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Ministers'
Deputies Strasbourg,
5-8 June 2000 Introduction 1. The Steering Committee on Bioethics (CDBI) met at the Palais de l'Europe (Strasbourg) from 5 to 8 June 2000. 2. The meeting was chaired by Dr Elaine GADD (United Kingdom). 3.
The list of participants and the agenda are set out in
Appendices I and II respectively. 4. The Chair welcomed the new delegation members: Ms N Van Den Bossche (Belgium), Ms M Gajski-Kneklin (Croatia), Mr R Meilicke (Germany), Ms D Mogyorosi (Hungary), Ms A O'Flynn (Ireland), Ms T Parvu (Moldova), Mrs SE Bastijn (Netherlands), Mr J Bielik (Slovakia), Mrs S Gubová (Slovakia), Mrs V Schwander (Switzerland), Mr K Boskovski (“The Former Yugoslav Republic of Macedonia”), Ms M Jean (Canada), Ms M Minkowski (ESF), Ms MC Bercot (UNESCO), Ms L Kumlin (KEK). 5.
The full Committee adopted the draft agenda and the order of
business. Israel
– Observer status 6.
The Chair reminded the CDBI that Israel had requested observer
status on the CDBI. 7.
The Chair indicated that the procedure for
obtaining observer status had been followed and that the Committee of
Ministers had delegated this decision to the CDBI. She noted that
there were no objections on the part of the latter and consequently
observer status had been accorded to Israel. Chart
of signatures and ratifications of the Convention on Human Rights and
Biomedicine and the Protocol on the Prohibition of Cloning Human
Beings 8.
The Chart of signatures was presented and the signature of the
Convention by Georgia was welcomed. 9.
The Czech Republic, France, Cyprus, and Romania presented their
progress towards ratification of the Convention and its additional
Protocol. Ireland explained that it was having a discussion of the
relevant national law at the moment and the outcome of that debate
would decide signature. The Russian Federation stated that it planned
to sign the Convention by the time of the next CDBI. Developments
in the field of bioethics in member States, other States and
international organisations 10.
The Committee took note of the developments in member States,
other States and international organisations, as described in document
CDBI (99) 4 rev 4. In
particular, the Committee listened to a presentation made by a
representative from UNESCO (See paragraph 46). Working
Party on Organ Transplantation (CDBI-CO-GT1) 11. Articles 1 and 3 to 17 having been formally adopted by the CDBI at its previous meeting, only Articles 2 and 18 to 31 were discussed at this meeting. 12. Article 2 (Scope and definitions) was amended to specifically include cells, and in particular haematopoietic stem cells, within the scope of the Protocol. The new Article 14 (Cell removal from a living donor), whereby states could refrain from applying the provisions of Article 13 paragraph 2, indents ii. and iii. to cells insofar as it was established that their removal only implied minimal risk and minimal burden for the donor, was adopted. 13.
Article 18 (new Article 19) (Implantation of an organ or tissue
removed for a purpose other than donation for implantation) was
adopted by 31 votes for, 1 against and 3 abstentions, following
stylistic amendments. 14.
Article 19 (new Article 20) (Prohibition of financial gain) was
adopted by 32 votes for, 0 against and 2 abstentions.
The prohibition of organ and tissue trafficking was provided
for in the new Article 21 (Prohibition of organ and tissue
trafficking), adopted by 27 votes for, 0 against and 2 abstentions. 15.
Article 20 (new Article 22) (Confidentiality) was adopted by 33
votes for, 0 votes against and 2 abstentions, after deletion of the
reference to Convention ETS 108 and the inclusion of a reference to
the rules on professional confidentiality. 16.
Articles 21 (new Article 23) (Infringements of rights or
principles), 22 (new Article 24) (Compensation for undue damage), 23
(new Article 25) (Sanctions), 24 (new Article 26) (Co-operation
between Parties), 25 (new Article 27) (Relation between the Convention
and this Protocol), 26 (new Article 28) (Re-examination of the
Protocol), 27 (new article 29) (Signature and ratification), 28 (new
Article 30) (Entry into force), 29 (new Article 31) (Accession), 30
(new Article 32) (Denunciation), and 31 (new Article 33)
(Notification) were adopted unanimously. 17.
The
CDBI adopted the draft Protocol by 33 votes for, 0 against and 4
abstentions (Denmark,
France, Germany and Norway). The
text of the draft Protocol as adopted by the CDBI appears in Appendix
III. 18.
The CDBI decided unanimously in favour of declassifying the
draft Protocol, on the understanding that this was an instrument which
had been adopted by the CDBI and not the Committee of Ministers. It is
foreseen that the draft Protocol would be forwarded to the
Parliamentary Assembly for opinion before being submitted to the
Committee of Ministers for adoption. 19. The Committee agreed to entrust the Secretariat with the task of amending the explanatory report, in consultation with the Bureau and the Chair of the Working Party, to reflect the amendments made to the draft Protocol. It was pointed out that responsibility for publishing the explanatory report fell to the Secretary General of the Council of Europe and that the report, which was not an authoritative interpretation of the Protocol, did not have to be approved formally by the CDBI. Working
Party on Xenotransplantation (CDBI/CDSP-XENO) 20. The CDBI decided in favour of declassifying and disseminating the Interim Report on the State of the Art in the field of Xenotransplantation, prepared by the Working Party for the information of the Committee of Ministers and the general public, on the understanding that this report reflected only the views of the Working Party that had produced it. 21. The CDBI agreed that it was important to hold a European Conference on Xenotransplantation and asked the Working Party to discuss the matter further at its next meeting. 22. The CDBI recommended that the Working Party continue preparing guidelines for xenotransplantation in the form of a recommendation. Working
Party on Biomedical Research (CDBI-CO-GT2) 23. Dr. Rosemary BOOTHMAN (Ireland), Chair of the Working Party on biomedical research, presented the report of the 9th meeting of the CDBI-CO-GT2 (CDBI-CO-GT2 (2000) RAP 9) including the most recent draft of the Protocol on Biomedical Research (see Appendix IV of this report). 24. Dr. BOOTHMAN noted that the Working Party had combined the Chapters addressing research on personal data and research on biological materials. The Chair of the CDBI concluded that the Committee was provisionally satisfied with the current layout of the draft Protocol.
25. The CDBI agreed that the Plenary could realistically discuss Articles 1 to 26 in December 2000 and could address the remaining Articles in June 2001. The Chair noted that written comments by CDBI delegations on the draft Protocol would have to be submitted to the Secretariat by 30 September 2000 in order for them to be considered by the Working Party during the October 2000 meeting. The CDBI requested that the Working Party meet for 4 days in October. Working
Party on the Protection of Human Embryo and Foetus (CDBI-CO-GT3) 26. Professor D SERRÃO, Chair of the Working Party, asked the delegations to suggest other topics for inclusion in the draft Protocol, but the Committee felt that the Working Party had already clearly identified the subjects that needed to be addressed. The Working Party wished to receive detailed written comments on this preliminary draft Protocol by 20 July 2000 (document CDBI-CO-GT3/RAP11). Working
Party on Human Genetics (CDBI-CO-GT4) 27. The Chair of the CDBI informed the Committee that the Parliamentary Assembly's Committee on Science and Technology was planning to hold a Euroforum on issues relating to human genetics. The Committee on Science and Technology had asked the CDBI to appoint a representative to attend the preparatory meetings and the Bureau of the CDBI had provisionally appointed Stefan WINTER, Chair of the CDBI-CO-GT4. The Committee approved this appointment. 28.
