Teilnehmerverzeichnis / List of Participants - Springer978-3-642-57326-2/1.pdf · 370 TeilnehmerverzeichnisIList of Participants Professor Dr. Elmar Doppelfeld Vorsitzender des Arbeitskreises

Teilnehmerverzeichnis / List of Participants

Professor Dr. Hans Jiirgen Ahrens Professur fUr Burgerliches Recht, Handels- und Wirtschaftsrecht, deutsches und intemationales ProzeBrecht Universitat Osnabrock KatharinenstraBe 13-15 49069 Osnabrock Deutschland

Professor Anthony Angelo Faculty of Law Victoria University of Wellington Old Government Building P. O. Box 600 Wellington Neuseeland

Professor Dr. Jan P. Beckmann Institut fUr Philosophie, FernUniversitat FeithstraBe 140/ AVZ II 58084 Hagen Deutschland

Professor Dr. Erwin Bernat Institut fUr Burgerliches Recht der Karl-Franzens-Universitat Graz Universitatsstr. 15104 8010 Graz Osterreich

Professor John W. G. B1ackie The Law School, Stenthouse Building 173 Cathedral Street Glasgow G4 ORQ Schottland

Professor (em.) Dr. Dr. h.c. mult. Erwin Deutsch Direktor der Abteilung fUr Arzt- und Arzneimittelrecht des Iuristischen Seminars der Universitat Gottingen GoBlerstraBe 19 37073 Gottingen Deutschland

370 TeilnehmerverzeichnisIList of Participants

Professor Dr. Elmar Doppelfeld Vorsitzender des Arbeitskreises Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland Leiter der Medizinisch-Wissenschaftlichen Redaktion des Deutschen Arzteblattes OttostraBe 12 50859 Koln Deutschland

Professor Guido Gerin International Institute for Human Rights Studies Centre International d'Etudes de Bioethique Via Cantil 10 34127 Trieste Italien

Professor Timothy S. Jost Newton D. Baker, Baker & Hostetler Chair The Ohio State University 3445 Live Oak Place Columbus, Ohio 43221 USA

Dr. med. Dr. med. dent. Hans-Walter Krannich Arztlicher Geschaftsflihrer der Arztekammer Niedersachsen Berliner Allee 20 30175 Hannover Deutschland

Professor Dr. Gunther Kuhne Institut fUr deutsches und internationales Berg- und Energierecht Technische Universitat Clausthal Arnold Sommerfeld Str. 6 38678 Clausthal-Zellerfeld Deutschland

Professor Dr. Lothar Kuhlen Lehrstuhl fur Strafrecht und Kriminologie Universitat Mannheim SchloI3 68131 Mannheim Deutschland

TeilnehmerverzeichnislList of Participants 371

Tatsuo Kuroyanagi Lawyer and Legal Advisor Japan Medical Association Kaneko-Iwamatsu Houritsu-Jimusho Shin-Kokusai Bldg. No. 801 Chiyoda-ku Marunouchi 3-4-1 Tokyo 100-0005 Japan

Professor Dr. Hans Lilie Lehrstuhl fUr Straf-, StrafprozeBrecht, Rechtsvergleichung und Medizinrecht Martin-Luther-Universitat Halle-Wittenberg Franz-von-Liszt-Haus Universitatsplatz 6 06108 Halle Deutschland

Dr. Hans-Dieter Lippert Abteilung Rechtsmedizin Universitatsklinikum Ulm Albert-Einstein-Allee 47 89073 Ulm Deutschland

Professor Dr. Gerard Memeteau Faculte de Droit et des Sciences Sociales Universite de Poitiers 93, Ave. Du Recteur Pineau 86022 Poitiers Cedex Frankreich

Professor Dr. Joachim Munch Dekan der Juristischen Fakultat der Georg-August-Universitat Gottingen Platz der Gottinger Sieben 6 37073 Gottingen Deutschland

Professor Dr. Ferdinand van Oosten Department of Public Law Law Faculty, University of Pretoria 0002 Pretoria Republik Sud Afrika

372 TeilnehmerverzeichnisIList of Participants

Adj. Professor Dr. Joan Rapp Owen Registered Patent Attorney 301 Wateree Avenue Columbia, South Carolina 29205 USA

Professor Dr. David G. Owen University of South Carolina / School of Law Columbia, South Carolina 29208 USA

Andre Dias Pereira Patio da Universidade Faculdade de Direito da Universidade de Coimbra 3059 Coimbra Codex Portugal

Professor Dr. Jakov Radish! Institut drustvenih nauka Narodnog fronta 45 P. O. Box 927 11000 Belgrade Republik Jugoslawien

Professor Dr. Povl Riis Nerievej 7 2900 Hellerup Danemark

Professor Dr. iur. Dr. med. Carlos Maria Romeo Casabona, LL.D., M.D Director, Catedra Interuniversitaria de Derecho y Genoma Humano Avda. de las Universidades, 24 48007 Bilbao Spanien

Wiss. Ass. Dr. Henning Rosenau Juristische Fakultat der Georg-August-Universitat Gottingen Platz der Gottinger Sieben 6 37073 Gottingen Deutschland

Holger Schelling Wissenschaftlicher Mitarbeiter Fakultat fur Rechtswissenschaft Universitat Mannheim SchloB 68131 Mannheim Deutschland

Pastor Udo Schlaudraff Zentrum fUr Gesundheitsethik


an der Evangelischen Akademie Loccum KnochenhauerstraBe 33 30159 Hannover Deutschland

Dr. Karsten Scholz Arztekammer Niedersachsen Postfach 3 07 30003 Hannover Deutschland

Professor Dr. Dr. h. c. mult. Hans-Ludwig Schreiber Lehrstuhl fUr Strafrecht und Allgemeine Rechtstheorie Juristische Fakultiit der Georg-August-Universitat G6ttingen Grazer StraBe 14 30519 Hannover Deutschland

Professor Amos Shapira The Lubowski Chair of Law and Biomedical Ethics Tel Aviv University Faculty of Law P. O. Box 39040 69978 Tel Aviv Israel

Professor Dr. Jorge Sinde Monteiro Faculdade de Direito de Coimbra Av. Mamoco e Sousa 26 - 3D 3000 Coimbra Portugal

Professor Dr. Michael Staak Direktor des Instituts fUr Rechtsmedizin der Universitat zu K6ln Melatengurtel 60-62 50823 K6ln Deutschland

374 TeilnehmerverzeichnislList of Participants

Professor Dr. Jochen Taupitz Geschaftsfiihrender Direktor des Instituts fUr Deutsches, Europaisches und Intemationales Medizinrecht, Gesundheitsrecht und Bioethik der Universitaten Heidelberg und Mannheim Kaiserring 10-12 68161 Mannheim Deutschland

Professor Michiatro Urakawa Faculty of Law Waseda University Shinjuku-Ku Nishiwaseda 1-6-1 Tokyo 169-8050 Japan

Professorin Dr. Christiane Wendehorst Lehrstuhl fUr Biirgerliches Recht, Medizinrecht, Intemationales Recht und Rechtsvergleichung Juristische Fakultat der Georg-August-Universitat Gottingen Platz der Gottinger Sieben 6 37073 Gottingen Deutschland

Frau Dr. Isabelle Wildhaber Gloor & Christ - Advokatur und Notariat Aeschenvorstadt 4 4051 Basel Schweiz

Priv.-Doz. Dr. med. Stefan Winter Leiter des Dezemats Wissenschaft und Forschung der Bundesiirztekammer Postfach 41 02 20 50862 Koln Deutschland

Professorin Dr. Gabriele Wolfslast Lehrstuhl fUr Strafrecht und StrafprozeBrecht Fachbereich Rechtswissenschaft Justus-Liebig-Universitat GieBen Hein-Heckroth-Str.3 35390 GieBen Deutschland


Dr. Peteris Zilgalvis Council of Europe, Directorate of Legal Affairs 67075 Strasbourg Cedex Frankreich

Declaration of Helsinki

Recommendations guiding physicians in biomedical research involving human subjects

Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964

and amended by the 29th World Medical Assembly, Tokyo, Japan, October 1975 35th World Medical Assembly, Venice, Italy, October 1983 41st World Medical Assembly, Hong Kong, September 1989 and the 48th General Assembly, Somerset West, Republic of South Africa, October 1996

Document 17.C (October 1996) Original: English

Introduction

1. It is the mission of the physician to safeguard the health of the people. His or her knowledge and conscience are dedicated to the fulfillment of this mission.

2. The Declaration of Geneva of the World Medical Association binds the physician with the words, "The Health of my patient will be my first consideration," and the International Code of Medical Ethics declares that, "A physician shall act only in the patient's interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient."

3. The purpose of biomedical research involving human subjects must be to improve diagnostic, therapeutic and prophylactic procedures and the understanding of the aetiology and pathogenesis of disease.

4. In current medical practice most diagnostic, therapeutic or prophylactic procedures involve hazards. This applies especially to biomedical research.

5. Medical progress is based on research which ultimately must rest in part on experimentation involving human sUbjects.

378 World Medical Association

6. In the field of biomedical research a fundamental distinction must be recognized between medical research in which the aim is essentially diagnostic or therapeutic for a patient, and medical research, the essential object of which is purely scientific and without implying direct diagnostic or therapeutic value to the person subjected to the research.

7. Special caution must be exercised in the conduct of research which may affect the environment, and the welfare of animals used for research must be respected.

8. Because it is essential that the results of laboratory experiments be applied to human beings to further scientific knowledge and to help suffering humanity, the World Medical Association has prepared the following recommendations as a guide to every physician in biomedical research involving human subjects. They should be kept under review in the future. It must be stressed that the standards as drafted are only a guide to physicians all over the world. Physicians are not relieved from criminal, civil and ethical responsibilities under the laws of their own countries.

I. Basic Principles

1. Biomedical research involving human subjects must conform to generally accepted scientific principles and should be based on adequately performed laboratory and animal experimentation and on a thorough knowledge of the scientific literature.

2. The design and performance of each experimental procedure involving human subjects should be clearl,. formulated in an experimental protocol which should be transmitted for consideration, comment and guidance to a specially appointed committee independent of the investigator and the sponsor provided that this independent committee is in conformity with the laws and regulations of the country in which the research experiment is performed.

3. Biomedical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given his or her consent.

4. Biomedical research involving human subjects cannot legitimately be carried out unless the importance of the objective is in proportion to the inherent risk to the subject.

Declaration of Helsinki 379

5. Every biomedical research project involving human subjects should be preceded by careful assessment of predictable risks in comparison with foreseable benefits to the subject or to others. Concern for the interests of the subject must always prevail over the interests of science and society.

6. The right of the research subject to safeguard his or her integrity must always be respected. Every precaution should be taken to respect the privacy of the subject and to minimize the impact of the study on the subject's physical and mental integrity and on the personality of the subject.

7. Physicians should abstain from engaging in research projects involving human subjects unless they are satisfied that the hazards involved are believed to be predictable. Physicians should cease any investigation if the hazards are found to outweigh the potential benefits.

8 In publication of the results of his or her research, the physician is obliged to preserve the accuracy of the results. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for pUblication.

9. In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be informed that he or she is at liberty to abstain from participation in the study and that he or she is free to withdraw his or her consent to participation at any time. The physician should then obtain the subject's freely-given informed consent, preferably in writing.

10. When obtaining informed consent for the research project the physician should be particularly cautious if the subject is in a dependent relationship to him or her or may consent under duress. In that case the informed consent should be obtained by a physician who is not engaged in the investigation and who is completely independent of this official relationship.

11. In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject in accordance with national legislation.

Whenever the minor child is in fact able to give a consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian.


12. The research protocol should always contain a statement of the ethical considerations involved and should indicate that the principles enunciated in the present Declaration are complied with.

II. Medical research combined with professional care (Clinical Research)

1. In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure, if in his or her judgement it offers hope of saving life, reestablishing health or alleviating suffering.

2. The potential benefits, hazards and discomfort of a new method should be weighed against the advantages of the best current diagnostic and therapeutic methods.

3. In any medical study, every patient - including those of a control group, if any - should be assured of the best proven diagnostic and therapeutic method. This does not exclude the use of inert placebo in studies where no proven diagnostic or therapeutic method exists.

4. The refusal of the patient to participate in a study must never interfere with the physician-patient relationship.

5. If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal should be stated in the experimental protocol for transmission to the independent committee (I, 2).

6. The physician can combine medical research with professional care, the objective being the acquisition of new medical knowledge, only to the extent that medical research is justified by its potential diagnostic or therapeutic value for the patient.

III. Non-therapeutic biomedical research involving human subjects (Non-Clinical Biomedical Research)

1. In the purely scientific application of medical research carried out on a human being, it is the duty of the physician to remain the protector of the life and health of that person an whom biomedical research is being carried out.

2. The subject should be volunteers - either healthy persons or patients for whom the experimental design is not related to the patient's illness.

Declaration of Helsinki 381

3. The investigator or the investigating team should discontinue the research if in his/her or their judgement it may, if continued, be harmful to the individual.

4. In research on man, the interest of science and society should never take precedence over considerations related to the wellbeing of the subject.

Deklaration von Helsinki

Empfehlungen fUr Arzte, die in der biomedizinischen F orschung am Menschen tatig sind

verabschiedet von der 18. Generalversammlung des Weltarztebundes Helsinki, Finnland, Juni 1964

revidiert von der 29. Generalversammlung des Weltarztebundes, Tokyo, Japan, Oktober 1975 35. Generalversammlung des Weltfu'ztebundes, Venedig, Italien, Oktober 1983 41. Generalversammlung des Weltfu'ztebundes, Hong Kong, September 1989 und von der 48. Generalversammlung des Weltarztebundes, Somerset West, Republik Siidafrika, Oktober 1996

Dokument 17.C (Oktober 1996) (Nichtamtliche deutsche Fassung)

Vorwort

Aufgabe des Arztes ist die Erhaltung der Gesundheit des Menschen. Der Erftillung dieser Aufgabe dient er mit seinem Wissen und Gewissen.

Die Genfer Deklaration des Weltarztebundes verpflichtet den Arzt mit den Worten: "Die Gesundheit meines Patienten solI mein vomehmstes Anliegen sein", und der intemationale Codex fur arztliche Ethik legt fest: "Jegliche Handlung oder Beratung, die geeignet erscheinen, die physische oder psychische Widerstandskraft des Menschen zu schwachen, diirfen nur in seinem Interesse zur Anwendung gelangen".

Ziel der biomedizinischen Forschung am Menschen muB es sein, diagnostische, therapeutische und prophylaktische Verfahren -sowie das Verstandnis fur die Aetiologie und Pathogenese der Krankheit zu verbessem.

In der medizinischen Praxis sind diagnostische, therapeutische oder prophylaktische Verfahren mit Risiken verbunden; dies gilt urn so mehr fur die biomedizinische Forschung am Menschen.

384 Weltiirztebund

Medizinischer Fortschritt beruht auf Forschung, die sich letztlich auch auf Versuche am Menschen stiitzen muB.

Bei der biomedizinischen Forschung am Menschen muB grundsatzlich unterschieden werden zwischen Versuchen, die im wesentlichen im Interesse des Patienten liegen und solchen, die mit rein wissenschaftlichem Ziel ohne unmittelbaren diagnostischen oder therapeutischen Wert fUr die Versuchsperson sind.

Besondere Vorsicht muB bei der DurchfUhrung von Versuchen walten, die die Umwelt in Mitleidenschaft ziehen konnen. Auf das Wohl der Versuchstiere muB Rilcksicht genommen werden.

Da es notwendig ist, die Ergebnisse von Laborversuchen auch auf den Menschen anzuwenden, urn die wissenschaftliche Erkenntnis zu fOrdem und der leidenden Menschheit zu helfen, hat der Weltarztebund die folgenden Empfehlungen als eine Leitlinie fur jeden Arzt erarbeitet, der in der biomedizinischen Forschung tatig ist. Sie sollte in der Zukunft iiberpriift werden.

