:
\n(a) the rights, safety, dignity
\nand well-being of subjects
\nare protected and prevail
\nover all other interests\u2026
\nPrimacy of the Human Being
\n12\/11\/14
\nWMA 11.11.2014
\nLasse Lehtonen 6
\nDoH article 8: While the primary purpose of medical research is to
\ngenerate new knowledge, this goal can never take precedence over the
\nrights and interests of individual research subjects
\n12\/11\/14
\n4
\nwww.helsinki.fi\/yliopisto
\nDoH article 23:
\n\u2022\u202fthe research protocol must be submitted for consideration, comment, guidance and
\napproval to the concerned research ethics committee before the study begins
\nEC Convention on Biomedicine: Research on a person may only be undertaken if all the
\nfollowing conditions are met
\n\u2022\u202fthe research project has been approved by the competent body after independent
\nexamination of its scientific merit, including assessment of the importance of the aim of
\nthe research, and multidisciplinary review of its ethical acceptability
\nEU Regulation No 536\/2014 on Clinical Trials
\n\u2022\u202fEthics committee\u2019 means an independent body established in a Member State in
\naccordance with the law of that Member State and empowered to give opinions for the
\npurposes of this Regulation, taking into account the views of laypersons, in particular
\npatients or patients’ organisations
\n\u2022\u202fA clinical trial shall be subject to scientific and ethical review and shall be authorised in
\naccordance with this Regulation\u2026
\n.
\nEthical Review of the Research
\nProtocol
\n12\/11\/14
\nWMA 11.11.2014
\nLasse Lehtonen 7
\nwww.helsinki.fi\/yliopisto
\nThe committee must be transparent in its functioning,
\nmust be independent of the researcher, the sponsor
\nand any other undue influence and must be duly
\nqualified.
\nEven though the committee must take into
\nconsideration the laws and regulations of the country
\nor countries in which the research is to be performed
\nas well as applicable international norms and
\nstandards but these must not be allowed to reduce
\nor eliminate any of the protections for research
\nsubjects set forth in this Declaration.
\nIndependence of the Ethics
\nCommittee
\n12\/11\/14
\nWMA 11.11.2014
\nLasse Lehtonen 8
\n12\/11\/14
\n5
\nwww.helsinki.fi\/yliopisto
\nThe Swedish Parliamentary Ombudsman brought criminal proceedings against Mr.
\nGillberg, and short time later he was convicted of misuse of office. Mr. Gillberg was
\ngiven a suspended sentence and a fine of the equivalent of 4,000 euros. The
\nuniversity\u2019s vice president and the officials who had destroyed the research
\nmaterial were also convicted.
\nMr. Gillberg\u2019s conviction was upheld by the Court of Appeal and leave to appeal to
\nthe Supreme Court was refused. Short time later Mr. Gillberg lodged an application
\nwith the Strasbourg Court of Human Rights. He complained in particular that his
\ncriminal conviction breached his rights under Articles 8 and 10, because his
\npromise of confidentiality to the participants in the research was allegedly
\nimposed on him by the university\u2019s ethics committee, as a precondition for
\ncarrying out his research.
\nThe Court considered itself only being in a position to examine whether Mr.
\nGillberg\u2019s criminal conviction for refusing to execute a court order granting access
\nto official documents was compatible with the Convention. The conviction of
\nprofessor for refusal to grant access to sensitive research data was not in
\nbreach of ECHR
\nECHR 2012: Case of Gillberg v.
\nSweden
\n12\/11\/14
\nWMA 11.11.2014
\nLasse Lehtonen 9
\nwww.helsinki.fi\/yliopisto
\nDoH article 26: In medical research involving human subjects capable of giving informed
\nconsent, each potential subject must be adequately informed of the aims, methods, sources
\nof funding, any possible conflicts of interest, institutional affiliations of the researcher, the
\nanticipated benefits and potential risks of the study and the discomfort it may entail, post-
\nstudy provisions and any other relevant aspects of the study. The potential subject must be
\ninformed of the right to refuse to participate in the study or to withdraw consent to participate
\nat any time without reprisal.
\nEC Convention on Biomedicine: Research on a person may only be undertaken \u2026 if
\n\u2022\u202fthe persons undergoing research have been informed of their rights and the safeguards
\nprescribed by law for their protection;
\n\u2022\u202fthe necessary consent as provided for under Article 5 has been given expressly, specifically
\nand is documented. Such consent may be freely withdrawn at any time.