Dr Stefan WINTER informed the CDBI that Professor MATTEÏ and
Mr WODARG of the Parliamentary Assembly had posted a petition on the
Internet, opposing gene patenting.
Professor MATTEÏ explained the background to this initiative. 29.
The Chair of the Working Party on Human Genetics, Stefan
WINTER, asked the CDBI delegations to send the Secretariat (by 11
September 2000) their opinions on the confidentiality of genetic data
and the disclosure of information resulting from genetic tests, and on
the issue of family studies involving persons not able to consent,
together with comments on the preliminary draft Protocol
(CDBI-CO-GT4/RAP4). Consultation
on the White Paper « Psychiatry and Human Rights » 30.
The Chair asked Member States to make written contributions by
October 2000 to the Secretariat on the results of any consultations
undertaken. Working
Party on biotechnology (CDBI-Biotech) 31. The Chair of the CDBI noted that, in December 1999, the CDBI had agreed on draft terms of reference for this Working Party, whose goal would be to develop a strategy during its two meeting mandate to address ethical, social, and legal issues arising from the application of biotechnology, identifying the appropriate bodies to take action. She noted that the terms of reference had been approved by the Committee of Ministers. The CDBI agreed to extend the mandate of the Working Party to 2001. 32. The CDBI designated Dr. QUINTANA as Chairman of the Working Party on Biotechnology. 33. Addressing the membership of the Working Party, the Chair of the CDBI noted that the remit of this Working Party was huge. It needed a wide-range of expertise but could have only 8 members plus the representatives of the Parliamentary Assembly and the European Commission. The CDBI agreed to form a core group, like in the Working Party on Human Genetics, with certain other experts contributing on their subjects. 34.
The Chair summarised that nominations should be sent to the
Secretariat by the deadline of 30 August, whereupon the Chair of the
Working Party and the CDBI Bureau would make the decision as to the
Working Party's composition. The expertise needed had been set out
in the terms of reference. DEBRA Project 35. The Secretariat presented the most recent activities and future activities foreseen under the DEBRA and ADACS programmes in 2000. The participating experts were thanked for their vital contribution. Information
on the preparation of the 5th European Conference of National Ethics
Committees 36. Professor SERRÃO, member of the Conference Bureau, said that the 5th Conference of National Ethics Committees would be held in Strasbourg on 4 and 5 September 2000. The subject of the Conference would be « Science, Communication and Society » (Draft programme in Appendix V to the present report). Election
of the Chair and Vice-Chair 38.
Nominations for the posts of Chair and Vice-Chair of the CDBI
were requested. Dr. Elaine GADD (UK) was the only nomination for the
post of Chair of the CDBI and Ms. Ruth REUSSER (Switzerland) was the
only person nominated for the post of Vice-Chair. 39.
Dr. GADD and Ms. REUSSER were elected unanimously
by the CDBI. Working
methods of the CDBI a)
Improving efficiency 40.
The Chair of the CDBI noted the conclusions of the
CDBI Bureau stating the need to move towards shorter presentations and
more focused discussions in the plenary, along with the efficiency
gains that would result from more use of new information technologies
between meetings. The Chair also noted that the Secretariat would
prepare a framework efficiency document for review by the Bureau at
its next meeting in November 2000. b) Transparency
and consultation procedures 41. The Chair noted that the CDBI had already agreed to declassify the preparatory work of the Convention. The Chair noted that these were the final documents but that specific comments could be made to the Secretariat by 30 June 2000. 42.
The Chair explained that publishing abridged
summaries of CDBI Plenary meetings on the Internet had been proposed.
She noted that such a summary would be anonymised. The CDBI agreed
that such summaries would be published starting with the current
meeting. Delegations were informed that they would receive the
aforementioned summaries by e-mail. c)
Relations with other international organisations 43.
The Chair asked for written comments to be sent to
the Secretariat on this important issue. Dates
of future meetings 44.
It was noted that the next meeting of the CDBI was
to be held in Strasbourg on 4 to 7 December 2000 and that the next
meeting of the CDBI Bureau would take place from 8 to 9 November 2000. Other
business 45.
At the request of one delegation, the CDBI agreed
to ask the Working Party on the Protection of the Human Embryo and
Foetus to examine the issue of the sale of gametes on the Internet. 46.
Ms. Marie-Christine BERCOT (UNESCO), from the
Division of Ethics in Science and Technologies made a presentation on
the recent activities of UNESCO in the field of bioethics. She noted
that UNESCO would be glad to receive comments or suggestions from the
Council of Europe on its “Guidance for the implementation of the
Universal Declaration on the Human Genome and Human Rights.” She
also informed the CDBI of the adoption of the “Declaration of
Monaco: reflections on bioethics and the rights of the child.” APPENDIX I List
of participants MEMBER
STATES
Albania– M.
Andrea GUDHA, Ministère de la Santé, TIRANA
Andorra - Austria - Dr Renate FALLY-KAUSEK, Bundesministerium für
Soziale Sicherheit und Generationen, WIEN Mr Erich Michael
STORMANN, Bundesministerium für
Justiz, WIEN Belgium– Mme Nathalie VAN DEN BOSSCHE, Cabinet de M. le
Ministre de l'Economie et la Recherche scientifique, BRUXELLES M. Christian
SCHUTYSER, Cabinet fédéral de la Protection de la Consommation, de
la Santé publique et de l'Environnement, BRUXELLES Mme
Sylviane FRIART, Ministère de la Justice, BRUXELLES Bulgaria– Ms Silvia TOMOVA, Université de médecine,
SOFIA Croatia– Dr Dubravka ŠIMONOVIC, Permanent Mission of
the Republic of Croatia to the United Nations, NEW YORK Dr Marija
GAJSKI-KNEKLIN, Ministry of
Health, ZAGREB Chypre – Mrs Rena PETRIDOU, Office of the Attorney
General of the Republic of Cyprus, NICOSIA République Tchèque
– Mr Jan PAYNE, Ministry of Health, PRAHA Danemark - Mrs Maja-Lisa AXEN, Danish Ministry of Health,
COPENHAGEN Estonie - Mr Arvo TIKK, Tartu University, TARTU Finlande – Mrs Ritva HALILA, Ministry of Social Affairs
and Health, HELSINKI Dr Terhi
HERMANSON, Ministry of Social Affairs and Health, HELSINKI France - M. André ALBERT, Ministère de la Justice,
PARIS M.
Pierre BOUSSAROQUE, Direction des Affaires juridiques du Ministère
des Affaires étangères, PARIS Mme Isabelle ERNY,
Direction général de la Santé, PARIS M. Jean MICHAUD,
Cour de Cassation, PARIS Géorgie – Mr Givi JAVASHVILI, Ministry of Health of
Georgia, TBILISI Allemagne – Dr Birgit-Maria BORN, Federal Ministry of
Justice, BERLIN Prof. Dr. med.