Es muB betont werden, daB diese Empfehlungen nur als Leitlinie fUr die Ante auf der ganzen Welt gedacht ist; kein Arzt ist von der straf-, zivil- und berufsrechtlichen Verantwortlichkeit nach den Gesetzen seines Landes befreit.

1. Allgemeine Grundsatze

1. Biomedizinische Forschung am Menschen muB den aUgemein anerkannten wissenschaftlichen Grundsatzen entsprechen; sie soUte auf ausreichende Laboratoriums- und Tierversuche sowie einer umfassenden Kenntnis des wissenschaftlichen Literatur aufbauen.

2. Die Planung und Durchftihrung eines jeden Versuches am Menschen soUte eindeutig in einem Versuchsprotokoll niedergelegt werden, welches einem besonders berufenen, vom Forschungsteam und Sponsor unabhlingigen AusschuB zur Beratung, SteUungnahme und Orientierung vorgelegt werden soUte. Dabei wird davon ausgegangen, daB dieser AusschuB gemliB den Gesetzen oder Bestimmungen des Landes, in welchem der Versuch durchgefUhrt werden soU, anerkannt ist.

3. Biomedizinische Forschung am Menschen soUte nur von wissenschaftlich qualifizierten Personen und unter Aufsicht eines klinisch erfahrenen Arztes durchgefUhrt werden. Die Verantwortung fUr die Versuchsperson tragt stets ein Arzt und nie die Versuchsperson selbst, auch dann nicht, wenn sie ihr Einverstlindnis gegeben hat.

Deklaration von Helsinki 385

4. Biomedizinische Forschung am Menschen ist nur zulassig, wenn die Bedeutung des Versuchsziels in einem angemessenen Verhiiltnis zum Risiko fUr die Versuchsperson steht.

5. Jedem biomedizinischen Forschungsvorhaben am Menschen sollte eine sorgfli1tige Abschiitzung der voraussehbaren Risiken im Vergleich zu dem voraussichtlichen Nutzen fur die Versuchsperson oder andere vorausgehen. Die Sorge urn die Belange der Versuchsperson muB stets ausschlaggebend sein im Vergleich zu den Interessen der Wissenschaft und der Gesellschaft.

6. Das Recht der Versuchsperson auf Wahrung ihrer Unversehrtheit muB stets geachtet werden. Es sollte alles getan werden, urn die Privatsphiire der Versuchsperson zu wahren; die Wirkung auf die korperliche und geistige Unversehrtheit sowie die Personlichkeit der Versuchsperson so lIte so gering wie moglich gehalten werden.

7. Der Arzt sollte es unterlassen, bei Versuchen am Menschen tatig zu werden, wenn er nicht tiberzeugt ist, daB das mit dem Versuch verbundene Wagnis fUr vorhersagbar gehalten wird. Der Arzt sollte den Versuch abbrechen, sobald sich herausstellt, daB das Wagnis den moglichen Nutzen tibersteigt.

8. Der Arzt ist bei der VerOffentlichung der Versuchsergebnisse verpflichtet, die Befunde genau wiederzugeben. Bericht tiber Versuche, die nicht in Ubereinstimmung mit den in dieser Deklaration niedergelegten Grundsatzen durchgefUhrt wurden, sollten nicht zur VerOffentlichung angenommen werden.

9. Bei jedem Versuch am Menschen muB jede Versuchsperson ausreichend tiber Absicht, DurchfUhrung, erwarteten Nutzen und Risiken des Versuches sowie tiber moglicherweise damit verbundene Storungen des Wohlbefindens unterrichtet werden. Die Versuchsperson sollte darauf hingewiesen werden, daB es ihr freisteht, die Teilnahme am Versuch zu verweigem und daB sie jederzeit eine einmal gegebene Zustimmung widerrufen kann. Nach dieser Aufklarung sollte der Arzt die freiwillige Zustimmung der Versuchsperson einholen; die ErkHirung sollte vorzugsweise schriftlich abgegeben werden.

10. 1st die Versuchsperson yom Arzt abhangig oder erfolgte die Zustimmung zu einem Versuch moglicherweise unter Druck, so solI der Arzt beim Einholen der Einwilligung nach Aufklarung besondere Vorsicht walten lassen. In einem solchen Fall so lIte die Einwilligung durch einen Arzt eingeholt werden, der mit dem Versuch nicht befaBt ist und der auBerhalb eines etwaigen Abhiingigkeitsverhiiltnisses steht.

386 Weltiirztebund

11. 1st die Versuchsperson nicht voU geschaftsfahig, soUte die Einwilligung nach Autklarung yom gesetzlichen Vertreter entsprechend dem nationalen Recht eingeholt werden. Die Einwilligung des mit der Verantwortung betrauten Verwandten (darunter ist nach deutschem Recht der "Personensorgeberechtigte" zu verstehen) ersetzt die der Versuchsperson, wenn diese infolge korperlicher oder geistiger Behinderung nicht wirksam zustimmen kann oder minderjiihrig ist.

Wenn das minderjiibrige Kind fahig ist, seine Zustimmung zu erteilen, so muI3 neben der Zustimmung des Personensorgeberechtigten auch die Zustimmung des Minderjiibrigen eingeholt werden.

12. Das Versuchsprotokoll sollte stets die ethischen Uberlegungen im Zusammenhang mit der Durchfiihrung des Versuchs darlegen und aufzeigen, daB die Grundsatze dieser Deklaration eingehalten werden.

II. Medizinische Forschung in Verbindung mit arztlicher Versorgung (Klinische V ersuche)

1. Bei der Behandlung eines Kranken muB der Arzt die Freiheit haben, neue diagnostische und therapeutische MaBnahmen anzuwenden, wenn sie nach seinem Urteil die Hoffnung bieten, das Leben des Patienten zu retten, seine Gesundheit wiederherzustellen oder seine Leiden zu lindem.

2. Die mit der Anwendung eines neuen Verfahrens verbundenen moglichen Vorteile, Risiken und Storungen des Befindens sollten gegen die Vorztige der bisher bestehenden diagnostischen und therapeutischen Methoden abgewogen werden.

3. Bei jedem medizinischen Versuch sollten aIle Patienten - einschlieBlich die einer eventuell vorhandenen Kontrollgruppe - die beste erprobte diagnostische und therapeutischen Behandlung erhalten. Dies schlieBt nicht die Verwendung von reinen Placebos bei Versuchen aus, fUr die es kein erprobtes diagnostisches oder therapeutisches Verfahren gibt.

4. Die Weigerung eines Patienten, an einem Versuch teilzunehmen, darf niemals die Beziehung zwischen Arzt und Patient beeintrachtigen.

5. Wenn der Arzt es fUr unentbehrlich halt, auf die Einwilligung nach Autklarung zu verzichten, sollten die besonderen Griinde fUr dieses Vorgehen in dem fur den unabhangigen AusschuI3 bestimmten Versuchsprotokoll niedergelegt werden.

Deklaration von Helsinki 387

6. Der Arzt kann medizinische Forschung mit dem Ziel der Gewinnung neuer wissenschaftlicher Erkenntnisse mit der arztlichen Betreuung nur soweit verbinden, als diese medizinische Forschung durch ihren moglichen diagnostischen oder therapeutischen Wert fUr den Patienten gerechtfertigt ist.

III. Nicht-therapeutische biomedizinische Forschung am Menschen

1. In der rein wissenschaftlichen Anwendung der medizinischen Forschung am Menschen ist es die Pflicht des Arztes, das Leben und die Gesundheit der Person zu schOtzen, an der biomedizinische Forschung durchgefiihrt wird.

2. Die Versuchspersonen sollten Freiwillige sein, entweder gesunde Personen oder Patienten, flir die die Versuchsabsicht nicht mit ihrer Krankheit in Zusammenhang steht.

3. Der iirztliche Forscher oder das Forschungsteam sollten den Versuch abbrechen, wenn dies nach seinem oder ihrem Urteil im Falle der Fortflihrung dem Menschen schaden konnte.

4. Bei Versuchen am Menschen sollte das Interesse der Wissenschaft und der Gesellschaft niemals Vorrang vor den Erwiigungen haben, die das Wohlbefinden der Versuchsperson betreffen.

The World Medical Association, Inc.

Proposed Revision of the WMA Declaration of Helsinki (Recommendations guiding physicians and other investigators in biomedical research involving human subjects)

submitted by the American Medical Association 49th WMA General Assembly Hamburg, Germany 10-14 November, 1997

Document 17.C Rev./97/ A (Initiated: September, 1997) Original: English

Preamble

The American Medical Association proposes that the current text of the Declaration of Helsinki (Document 17.C - a copy of which will be circulated with this document) be amended to read.

Introduction

It is the mission of physicians to promote and safeguard the health of the people. Their knowledge and consciences are dedicated to the fulfillment of this mission.

The Declaration of Geneva of the Wodd Medical Association binds physicians with the words, "The Health of my patient will be my first consideration," and the International Code of Medical Ethics declares that, "A physician shall act only in the patient's interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient."

As long as knowledge about diseases is incomplete and diagnosis, treatment, and prevention can be improved, the profession of medicine has an obligation to help advance the art and science of medicine through sharing and building upon clinical and epidemiologic observations and being involved in scientifically and ethi-

390 Proposal submitted by the American Medical Association

cally competent research. Medical progress is based in large part on critical observations and research that ultimately require studies and investigations involving human subjects. The appropriate purpose of biomedical research involving human subjects is to improve diagnostic, therapeutic and prophylactic procedures and the understanding of the aetiology and pathogenesis of disease.

In practicing their profession and in conducting research, physicians recognize that most diagnostic, therapeutic or prophylactic procedures involve potential hazards or risks of adverse consequences. This fact provides both a stimulus for trying to improve these procedures and a reason for asking research subjects to accept the risks involved in research when they are proportionately balanced with potential benefits.

It is essential that biomedical research involving human beings be carried out to further scientific knowledge and to alleviate human suffering. To provide guidance for all physicians participating in biomedical research involving human subjects, the World Medical Association has prepared the following recommendations. Non-physician investigators also are important in biomedical research, and the principles in this Declaration apply equally to all non-physician investigators conducting or collaborating on biomedical research involving human subjects. It should be stressed that the principles in this Declaration provide only general guidance to physicians and other investigators in all countries around the world.

Physicians and other research investigators are not relieved from criminal, civic and ethical responsibilities under the laws of their own countries.

The principles in this Declaration are based on the fundamental concept that all biomedical research involving human subjects is subject to ethical Standards that promote respect for all humans, protect their health and rights as individuals, and assure that anticipated risks associated with biomedical research are acceptably low and proportionate to the potential benefits and the importance of the knowledge expected to be gained.

Because of the changing circumstances and nature of the conduct of biomedical research over time, the principles in this Declaration should be kept under review in the future and modified as appropriate to keep them current.

It is important that the Declaration and the principles enunciated in it be considered and applied in its entirety to avoid misunderstanding and misinterpretation that could result from taking a section out of context.

Proposal submitted by the American Medical Association 391

Basic Principles

Fundamental Requirements for Conduct of Biomedical Research Involving Human Subjects

1. Scientific basis for research. Biomedical research involving human subjects must conform to generally accepted scientific principles. It should be based on adequately performed laboratory and animal research and investigation and on a thorough knowledge of the scientific literature.

2. Scientific validity of the study design. Biomedical research involving human subjects cannot ethically and legitimately be carried out without a scientifically valid study design.

3. Balance of risks and benefits. The importance of the objectives, the potential benefits to the subject, and the anticipated benefit of the knowledge to be gained from an investigation must be proportionate to the known and potential risks to the subject.

4. Altruistic participation in research. Every biomedical research project involving human subjects must be preceded by careful assessment of predictable risks in comparison with potential benefits to the subject or to others. Concern for the interest of the subject must always prevail over the interests of science and society. Subjects may, however, elect to participate in research that they are aware will have no direct benefit to themselves if the protocol has been approved by an independent research ethics committee and the anticipated benefits of the knowledge to be gained are proportionate to the known and anticipated risks. In this circumstance, fully informed prospective research subjects may voluntary and altruistically consent to accept discomfort or inconvenience in order to advance societal and/or scientific interests, knowing there will be no personal health benefit.

5. Qualifications of research investigators. Biomedical research involving human subjects should be conducted only by scientifically qualified persons.

6. Protecting the rights or research subjects. The rights of research subjects to safeguard their integrity must always be respected. Every precaution should be taken to respect the privacy of the subjects and to minimize any negative impact of the study on the subjects physical or mental health.

7. Responsibility for research subjects. When appropriate, the responsibility for the well-being of research subjects with ongoing need for clinical care should rest with an identified physician or other suitably qualified professional. The responsi-


bility for the health of the human subject must never rest solely on the subject of the research, even though the subject has given consent to participate in the study.

8. Clinical care for research subjects. In any research study that involves subjects with an ongoing need for clinical care, it is particularly important that all research subjects, including those in a control group, if any, be provided with appropriate diagnostic, therapeutic, and prophylactic interventions for aspects of their care not related directly to the research intervention for which they have given consent.

9. Randomization of subjects and use of placebo. The principle of assuring appropriate diagnostic and therapeutic care for research subjects does not exclude the use or randomization of the subjects to defined treatment groups in the protocol, including the use of placebo or, for defined periods of time, providing placebo or no treatment if justified by a scientifically and ethically sound research protocol.

10. Compassionate therapy. As a compassionate measure in the treatment of a sick person with a progressive or fatal illness for whom existing therapy is not effective or no standard therapy is available and for whom entry into an appropriate research investigation is not an option, physicians should be free to consider recommending use of any available procedure or therapy, including investigational procedures or therapies, if in their judgement the procedure or therapy has the potential to save life, reestablish health or alleviate suffering.

11. Environmental and animal welfare concerns. Because of global concern about the world's environment and its potential impact on human health and about the welfare of laboratory animals. It is incumbent on all investigators to exercise special caution in the conduct of biomedical research to assure the research does not adversely affect the environment and that the welfare of animals used for research is respected.

Scientific and Ethical Review or Research Protocols

12. Independent research ethic committee. The design and performance of each proposed research study involving human subjects should be clearly formulated in a research protocol that should be transmitted for consideration, guidance and approval to an independent research ethics committee. This independent committee, which shall comply with the laws and regulations of the country in which the research is performed, is charged with: evaluating carefully the risk and benefit balance of the research, including the safety and well-being of subjects and the process of research oversight; assuring that there has been adequate review of the scientific integrity of the research design; assessing the ethical integrity of the


research design, including the need for and choice of control procedure or therapy; evaluating the adequacy of the infonned consent process and the consent documents; and assessing the fairness of the methods by which human subjects are selected for participation in the research. If appropriate, the protocol for an interventional research study should include a process to monitor progress of the study so that placebo is not continued if no longer justified and the study can be considered for tennination for demonstrated benefit of therapy.

13. Statement of ethical principles and conflict of interest. Each and every research protocol should contain a statement of the ethical considerations involved, and should indicate that the principles enunciated in the present Declaration are and will be complied with. All investigators participating in a research investigation should disclose to the research ethics committee any actual or potential financial or other pertinent conflict of interest they may have.

Infonned Consent and Selection of Research Subjects

14. Legally competent research subjects. Except in certain limited and justified circumstances, research involving human beings should only be conducted on subjects who are fully competent. In research involving legally competent human beings, each prospective subject must be adequately and objectively infonned about the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. Potential subjects must be made aware of all possible alternatives to the investigational procedures. Subjects must be given an opportunity to ask questions and receive appropriate answers. It is especially important that no type of coercion or undue influence to participate be used to influence the decision to participate, including inducement by offering compensation other than nonnallevels of reimbursement for time, travel or discomfort. Research subjects should be infonned they are at liberty to abstain from participation in the study and they are free to withdraw consent to participate at any time without jeopardizing their medical care or other benefits to which they are entitled.