\nEU Regulation No 536\/2014 on Clinical Trials: A clinical trial may be conducted only
\nwhere all of the following conditions are met\u2026:
\n\u2022\u202fthe subjects, or where a subject is not able to give informed consent, his or her legally
\ndesignated representative, have been informed in accordance\u2026
\nInformed Consent
\n12\/11\/14
\nWMA 11.11.2014
\nLasse Lehtonen 10
\n12\/11\/14
\n6
\nwww.helsinki.fi\/yliopisto
\nInformation given to the subject or, where the subject is not able to give informed consent, his
\nor her legally designated representative for the purposes of obtaining his or her informed
\nconsent shall:
\n(a) enable the subject or his or her legally designated representative to understand:
\ni.\u202fthe nature, objectives, benefits, implications, risks and inconveniences of the clinical trial;
\nii.\u202fthe subject’s rights and guarantees regarding his or her protection, in particular his or her
\nright to refuse to participate and the right to withdraw from the clinical trial at any time without
\nany resulting detriment and without having to provide any justification;
\niii.\u202fthe conditions under which the clinical trial is to be conducted, including the expected
\nduration of the subject’s participation in the clinical trial; and
\niv.\u202fthe possible treatment alternatives, including the follow-up measures if the participation of
\nthe subject in the clinical trial is discontinued;
\n(b) be kept comprehensive, concise, clear, relevant, and understandable to a layperson;
\n(c) be provided in a prior interview with a member of the investigating team who is
\nappropriately qualified according to the law of the Member State concerned;
\n(d) include information about the applicable damage compensation system
\n(e) include the EU trial number and information about the availability of the clinical trial results
\nInformation for the Research
\nsubjects in Clinical Trials with
\nMedicinal Products (article 29)
\n12\/11\/14
\nWMA 11.11.2014
\nLasse Lehtonen 11
\nwww.helsinki.fi\/yliopisto
\nDoH article 20: Medical research with a vulnerable group is only justified
\nif the research is responsive to the health needs or priorities of this
\ngroup and the research cannot be carried out in a non-vulnerable group.
\nIn addition, this group should stand to benefit from the knowledge,
\npractices or interventions that result from the research.
\nDoH article 28: For a potential research subject who is incapable of
\ngiving informed consent, the physician must seek informed consent
\nfrom the legally authorised representative. These individuals must not
\nbe included in a research study that has no likelihood of benefit for them
\nunless it is intended to promote the health of the group represented by
\nthe potential subject, the research cannot instead be performed with
\npersons capable of providing informed consent, and the research entails
\nonly minimal risk and minimal burden
\nProtection of Persons not able to
\nConsent
\n12\/11\/14
\nWMA 11.11.2014
\nLasse Lehtonen 12
\n12\/11\/14
\n7
\nwww.helsinki.fi\/yliopisto
\nIn the case of incapacitated subjects, a clinical trial may be conducted only where all of the following
\nconditions are met:
\na)\u202fthe informed consent of their legally designated representative has been obtained;
\nb)\u202fthe incapacitated subjects have received the information referred to in Article 29(2) in a way that is adequate in view of their
\ncapacity to understand it;
\nc)\u202fthe explicit wish of an incapacitated subject who is capable of forming an opinion and assessing the information referred to
\nin Article 29(2) to refuse participation in, or to withdraw from, the clinical trial at any time, is respected by the investigator;
\nd)\u202f(no incentives or financial inducements are given to the subjects or their legally designated representatives, except for
\ncompensation for expenses and loss of earnings directly related to the participation in the clinical trial;
\ne)\u202fthe clinical trial is essential with respect to incapacitated subjects and data of comparable validity cannot be obtained in
\nclinical trials on persons able to give informed consent, or by other research methods;
\nf)\u202fthe clinical trial relates directly to a medical condition from which the subject suffers;
\ng)\u202fthere are scientific grounds for expecting that participation in the clinical trial will produce:
\ni.\u202f a direct benefit to the incapacitated subject outweighing the risks and burdens involved; or
\nii.\u202f some benefit for the population represented by the incapacitated subject concerned when the clinical trial relates
\ndirectly to the life-threatening or debilitating medical condition from which the subject suffers and such trial will pose
\nonly minimal risk to, and will impose minimal burden in comparison with the standard treatment
\nClinical trials on incapacitated
\nsubjects (article 31)
\n12\/11\/14
\nWMA 11.11.2014
\nLasse Lehtonen 13
\nwww.helsinki.fi\/yliopisto
\n\u2022\u202f Both the Convention on
\nBiomedicine of the Council of
\nEurope and EU regulation on
\nclinical trials follow the
\nprinciples that have their origin
\nin the Declaration of Helsinki.
\n\u2022\u202f New issues, however, may rise
\nwhen IT-technology (e.g. big
\ndata analysis) and whole-
\ngenome sequencing are
\nbecoming widely used
\nresearch methods
\n\u2022\u202f The compliance of research
\nmethodology with the
\nprinciples of the Declaration
\nhas to be constantly monitored
\nConclusions
\n12\/11\/14
\nWMA 11.11.2014
\nLasse Lehtonen 14<\/p>\n"},"caption":{"rendered":"

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 […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{},"post":null,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Lehtonen-DoH-Helsinki-20141111.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/3930"}],"collection":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media"}],"about":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/types\/attachment"}],"author":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/comments?post=3930"}]}}