Elmar DOPPELFELD, Union des Comités d'Ethique, KÖLN Prof. Dr. Phil.
Ludger HONNEFELDER, Philosophisches Seminar LFBII der Universität
Bonn, BONN PD Dr Stefan
WINTER, Federal Chamber of Physicians, KÖLN Dr Rainer
MEILICKE, Bundesministerium für Gesundheit, BONN Grèce - Mrs Panagiota DALLA-VORGIA, University of Athens
Medical School, ATHENS Hongrie
- Dr Dorottya MOGYOROSI, Ministry of Health, BUDAPEST Islande - Dr Örn BJARNASON, National University
Hospitals, REYKJAVIK Irlande - Dr Rosemary BOOTHMAN, Department of Health,
DUBLIN Ms Angela
O'FLYNN, Department of Health and Children, DUBLIN Italie - M. le Professeur Adriano BOMPIANI, Ospedale
Pediatrico « Bambino Gesù », ROMA Mr Giovanni
BERLINGUER, National Bioethics Committee, ROMA Lettonie - Dr Laima RUDZE, Central Medical Ethics Committee
of Latvia, RIGA Liechtenstein
- Lituanie - M. Romualdas LEKEVICIUS, Department of Genetics
of Vilnius University, VILNIUS Luxembourg – M. Raymond MOUSTY, Ministère de la Santé,
LUXEMBOURG Malte - Prof. Maurice CAUCHI, Ministry of Health, GOZO Moldova – Ms Tatiana PARVU, Ministry of Foreign Affairs,
CHISINAU Dr Svetlana
CODREANU, Institut de Microbiologie, CHISINAU Pays-Bas – M. Bart WIJNBERG, Minstry of Health, Welfare
and Sports, DEN HAAG Mrs Sophie
BASTIJN, Ministry of Health, Welfare and Sport, DEN HAAG Norvège - Mrs Grete GJERTSEN, Ministry of Health and
Social Affairs, OSLO Pologne - Prof Andrzej RZEPLINSKI, Warsaw University,
WARSAW Portugal - Dr Daniel SERRÃO, Faculté de Médecine de
Porto, PORTO Roumanie – Prof Vladimir BELIS, Institut National de Médecine
légale, BUCAREST Russie – Mr Boris YUDIN, Institute of Human Studies,
MOSCOW Saint Marin – Dr Pietro BERTI, Parliament, SAN MARINO Slovaquie – Dr Jan BIELIK, Hospital, BRATISLAVA Ms Silvia GUBOVA,
Ministry of Health of the Slovak Republic, BRATISLAVA Slovénie - M. Joze V. TRONTELJ, Institute of Clinical
Neurophysiology, LJUBLJANA Espagne – Dr Octavi QUINTANA, Insalud, MADRID Suède – Mrs Lena JONSSON, Ministry of Health and Social
Affairs, STOCKHOLM Suisse - Mme Ruth REUSSER, Office fédéral de la
Justice, BERNE Mme Rafaella
MARTINELLI, Office fédéral de la Santé, BERNE Mrs Verena
SCHWANDER, Swiss Federal Office of Public Health, BERNE « l'ex-République yougoslave de Macédoine » - Dr Karpos BOSKOVSKI, Faculty of Medicine, SKOPJE Turquie - M. Ergun ÖZSUNAY, Faculty of Law, ISTANBUL Ukraine - Mrs Zoreslava SHKIRYAK-NYZHNYK, Institute of
Paediatrics, KYIV Royaume-Uni - Dr Elaine GADD, (CHAIR), Department of Health,
LONDON Dr Peter DOYLE,
Department of Health, LONDON Assemblée parlementaire
– M. Jean-François MATTEI, Hôtel-de-Ville, MARSEILLE Communauté européenne –
OBSERVATEURS Australie - Canada – Mme
Michème JEAN, Ministère des Affaires étrangères, BRUXELLES Mr
Bernard STARKMAN, Department of Justice, OTTAWA Saint-Siège – Dr Axel
CARLBERG, University Hospital, LUND Rev. Prof.
Maurice DOOLEY, TEMPLEMORE Japon – Ito FUMIYASU, Consulat général du Japon,
STRASBOURG Etats Unis d'Amérique
- Dr Duane ALEXANDER, National Institute of Child Health an Human
Development, BETHESDA Commission Internationale de l'Etat Civil (CIEC)
– apologised for absence Fondation européenne de science (ESF)
– Dr Marianne MINKOWSKI, Unit of Biomedical Sciences, STRASBOURG OCDE - apologised for absence UNESCO – Mme Marie-Christine BERCOT, Division de
l'Ethique et des Technologies, PARIS Organisation mondiale de la santé (OMS) – CDSP - Prof. Dr. H. ROSCAM ABBING, Ministry of Health,
Welfare and Sport, DEN HAAG CDDH - M. E. ROUCOUNAS, Athens Academy, ATHENS KEK – Church and Society Commission of the
Conference of European Churches – Pasteur Richard FISCHER, STRASBOURG Dr Lena KUMLIN,
HELSINKI SECRETARIAT Direction Générale des Affaires Juridiques, Division de
la Bioéthique M.
Carlos de SOLA, Secretary of the Steering Committee on Bioethics,
Principal Administrative Officer M.
Péteris ZILGALVIS, Administrative Officer Mme Martine
GABOLDE, Administrative Officer Melle Sandrine
SABATIER, Administrative Officer Mrs Terry
JOURNIAC, Assistant Mme Nathalie
DELOBEL, Secretary APPENDIX
II Agenda 1.
Adoption of the Agenda 2.
Israel – Observer status §
Decision on the
request for observer status made by Israel 3.
Chart of signatures and ratifications of the Convention on
Human Rights and Biomedicine and the Protocol on the Prohibition of
Cloning Human Beings 4.
Developments in the field of bioethics in member States, other
States and international organisations 5.
Working Party on Organ Transplantation (CDBI-CO-GT1) §
Examination of the
draft Protocol, with a view to its adoption §
Examination of the
draft Explanatory report, with a view to deciding on a final text §
Follow-up to the
adoption of the draft Protocol 6.
Working Party on Xenotransplantation (CDBI/CDSP-XENO) §
Authorisation for
declassification and dissemination of the Intermediate Report on the
state of the art in the field of xenotransplantation §
Consideration of
holding a European Conference on xenotransplantation 7.
Working Party on Biomedical Research (CDBI-CO-GT2) §
Presentation of the
draft Protocol on Biomedical Research by Dr R. BOOTHMAN (Ireland),
Chair of CDBI-CO-GT2, following the 9th meeting (Strasbourg, 9-11
February 2000). §
Examination of the
draft Protocol on Biomedical Research 8.
Working Party on the Protection of Human Embryo and Foetus
(CDBI-CO-GT3) §
Examination of the
preliminary draft Protocol on the protection of human embryo and
foetus, in particular Chapter II on the protection of the embryo in
vitro 9.