15. Investigator responsibility for informed consent. Investigators are responsible for assuring that all: legally competent subjects participating in research have given infonned consent. While investigators may allow another appropriately trained and qualified person to obtain consent from prospective subjects, the responsibility for assuring that proper consent has been obtained remains with the investigator.

16. Precautions for investigators. Investigators should take particular care not to use their authority to obtain consent that otherwise might not be granted, nor should they encourage expectations beyond those that the circumstances reasonably and realistically justify. Investigators should be particularly vigilant and judi-


cious when obtaining infonned consent from prospective research subjects if the subjects are in a dependent relationship to them and might be susceptible to consenting under duress. This is especially relevant for physicians who serve both as primary treating physician and research investigator for any patients who also are prospective research subjects. In some such cases, it may be preferable if the infonned consent is obtained by a qualified person who is independent of the physician-patient relationship.

17. Documentation of informed consent. After providing infonnation to the prospective research subject, the investigator should ensure that each subject's freely-given infonned consent is then obtained. Written consent is not necessary if the research involves only minimal risk such as from the use of routine procedures that are customarily used in the practice of medicine without documentation of consent. Documentation of infonned consent for research in a durable fonn such as writing is essential if the research involves interventions or procedures for which written consent is nonnally required outside the research context, if the involvement of the subjects with the research is complex or lengthy, or if the known or anticipated risks are significant. If identification of subjects participating in clinical research could jeopardize them or result in discrimination, the investigator, with the approval of the independent research ethics committee, should establish appropriate procedures to protect the rights and privacy of the subjects, including waiving documentation of infonned consent if justified.

18. Prior and proxy consent. If the physician investigator anticipates special situations in which it will not be possible to obtain infonned consent because of the medical condition or circumstances of the potential subjects, it may be justifiable to obtain prior or proxy infonned consent. The specific reasons for the requested exemption should be stated in the research protocol for consideration and approval by the independent research ethics committee. In addition to a justification, the investigator should describe the alternative infonned consent procedures and oversight measures that will be implemented to assure the interests and rights of the subjects are protected.

19. Waiver of consent. When specifically provided for by applicable law, infonned consent may be waived prospectively by the independent research ethics committee in accordance with a protocol confmning that infonned consent or pennission will be obtained unless the prospective subject's medical condition does not pennit this to be done before the decision must be made to enroll the subject.

20. Research involving pregnant women and vulnerable subjects. The inclusion of pregnant women or medically or socially vulnerable subjects in biomedical research must be justifiable medically and ethically, and special consideration


must be given to research protocols that involve these subjects. Vulnerable subjects requiring this heightened protection include children, persons from technologically developing countries and communities or populations with unique circumstances, prison inmates, or persons with mental or behavioral disorders or physical conditions that impair or prevent their ability to give informed consent. The interests of vulnerable subjects must be predominant, and special efforts made to protect their rights and welfare. Conversely, people in these special populations must not arbitrarily be denied access to investigational procedures or therapies that have demonstrated promise for the treatment of their disease or condition. In studies involving pregnant women or women with child-bearing potential, consent must include a clear explanation of risks to an exposed fetus.

21. Legally incompetent research subjects. For a prospective research subject who is legally incompetent, the investigator must obtain informed consent from the legally authorized representative in accordance with applicable law. Whenever a legally incompetent prospective subject, including a minor child, is in fact able to give assent to decisions about participation in research, the investigator should obtain the prospective subject's legally authorized representative. If the intervention is critical to the health of the prospective subject, the permission of the prospective subject's legally authorized representative should suffice.

Responsibilities of Physicians and Other Research Investigators

22. Protecting research subjects. In all medical research carried out on a human being, it is the duty of physicians and other investigators to remain the protector of the life and health of those persons on whom biomedical research is carried out.

23. Investigator oversight of a research study. Physicians and other investigators should engage in research projects involving human subjects only if they are satisfied that the research is scientifically and ethically justified, the anticipated risks are acceptable, and the potential benefits are proportional to the expected hazards. Physicians and other investigators conducting research should cease any study in which the hazards are found to be disproportionate to the benefits, and they should stop the involvement of an individual subject if, in their judgement, the research may be harmful to that individual subject if continued. Conversely, investigators are responsible to assure that progress on an interventional research study is monitored so that placebo is not continued if no longer justified and the study can be considered for termination for demonstrated benefit of therapy.

24. Weighing the risks and benefits for each research subject. In deciding whether to suggest to patients that they consider involvement in a research study, physicians and other investigators should weigh the potential benefits, hazards and


discomforts of the investigational procedures or therapies for each patient against the known benefits, hazards and discomforts of the best diagnostic, therapeutic, and prophylactic methods currently available.

25. Responsibility for medical services. Research investigators should infonn prospective human subjects about the extent of the researcher's responsibility to provide medical services for the patient. In addition, physician investigators should clearly infonn potential research subjects whether they are serving only as a research investigator or serving both as treating physician and research investigator. Physicians who serve as both research investigator and treating physician have a special obligation to protect the rights and welfare of the research subjects, and they assume the legal and ethical responsibility of the subjects' principal care physician. It is especially important to be able to assure prospective research subjects that their refusal to participate in a study or their withdrawal from a study, either voluntarily or for reasons related to the study, will not interfere with the physician-patient relationship or their continuing medical care. If this is not possible, the physician investigator must arrange for the patient to receive appropriate medical services through another physician.

Data Management and Publication of Results

26. Recording and preserving research results. It is the obligation of investigators conducting biomedical research to record their findings and observations fully and accurately and to preserve them for subsequent examination or future use as necessary and appropriate, while safeguarding the privacy of infonnation about the subjects. Research investigators should not misappropriate, interfere with, or misinfonn anyone regarding the proposal, methods used, data, data analysis, or publication of findings from research.

27. Validity of research reports and conflict of interest. In publishing the results of their research, investigators are obliged to report the methods, results, conclusions, and interpretation of their research fully and accurately, to remain accountable for future inquiry into their work, and to disclose to others any actual or potential financial or other pertinent conflict of interest they may have had.

28. Adherence to Declaration of Helsinki. Any published reports or research involving human subjects should include a statement from the investigators that the research was conducted in accordance with the principles laid down in this Declaration. Variances from these principles should be explained and justified in the report. Editors are obligated to consider carefully the justification for any variance from these principles in deciding whether to accept or reject the report for publication.


Background Comments and Text Comparison Aid for the Proposed Draft of the WMA Declaration of Helsinki (Recommendations guiding physicians and other investigators in biomedical research involving human subjects)

submitted by the American Medical Association

Document 17.CRev./971B (Initiated: September 1997) Original: English

The World Medical Association Declaration of Helsinki has been a sentinel beacon of the ethical principles of biomedical research since its adoption in 1964. The scientific principles underlying the conduct of biomedical research have evolved significantly over the last three decades, however, calling to the fore the statement included in the Declaration that the recommendations in it "should be kept under review in the future." In keeping with that admonition, the American Medical Association has undertaken a thorough review of the Declaration and is proposing a significantly revised version.

The revised draft version is reorganized. The original Declaration includes an Introduction and three sections: I. Basic Principles; II. Medical Research Combined with Professional Care (Clinical Research); and III. Non-therapeutic Biomedical Research Involving Human Subjects (Non-Clinical Biomedical Research). The revised draft has an Introduction and one section, Basic Principles. This section is divided into five subsections:

• Fundamental Requirements for Conduct of Biomedical Research Involving Human Subjects

• Scientific and Ethical Review of Research Protocols • Informed Consent and Selection of Research Subjects • Responsibilities of Physicians and Other Research Investigators • Data Management and Publication of Results.

Central to this draft revision is the current belief on the part of many prominent research investigators and ethicists that, from an ethical perspective, there is no distinction between medical research combined with professional care (clinical

398 Background Document submitted by the American Medical Association

research) and non-therapeutic biomedical research involving human subjects (nonclinical biomedical research). Although this appears to be a major shift in emphasis for the Declaration, making this change allows a consistency of focus and presentation that was not previously possible. And, as will be seen from the comparisons that follow, the fundamental principles of the original Declaration have been preserved, although they have been expanded and modified as necessary so that they address in a cogent fashion the important ethical issues in biomedical reseach facing physicians and other investigators around the world.

In addition to the substantive revision, the text also has undergone editorial changes, such as the uniform use of the plural to simplify gender neutral references. These changes are not highlighted in the comparison aid.

Comparison Aid

The following is a guide to assist reviewers in locating in the proposed revised draft each portion of text from the the original Declaration of Helsinki. The language in italics represents the original Declaration's text in its entirety. After each concept, reviewers will find a Comment which indicates where to find the concept in the proposed revised draft, and explains where modifications have been made.

Introduction

It is the mission of the physician to safeguard the health of the people. His or her knowledge and conscience are dedicated to the fulfillment of this mission.

COMMENT: No change; first paragraph of the Introduction.

The Declaration of Geneva of the World Medical Association binds the physician with the words, "The Health of my patient will be my first consideration, " and the International Code of Medical Ethics declares that, "A physician shall act only in the patient's interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient. "

COMMENT: No change; second paragraph of the Introduction.

The purpose of biomedical research involving human subjects must be to improve diagnostic, therapeutic and prophylactic procedures and the understanding of the denology and pathogenesis of disease.

COMMENT: Incorporated into an expanded third paragraph of the Introduction.

Background Document submitted by the American Medical Association 399

In current medical practice most diagnostic, therapeutic or prophylactic procedures involve hazards. This applies especially to biomedical research.

COMMENT: Modified and incorporated into an expanded fourth pharagraph of the Introduction.

Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects.

COMMENT: Modified and incorporated into an expanded third paragraph of the Introduction.

In the field of biomedical research a fundamental distinction must be recognized between medical research in which the aim is essentially diagnostic or therapeutic for a patient, and medical research, the essential object of which is purely scientific and without implying direct diagnostic or therapeutic value to the person subjected to the research.

COMMENT: Eliminated since this "fundamental distinction" is no longer recognized, as discussed in the Background Comment.

Special caution must be exercised in the conduct of research which may affect the environment, and the welfare of animals used for research must be respected.

COMMENT: Included, with modifications, in the Basic Principles, numbered pararagraph 11 (Environmental and animal welfare concerns).

Because it is essential that the result of laboratory experiments be applied to human beings to further scientific knowledge and to help suffering humanity, the World Medical Association has prepared the following recommendations as a guide to every physician in biomedical research involving human subjects. They should kept under review in the future. It must be stressed that the standards as drafted are only a guide to physicians all over the world. PhysiCians are not relieved from criminal, civil and ethical responsibilities under the laws of their own countries.

COMMENT: Incorporated into expanded fifth, sixth, seventh, and eighth paragraphs of the Introduction. The recommendations of the Declaration have been extended to include non-physician research investigators. The sixth and eighth paragraphs of the Introduction, which are new, reiterate the fundamental concepts of ethical research and state the Declaration must be viewed as a whole.


I. Basic Principles


COMMENT: Incorporated into the Basic Principles, numbered pargraph 1 (Scientific basis for research) and 2 (Scientific validity of the study design).

2. The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol which should be transmitted for consideration. comment and guidance to a specially appointed committee independent of the investigator and the sponsor provided that this independent committee is in conformity with the laws and regulations of the country in which the research experiment is performed.

COMMENT: Incorporated into the Basic.Principles, numbered paragraph 12 (Independent research ethics committee), and expanded.

3. Biomedical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and nerver rest on the subject of the research. even though the subject has given his or her consent.

COMMENT: Incorporated into the Basic Principles, numbered paragraphs 5 (Qualifications of research investigators) and 7 (Responsibility for research subjects), which have been modified to reflect the wide variety of biomedical research involving human subjects, much of which does not require medical care for the research subject. The issue is also addressed in numbered paragraph 22 (Protecting research subjects).

4. Biomedical research involving human subjects cannot legitimately be carried out unless the importance of the objective is in proportion to the inherent risk to the subject.

COMMENT: Incorporated into the Basic Principles, numbered paragraph 3 (Balance of risks and benefits).

5. Every biomedical research project involving human subjects should be preceded by careful assessment of predictable risks in comparison with foresee-


able benefits to the subject or to others. Concern for the interests of the subject must always prevail over the interests of science and society.

COMMENT: Incorporated into the Basic Principles, numbered parargraphs 3 (Balance of risks and benefits) and 4 (Altruistic participation in research). The expanded concepts allow for the voluntary and altruistic participation of subjects in approved research for which they have given infonned consent and for which they understand there will be no personal health benefit to themselves.


COMMENT: Incorporated into the Basic Principles, numbered praragraph 6 (Protecting the rights of research subjects).


COMMENT: Incorporated into the Basic Principles, numbered paragraphs 22 (Protecting research subjects) and 23 (Investigator oversight of a research study), which have been expanded.

8. In publicatian af the results af his ar her research. the physician is obliged ta preserve the accuracy of the results. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication.

COMMENT: Incorporated into the Basic Principles, numbered paragraphs 26 (Recording and preserving research results), 27 (Validity of research reports and conflict of interest), and 28 (Adherence to Declaration of Helsinki), which have been expanded and modified to achieve consistency which current scientific and ethical concepts.

9. In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be informed that he or she is at liberty to abstain from participation in the study and that he or


she is free to withdraw his or her consent to participation at any time. The physician should then obtain the subject's freely-given informed consent, pre} erably in writing.

COMMENT: Incorporated into the Basic Principles, numbered pargraphs 14 (Legally competent research subjects), 15 (Investigator responsibility for informed consent), and 17 (Documentation of informed consent), which have been expanded. The issue of documentation of informed consent has been brought into line with current concepts in other ethical guides to human subjects research.

10. When obtaining informed consent for the research project the physician should be particularly cautious if the subject is in a dependent relationship to him or her or may consent under duress. In that case the informed consent should be obtained by a physician who is not engaged in the investigation and who is completely independent of this official relationship.

COMMENT: Incorporated into the Basic Principles, numbered paragraph 16 (Precautions for investigators), which has been modified to bring it into line with accepted practice and other ethical guides to human subjects research.



COMMENT: Incorporated into the Basic Principles, numbered parargraphs 18 (Prior and proxy consent), 19 (Waiver of consent), 20 (Research involving pregnant women and vulnerable subjects), and 21 (Legally incompetent research subjects), and expanded. New praragraphs have been added to address the concepts of prior and proxy consent and waiver of consent.

12. The research protocol should always contain a statment of the ethical considerations involved and should indicate that the principles enunciated in the present Declaration are complied with.


COMMENT: Incorporated into the Basic Principles, numbered paragraph 13 (Statement of ethical principles and conflict of interest), which has been expanded to include a statment about conflict of interest on the part of the research investigators.

II. Medical Research combined with professional care (Clinical Research)

COMMENT: This section heading has been eliminated since the revised draft Declaration does not acknowledge a distinction between medical research combined with professional care (clinical research) and non-therapeutic biomedical research involving human subjects (non-clinical biomedical research).

1. In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure, if in his or her judgment it offers hope of saving life, reestablishing health or alleviating suffering.

COMMENT: Incorporated into the Basic Principles, numbered paragraph 10 (Compassionate therapy), which has been revised to clarify the intent.

2. The potential benefit, hazards and discomfort of a new method should be weighed against the advantages of the best current diagnostic and therapeutic methods.

COMMENT: Incorporated into the Basic Principles, numbered paragraph 24 (Weighing the risks and benefits for each research subject).

3. In any medical study, every patient - including those of a control group, if any should be assured of the best proven diagnostic and therapeutic method. This does not exclude the use inert placebo in studies where no proven diagnostic or therapeutic method exits.

COMMENT: Incorporated into the Basic Principles, numbered praragraphs 8 (Clinical care for research subjetcs) and 9 (Randomization of subjects and use of placebo), which have been expanded and modified to clarify the intent and to achieve consistency with current scientific and ethical concepts.



COMMENT: Incorporated into the Basic Principles, numbered paragraph 25 (Responisbility for medical services), which has been expanded.