Working Party on Human Genetics (CDBI-CO-GT4) §
Examination of the
preliminary draft Protocol on Human Genetics 10.
Consultation on the White Paper « Psychiatry and Human
Rights » 11.
Working Party on
biotechnology 12.
DEBRA Project §
Presentation of
DEBRA activities for the year 2000 13.
Information on the preparation of the 5th European Conference
of National Ethics Committees 14.
Election of the Chair and Vice-Chair 15.
Working methods of the CDBI a) Improving efficiency b) Transparency and consultation procedures c) Relationship with
other international organisations 16.
Dates of future meetings 17.
Other business APPENDIX III
Draft Protocol on Transplantation of Organs
and Tissues of Human Origin Preamble The
member States of the Council of Europe, the other States and the
European Community signatories to this additional Protocol to the
Convention for the Protection of Human Rights and Dignity of the Human
Being with regard to the Application of Biology and Medicine
(hereinafter referred to as "Convention on Human Rights and
Biomedicine"), 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 on Human Rights and
Biomedicine, 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 science, in particular in the field of organ
and tissue transplantation, contributes to saving lives or greatly
improving their quality; Considering that transplantation of organs and tissues is
an established part of the health services offered to the population; Considering
that, in view of the shortage of organs and tissues, appropriate
action should be taken to increase organ and tissue donation, in
particular by informing the public of the importance of organ and
tissue transplantation and by promoting European co-operation in this
field; Considering moreover the
ethical, psychological and socio-cultural problems inherent in the
transplantation of organs and tissues; Considering that the misuse of organ and tissue
transplantation may lead to acts endangering human life, well being or dignity; Considering that organ and tissue transplantation should take place
under conditions protecting the rights and freedoms of donors,
potential donors and recipients of organs and tissues; Recognising that, in facilitating the transplantation of organs and tissues in the interest of patients in Europe, there is a need to protect individual rights and freedoms and to prevent the commercialisation of parts of the human body involved in organ and tissue procurement, exchange and allocation activities; Taking
into account previous work of the Committee of Ministers and the
Parliamentary Assembly of the Council of Europe in this field; Resolving to take such measures as are necessary to
safeguard human dignity and the fundamental rights and freedoms of the
individual with regard to organ and tissue transplantation, Have agreed as follows: Chapter I
– Object and scope
Article 1 – Object Parties to this Protocol shall protect the dignity and
identity of everyone and guarantee, without discrimination, respect
for his or her integrity and other rights and fundamental freedoms
with regard to transplantation of organs and tissues of human origin. Article 2 – Scope and definitions 1. This Protocol applies to the transplantation of organs and tissues of human origin carried out for therapeutic purposes. 2. The provisions of this Protocol applicable to tissues shall apply also to cells, including haematopoietic stem cells. 3. The Protocol does not apply: a. to reproductive organs and tissue; b. to embryonic or foetal organs and tissues; c. to blood and blood derivatives. 4.
For the purposes of this Protocol: –
the term "transplantation" covers the complete
process of removal of an organ or tissue from one person and
implantation of that organ or tissue into another person, including
all procedures for preparation, preservation and storage; –
subject to the provisions of Article 19, the term
"removal" refers to removal for the purposes of
implantation. Chapter II
– General provisions
Article 3 – Transplantation system Parties shall guarantee that a system exists to provide equitable access to transplantation services for patients which ensures that organs and tissues are allocated in conformity with transparent and duly justified rules taking particular account of medical criteria. The persons or bodies responsible for the allocation decision shall be
designated within this framework. The transplantation system shall ensure the collection
and recording of the information required to ensure traceability of
organs and tissues. Article 4 – Professional
standards Any intervention in the field of organ or tissue
transplantation must be carried out in accordance with relevant
professional obligations and standards. Article 5 – Information for the recipient The recipient and, where appropriate, the person or body
providing authorisation for the implantation shall beforehand be given
appropriate information as to the purpose and nature of the
implantation, its consequences and risks,
as well as on the alternatives to the intervention. Article 6 – Health and safety All professionals involved in organ or tissue transplantation shall take
all reasonable measures to minimise the risks of transmission of any
disease to the recipient and
to avoid any action which might affect the suitability of an organ or
tissue for implantation. Article 7 – Information for health
professionals and the public Parties shall provide information for health
professionals and for the public in general on the need for organs and
tissues. They shall also provide information on the conditions
relating to removal and implantation of organs and tissues, including
matters relating to consent or authorisation, in particular with
regard to removal from deceased persons. Chapter
III – Organ and tissue removal from living persons
Article 8 – General rule Removal of organs or tissues from a living person may
be carried out solely for the therapeutic benefit of a recipient and
where there is no suitable organ or tissue available from a deceased
person and no other alternative therapeutic method of comparable
effectiveness. Article 9 – Potential organ donors Organ removal from a living donor
may be carried out for the benefit of a recipient with whom the donor
has a close personal relationship
as defined by law, or, in the absence of such relationship, only under
the conditions defined by law and with the approval of an appropriate
independent body. Article 10 – Evaluation of risks for the
donor Before organ or tissue
removal, appropriate medical investigations and interventions shall be
carried out to evaluate and reduce physical and psychological risks to
the health of the donor. The removal may not be carried out if there is a serious risk
to the life or health of the donor. Article 11 – Information for the donor The donor and, where appropriate, the person or body providing
authorisation according to Article 13, paragraph 2, of this Protocol,
shall beforehand be given appropriate information as to the purpose
and nature of the removal as well as on its consequences and risks. They shall also be informed of the rights and the
safeguards prescribed by law for the protection of the donor. In
particular, they shall be
informed of the right to have access to independent advice about such
risks by a health professional having appropriate experience and who
is not involved in the organ or tissue removal or subsequent
transplantation procedures. Article 12 – Consent of the living donor Subject to Articles 13 and 14 of this Protocol, an organ or tissue may
be removed from a living donor only after the person concerned has
given free, informed and specific consent to it either in written form
or before an official body. The person concerned may freely withdraw consent at any time. Article 13 – Protection of persons not
able to consent to organ or tissue removal 1.
No organ or tissue removal may be carried out on a person who does not have the
capacity to consent under Article 12 of this Protocol. 2.
Exceptionally, and under the protective conditions prescribed
by law, the removal of regenerative tissue from a person who does not
have the capacity to consent may be authorised provided the following
conditions are met: i.
there is no compatible donor available who has the capacity to
consent; ii.
the recipient is a brother or sister of the donor; iii.
the donation has the potential to be life-saving for the
recipient; iv.
the authorisation of his or her representative or an authority
or a person or body provided for by law has been given specifically
and in writing and with the approval of the competent body; v.
the potential donor concerned does not object. Article 14 – Cell removal from a living
donor The law may provide that the provisions of Article 13,
paragraph 2, indents ii and iii, shall not apply to cells insofar as
it is established that their removal only implies minimal risk and
minimal burden for the donor. Chapter IV
– Organ and tissue removal from deceased persons
Article 15 – Certification
of death Organs or tissues shall not be removed from the body of a
deceased person unless that person has been certified dead in
accordance with the law. The doctors certifying the death of a person shall not be the same
doctors who participate directly in removal of organs or tissues from
the deceased person, or subsequent transplantation procedures, or
having responsibilities for the care of potential organ or tissue
recipients. Article 16 – Consent and authorisation Organs or tissues shall not be removed from the body of a
deceased person unless consent or authorisation required by law has
been obtained. The removal shall not be carried out if the deceased person had objected
to it. Article 17 – Respect for the human body During removal the human body must be treated with
respect and all reasonable measures shall be taken to restore the
appearance of the corpse. Article 18 – Promotion
of donation Parties shall respond to shortages of organs and tissues
by taking all appropriate measures to promote the procurement of
organs and tissue from deceased persons in accordance with the
provisions laid down in this Protocol. Chapter V – Implantation
of an organ or tissue removed for a purpose other than donation for
implantation Article 19 – Implantation
of an organ or tissue removed for a purpose other than donation for
implantation 1.
When an organ or tissue is removed from a person
for a purpose other than donation for implantation, it may only be
implanted if the
consequences and possible risks
have been explained to that person and his/her informed consent,
or appropriate authorisation in the case of a person not able to
consent, has been obtained. 2.
All the provisions of this Protocol apply to the situations
referred to in paragraph 1, except for those in Chapter III and IV. Chapter VI
– Prohibition of financial gain
Article 20 – Prohibition of financial gain
1.
The human body and its parts shall not, as such, give rise to
financial gain or comparable advantage.
The aforementioned provision shall not prevent payments which
do not constitute a financial gain or a comparable advantage, in
particular: –
compensation of living donors for loss of earnings and any
other justifiable expenses caused by the removal or by the related
medical examinations; –
payment of a justifiable fee for legitimate medical or related
technical services rendered in connection with transplantation; –
compensation in
case of undue damage resulting from the removal of organs or tissues
from living persons. 2.
Advertising the need for, or availability of, organs or
tissues, with a view to offering or seeking financial gain or
comparable advantage, shall be prohibited. Article 21 – Prohibition of organ and tissue trafficking Organ
and tissue trafficking shall be prohibited. Chapter
VII – Confidentiality
Article 22 – Confidentiality
1. All personal data relating to either the person from whom organs or tissues have been removed or the recipient shall be considered to be confidential. Such data may only be collected, processed and communicated according to the rules relating to professional confidentiality and personal data protection. 2. The provisions of paragraph 1 shall be interpreted without prejudice to the provisions making possible, subject to appropriate safeguards, the collection, processing and communication of the necessary information about the person from whom organs or tissues have been removed or the recipient(s) of organs and tissues in so far as this is required for medical purposes, including traceability, as provided for in Article 3 of this Protocol. Chapter
VIII – Infringements of the provisions of the Protocol
Article 23 – Infringements of rights or principles Parties shall provide appropriate judicial protection to
prevent or to put a stop to an
unlawful infringement of the rights and principles set forth in this Protocol at
short notice. Article 24 – Compensation for undue damage The person who has suffered undue damage resulting from
transplantation procedures is entitled to fair compensation according
to the conditions and procedures prescribed by law. Article 25 – Sanctions Parties shall provide for appropriate sanctions to be
applied in the event of infringement of the provisions contained in
this Protocol. Chapter IX
– Co-operation between Parties
Article 26 – Co-operation
between Parties Parties shall take appropriate measures to ensure that
there is efficient co-operation between them on organ and tissue
transplantation, inter alia
through information exchange. In particular, they shall undertake appropriate measures to facilitate
the rapid and safe transportation of organs and tissues to and from
their territory. Chapter X
– Relation between this Protocol and the Convention, and
re-examination of the Protocol
Article 27 – Relation between this
Protocol and the Convention As between the Parties, the provisions of Articles 1 to
26 of this Protocol shall be regarded as additional articles to the
Convention on Human Rights and Biomedicine, and all the provisions of
that Convention shall apply accordingly. Article 28 – 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 on Human Rights and Biomedicine no later than
five years from the entry into force of this Protocol and thereafter
at such intervals as the Committee may determine. Chapter XI
– Final clauses
Article 29 – 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 30 – 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 29. 2.
In respect of any signatory 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 31 – 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 32 – 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 33 – Notification 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 Convention 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 30 and 31; 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 …, this …, in English and 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 IV
Draft Protocol on Biomedical Research
*
Changes made by the Working Party
are in bold
Changes to the text proposed provisionally by the Secretariat
are in italics
CHAPTER I
General provisions 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 in the field of biomedicine. Article 2 (Scope and definitions) This Protocol covers the full range of biomedical research activities involving individuals, groups or populations. This includes research into molecular, cellular and other mechanisms in health, disorders and disease; and diagnostic, therapeutic, preventive and epidemiological studies. The scope of this Protocol includes research based on personal data and biological materials of human origin.
This Protocol applies to research
on embryos and foetuses in vivo
and to research on pregnant women. However, it does not apply to
research on embryos in vitro. 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)
Biomedical research shall be carried out freely, subject to the
provisions of this Protocol and of other legal provisions ensuring the
protection of the human being. CHAPTER
II Requirements
for all biomedical research
Article
5 (Quality standards)
Any research must be of acceptable scientific quality and be
carried out in accordance with relevant professional obligations and
standards under the supervision of a responsible researcher. Article 6 (Independent examination by an
authorised body)
Every research project on
persons, personal data
including anonymised personal data, or biological materials
shall be submitted to the authorised body
or bodies for independent examination of its scientific merit and
ethical acceptability in each country in which research is to take
place.
The primary function of the multidisciplinary examination of
the ethical acceptability, assuming that the condition of scientific
quality has been met, is to protect the safety, rights and well-being
of the research participants and those whose personal data or
biological materials are to be used in conformity with the highest
ethical standards.
The assessment of the ethical acceptability, taking into
account the nature of the project under review, shall
draw on a broad range of expertise and experience adequately
reflecting professional, lay, gender, and cultural views.