5. If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal should be stated in the experimental protocol for transmission to the independent committee (I, 2).

COMMENT: Incorporated into the Basic Principles, numbered paragraphs 18 (Prior and proxy consent) and 19 (Waiver of consent), which have been rewritten to clarify the principles and to achieve consistency with current ethical concepts.


COMMENT: This paragraph has not been incorporated directly into the revised draft Declaration but the concepts are addressed in the Basic Principles, numbered paragraphs 2 (Scientific validity of the study design), 3 (Balance of risks and benefits), 7 (Responsibility for research subjects), 8 (Clinical care for research subjects), 22 (Protecting research subjects), 23 (Investigator oversight of a research study), 24 (Weighing the risks and the benefits for each research subject), and 25 (Responsibility for medical services).

III. Non-therapeutic Biomedical Research involving human subjects (Non-Clinical Biomedical Research)

COMMENT: This section heading has been eliminated since the revised draft Declaration does not acknowledge a distinction between medical research combined with professional care (clinical research) and non-therapeutic biomedical research involving human subjects (non-clinical biomedical research).

1. In the purely scientific application of the medical research carried out on a human being, it is the duty of the physician to remain the protector of the lifr; and health of that person on whom biomedical research is being carried out.


COMMENT: Incorporated into the Basic Principles, numbered paragraph 22 (Protecting research subjects); the concept is also addressed in numbered paragraph 4 (Altruistic participation in research).

2. The subject should be volunteers - either healthy persons or patiens for whom the experimental design is not related to the patient's illness.

COMMENT: Since the revised draft Declaration does not acknowledge a distinction between medical research combined with professional care (clinical research) and non-therapeutic biomedical research involving human subjects (non-clinical biomedical research), this paragraph has not been incorporated into the revised draft. The issue of selection of appropriate subjects is addressed in the Basic Principles, numbered paragraphs 14 (Legally competent research subjects), 15 (Investigator responibility for informed consent), and 20 (Research involving pregnant women and vulnerable subjects).

3. The investigator or the investigating team should discontinue the research ifin his/her or their judgment it may, if continued, be harmfull to the individual.

COMMENT: Incorporated into the Basic Principles, numbered paragraphs 22 (Protecting research subjects) and 23 (Investigator oversight of a research study).


COMMENT: Incorporated into the Basic Principles, numbered paragraph 4 (Altruistic participation in research). Numbered paragraphs 3 (Balance of risks and benefits) and 22 (Protecting research subjects) also address the concerns stated in this paragraph.


Proposed Revision of the World Medical Association Declaration of Helsinki (Doc. 17.C)

Document 17.ClRev1l99 (Initiated: March 1999) Original: English

Introduction

§ 1 It is the mission of the physician to promote and safeguard the health of the people. His or her knowledge and conscience are dedicated to the fulfillment of this mission.

§ 2 The Declaration of Geneva of die World Medical Association binds the physician with the words, "The health of my patient will be my first consideration," and the International Code of Medical Ethics declares that, "A physician shall act only in the patient's interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient."

§ 3 The purpose of biomedical research involving human subjects is to improve diagnostic, therapeutic and prophylactic procedures and the understanding of the aetiology and pathogenesis of disease.

§ 4 In current medical practice most diagnostic, therapeutic or prophylactic procedures involve hazards. This fact provides both a stimulus for trying to improve these procedures and a reason for asking patients and other persons to accept the risks involved in research when they are proportionately balanced with potential benefits.

§ 5 The term ,research' refers to a class of activities designed to develop or contribute to the development of generalizable new knowledge. Generalizable knowledge consists of theories, principles or relationships (or the accumulation of data on which they may be based) that can be corroborated by accepted methods of scientific observation and inference.

§ 6 ,Biomedical research involving human subjects' refers to activities in which the techniques, procedures and observations designed to contribute to the development of generalizable new knowledge are applied to human persons, to organs, tissues, cells or body fluids derived from human

408 W orJd Medical Association

persons, or to records of attributes of individual persons including those prepared for purposes unrelated to research.

§ 7 In the treatment of a sick person with a progressive, disabling or potentially fatal disease for whom existing therapy is either not effective or not available, the physician should be free to recommend use of a new diagnostic and therapeutic measure, if in his or her judgement it offers hope of saving life, re-establishing health or alleviating suffering. Employment of such interventions, commonly called ,compassionate use' and formerly called ,clinical research', is not properly regarded as research. However, the interventions should generally be made the objects of research designed to evaluate their safety and efficacy. Plans to employ such therapeutic interventions should be reviewed and approved by the independent research ethics committee (Article 20) unless the urgency of the situation makes it unreasonable to await such committee action.

§ 8 The concept termed ,clinical research' was introduced in 1953 by the World Medical Association to describe "experiments in new diagnostic and therapeutic methods" and to distinguish them from a category of activities termed ,non-clinical research' defined as "experiments undertaken to serve other purposes than simply to cure an individual." In its time this distinction served a very important purpose. However, in the 1960s, as medical researchers developed an increasing reliance on the use of the randomized clinical trial to establish the safety and efficacy of new therapies, the term, ,clinical research' was extended to attempt to embrace the conduct of randomized clinical trials. This attempt did not succeed, primarily because randomized clinical trials are not properly categorized as experiments undertaken simply to cure an individual. Rather they are complex activities that invariably include both therapeutic and nontherapeutic components. For this reason, the distinction is no longer used in this Declaration.

§ 9 It is essential that biomedical research involving human beings be carried out to further scientific knowledge and to alleviate human suffering. To provide guidance for all physicians participating in biomedical research involving human subjects, the World Medical Association has prepared the following recommendations. Non-physician investigators are also important in biomedical research, and the principles in this Declaration apply equally to all nonphysician investigators conducting or collaborating on biomedical research involving human subjects. It must be stressed that the principles in this Declaration provide only general guidance to physicians and other investigators in all countries around the world. Physicians and other investigators are not relieved from criminal, civic and ethical responsibilities under the laws of their own countries.

Proposed Revision of the Declaration of Helsinki 409

§ 10 The World Medical Association recognizes that its authority to provide guidance is limited to the medical profession. Application of these principles to non-physician investigators depends on their ratification by the relevant organizations of professionals, their incorporation in national legislation, or both. Until such ratification or legislation occurs, physicians should refrain from collaboration in research activities that are not conducted in accordance with the principles laid down in this Declaration.

§ 11 Special caution must be exercised in the conduct of research which may affect the environment, and the welfare of animals used for research must be respected.

§ 12 Because of the changing circumstances and nature of the conduct of biomedical research over time, the principles in this Declaration should be kept under review and modified as appropriate to keep them current.

Fundamental Requirements for Conduct of Biomedical Research Involving Human Subjects

§ 13 Scientific basis for research

Biomedical research involving human subjects must conform to generally accepted scientific principles and should be based on adequately performed laboratory and animal research and on a thorough knowledge of the scientific literature.

§ 14 Qualifications of investigators

Biomedical research involving human subjects should be conducted only by persons having the requisite scientific competence. If there is risk of physical or psychological injury to the subjects, or if they are patients who require continuing clinical care, responsibility for their well-being should rest with a professional having the appropriate medical or other clinical qualifications.

§ 15 Balance of risks and benefits

Biomedical research involving human subjects cannot legitimately be carried out unless the importance of the objective is in proportion to the inherent risk to the subject. The risks of procedures or interventions that are performed with the intent and reasonable probability of providing direct health-related benefit to patient-subjects may be justified in part by the anticipated benefit to the patient-subjects. The risks of all other procedures

41 0 World Medical Association

and interventions must be justified exclusively in tenus of the anticipated benefit to society.

§ 16 Altruistic participation in research

Every biomedical research project involving human subje~ts must be preceded by careful assessment of the risks to the subjects and anticipated benefits to the subjects or to others. Concern for the interests of the subject must always prevail over the interests of science and society. Persons may, however, elect to participate as subjects in research protocols in which there is no prospect of direct health-related benefit to themselves. In such cases, their motivation may be primarily or exclusively an altruistic wish to advance the interests of science and society.

§ 17 The rights of research subjects

The right of the research subject to safeguard his or her integrity must always be respected. Every precaution should be taken to respect the privacy of the subject and to minimize any negative impact of the study on the subject's physical or mental health.

§ 18 Access to health care

In any biomedical research protocol every patient-subject, including those of a control group, if any, should be assured that he or she will not be denied access to the best proven diagnostic, prophylactic or therapeutic method that would otherwise be available to him or her. This principle does not exclude the use of placebo or no-treatment control groups if such are justified by a scientifically and ethically sound research protocol.

§ 19 Controlled clinical trials

The central ethical and scientific justification for conducting a controlled clinical trial in which the outcome measures are either death or disability is that there is within the expert clinical community genuine uncertainty or otherwise irreconcilable controversy as to which of the two or more interventions or procedures to be compared is superior. This justification criterion applies equally to clinical trials in which the control group will receive placebo or no achtive treatment. When the outcome measures are neither death nor disability, placebo or other no-treatment controls may be justified on the basis of their efficiency.

Proposed Revision ofthe Declaration of Helsinki 411

Scientific and Ethical Review of Research Protocols

§ 20 Independent research ethics committees

The design and perfonnance of each proposal to conduct research involving human subjects should be clearly fonnulated in a protocol that should be transmitted to a specially appointed committee independent of the investigator and the sponsor for its consideration, guidance and approval. This research ethics committee, which should operate in confonnity with the laws and regulations of the country in which the research is to be carried out, is charged to detennine that plans to conduct research are in accordance with the standards set forth in this Deelaration. The committee should have die authority to monitor the conduct of research, when appropriate, to assure continuing compliance with these standards.

§ 21 Ethical considerations and conflicts of interest

Each research protocol should contain a statement of the ethical considerations involved and an assurance of the investigator's plans to comply with the principles set forth in this Declaration. Each investigator should disclose to the research ethics committee any and all of his or her actual or potential financial or other pertinent conflicts of interest.

Infonned Consent and Selection of Research Subjects

§ 22 Infonned consent

Unless otherwise specified in this Declaration, each potential subject must be adequately and objectively infonned about the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. Potential subjects must be made aware of all reasonable alternatives to those procedures or interventions that are perfonned with the intent and reasonable probability of providing direct health-related benefit to the SUbjects. There must be no coercion, constraint, duress, unjustified deception or undue influence. Material inducements should be limited to reimbursement for out-of-pocket expenses and nonnal levels of compensation for time, inconvenience or discomfort. The subject should be infonned that he or she is at liberty to abstain from participation in the study and that he or she is free to withdraw his or her consent to participate at any time without jeopardizing his or her medical care and without loss of any other benefits to which he or she is entitled.


§ 23 The investigator's responsibilities

The investigator is responsible for assuring the adequacy of informed consent from or on behalf of each subject. Although the investigator may delegate another appropriately qualified person to obtain consent from prospective subjects, the responsibility for assuring that adequate consent has been accomplished remains with the investigator. When obtaining informed consent, the investigator should be particularly cautious if the subject is in a dependent relationship to him or her or may consent under duress. In some cases of this tYpe, it may be preferable if the informed consent were to be obtained by a qualified person who is either not engaged in the investigation, independent of the dependent relationship, or both.

§ 24 Documentation of informed consent

In most research the subject's informed consent should be documented in writing. The requirement for written documentation may be waived by the research ethics committee in certain circumstances such as when the research involves only slight risk, when the procedures to be used are customarily used in the practice of medicine without documentation of consent, or when a signed consent document would create an unwarranted risk of a breach of the subject's confidentiality.

§ 25 Waiver of consent

When permitted by applicable law, the requirement for informed consent may be waived by the independent research ethics committee. Such waiver may be appropriate in research that presents little or no threat to the rights and welfare of research subjects as exemplified by use of anonymous tissue samples for research purposes and in certain other types of research in such fields as epidemiology and policy evaluation. It may also be justified in research in emergency situations in which patient-subjects have temporary or enduring loss of decisional capacity and interventions or procedures must be initiated before informed consent can be obtained from patientsubjects or their legally authorized representatives. In the latter case the research ethics committee may require special procedures to protect the rights and welfare of the research SUbjects.

§ 26 Research involving women

Women who are biologically capable of becoming pregnant should not be excluded from research for which they are otherwise eligible unless participation entails exposure to substances likely to be dangerous to a


fetus (e. g., known or suspected mutagens or teratogens). Involvement of pregnant or brestfeeding women should generally be postponed until suitable pre-clinical and preliminary clinical studies have provided a basis for advising such women of the nature, probability and magnitude of anticipated effects on them, the fetus and the nursling. When appropriate, prospective subjects should be advided of risks to the fetus or nursling and on what they can do to minimize such risks.

§ 27 Research involving vulnerable subjects

Vulnerable subjects need special protection of their rights and welfare to ensure that they do not bear more than their fair share of the burdens of participation in research. Involvement of vulnerable persons rather than competent consenting adults as research subjects requires special ethical justification. Groups of vulnerable persons include but are not limited to those who are legally incompetent by virtue of their status (e. g., children) or individual condition (e. g., cognitive impairment by mental disease); those who lack the capacity to comprehend (e. g., persons for whom Western concepts of disease causation are unknown); and those with limited freedom to exercise free power of choice (e. g., institutionalized or incarcerated persons and junior or subordinate members of hierarchical groups). The inclusion of vulnerable subjects in biomedical research is most readily justified in the context of research designed to develop new diagnostic, prophylactic or therapeutic modalities for classes of vulnerable subjects (e. g., children or persons with mental diseases) or the basic knowledge upon which such developments can be based; such research must necessarily involve members of the relevant vulnerable groups as subjects.

§ 28 Subjects who are incapable of valid consent

For a prospective research subject who is legally incompetent, the investigator must obtain informed consent from the legally authorized representative in accordance with applicable law. For prospective subjects who are incapable of valid consent but not adjudicated incompetent, investigators may rely on the permission of a responsible relative or other appropriate person to the extent allowed by applicable law and approved by the research ethics committee. Persons who are partially capable of valid consent should generally be invited to assent to the extent of their capability; such assent should generally be supplimented with the permission of the responsible relative or other appropriate person.


Responsibilities of Physicians and Other Investigators

§ 29 Protecting research subjects

It is the duty of physicians and other investigators to remain the protectors of the life and health of those persons on whom biomedical research is being carried out. The responsibility for the health of the human subject must never rest solely on the subject of the research, even though the subject has given consent to participate in the study.

§ 30 Oversight of research

Physicians and other investigators conducting research involving human subjects should cease any study in which the hazards are found to be disproportionate to the benefits, and they should terminate the involvement of any individual subject if, in their judgement, continued participation in the research may be harmful to that individual. Fulfilling these responsibilities in some studies (e. g., double-blind, controlled clinical trials) may require the establishment of an independent data and safety monitoring committee.

§ 31 Responsibility for medical services

Investigators should inform prospective patient-subjects about the extent of the investigators' responsibility to provide medical services during the course of the research. Health care professionals who are also investigators should specify whether they are serving only as investigators or as both treating professionals and investigators. Those who serve in the combined roles of investigator and treating professional have a special obligation to protect the rights and welfare of the patient-subjects.

Data Management and Publication of Results

§ 32 Recording and preserving research results

Investigators who conduct biomedical research should record their findings and observations fully and accurately and preserve them for subsequent examination or future use as necessary and appropriate, while safeguarding the privacy of information about the subjects. Investigators should not inform anyone about any aspect of the research.


§ 33 Validity of research reports and conflicts of interest

In publishing the results of their research, investigators are obliged to report the methods, results, conclusions, and interpretation of their research fully and accurately, to remain accountable for future inquire into their work, and to disclose to others any actual or potential financial or other pertinent conflicts of interest they may have had.

§ 34 Adherence to this Declaration

Any published reports of research involving human subjects should enclude a statement from investigators that the research was conducted in accordance with the principles laid down in this Declaration. Variances from these principles should be explained and justified in the report. Editors are obligated to consider carefully the justification for any variances from these principles in deciding whether to accept or reject the report for publication.


Summary Minutes of the 153rd Council Session Santiago, Chile, 15 - 18 April 1999

Document 4.1/99 (May 1999) Original: English

[ ... ]

11. Report of the Medical Ethics Committee

The report of the Medical Ethics Committee was presented by the Chairperson of the Committee, Dr. E. Accorsi.

11.1 Declaration of Helsinki

The Council accepted the following recommendations:

1. That the Working Group on the Revision of the Declaration of Helsinki be thanked for drafting a proposed revision and for completing its task.

2. That a new Working Group comprised of Dr. N. Dickey (Chairperson), Dr. J. Kazimirski and Dr. D. Myllimaki be established to analyze the ex· isting information on the Declaration of Helsinki and to coordinate further action, under the supervision of the Medical Ethics Committee.

3. That national experts and other representative groups continue to provide input, but that their opinions and suggestions be submitted directly to the NMA in their country. The views submitted to the WMA Working Group should represent the official views of the NMA.

4. That NMAs be given an additional six Months to provide comments. The comments should: a) identify specific concerns regarding terminology, concepts and struc

ture in the original Declaration of Helsinki (Doc. 17.C) and the proposed Revision (Doc. 17 .ClRev 1/99);

b) provide explicit suggestions for revision of the areas identified; c) include interpretations of the following terms: Biomedical Research

Involving Human Subjects; Clinical Research; Non-Clinical Re-

418 Summary Minutes of the 153rd Council Session

[ ... ]

search; Therapeutic Research; Non-Therapeutic Research; and Compassionate Care.

In discussion it was confirmed that the Proposed Revision of the Declaration of Helsinki (Doc. 17.c/Rev1l99) would be sent to NMAs as a "Background Document", and that the Working Group would consider carefully all of the points from that paper as it prepared its plan for a new document based on the original Declaration of Helsinki (Doc. 17.C).

Weltarztebund

Ergebnisprotokoll der 153. Vorstandssitzung Santiago, Chile, 15. - 18. April 1999

Dokument 4.1199 (Mai 1999) Original: Englisch

[ ... ]

11. Bericht des Ausschusses fUr Arztliche Ethik

Der Bericht des Ausschusses fur Arztliche Ethik wurde yom Ausschu13vorsitzenden, Dr. E. Accorsi, vorgelegt.

11.1 Deklaration von Helsinki

Der Vorstand nahm die folgenden Empfehlungen an:

1. der Arbeitsgruppe "Uberarbeitung der Deklaration von Helsinki" fUr die Ausarbeitung dieses Vorschlags zu danken;

2. eine neue Arbeitsgruppe bestehend aus Dr. N. Dickey (Vorsitzende), Dr. J. Kazimirski sowie Dr. K. Myllimaki einzusetzen mit dem Aufirag, unter der Regie des Ausschusses fur Arztliche Ethik die vorhandenen Informationen iiber die Deklaration von Helsinki zu analysieren und die weiteren Aktionen zu koordinieren;

3. daJ3 nationale Experten und andere reprasentative Gruppen weiterhin ihren Sachverstand einbringen, aber da13 sie ihre Stellungnahmen und Vorschlage direkt ihren jeweiligen nationalen Organisationen vorlegen, die diese dann als ihre offiziellen Stellungnahmen der Arbeitsgruppe des Weltarztebundes iibermitteln;

4. den nationalen Mitgliedsorganisationen weitere sechs Monate zur Abgabe ihrer Stellungnahmen einzuraumen. Die Stellungnahmen sollten: a) konkrete Probleme in bezug auf die Terminologie und den Aufbau der

Deklaration von Helsinki (Dok. 17.C) bzw. des Vorschlags zur Uberarbeitung dieser Deklaration (Dok. 17.C/Revl/99) aufzeigen;

b) explizite Vorschlage zur Uberarbeitung der identifizierten Bereiche machen;

420 Ergebnisprotokoll der 153. Vorstandssitzung

c) Interpretationen der folgenden Gebiete beinhalten: Biomedizinische Forschung am Menschen; Klinische Forschung; Nicht-klinische Forschung; Therapeutische Forschung; Nicht-therapeutische Forschung; und Heilversuche.

In der Diskussion wurde beschlossen, den nationalen Mitgliedsorganisationen den Vorschlag zur Uberarbeitung der Deklaration von Helsinki (Dok. 17.C/Revl/99) als "Hintergrundpapier" zu iibermitteln und daB die Arbeitsgruppe bei der Erstellung ihres auf der urspriinglichen Deklaration (Dok. 17.C) basierenden neuen Dokuments sorgfaitig alle Punkte dieses Papiers beriicksichtigt.


Proposed Revision of the Wodd Medical Association Declaration of Helsinki (Recommendations guiding physicians and other investigators in biomedical research involving human subjects)

submitted by the German Medical Association

51 st WMA General Assembly Tel Aviv, Israel 13. -17. October, 1999

Document 17.C Rev.!GMAl99 (18. August 1999) Original: English

(Provisional numbering!)

Introduction

1. It is the mission of the physician to safeguard the health of the people. His or her knowledge and conscience are dedicated to the fulfillment of this mission.

2. The Declaration of Geneva of the World Medical Association binds the physician with the words, "The Health of my patient will be my first consideration," and the International Code of Medical Ethics declares that, "A physician shall act only in the patient's interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient." Therefore, in research on men the interest of science and society should never take precedence over considerations related to the wellbeing of the subject.

3. The purpose of biomedical research involving human subjects must be to improve diagnostic, therapeutic and prophylactic procedures and the understanding of the aetiology and pathogenesis of disease.

4. In current medical practice most diagnostic, therapeutic or prophylactic procedures involve hazards. This applies especially to biomedical research.

422 Proposal submitted by the Gennan Medical Association

5. Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects.

6. In the field of biomedical research a fundamental distinction must be recognized between medical research in which the aim is essentially diagnostic or therapeutic for a patient, and medical research, the essential object of which is purely scientific and without implying direct diagnostic or therapeutic value to the person subjected to the research.

7. Special caution must be exercised in the conduct of research which may affect the environment, and the welfare of animals used for research must be respected.

8. Because it is essential that the results of laboratory experiments be applied to human beings to further scientific knowledge and to help suffering humanity, the World Medical Association has prepared the following recommendations as a guide to every physician in biomedical research involving human subjects (including embryos, if permitted by law,) or identifiable human materials (e.g. organs, tissues, cells, genes) or identifiable data. These guidelines should be kept under review in the future. It must be stressed that the standards as drafted are only a guide to physicians all over the world. Physicians are not relieved from criminal, civil and ethical responsibilities under the laws of their own countries.

9. The WMA deems it necessary that the principles laid down in this declaration should be applied to all other kinds of research involving human subjects, which may deal with or potentially have an influence on their health.

I. Basic Principles


la. In the interest of the subjects unjustified research should not be performed.

2. The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol which should be transmitted for consideration, comment and guidance to a specially appointed committee independent of the investigator and the sponsor provided that this independent committee is in conformity with the laws and

Proposal submitted by the German Medical Association 423

regulations of the country in which the research experiment is performed. The committee should include lay persons.

2a. For reasons of the protection of the subject and researcher these specially appointed committees - usually called "ethics committees" or "institutional review boards" - should be local and institutional.

2b. The committee may request information about financial or material incentives or conditions to researchers and subjects.

2c. If at the location the study shall be performed no statement of a committee as laid out under I.2 can be obtained, a statement of the committee at the location of the performing institution should be obtained. However, in no case the standards set by this declaration must be compromised.

2d. The committee has the right to monitor ongoing trials. It should request that serious adverse events occuring during the trial should be reported to the committee.

2e. The communication between committees should be promoted especially when multicentric studies are concerned.

3. Biomedical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given his or her consent.

4. Biomedical research involving human subjects cannot legitimately be carried out unless the importance of the objective is in proportion to the inherent risk and burden to the subject.

5. Every biomedical research project involving human subjects should be preceded by careful assessment of predictable risks and burdens in comparison with foreseable benefits to the subject or to others. Concern for the interests of the subject must always prevail over the interests of science and society.


424 Proposal submitted by the German Medical Association

6a. For the occurrence of damages to the subject during and in connection with or in consequence of the study they subjects are to be protected by third party insurance or objective liability.


8. In publications of the results of his or her research, the physician is obliged to preserve the accuracy of the results. The right of the researcher to freely publish the results of his or her research should be respected. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication.

9. In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be informed that he or she is at liberty to abstain from participation in the study and that he or she is free to withdraw his or her consent to participation without any disadvantage to him or her at any time. The physician should then obtain the subject's freely-given informed consent, preferably in writing. The consent must be defined in its nature and duration. The consent thus is limited to the scope, methods and procedures of the study and its follow-up, if appropriate, as they have been explained to the patient.

9a. In controlled clinical studies especially in blind and double blind studies all subjects involved including those serving in control groups have to be informed that they are part of a clinical study.

9b. After completion of the trial the subjects have the right to be informed whether and when they were part of the treatment or control group and which personal consequences - if any - this may bear.

9c. Members of a control group, including those of crossover studies or patients in "wash-out-phases" can receive placebo treatment only if they are suffering of a mild disease or they are exposed only to a mild burden or if there is no proven diagnostic and therapeutical method for their illness. Avoidable health risks should not be accepted.

10. When obtaining informed consent for the research project the physician should be particularly cautious if the subject is in a dependent relationship to him or her or may consent under duress. In that case the informed consent


should be obtained by a physician who is not engaged in the investigation and who is completely independent of this official relationship.

10a.On persons who are not able to give informed consent studies are only permissible if they are relevant to their group and cannot be carried out on other groups.



11a.Financial incentives to the subjects or the researcher must not influence the judgement between risk and burden on one side and the benefit of the study on the other side.

12. The research protocol should always contain a statement of the ethical considerations involved and should indicate that the principles enunciated in the present Declaration are complied with.

II. Medical Research combined with Professional Care (Clinical Research)

1. In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure, if in his or her judgement it offers hope of saving life, reestablishing health or alleviating suffering.

1 a. Individual treatment attempts do not have to be presented to a committee as laid out under 1.2. However, consultation should always be possible.

I b. Pilots studies, however, designed to prepare a clinical study should be presented to a committee as laid out in 1.2.

2. The potential benefits, hazards and discomfort of a new method should be weighed against the advantages of the best current diagnostic and therapeutic methods.

3. In any medical study, every patient - including those of a control group, if any - should be assured of the best proven diagnostic and therapeutic method.

426 Proposal submitted by the Gennan Medical Association

This does not exclude the use of inert placebo in studies where no proven diagnostic or therapeutic method exists.


5. If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal should be stated in the experimental protocol for transmission to the independent committee (1.2).


III. Non-Therapeutical Biomedical Research Involving Human Subjects (Non-Clinical Biomedical Research)

1. In the purely scientific application of medical research including epidemiological research carried out on a human being (including embryos, if permitted by law,) or identifiable human materials (e.g. organs, tissues, cells, genes) or identifiable data, it is the duty of the physician to remain the protector of the life, health, privacy and dignity of that person on whom biomedical research is being carried out.

2. The subject should be volunteers. For their protection the judgement of risk and burden versus the benefit for the society should adhere to strict criteria taking in account that there is no medical benefit in their participation. Under these circumstances the application of basic principles as laid out in 1.9, 1.1 Oa and 1.11 require utmost attention.

2a. On legally incompetent persons (subjects which are not able to give informed consent) studies are only permissible, if the research has the aim of contributing, through significant improvement in 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 afflicted with the same disease or disorder or having the same medical condition. This research may only entail minimal risk and minimal burden for the individual concerned.

3. The investigator or the investigating team should discontinue the research if in hislher or their judgement it may, if continued, be harmful to the individual.



Weltarztebund

Vorschlag flir eine Uberarbeitung der Deklaration des WeWirztebundes von Helsinki (Empfehlungen flir Arzte und andere Forscher, die in der biomedizinischen F orschung am Menschen tatig sind)

vorgelegt von der Bundesarztekammer

51. Generalversammlung des Weltiirztebundes Tel Aviv, Israel 13. -17. Oktober 1999

Dokument 17.C Rev.lGMAl99 (18. August 1999) (Nicht-offizielle Arbeitsiibersetzung)

(Vorliiufige Nummerierung!)

Einleitung

1. Aufgabe des Arztes ist die Erhaltung der Gesundheit des Menschen. Der Erfullung dieser Aufgabe dient er mit seinem Wissen und Gewissen.

2. Die Genfer Deklaration des Weltarztebundes verpflichtet den Arzt mit den Worten: "Die Gesundheit meines Patienten soll mein vomehmstes Anliegen sein", und der intemationale Codex fUr iirztliche Ethik legt fest: "Jegliche Handlung oder Beratung, die geeignet erscheinen, die physische oder psychische Widerstandskraft des Menschen zu schwiichen, diirfen nur in seinem Interesse zur Anwendung gelangen". Aus diesem Grund sollte bei Versuchen am Menschen das Interesse der Wissenschaft und der Gesellschaft niemals Vorrang vor den Erwiigungen haben, die das W ohlergehen der Versuchsperson betreffen.

3. Ziel der biomedizinischen Forschung am Menschen muB es sein, diagnostische, therapeutische und prophylaktische Verfahren sowie das Verstiindnis fur die Atiologie und Pathogenese der Krankheit zu verbessem.

430 Vorschlag der Bundesarztekammer

4. In der medizinischen Praxis sind diagnostische, therapeutische oder prophylaktische Verfahren mit Risiken verbunden; dies gilt umsomehr fur die biomedizinische Forschung am Menschen.

5. Medizinischer Fortschritt beruht auf Forschung, die sich letztlich auch auf Versuche am Menschen stiitzen muB.

6. Bei der biomedizinischen Forschung am Menschen muB grundsatzlich unterschieden werden zwischen Versuchen, die im wesentlichen im Interesse des Patienten liegen und solchen, die mit rein wissenschaftlichem Ziel ohne unmittelbaren diagnostischen oder therapeutischen Wert fUr die Versuchsperson sind.

7. Besondere Vorsicht muB bei der Durchflihrung von Versuchen walten, die die Umwelt in Mitleidenschaft ziehen konnen. Auf das Wohl der Versuchstiere muB Riicksicht genommen werden.

8. Da es notwendig ist, die Ergebnisse von Laborversuchen auch auf den Menschen anzuwenden, urn die wissenschaftliche Erkenntnis zu fOrdern und der leidenden Menschheit zu helfen, hat der Weltarztebund die folgenden Empfehlungen als eine Leitlinie fUr jeden Arzt erarbeitet, der in der biomedizinischen Forschung am Menschen (einschlieBlich Embryonen, wenn dies gesetzlich zuHissig ist), identifizierbarem menschlichen Material (Organen, Gewebe, Zellen, Genen) oder identifizierbaren Daten tatig ist. Diese Leitlinien sollten in der Zukunft iiberpriift werden. Es muB betont werden, daB diese Standards nur als Leitlinie fUr die Arzte auf dec ganzen Welt gedacht ist; kein Arzt ist von der straf-, zivil- und berufsrechtlichen Verantwortung nach den Gesetzen seines Landes befreit.

9. Der Weltarztebund halt es fUr notwendig, daB die in dieser Deklaration dargelegten Grundsatze in allen anderen Foemen der Forschung am Menschen, die dessen Gesundheit betreffen oder moglicherweise Auswirkungen auf seine Gesundheit haben, Anwendung finden.

I. Allgemeine Grundsatze

1. Biomedizinische Forschung am Menschen muB den allgemein anerkannten wissenschaftlichen Grundsatzen entsprechen; sie so lite auf ausreichende Laboratoriums- und Tierversuche sowie einer umfassenden Kenntnis der wissenschaftlichen Literatur aufbauen.