For the protection of persons participating in research and those whose personal data or biological materials are used, the
researcher shall inform the body or bodies in charge of ethical
assessment of progress, of unforeseen events giving rise to new
ethical issues, and submit the final report of the research. It shall
be ensured that the results of research projects be made available to
participants, on request. The opinion of an authorised body or bodies
shall be delivered before research commences. New Article 7 (Independence of the
authorised body or bodies)
Parties to this Protocol shall assure the independence of the authorised
body or bodies. The authorised body or bodies shall not be subject to
undue external influences. All direct or indirect conflicts of interest on the part of members of such bodies shall be declared and if such conflicts occur, those involved shall be excluded from the decision-making process. Article
8 (Information for
the authorised body)
Clear, documented information on the proposed research shall be
provided to the authorised body or bodies
as the basis for assessment of the ethical acceptability of each
research project including:
i)
the name of the principal researcher, qualifications and
experience of researchers and, where appropriate, the clinically
responsible person;
ii)
the aim and justification for the research supported by an
updated survey of relevant scientific literature; iii)
methods and procedures envisaged, including statistical and
other analytical techniques; iv) the categories of persons who would participate in or whose data or biological materials would be used in the research project and how they are to be selected and recruited; justification for inclusion or exclusion of any persons or categories of persons in particular those not able to consent to research or those for whom other special circumstances apply;
v)
details of information which
has been or will be provided to those persons who would
participate or whose data or biological materials would be used in the
research project and the means proposed for provision of this
information; vi)
documentation intended to be used to seek consent or, in the
case of persons not able to
consent, authorisation for participation or use of data or biological
materials in the research project; vii)
arrangements to ensure respect for the private life of those
persons who would participate or whose data or biological materials
would be used in research and assure the confidentiality of personal
data;
viii) the management of information
which may be generated and be relevant to the present or future health
of those persons who would participate or whose data or biological
materials would be used in research and their family members;
ix)
the funding arrangements including details of all payments or
rewards;
x)
any potential conflicts of interest affecting the independence
of the researchers; xi)
any foreseen commercial use of data or biological materials; xii)
a comprehensive summary of the research project in lay
language; xiii)
specific ethical issues as perceived by the researcher,
particularly in regard to the aim, methods, and potential implications
of the results, including the risk of stigmatisation or
discrimination; xiv)
a record of previous and concurrent submissions of the research
project for assessment or approval and the decisions, if any, taken; xv)
arrangements for compensation in the event of damage; Additional information which must be provided to the authorised body or bodies reviewing research specifically involving interventions on persons, personal data or biological materials is found in Articles 16, 32 and 34. Article
9 (Confidentiality)
Any information of a personal nature obtained during biomedical
research shall be considered as confidential and treated according to
the rules relating to the protection of private life and subject to
data protection legislation.
Information collected on their health shall be accessible to
data subjects, in conformity with the provisions of Article 10 of the
Convention[1],
and data protection legislation. Article
10 (Duty of care)
If research gives rise to conclusions
[results] of relevance to
the current or future health
or quality of life of identifiable participants
or those whose data or biological materials are used, these
conclusions [results] must be
made accessible to those
included in the research.
This shall be done within a framework of healthcare or counselling.
In communication of such
conclusions [results], due care
must be taken in order to protect confidentiality
and to respect the right of the data subject not to receive conclusions
[results]. Article 11 (Availability of results)
Researchers shall publish or
make otherwise available the results of research projects in
reasonable time, regardless of their outcome. Article 12 (Research in
states not Party to this Protocol)
Sponsors and researchers based in the
territory of a Party to this Protocol who plan research in a state not
Party to this Protocol, shall satisfy both the conditions applicable
in the state in the territory of which research is to be carried out
and the fundamental ethical standards and safety guarantees laid down
in this Protocol.
CHAPTER III
Additional
requirements for research involving interventions on
or
interactions with persons
Article 13 (Justification for research)
Research involving
interventions on or
interactions
with persons is only justified if it will generate new scientific
understanding that has the potential to lead to improvements in human
health. Article
14 (Absence of
alternatives)
Research involving interventions on or interactions with
persons may only be justified if there is no alternative of comparable
effectiveness. Article
15 (Risks and benefits)
Research shall not
involve risks disproportionate to its potential benefits. Article
16 (Additional
information for the authorised body or bodies)
In addition to the items listed in Article 8, the following
clear, documented information must be provided for the assessment of
the ethical acceptability of each research project involving interventions
on or interactions with persons: i)
special justification for involving persons; ii)
the
nature, extent and duration of the procedures involved, in particular
of any burden imposed; iii)
justification for the use or the absence of control groups; iv)
a description of the
nature and degree of any foreseeable risks
which may be incurred through participating in research which shall
not be disproportionate to the potential benefits of the research; v)
arrangements to monitor, evaluate and react to contingencies
which may have consequences for the present or future health of
research participants or others; vi) arrangements for compensation in the event of injury or death. New
Article 17 (Premature termination of research)
The research shall be terminated prematurely if new knowledge
invalidates the justification for the research. The termination shall
be reviewed by the authorised body or bodies. Article
18 (Consent) 1. No research involving interventions on or interactions with persons may be carried out without the informed, free, express, specific and documented consent of the person. Refusal to participate in research shall not prejudice the right of the individual to receive appropriate and timely medical care. 2.
Such consent may be freely withdrawn by participants at any
phase of the research without prejudice to their right to future
medical care. Article
19 (Research involving
persons without potential direct benefit)
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 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 persons in the same age
category or afflicted with the same disease or having the same
condition; or ii)
the research has the aim of contributing through significant
improvement in the scientific understanding of biological,
physiological, psychological, and pharmacological processes in ways
which have the potential to benefit human health, and iii)
the research entails only acceptable risk and acceptable burden
for the individual concerned. Article
20 (Undue influence)
The authorised body or bodies
assessing the ethical acceptability of the research project must
be satisfied that no undue influence, particularly financial gain,
will be exerted on persons to participate in research. Article
21 (Information for
research participants)
The persons asked to participate in a research project shall be
given adequate information in a documented and comprehensible form on
the purpose, overall plan and methods to be applied in the research
project, including the decisions of the authorised body or bodies,
according to national law. They shall also be specifically informed
before participating in research: i)
of the nature, extent and duration of the procedures involved,
in particular of any burden imposed; ii)
of the foreseeable risks and the arrangements for compensation
in the case of injury; iii)
of the arrangements for responding to adverse events or the
concerns of participants; iv)
of the rights and safeguards prescribed by law for their
protection; v)
of their right to refuse consent or to withdraw consent at any
time, without prejudice to their right to appropriate and timely
medical care; vi)
of arrangements to assure the confidentiality of personal data; vii)
of any foreseen commercial use of the data or biological
materials. Article 22 (Safety)
All measures shall be
taken to protect the health, well being and safety of the
participants.
Research involving interventions on or interactions with
persons shall only be carried out provided that all necessary
preconditions as to its safety have been fulfilled.
Research involving interventions on or interactions with
persons shall be carried out under the direct supervision of a
professional who exercises clinical responsibility and who possesses
the necessary qualifications and experience to respond appropriately
to clinical contingencies.
The participants shall be informed immediately of any relevant
developments, in particular of any risks which have become apparent in
the course of the research. If, in the course of the research,
unforeseen adverse events arise, their causes and severity shall be
evaluated. Participation of the individual or the research itself
shall only be continued, after amendment of the protocol if necessary and
with the informed consent of the
participants, if the risks are still not disproportionate to the
potential benefits of the research. Article
23 (Assessment of
health status)
The researcher shall take all necessary steps to assess the
state of health of potential participants in research
if the research involves interventions on or interactions with
persons, to ensure that those at increased risk in relation to a
specific project be excluded.
Where research is undertaken on women in the reproductive stage
of their lives, particular consideration must be given to the possible
adverse impact on a current or
future pregnancy and the health of the embryo or foetus. Article
24 (Non-interference
with necessary clinical interventions)
Research involving interventions on or interactions with
persons shall not delay or deprive them of medically necessary
diagnostic or therapeutic procedures.
In research associated with treatment, patients assigned to
control groups shall be assured of a proven method of treatment.