Vorschlag der Bundesarztekammer 431

la. 1m Interesse der Versuchspersonen sollten nicht zu rechtfertigende Versuche unterlassen werden.

2. Die Planung und Durchfiihrung eines jeden Versuches am Menschen soUte eindeutig in einem Versuchsprotokoll niedergelegt werden, welches einem besonders berufenen, vom Forschungsteam und Sponsor unabhangigen AusschuB zur Beratung, Stellungnahme und Orientierung vorgelegt werden sollte. Dabei wird davon ausgegangen, daB dieser AusschuB gemiiB den Gesetzen oder Bestimmungen des Landes, in welchem der Versuch durchgefUhrt werden soU, anerkannt ist. In diesem AusschuB sollten Laien vertreten sein.

2a. Zum Schutz der Versuchsperson und des Forschers sollten diese besonders berufenen Ausschusse - die in der Regel "Ethikausschusse" oder "institutionelle Begutachtungskommissionen heiBen - lokal sein und institutionellen Charakter haben.

2b. Der AusschuB kann Informationen tiber finanzielle oder materielle Anreize oder Bedingungen, die die Forscher und Versuchspersonen erhalten oder die an sie gestellt werden, verlangen.

2c. Wenn es nicht moglich ist an dem Ort, an dem der Versuch durchgefiihrt werden solI, eine Stellungnahme von einem wie in 1.2 beschriebenen AusschuI3 zu erhalten, dann sollte eine Stellungnahme des Ausschusses angefordert werden, der am Ort der den Versuch durchfiihrenden Institution ansassig ist.

2d. Der AusschuB hat das Recht, den Versuchsverlauf zu uberwachen. Er sollte verlangen, daB schwerwiegende nachteilige Vorfalle, die wahrend des Versuchs aufireten, dem AusschuB berichtet werden.

2e. Zwischen Ausschussen so lIte insbesondere bei multizentrischen Studien die Kommunikation gefordert werden.

3. Biomedizinische Forschung am Menschen sollte nur von wissenschaftlich qualifizierten Personen und unter Aufsicht eines klinisch erfahrenen Arztes durchgefiihrt werden. Die Verantwortung fiir die Versuchsperson tragt stets ein Arzt und nie die Versuchsperson selbst, auch dann nicht, wenn sie ihr Einverstandnis gegeben hat.

4. Biomedizinische Forschung am Menschen ist nur zulassig, wenn die Bedeutung des Versuchsziels in einem angemessenen Verhaltnis zum Risiko und zur Belastung fur die Versuchsperson steht.

432 Vorschlag der Bundesiirztekammer

5. Jedem biomedizinischen Forschungsvorhaben am Menschen sollte eine sorgfaltige Abschlitzung der voraussehbaren Risiken und Belastungen im Vergleich zu dem voraussichtlichen Nutzen flir die Versuchsperson oder anderen vorausgehen. Die Sorge urn die Belange der Versuchsperson muB stets ausschlaggebend sein im Vergleich zu den Interessen der Wissenschaft und der Gesellschaft.

6. Das Recht der Versuchsperson aufWahrung ihrer Unversehrtheit muB stets geachtet werden. Es sollte alles getan werden, urn die Privatsphlire der Versuchsperson zu wahren; die Wirkung auf die korperliche und geistige Unversehrtheit sowie die Personlichkeit der Versuchsperson sollte so gering wie moglich gehalten werden.

6a. Schaden, die die Versuchsperson bei, in Zusammenhang mit oder als Foige der Studie erleidet, sollten durch eine Haftpflichtversicherung oder durch eine objektive Haftung abgedeckt werden.

7. Der Arzt solle es unterlassen, bei Versuchen am Menschen tatig zu werden, wenn er nicht uberzeugt ist, daB das mit dem Versuch verbundene Wagnis flir vorhersagbar gehalten wird. Der Arzt sollte den Versuch abbrechen, sobald sich herausstellt, daB das Wagnis den moglichen Nutzen ubersteigt.

8. Bei VerOffentlichung seiner Versuchsergebnisse ist der Arzt verpflichtet, die Befunde genau wiederzugeben. Das Recht des Forschers, seine Versuchsergebnisse ungehindert veroffentlichen zu konnen, sollte respektiert werden. Beriehte tiber Versuche, die nieht in Ubereinstimmung mit den in dieser Deklaration niedergelegten Grundsatzen durehgefiihrt wurden, sollten nieht zur Veroffentliehung angenommen werden.

9. Bei jedem Versuch am Menschen muB jede Versuehsperson ausreiehend uber Absicht, Durchflihrung, erwarteten Nutzen und Risiken des Versuches sowie uber moglicherweise damit verbundene Storungen des Wohlbefindens unterrichtet werden. Die Versuchsperson sollte darauf hingewiesen werden, daB es ihr freisteht, die Teilnahrne am Versuch zu verweigem und daB sie jederzeit eine einmal gegebene Zustimmung widerrufen kann, ohne daB ihr irgendwelche Nachteile entstehen. Nach dieser Autklarung sollte der Arzt die freiwillige Zustimmung der Versuehsperson einholen; die Erklarung sollte vorzugsweise schriftlich abgegeben werden. Art und Dauer der Zustimmung mussen definiert werden. Somit ist die Zustimmung auf den Umfang, die Methoden und Verfahren und gegebenenfalls den "Follow-up" der Studie, wie sie dem Patienten erkllirt worden sind, beschrlinkt.

Vorschlag der Bundesarztekammer 433

9a. In kontrollierten klinischen Versuchen, insbesondere in Blind- und Doppelblindversuchen, mussen alle Versuchspersonen, einschlieBlich der in Kontrollgruppen Mitwirkenden, dariiber informiert werden, daB sie an einem klinischen Versuch teilnehmen.

9b. Nach Beendigung des Versuchs haben die Versuchspersonen das Recht daruber informiert zu werden, ob und wann sie Teil des Versuchs oder der Kontrollgruppe waren und welche Folgen dies fUr sie gegebenenfalls haben konnte.

9c. Teilnehmer einer Kontrollgruppe, einschlieBlich der von "Crossover"Versuchen oder Patienten in "Auswaschphasen", durfen eine PlaceboBehandlung nur erhalten, wenn sie an einer leichten Erkrankung leiden 0-

der nur einer geringen Belastung ausgesetzt werden oder wenn es keine erprobte Diagnostik- oder Therapieverfahren fUr ihre Krankheit gibt. Vermeidbare Risiken fUr die Gesundheit sollten nicht akzeptiert werden.

10. 1st die Versuchsperson yom Arzt abhangig oder erfolgte die Zustimmung zu einem Versuch moglicherweise unter Druck, so soll der Arzt beim Einholen der Einwilligung nach Aufklarung besondere Vorsicht walten lassen. In einem solchen Fall sollte die Einwilligung durch einen Arzt eingeholt . werden, der mit dem Versuch nicht befaBt ist und der auBerhalb eines etwaigen Abhiingigkeitsverhaltnisses steht.

lOa. Bei Personen, die nicht in der Lage sind, ihre Zustimmung nach Aufklarung abzugeben, sind Versuche nur dann zulassig, wenn sie fUr ihre Gruppe relevant sind und nicht an anderen Gruppen durchgeflihrt werden konnen.

11. 1st die Versuchsperson nicht voll geschaftsfdhig, sollte die Einwilligung nach Aufklarung yom gesetzlichen Vertreter entsprechend dem nationalen Recht eingeholt werden. Die Einwilligung des mit der Verantwortung betrauten Verwandten (darunter ist nach deutschem Recht der "Personensorgeberechtigte" zu verstehen) ersetzt die der Versuchsperson, wenn diese infolge korperiicher oder geistiger Behinderung nicht wirksam zustimmen kann oder minderjiihrig ist.

Wenn das minderjahrige Kind fahig ist, seine Zustimmungzu erteilen, so muB neben der Zustimmung des Personensorgeberechtigen auch die Zustimmung des Minderjahrigen eingeholt werden.

lla. Finanzielle Anreize fUr die Versuchspersonen oder den Forscher durfen die Abschiitzung des Risikos und der Belastung auf der einen Seite und den Nutzen des Versuchs auf der anderen Seite nicht beeinflussen.

434 Vorschlag der Bundesiirztekammer

12. Das Versuchsprotokoll sollte stets die ethischen Uberlegungen im Zusammenhang mit der DurchfUhrung des Versuchs darlegen und aufzeigen, daB die Grundsiitze dieser Deklaration eingehalten werden.

II. Medizinische Forschung in Verbindung mit arztlicher Versorgung (Klinische Versuche)

1. Bei der Behandlung eines Kranken muB der Arzt die Freiheit haben, neue diagnostische und therapeutische Mal3nahmen anzuwenden, wenn sie nach seinem Urteil die Hoffnung bieten, das Leben des Patienten zu retten, seine Gesundheit wiederherzustellen oder seine Leiden zu lindem.

lao Individuelle Behandlungsversuche mUssen einem AusschuB nieht wie in 1.2 dargelegt mitgeteilt werden. Die Konsultation sollte jedoch jederzeit moglich sein.

lb. Pilotversuche zur Vorbereitung eines klinischen Versuchs mUssen einem Ausschul3 jedoch wie in 1.2 dargelegt vorgelegt werden.

2. Die mit der Anwendung eines neuen Verfahrens verbundenen moglichen Vorteile, Risiken und StOrungen des Befindens sollten gegen die Vorziige der bisher bestehenden diagnostischen und therapeutischen Methoden abgewogen werden.

3. Bei jedem medizinischen Versuch sollten aIle Patienten - einschliel3lich die einer eventuell vorhandenen Kontrollgruppe - die beste erprobte diagnostische und therapeutischen Behandlung erhalten. Dies schlieBt nicht die Verwendung von reinen Placebos bei Versuchen aus, fUr die es keine erprobte diagnostische oder therapeutische Behandlung gibt.

4. Die Weigerung eines Patienten, an einem Versuch teilzunehmen, darf niemals die Beziehung zwischen Arzt und Patient beeintriichtigen.

5. Wenn der Arzt es fUr unentbehrlich halt, auf die Einwilligung nach Autkliirung zu verzichten, sollten die besonderen Griinde fUr dieses Vorgehen in dem flir den unabhiingigen AusschuB bestimmten Versuchsprotokoll niedergelegt werden (1.2).

6. Der Arzt kann medizinische Forschung mit dem Ziel der Gewinnung neuer wissenschaftlicher Erkenntnisse mit der iirztlichen Betreuung nur soweit verbinden, als diese medizinische Forschung durch ihren moglichen diagnostischen oder therapeutischen Wert fUr den Patienten gerechtfertigt ist.

Vorschlag der Bundesarztekarnmer 435

III. Nicht-therapeutische biomedizinische Forschung am Menschen (Nicht-klinische biomedizinische Forschung)

1. In der rein wissenschaftlichen Anwendung der medizinischen wie auch epidemiologischen Forschung am Menschen (einschlieBlich Embryonen, wenn dies gesetzlich zuHissig ist) oder identifizierbarem menschlichen Material (Organen, Gewebe, Zellen, Genen) oder identifizierbaren Daten ist es die Ptlicht des Arztes, das Leben, die Gesundheit, die Privatsphiire und Wurde der Person zu schiitzen, an der biomedizinische Forschung durchgefUhrt wird.

2. Die Versuchspersonen sollten Freiwillige sein. Zu ihrem Schutz sollten bei der Abschatzung des Risikos und der Belastung im Verhiiltnis zum Nutzen fUr die Gesellschaft strenge Kriterien befolgt werden unter der Berucksichtigung, daB ihre Teilnahme mit keinem medizinischen Nutzen verbunden ist. Unter diesen Umstanden muB die Anwendung der in I.9, 1.10 und 1.11 dargelegten Grundsatze unbedingt beachtet werden.

2a. Versuche an nicht voU geschiiftsfahigen Menschen (Versuchspersonen, die nicht in der Lage sind, ihre Einwilligung nach Aufklarung abzugeben) sind nur zulassig, wenn das Ziel des Y~rsuchs darin besteht, durch eine wesentliche Verbesserung des wissenschaftlichen Verstandnisses des Gesundheitszustandes, der Erkrankung bzw. der Gesundheitsstorung des Patienten, die letztendlich zur Gewinnung von Ergebnissen beitragen, die dem betreffenden Patienten oder anderen Personen, die an der gleichen Erkrankung bzw. Gesundheitsstorung leiden oder den gleichen Gesundheitszustand haben, zugute kommen. Fur die Versuchsperson darf dieser Versuch nur mit einem minimalen Risiko und einer minimalen Belastung verbunden sein.

3. Der arztliche Forscher oder das Forschungsteam sollten den Versuch abbrechen, wenn dies nach seinem oder ihrem Urteil irn Falle der FortfUhrung dem Menschen schaden konnte.

4. Bei Versuchen am Menschen sollte das Interesse der Wissenschaft und der Gesellschaft niemals Vorrang vor den Erwagungen haben, die das Wohlbefinden der Versuchsperson betreffen.

Council of Europe

Convention for the Protection of Human Rights and Dignisty of the Human Being with regard to the Application of Biology and Medicine:

Convention on Human Rights and Biomedicine April 4, 1997

Original: English

Preamble

The Member States of the Council of Europe, the other States and the European Community signatories hereto,

Bearing in mind the Universal Declaration of Human Rights proclaimed by the General Assembly of the United Nations on 10 December 1948;

Bearing in mind the Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950;

Bearing in mind the European Social Charter of 18 October 1961;

Bearing in mind the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights of 16 December 1966;

Bearing in mind the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data of 28 January 1981;

Bearing also in mind the Convention on the Rights of the Child of 20 November 1989;

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

438 Council of Europe

Conscious of the accelerating developments in biology and medicine;

Convinced of the need to respect the human being both as an individual and as a member of the human species and recognising the importance of ensuring the dignity of the human being;

Conscious that the misuse of biology and medicine may lead to acts endangering human dignity;

Affirming that progress in biology and medicine should be used for the benefit of present and future generations;

Stressing the need for international co-operation so that all humanity may enjoy the benefits of biology and medicine;

Recognising the importance of promoting a public debate on the questions posed by the application of biology and medicine and the responses to be given thereto;

Wishing to remind all members of society of their rights and responsibilities;

Taking account of the work of the Parliamentary Assembly in this field, including Recommendation 1160 (1991) on the preparation of a Convention on bioethics;

Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to the application of biology and medicine;

Have agreed as follows:

Chapter I - General provisions

Article 1 - Purpose and object

Parties to this Convention 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 the application of biology and medicine.

Each Party shall take in its internal law the necessary measures to give effect to the provisions of this Convention.

Convention on Human Rights and Biomedicine 439

Article 2 - Primacy of the human being

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

Article 3 - Equitable access to health care

Parties, taking into account·health needs and available resources, shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality.

Article 4 - Professional standards

Any intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards.

Chapter II - Consent

Article 5 - General rule

An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.

This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks.

The person concerned may freely withdraw consent at any time.

Article 6 - Protection of persons not able to consent

1. Subject to Articles 17 and 20 below, an intervention may only be carried out on a person who does not have the capacity to consent, for his or her direct benefit.

2. Where, according to law, a minor does not have the capacity to consent to an intervention, the intervention may only be carried out with the authorisation of his or her representative or an authority or a person or body provided for by law.

The opinion of the minor shall be taken into consideration as an increasingly determining factor in proportion to his or her age and degree of maturity.

3. Where, according to law, an adult does not have the capacity to consent to an intervention because of a mental disability, a disease or for similar reasons, the


intervention may only be carried out with the authorisation of his or her representative or an authority or a person or body provided for by law.

The individual concerned shall as far as possible take part in the authorisation procedure.

4. The representative, the authority, the person or the body mentioned in paragraphs 2 and 3 above shall be given, under the same conditions, the information referred to in Article 5.

5. The authorisation referred to in paragraphs 2 and 3 above may be withdrawn at any time in the best interests of the person concerned.

Article 7 - Protection of persons who have mental disorder

Subject to protective conditions prescribed by law, including supervisory, control and appeal procedures, a person who has a mental disorder of a serious nature may be subjected, without his or her consent, to an intervention aimed at treating his or her mental disorder only where, without such treatment, serious harm is likely to result to his or her health.

Article 8 - Emergency situation

When because of an emergency situation the appropriate consent cannot be obtained, any medically necessary intervention may be carried out immediately for the benefit of the health of the individual concerned.

Article 9 - Previously expressed wishes

The previously expressed wishes relating to a medical intervention by a patient who is not, at the time of the intervention, in a state to express his or her wishes shall be taken into account.

Chapter III - Private life and right to information

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.

Chapter IV - Human genome

Article 11 - Non-discrimination

Any form of discrimination against a person on grounds of his or her genetic heritage is prohibited.

Article 12 - Predictive genetic tests

Tests which are predictive of genetic diseases or which serve either to identify the subject as a carrier of a gene responsible for a disease or to detect a genetic predisposition or susceptibility to a disease may be performed only for health purposes or for scientific research linked to health purposes, and subject to appropriate genetic counselling.

Article 13 - Interventions on the human genome

An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants.

Article 14 - Non-selection of sex

The use of techniques of medically assisted procreation shall not be allowed for the purpose of choosing a future child's sex, except where serious hereditary sexrelated disease is to be avoided.

Chapter V - Scientific research


Scientific research in the field of biology and medicine shall be carried out freely, subject to the provisions of this Convention and the other legal provisions ensuring the protection of the human being.


Article 16 - Protection of persons undergoing research

Research on a person may only be undertaken if all the following conditions are met: i) there is no alternative of comparable effectiveness to research on humans,

ii) the risks which may be incurred by that person are not disproportionate to the potential benefits of the research,

iii) 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,

iv) the persons undergoing research have been informed of their rights and the safeguards prescribed by law for their protection,

v) 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.

Article 17 - Protection of persons not able to consent to research

I.Research on a person without the capacity to consent as stipulated in Article 5 may be undertaken only if all the following conditions are met:

i) the conditions laid down in Article 16, sub-paragraphs i to iv, are fulfilled;

ii) the results of the research have the potential to produce real and direct benefit to his or her health;

iii) research of comparable effectiveness cannot be carried out on individuals capable of giving consent;

iv) the necessary authorisation provided for under Article 6 has been given specifically and in writing, and

v) the person concerned does not object.

2.Exceptionally and under the protective conditions prescribed by law, where the research has not the potential to produce results of direct benefit to the health of the person concerned, such research may be authorised subject to the conditions laid down in paragraph 1, sub-paragraphs i, iii, iv and v above, and to the following additional conditions:


i) the research has the aim of contributing, through significant improvement in the scientific understanding of the individual's condition, disease or disorder, to the ultimate attainment of results capable of conferring benefit to the person concerned or to other persons in the same age category or afflicted with the same disease or disorder or having the same condition.

ii) the research entails only minimal risk and minimal burden for the individual concerned.

Article 18 - Research on embryos in vitro

l.Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo.

2.The creation of human embryos for research purposes is prohibited.

Chapter VI - Organ and tissue removal from living donors for transplantation purposes


I.Removal of organs or tissue from a living person for transplantation purposes may be carried out solely for the therapeutic benefit of the recipient and where there is no suitable organ or tissue available from a deceased person and no other alternative therapeutic method of comparable effectiveness.

2. The necessary consent as provided for under Article 5 must have been given expressly and specifically either in written form or before an official body.

Article 20 - Protection of persons not able to consent to organ removal

I.No organ or tissue removal may be carried out on a person who does not have the capacity to consent under Article 5.

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 must have the potential to be life-saving for the recipient,


iv) the authorisation provided for under paragraphs 2 and 3 of Article 6 has been given specifically and in writing. in accordance with the law and with the approval of the competent body,

v) the potential donor concerned does not object.

Chapter VTI - Prohibition of financial gain and disposal of a part of the human body

Article 21 - Prohibition of financial gain

The human body and its parts shall not, as such, give rise to fmancial gain.

Article 22 - Disposal of a removed part of the human body

When in the course of an intervention any part of a human body is removed, it may be stored and used for a purpose other than that for which it was removed, only if this is done in conformity with appropriate information and consent procedures.

Chapter VTII - Infringements of the provisions of the Convention

Article 23 - Infringement of the rights or principles

The 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 Convention at short notice.

Article 24 - Compensation for undue damage

The person who has suffered undue damage resulting from an intervention 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 Convention.


Chapter IX - Relation between this Convention and other provisions

Article 26 - Restrictions on the exercise of the rights

1. No restrictions shall be placed on the exercise of the rights and protective provisions contained in this Convention 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 11, 13, 14, 16, 17, 19,20 and 21.

Article 27 - Wider protection

None of the provisions of this Convention shall be interpreted as limiting or otherwise affecting the possibility for a Party to grant a wider measure of protection with regard to the application of biology and medicine than is stipulated in this Convention.

Chapter X - Public debate

Article 28 - Public debate

Parties to this Convention shall see to it that the fundamental questions raised by the developments of biology and medicine are the subject of appropriate public discussion in the light, in particular, of relevant medical, social, economic, ethical and legal implications, and that their possible application is made the subject of appropriate consultation.

Chapter XI - Interpretation and follow-up of the Convention

Article 29 - Interpretation of the Convention

The European Court of Human Rights may give, without direct reference to any specific proceedings pending in a court, advisory opinions on legal questions concerning the interpretation of the present Convention at the request of:

- the Government of a Party, after having informed the other Parties,


- the Committee set up by Article 32, with membership restricted to the Representatives of the Parties to this Convention, by a decision adopted by a two-third majority of votes cast.

Article 30 - Reports on the application of the Convention

On receipt of a request from the Secretary General of the Council of Europe any Party shall furnish an explanation of the manner in which its internal law ensures the effective implementation of any of the provisions of the Convention.

Chapter XII - Protocols

Article 31 - Protocols

Protocols may be concluded in pursuance of Article 32, with a view to developing, in specific fields, the principles contained in this Convention.

The Protocols shall be open for signature by Signatories of the Convention. They shall be subject to ratification, acceptance or approval. A signatory may not ratify, accept or approve Protocols without previously or simultaneously ratifying accepting or approving the Convention.

Chapter XIII - Amendments to the Convention

Article 32 - Amendments to the Convention

1. The tasks assigned to "the Committee" in the present article and in Article 29 shall be carried out by the Steering Committee on Bioethics (CDBI), or by any other committee designated to do so by the Committee of Ministers.

2. Without prejudice to the specific provisions of Article 29, each member State of the Council of Europe, as well as each Party to the present Convention which is not a member of the Council of Europe, may be represented and have one vote in the Committee when the Committee carries out the tasks assigned to it by the present Convention.

3. Any State referred to in Article 33 or invited to accede to the Convention in accordance with the provisions of Article 34 which is not Party to this Convention may be represented on the Committee by an observer. If the European Community is not a Party it may be represented on the Committee by an observer.


4. In order to monitor scientific developments, the present Convention shall be examined within the Committee no later than five years from its entry into force and thereafter at such intervals as the Committee may determine.

5. Any proposal for an amendment to this Convention, and any proposal for a Protocol or for an amendment to a Protocol, presented by a Party, the Committee or the Committee of Ministers shall be communicated to the Secretary General of the Council of Europe and forwarded by him to the member States of the Council of Europe, to the European Community, to any Signatory, to any Party, to any State invited to sign this Convention in accordance with the provisions of Article 33 and to any State invited to accede to it in accordance with the provisions of Article 34.

6. The Committee shall examine the proposal not earlier than two months after it has been forwarded by the Secretary General in accordance with paragraph 5. The Committee shall submit the text adopted by a two-thirds majority of the votes cast to the Committee of Ministers for approval. After its approval, this text shall be forwarded to the Parties for ratification, acceptance or approval.

7. Any amendment shall enter into force, in respect of those Parties which have accepted it, on the first day of the month following the expiration of a period of one month after the date on which five Parties, including at least four member States of the Council of Europe, have informed the Secretary General that they have accepted it.

In respect of any Party which subsequently accepts it, the amendment shall enter into force on the first day of the month following the expiration of a period of one month after the date on which that Party has informed the Secretary General of its acceptance.

Chapter XIV - Final clauses

Article 33 - Signature, ratification and entry into force

1. This Convention shall be open for signature by the member States of the Council of Europe, the non-member States which have participated in its elaboration and by the European Community.

2. This Convention is subject to ratification, acceptance or approval. Instruments of ratification, acceptance or approval shall be deposited with the Secretary General of the Council of Europe.


3. This Convention 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 Convention in accordance with the provisions of paragraph 2 of the present article.

4. In respect of any Signatory which subsequently expresses its consent to be bound by it, the Convention 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 its instrument of ratification, acceptance or approval.

Article 34 - Non-member States

1. After the entry into force of this Convention, the Committee of Ministers of the Council of Europe may, after consultation of the Parties, invite any non-member State of the Council of Europe to accede to this Convention by a decision taken by the majority provided for in Article 20, sub-paragraph d, of the Statute of the Council of Europe, and by the unanimous vote of the representatives of the Contracting States entitled to sit on the Committee of Ministers.

2. In respect of any acceding State, the Convention shall enter into force on the first day of the month following the expiration of a period of three months after the date of deposit of the instrument of accession with the Secretary General of the Council of Europe.

Article 35 - Territories

1. Any Signatory may, at the time of signature or when depositing its instrument of ratification, acceptance or approval, specify the territory or territories to which this Convention shall apply. Any other State may formulate the same declaration when depositing its instrument of accession.

2. Any Party may, at any later date, by a declaration addressed to the Secretary General of the Council of Europe, extend the application of this Convention to any other territory specified in the declaration and for whose international relations it is responsible or on whose behalf it is authorised to give undertakings. In respect of such territory the Convention shall enter into force on the first day of the month following the expiration of a period of three months after the date of receipt of such declaration by the Secretary General.

3. Any declaration made under the two preceding paragraphs may, in respect of any territory specified in such declaration, be withdrawn by a notification addressed to the Secretary General. The withdrawal 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 36 - Reservations

1. Any State and the European Community may, when signing this Convention or when depositing the instrument of ratification, acceptance, approval or accession, make a reservation in respect of any particular provision of the Convention to the extent that any law then in force in its territory is not in confonnity with the provision. Reservations of a general character shall not be pennitted under this article.

2. Any reservation made under this article shall contain a brief statement of the relevant law.

3. Any Party which extends the application of this Convention to a territory mentioned in the declaration referred to in Article 35, paragraph 2, may, in respect of the territory concerned, make a reservation in accordance with the provisions of the preceding paragraphs.

4. Any Party which has made the reservation mentioned in this Article may withdraw it by means of a declaration addressed to the Secretary General of the Council of Europe. The withdrawal shall become effective on the first day of the month following the expiration of a period of one month after the date of its receipt by the Secretary General.

Article 37 - Denunciation

1. Any Party may at any time denounce this Convention 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 the notification by the Secretary General.

Article 38 - Notifications

The Secretary General of the Council of Europe shall notify the member States of the Council, the European Community, any Signatory, any Party and any other State which has been invited to accede to this 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 Convention in accordance with Articles 33 or 34;

d) any amendment or Protocol adopted in accordance with Article 32, and the date on which such an amendment or Protocol enters into force;

e) any declaration made under the provisions of Article 35;

f) any reservation and withdrawal of reservation made in pursuance of the provisions of Article 36;

g) any other act, notification or communication relating to this Convention.

In witness whereof the undersigned, being duly authorised thereto, have signed this Convention.

Done at Oviedo (Asturias), this 4th day of April 1997, 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 European Community, to the non-member States which have participated in the elaboration of this Convention, and to any State invited to accede to this Convention.

Europarat

Ubereinkommen zum Schutz der Menschenrechte und der Menschenwlirde im Hinblick auf die Anwendung von Biologie und Medizin:

Ubereinkommen tiber Menschenrechte und Biomedizin vom 4. April 199t

(Nichtamtliche deutsche Fassung)

Praambel

Die Mitgliedstaaten des Europarats, die anderen Staaten und die Europaische Gemeinschaft, die dieses Dbereinkommen unterzeichnen -

eingedenk der von der Generalversammlung der Vereinten Nationen am 10. Dezember 1948 verkiindeten Allgemeinen Erklarung der Menschemechte;

eingedenk der Konvention vom 4. November 1950 zum Schutze der Menschemechte und Grundfreiheiten;

eingedenk der Europaischen Sozialcharta vom 18. Oktober 1961;

eingedenk des Intemationalen Paktes tiber htirgerliche und politische Rechte und des Intemationalen Paktes tiber wirtschaftliche, soziale und kulturelle Rechte vom 16. Dezember 1966;

eingedenk des Dbereinkommens vom 28. Januar 1981 zum Schutz des Menschen bei der automatischen Verarbeitung personenbezogener Daten;

eingedenk auch des Dbereinkommens vom 20. November 1989 tiber die Rechte des Kindes;

in der Erwagung, daB es das Ziel des Europarats ist, eine engere Verbindung zwischen seinen Mitgliedem herbeizufUhren, und daB eines der Mittel zur

• Deutsche Ubersetzung; verbindlich ist nur der W ortlaut in englischer und franzosischer Sprache.

452 Europarat

Erreichung dieses Zieles darin besteht, die Menschenrechte und Grundfreiheiten zu wahren und fortzuentwickeln;

im BewuBtsein der raschen Entwicklung von Biologie und Medizin;

tiberzeugt von der Notwendigkeit, menschliche Lebewesen in ihrer Individualitat und als reil der Menschheit zu achten, und in der Erkenntnis, daB es wichtig ist, ihre Wtirde zu gewahrleisten;

im BewuBtsein, daB der MiBbrauch von Biologie und Medizin zu Handlungen ruhren kann, we1che die Menschenwiirde geflihrden;

bekraftigend, daB die Fortschritte in Biologie und Medizin zum Wohl der heutigen und der ktinftigen Generationen zu nutzen sind;

betonend, daB intemationale Zusammenarbeit notwendig ist, damit die gesamte Menschheit aus Biologie und Medizin Nutzen ziehen kann;

in Anerkennung der Bedeutung, die der Forderung einer Offentlichen Diskussion tiber Fragen im Zusammenhang mit der Anwendung von Biologie und Medizin und tiber die darauf zu gebenden Antworten zukommt;

von dem Wunsch geleitet, aIle Mitglieder der Gesellschaft an ihre Rechte und ihre Verantwortung zu erinnem;

unter Berucksichtigung cler Arbeiten der Parlamentarischen Versammlung auf diesem Gebiet, einschlieBlich der Empfehlung 1160 (1991) tiber die Ausarbeitung eines Ubereinkommens tiber Bioethik;

entschlossen, im Hinblick auf die Anwendung von Biologie und Medizin die notwendigen MaBnahrnen zu ergreifen, urn den Schutz der Menschenwiirde sowie der Grundrechte und Grundfreiheiten des Menschen zu gewahrleisten -

sind wie folgt tibereingekommen:

Kapitel I Allgemeine Bestimmungen

Artikell Gegenstand und Ziel

Die Vertragsparteien dieses Ubereinkommens schiitzen die Wiirde und die Identitat alier menschlichen Lebewesen und gewahrleisten jedermann ohne

Ubereinkommen iiber Menschenrechte und Biomedizin 453

Diskriminierung die Wahrung seiner Integritiit sowie seiner sonstigen Grundrechte und Grundfreiheiten im Hinblick auf die Anwendung von Biologie und Medizin.

Jede Vertragspartei ergreift in ihrem intemen Recht die notwendigen Mal3nahmen, urn diesem Ubereinkommen Wirksamkeit zu verleihen.

Artikel2 Vorrang des menschlichen Lebewesens

Das Interesse und das Wohl des menschlichen Lebewesens haben Vorrang gegenuber dem blol3en Interesse der Gesellschaft oder der Wissenschaft.