Placebo treatment may only be used in cases where there is no
treatment of proven effectiveness, or where withdrawal or withholding
of active treatment does not present unacceptable risk or burden. Article
25 (Persons not able to
consent to research) 1.
Research involving interventions on or interactions with
persons without the capacity to consent to research may be undertaken
only if all the above applicable conditions and all the following
conditions are met: i)
the results of the research have the potential to produce real
and direct benefit to his or her health, ii)
where appropriate, the persons undergoing research have been
informed of their rights and the safeguards prescribed by law for
their protection, iii)
research of comparable effectiveness cannot be carried out on
individuals capable of giving consent, iv)
the necessary authorisation has been given specifically and in
writing by the legal representative or an authority, person or body
provided for by national law, v)
the person concerned does not object to participating in the
research, taking into account previously stated objections; 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 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 documented minimal risk and minimal
burden for the individual concerned; 3.
Under the protective conditions provided by law, the opinions
expressed by a person shall be given due weight by their legal
representative or an authority, person or body provided for by
national law, and the opinion of a minor shall be taken into
consideration as an increasingly determining factor in proportion to
his/her age and degree of maturity. Article
26 (Interventions with
minimal risk and minimal burden) 1.
For the purposes of Article 25 paragraph 2 it shall be
considered that research bears a minimal risk if it is to be expected
that, in terms of the nature and scale of the intervention, it would
result in the individual case, at the most in a very slightly
detrimental and temporary effect on the health of the person
concerned. 2.
Research within the meaning of Article 25 paragraph 2 only
bears a minimal burden if it is to be expected that the symptoms or
unpleasantness possibly associated with the intervention in the
individual case will be felt by the person concerned to be, at the
most, temporary and very slight. Where appropriate, a person enjoying
the special confidence of the person concerned shall assess the
burden. 3.
Any consideration of expected benefit shall not be used to
justify an increased level of risk or burden. Article
27 (Emergency clinical
situations)
In recognised emergency situations where the consent or
authorisation required under Article 18 and Article 25 paragraph 1.iv.
cannot be obtained, research may be carried out if the following
additional conditions are met: i)
whenever possible, the relatives of the patients or persons
close to them shall be consulted, or other reasonable steps taken in
order to ascertain the wishes of the patient. If there are indications
that the patient would object, the research shall not be undertaken. ii)
the patient shall be informed, when it becomes possible, of
participation in the research. iii)........
the research has the potential to produce a significant benefit
to their health or is aimed at benefiting that of people in the same
situation. iv).......
research of comparable effectiveness cannot be undertaken on
persons not in an emergency situation. Article
28 (Research during pregnancy or breastfeeding)
Research involving pregnant
or breastfeeding women or
embryos or foetuses may not be carried out unless the following
conditions are met: i)
the research
will potentially benefit directly the health of the woman or that of
the embryo, foetus or child or this research is aimed at benefiting
other embryos, foetuses or children or women who are in the same
position; ii)
research of
comparable effectiveness cannot be carried out in other ways [utilising other
alternatives]; iii)
risks which may
be incurred by the mother and/or embryo or foetus through
participating in research shall not be disproportionate to the
potential benefits of that research; iv)
where the
research would not have the potential to produce results of direct
benefit for the woman or the embryo or foetus, there must be no more
than minimal risk and minimal burden; v)
the informed
consent or authorisation required by law has been obtained. Article
29 (Dependent persons)
The authorised body or bodies
must be satisfied that dependent persons and vulnerable groups in
society will not be subjected to undue influence. Article
30 (Reimbursement of
expenses)
Persons participating in
research have the right to reimbursement of any expenses or financial
loss. Article
31 (Persons deprived of
liberty)
Research may only be undertaken on persons deprived of liberty
exceptionally and under the protective conditions prescribed by law if
all of the following conditions are met: i)
it has the potential to produce a significant benefit to their
health [or is aimed at benefiting that of people in the same
situation] ii)
that particular attention is paid that the conditions of
Article 29 are fulfilled, and iii) where required by national law, approval has been given by the competent body provided for.
CHAPTER IV
Additional requirements for research on personal data or biological materials
Article
32 (Justification for research on personal data or biological materials)
The use of personal data
or biological materials for research purposes shall only be justified
by potential, proportional benefits of the research. Article
33 (Additional
information for the authorised body or bodies)
In addition to the items listed in Article 8, clear, documented
information shall be provided to the authorised body or bodies for the
assessment of ethical acceptability of each research project on
personal data or biological materials regarding: i).........
arrangements for
anonymisation [removal of personal identifiers]
and their effect on confidentiality, protection of private life, and
on communication of relevant results related to the health of the
subject; ii)........
information to be
provided to those whose data or biological materials are to be
utilised in research; iii)
the
type of consent sought, whether
specific to the project or general, and its duration; iv)
specific
justification if consent is not to be requested; v)
arrangements to make accessible, within a framework of healthcare or
counselling,
conclusions of relevance to research subjects in the event that
this may become necessary; vi)
arrangements for compensation; Article 34 (Information to be given to persons whose personal data or biological material may be used)
The persons whose personal data or biological material may be used shall be given adequate
information in a documented and comprehensible form on the purpose,
overall plan and methods to be applied in the research, including the
decisions of the authorised body or bodies, according to national law.
They shall also be specifically informed before their data
or biological material is used: i) in lay language, of the nature of storage and use of data or biological materials, ii) possibility of being informed of conclusions of the research and availability of related counselling, iii)
accessibility to them of the results of research, iv) purpose of the storage and possible future uses of their data or biological materials, v) the possibility of consenting only to specific research, vi) the possibility of being contacted for further research, and of the possibility of refusing such contact, vii) that every new research project using their data or biological materials will be submitted to an authorised body or bodies, viii)
of any possible commercial applications of their data
or biological materials, Article
35 (Consent
for research on archived data or biological materials )
Only those personal identifiers necessary for the research
shall be utilised by researchers.
Archived data or
biological materials are those which have been collected prior to the
entry into force of this Protocol. Whenever possible consent
should be obtained for the use of archived
personal data or biological materials for biomedical research
purposes.
However, such data or biological materials may be used, after review by the authorised body or bodies, without consent for
the purpose of a defined biomedical research project provided that:
i)
the person has not expressly opposed disclosure; and
ii)
despite reasonable efforts, it would be impracticable to
contact the person to seek consent; and
iii)
the interests of the research project justify the
authorisation; or iv)
the scientific research is provided for by law and constitutes
a necessary measure for public health reasons. 3.
Personal data used for biomedical research may not be published
in a form which enables the person to be identified, unless consent
has been given for the publication and publication is permitted by
law. Article 36 (Consent for
research on data and biological materials)
Personal data and biological materials collected for
non-research purposes after the entry into force of this Protocol
shall only be utilised with the free, informed, specific and
documented consent or authorisation of those whose data or biological
materials are to be used. It shall be specified whether the consent or
authorisation is general, specific to a type of research, or specific
to a research project. Such consent or authorisation may be freely withdrawn by those whose
data or biological materials are being used at any phase of the
research without prejudice to their right to future medical care. Article 37 (Damages)
Damage resulting from
the research use of personal data or biological materials shall be
appropriately compensated according to national law.
CHAPTER VI
Infringement of the provisions of the Protocol Article
38 (Infringement of the
rights and principles)
The Parties shall provide appropriate judicial protection to
prevent or put a stop to an unlawful infringement of the rights and
principles set forth in this Protocol at short notice. Article
39 (Compensation for
damage) Persons participating in research shall be appropriately compensated in the event of loss and/or injury according to the conditions and procedures prescribed by law. Article
40 (Sanctions)
Parties shall provide for appropriate
sanctions to be applied in the event of infringement of the provisions
contained in this Protocol. CHAPTER
VII
Relation between this protocol and other provisions Article
41 (Restrictions on the
exercise of rights) 1.
No restrictions shall be placed on the exercise of the rights
and protective provisions contained in this Protocol other than such
as are prescribed by law and are necessary in a democratic society in
the interest of public safety, for the prevention of crime, for the
protection of public health or for the protection of the rights and
freedoms of others. 2.
The restrictions contemplated in the preceding paragraph may
not be placed on Articles ……... Article
42 (Wider protection)
None of the provisions of this protocol shall be interpreted as
limiting or otherwise affecting the possibility for a Party to grant
persons participating in research or
those whose biological materials or data are used in research a
wider measure of protection than is stipulated in this protocol. CHAPTER
VIII Final
provisions
Article
43
As between the Parties, the provisions of Article 1 to 38 shall
be regarded as additional articles to the Convention, and all the
provisions of the Convention shall apply accordingly. Article
44
This Protocol shall be open for signature by States which have
signed the Convention. It is subject to ratification, acceptance or
approval. A State Signatory] may not ratify, accept or approve this
Protocol without previously or simultaneously ratifying the
Convention. Instruments of ratification, acceptance or approval shall
be deposited with the Secretary General of the Council of Europe. Article
45 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 5 States have expressed their consent to be bound by the
Protocol in accordance with the Provisions of Article 42. 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
46
The Secretary General of the Council of Europe shall notify the
member states of the Council of Europe, 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 or approval; c.
any date of entry into force of this Protocol in accordance with
Article 42; d.
any other act, notification or declaration relating to this Protocol. In
witness whereof the undersigned, being duly authorised thereto, have
signed this Protocol. Done at Strasbourg, this ...., in
English and 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 and to any State invited to accede to the Convention. APPENDIX V Draft Programm
Science,
Communication and Society dRAFT Programme Monday 4 September 2000:
Science day
9:00 am
Registration Opening session
10:00 am
Mr Roger-Gérard Schwartzenberg (to
be confirmed) (French Minister for Research) 10:15 am
Mr Walter Schwimmer (Secretary General of the Council of
Europe) or Mr Hans Christian Krüger (Deputy Secretary General) 10:30 am
Ms Nicole Questiaux (France)
(Chair of the Bureau of the European Conference of National Ethics
Committees) General Introduction : Communication
between Science and Society
10:45 am
Mr Howard Moore (Unesco)
(Director of the Unit for International Partnership in Science,
Unesco. Editor of the World Report on Science 1998) 11:15 am
Debate Biomedical sciences today:
“Science and Conscience”
11:30 am
Mr Sylvester Vizi (Hungary)
(Vice-Chair of the Hungarian Academy of Sciences, Chair of the
Hungarian National Ethics Committee) 12:00 noon
Debate Presentation of case studies: examples of
communication between Science and Society
12:15 pm
Communicating scientific information to the public: the example
of genetics Mr Ysbrand Poortman (Netherlands) (Chairman
of VSOP association: “Dutch alliance of parent/patient organisations
concerned by genetic and non-genetic congenital disorders”) 12:45 pm
Debate 1:00 pm
Lunch 2:30 pm
The Swiss experience of transmission of scientific information
to the public: example of communication concerning fertilisation in
vitro before a referendum Mr Claude Longchamp (Switzerland) (Co-Director
of the gfs Research Institute, Bern) 3:00 pm
Debate 3:10 pm
The Spanish experience of communication in the transplantation
field : “The youth public transplant information programme” Dr. Antonio Lopez-Navidad (Spain) (Director of the
Transplant Coordination Unit, Santa Creu Hospital, Barcelona) 3:40 pm
Debate 3:50 pm
Break Communication methods: Ways of improving
communication
4:20
pm
An innovative method of communication between Science and
Society : the “Dare to know” programme (“Oser le savoir”) of
the Science and Industry centre, Paris- La Villette. Ms Caroline Allain (France) (Head of the
Education Unit. Head of the programme « Oser le savoir ») 4:50
pm
Debate 5:00
pm
How to communicate on biomedical sciences? Mr Holger Wormer (Germany) (science
journalist, Science writer for the daily newspaper “Süddeutsche
Zeitung” (South of Germany Journal)) 5:30
pm
Debate 5:40
pm
informing the public and patients about cancer. Assessment of
communication methods. Ms
Heather Mercer
(European Association for Cancer Education) 6 :
00 pm
Debate 6:10 pm
End of the session Tuesday 5 September
2000: Experience
of Ethics Committees
Views of the National Ethics Committees and
similar bodies
9:00
am
Mr Luis Archer (National Ethics Committee of Portugal) 9:15
am
Ms Ritva Halila (National Ethics Committee of Finland) 9:30
am
Mr Gunnar Bengtsson (National Ethics Committee of
Sweden) 9:45
am
M…….(National Ethics Committee of…) 10:00
am
Mr Didier Sicard (National Ethics Committee of France) 10:15
am
debate 10:35 am
Break 11:00
am
Mr Jan Payne (National Ethics Committee of Czech
Republic) 11:15
am
Ms Laima Rudze (National Ethics Committee of Latvia) 11:30
am
M…….(National Ethics Committee of…) 11:45
am
Debate 12:00
noon
Election of the new members of the Bureau of the European
Conference of National Ethics Committees 12:30 pm
Lunch Views of the similar bodies
(continued)/questions raised by the institution and setting-up of the
National Ethics Committees
2:00
pm
Mr Bozidar Vrhovac (Croatia) 2:15
pm
M….() 2:30
pm
Mr Andreas N. Loizou (Cyprus) 2:45
pm
Debate 3:05
pm
Summing-up by Ms Nicole Questiaux Closing session
3:30
pm
Ms. Noëlle Lenoir (Chair of the Advisory Group on
Ethics of European Union) 3:50
pm
Mr Anatoliy Rakhansky (Chair of the Committee on Science
and Technology of the Parliamentary Assembly of the Council of Europe) 4:00
pm
Mr Guy De Vel (Director General of Legal Affairs of the
Council of Europe) 4:10
pm
Closing speech by the new Chair of the Bureau of the Conference 4:30 pm
End of the 5th Conference [1]
Article 10
–
Private life and right to information 1
Everyone has the right to respect for private life in
relation to information about his or her health. 2
Everyone is entitled to know any information collected about
his or her health. However, the wishes of individuals not to be so
informed shall be observed. 3
In exceptional cases, restrictions may be placed by law on
the exercise of the rights contained in paragraph 2 in the interests
of the patient.
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