Artikel3 Gleicher Zugang zur Gesundheitsversorgung

Die Vertragsparteien ergreifen unter Beriicksichtigung der Gesundheitsbedurfnisse und der verftigbaren Mittel geeignete Mal3nahmen, urn in ihrem Zustlindigkeitsbereich gleichen Zugang zu einer Gesundheitsversorgung von angemessener Qualitat zu schaffen.

Artikel4 Berufspflichten und Verhaltensregeln

Jede Intervention im Gesundheitsbereich, einschliel3lich Forschung, mu13 nach den einschliigigen Rechtsvorschriften, Berufspflichten und Verhaltensregeln erfolgen.

Kapitel II Einwilligung

Artikel5 Allgemeine Regel

Eine Intervention im Gesundheitsbereich darf erst erfolgen, nachdem die betroffene Person uber sie aufgekllirt worden ist und frei eingewilligt hat.

Die betroffene Person ist zuvor angemessen ubet: Zweck und Art der Intervention sowie uber deren Folgen und Risiken aufzuklliren.

Die betroffene Person kann ihre Einwilligung jederzeit frei widerrufen.

454 Europarat

Artikel6 Schutz einwilligungsunnihiger Personen

(1) Bei einer einwilligungsunfahigen Person darf eine Intervention nur zu ihrem unmittelbaren Nutzen erfolgen; die Artikel 17 und 20 bleiben vorbehalten.

(2) 1st eine minderjiihrige Person von Rechts wegen nicht fahig, in eine Intervention einzuwilligen, so darf diese nur mit Einwilligung ihres gesetzlichen Vertreters oder einer von der Rechtsordnung dafiir vorgesehenen BehOrde, Person oder Stelle erfolgen.

Der Meinung der minderjiihrigen Person kommt mit zunehmendem Alter und zunehmender Reife immer mehr entscheidendes Gewicht zu.

(3) 1st eine volljiihrige Person aufgrund einer geistigen Behinderung, einer Krankheit oder aus iihnlichen Grunden von Rechts wegen nicht fahig, in eine Intervention einzuwilligen, so darf diese nur mit Einwilligung ihres gesetzlichen Vertreters oder einer von der Rechtsordnung daflir vorgesehenen BehOrde, Person oder Stelle erfolgen.

Die betroffene Person ist soweit wie moglich in das Einwilligungsverfahren einzubeziehen.

(4) Der Vertreter, die BehOrde, die Person oder die Stelle nach den Absiitzen 2 und 3 ist in der in Artikel 5 vorgesehenen Weise aufzuklliren.

(5) Die Einwilligung nach den Absiitzen 2 und 3 kann im Interesse der betroffenen Person jederzeit widerrufen werden.

Artikel7 Schutz von Personen mit psychischer Storung

Bei einer Person, die an einer schweren psychischen StOrung leidet, darf eine Intervention zur Behandlung der psychischen Storung nur dann ohne ihre Einwilligung erfolgen, wenn ihr ohne die Behandlung ein emster gesundheitlicher Schaden droht und die Rechtsordnung Schutz gewlihrleistet, der auch Aufsichts-, Kontroll- und Rechtsmittelverfahren umfa13t.

Artikel8 Notfallsituation

Kann die Einwilligung wegen einer Notfallsituation nicht eingeholt werden, so darf jede Intervention, die im Interesse der Gesundheit der betroffenen Person medizinisch unerHilllich ist, umgehend erfolgen.

Ubereinkommen fiber Menschenrechte und Biomedizin 455

Artikel9 Zu einem froheren Zeitpunkt geiiu8erte Wonsche

Kann ein Patient im Zeitpunkt der medizinischen Intervention seinen Willen nicht auBem, so sind die Wfinsche zu beriicksichtigen, die er friiher im Hinblick auf eine solche Intervention geauBert hat.

Kapitel III Privatsphare und Recht auf Auskunft

Artikell0 Privatsphare und Recht auf Auskunft

(1) J eder hat das Recht auf Wahrung der Pri vatsphare in bezug auf Angaben tiber seine Gesundheit.

(2) Jeder hat das Recht auf Auskunft in bezug auf aIle tiber seine Gesundheit gesammelten Angaben. Will jemand jedoch keine Kenntnis erhalten, so ist dieser Wunsch zu respektieren.

(3) Die Rechtsordnung kann vorsehen, daB in Ausnahmefallen die Rechte nach Absatz 2 im Interesse des Patienten eingeschrankt werden konnen.

Kapitel IV

Menschliches Genom

Artikelll Nichtdiskriminierung

Jede Form von Diskriminierung einer Person wegen ihres genetischen Erbes ist verboten.

Artikel12 Pradiktive genetische. Tests

Untersuchungen, die es ermoglichen, genetisch bedingte Krankheiten vorherzusagen oder bei einer Person entweder das V orhandensein eines fUr eine Krankheit verantwortlichen Gens festzustellen oder eine genetische Priidisposition oder Anfalligkeit fUr eine Krankheit zu erkennen, dtirfen nur fUr Gesundheitszwecke oder fUr gesundheitsbezogene wissenschaftliche Forschung und nur

456 Europarat

unter der Voraussetzung einer angemessenen genetischen Beratung vorgenommen werden.

Artikel13 Interventionen in das menschliche Genom

Eine Intervention, die auf die Veranderung des menschlichen Genoms gerichtet ist, darf nur zu praventiven, diagnostischen oder therapeutischen Zwecken und nur dann vorgenommen werden, wenn sie nicht darauf abzielt, eine Veranderung des Genoms von Nachkommen herbeizuflihren.

Artikel14 Verbot der Geschlechtswahl

Die Verfahren der medizinisch unterstiitzten Fortpflanzung durfen nicht dazu verwendet werden, das Geschlecht des kunftigen Kindes zu wahlen, es sei denn, urn eine schwere, erbliche geschlechtsgebundene Krankheit zu vermeiden.

Kapitel V Wissenschaftliche Forschung


Vorbehaltlich dieses Ubereinkommens und der sonstigen Rechtsvorschriften zum Schutz menschlicher Lebewesen ist wissenschaftliche Forschung im Bereich von Biologie und Medizin frei.

Artikel16 Schutz von Personen bei Forschungsvorhaben

Forschung an einer Person ist nur zulassig, wenn die folgenden Voraussetzungen erflillt sind:

i) Es gibt keine Alternative von vergleichbarer Wirksamkeit zur Forschung am Menschen;

ii) die moglichen Risiken flir die Person stehen nicht im MiBverhaltnis zum moglichen Nutzen der Forschung;

iii) die zustandige Stelle hat das Forschungsvorhaben gebilligt, nachdem eine unabhangige Priifung seinen wissenschaftlichen Wert einschlieBlich der


Wichtigkeit des Forschungsziels besHitigt hat und eine interdisziplinare Prtifung ergeben hat, daB es ethisch vertretbar ist;

iv) die Personen, die sich fur ein Forschungsvorhaben zur Verfugung stellen, sind tiber ihre Rechte und die von der Rechtsordnung zu ihrem Schutz vorgesehenen SicherheitsmaBnahmen unterrichtet worden, und

v) die nach Artikel 5 notwendige Einwilligung ist ausdrticklich und eigens fur diesen Fall erteilt und urkundlich festgehalten worden. Diese Einwilligung kann jederzeit frei widerrufen werden.

Artikel17 Schutz einwilligungsunflihiger Personen bei Forschungsvorhaben

(1) Forschung an einer Person, die nicht fahig ist, die Einwilligung nach Artikel 5 zu erteilen, ist nur zulassig, wenn die folgenden Voraussetzungen erfuUt sind:

i) Die Voraussetzungen nach Artikel16 Ziffern ibis iv sind erfullt;

ii) die erwarteten Forschungsergebnisse sind fUr die Gesundheit der betroffenen Person von tatsachlichem und unmittelbarem Nutzen;

iii) Forschung von vergleichbarer Wirksarnkeit ist an einwilligungsfahigen Personen nicht moglich;

iv) die nach Artikel 6 notwendige Einwilligung ist eigens fur diesen Fall und schriftlich erteilt worden, und

v) die betroffene Person lehnt nicht abo

(2) In Ausnahmefallen und nach MaBgabe der durch die Rechtsordnung vorgesehenen Schutzbestimmungen darf Forschung, deren erwartete Ergebnisse fur die Gesundheit der betroffenen Person nicht von unmittelbarem Nutzen sind, zugelassen werden, wenn auBer den Voraussetzungen nach Absatz 1 Ziffern i, iii, iv und v zusatzlich die folgenden Voraussetzungen erfiiUt sind:

i) Die Forschung hat zum Ziel, durch eine wesentliche Erweiterung des wissenschaftlichen Verstandnisses des Zustands, der Krankheit oder der StOrung der Person letztlich zu Ergebnissen beizutragen, die der betroffenen Person selbst oder anderen Personen ntitzen konnen, welche derselben Altersgruppe angehOren oder an derselben Krankheit oder StOrung leiden oder sich in demselben Zustand befinden, und

458 Europarat

ii) die Forschung bringt ftir die betroffene Person nur ein minimales Risiko und eine minimale Belastung mit sich.

Artikel18 Forschung an Embryonen in vitro

(1) Die Rechtsordnung hat einen angemessenen Schutz des Embryos zu gewlihrleisten, sofern sie Forschung an Embryonen in vitro zulliBt.

(2) Die Erzeugung menschlicher Embryonen zu Forschungszwecken ist verboten.

Kapitel VI Entnahme von Organen und Gewebe von lebenden Spendern zu

Transplantationszwecken


(1) Einer lebenden Person darf ein Organ oder Gewebe zu Transplantationszwecken nur zum therapeutischen Nutzen des Empfangers und nur dann entnommen werden, wenn weder ein geeignetes Organ oder Gewebe einer verstorbenen Person verfUgbar ist noch eine alternative therapeutische Methode von vergleichbarer Wirksamkeit besteht.

(2) Die nach Artikel 5 notwendige Einwilligung muB ausdrlicklich und eigens fm diesen Fall entweder in schriftlicher Form oder vor einer amtlichen Stelle erteilt worden sein.

Artikel20 Schutz einwilligungsunfahiger Personen

(1) Einer Person, die nicht fahig ist, die Einwilligung nach Artikel 5 zu erteilen, diirfen weder Organe noch Gewebe entnommen werden.

(2) In Ausnahmefallen und nach MaBgabe der durch die Rechtsordnung vorgesehenen Schutzbestimmungen darf die Entnahme regenerierbaren Gewebes bei einer einwilligungsunfahigen Person zugelassen werden, wenn die folgenden Voraussetzungen erflillt sind:

i) Ein geeigneter einwilligungsfahiger Spender steht nicht zur VerfUgung;

ii) der Empfanger ist ein Bruder oder eine Schwester des Spenders;


iii) die Spende muB geeignet sein, das Leben des Empfangers zu retten;

iv) die Einwilligung nach Artikel6 Absatze 2 und 3 ist eigens fUr diesen Fall und schriftlich in Ubereinstimmung mit der Rechtsordnung und mit Billigung der zustandigen Stelle erteilt worden, und

v) der in Frage kommende Spender lehnt nicht abo

Kapitel VII Verbot finanziellen Gewinns;

Verwendung eines Teils des menschlichen Korpers

Artikel21 Verbot finanziellen Gewinns

Der menschliche Korper und Teile davon dfufen als solche nicht zur Erzielung eines finanziellen Gewinns verwendet werden.

Artikel22 Verwendung eines dem menschlichen Korper entnommenen Tells

Wird bei einer Intervention ein Teil des menschlichen Korpers entnommen, so darf er nur zu dem Zweck autbewahrt und verwendet werden, zu dem er entnommen worden ist; jede andere Verwendung setzt angemessene Informationsund Einwilligungsverfahren voraus.

Kapitel VIII Verletzung von Bestimmungen des Ubereinkommens

Artikel23 Verletzung von Rechten oder Grundsatzen

Die Vertragsparteien gewahrleisten einen geeigneten Rechtsschutz, der darauf abzielt, eine widerrechtliche Verletzung der in diesem Ubereinkommen verankerten Rechte und Grundsatze innerhalb kurzer Frist zu verhindem oder zu beenden.

460 Europarat

Artikel24 Schadensersatz

Hat eine Person durch eine Intervention in ungerechtfertigter Weise Schaden erlitten, so hat sie Anspruch auf angemessenen Schadensersatz nach MaBgabe der durch die Rechtsordnung vorgesehenen Voraussetzungen und Modalitiiten.

Artikel25 Sanktionen

Die Vertragsparteien sehen angemessene Sanktionen fUr Verietzungen von Bestimmungen dieses Obereinkommens vor.

Kapitel IX VerhiiItnis dieses Ubereinkommens zu anderen Bestimmungen

Artikel26 Einschriinkungen der Ausiibung der Rechte

(1) Die Ausubung der in diesem Obereinkommen vorgesehenen Rechte und Schutzbestimmungen darf nur insoweit eingeschriinkt werden, als diese Einschriinkung durch die Rechtsordnung vorgesehen ist und eine MaBnahme darstellt, die in einer demokratischen Gesellschaft fur die Offentliche Sicherheit, zur Verhinderung von strafbaren Handlungen, zum Schutz der Offentlichen Gesundheit oder zum Schutz der Rechte und Freiheiten anderer notwendig ist.

(2) Die nach Absatz 1 moglichen Einschrankungen durfen sich nicht auf die Artikelll, 13, 14, 16, 17, 19,20 und 21 beziehen.

Artikel27 Weiterreichender Schutz

Dieses Obereinkommen darf nicht so ausgelegt werden, als beschranke oder beeintrachtige es die Moglichkeit einer Vertragspartei, im Hinblick auf die Anwendung von Biologie und Medizin einen uber dieses Obereinkommen hinausgehenden Schutz zu gewahren.

Ubereinkommen uber Menschenrechte und Biomedizin 461

Kapitel X Offentliche Diskussion

Artikel28 Offentliche Diskussion

Die Vertragsparteien dieses Obereinkommens sorgen dafiir, daB die durch die Entwicklungen in Biologie und Medizin aufgeworfenen Grundsatzfragen, insbesondere in bezug auf ihre medizinischen, sozialen, wirtschaftlichen, ethischen und rechtlichen Auswirkungen, Mfentlich diskutiert werden und zu ihren moglichen Anwendungen angemessene Konsultationen stattfinden.

Kapitel XI Auslegung des Ubereinkommens und FolgemaOnahmen

Artikel29 Auslegung des Ubereinkommens

Der Europaische Gerichtshof flir Menschenrechte kann, ohne unmittelbare Bezugnahme auf ein bestimmtes, bei einem Gericht anhangiges Verfahren, Gutachten tiber Rechtsfragen betreffend die Auslegung dieses Ubereinkommens erstatten, und zwar auf Antrag

der Regierung einer Vertragspartei nach Unterrichtung der anderen Vertragsparteien,

des nach Artikel 32 vorgesehenen und auf die Vertreter der Vertragsparteien beschrankten Ausschusses, wenn der Antrag mit Zweidrittelmehrheit der abgegebenen Stimmen beschlossen worden ist.

Artikel30 Berichte iiber die Anwendung des Ubereinkommens

Nach Aufforderung durch den Generalsekretar des Europarats legt jede Vertragspartei dar, in welcher Weise ihr internes Recht die wirksame Anwendung der Bestimmungen dieses Obereinkommens gewahrleistet.

462 Europarat

Kapitel XII Protokolle

Artikel31 Protokolle

Zur Weiterentwicklung der Grundsiitze dieses Ubereinkomrnens in einzelnen Bereichen konnen Protokolle nach Artikel32 ausgearbeitet werden.

Die Protokolle liegen fUr die Unterzeichner dieses Ubereinkomrnens zur Unterzeichnung auf. Sie bediirfen der Ratiflkation, Annahme oder Genehmigung. Ein Unterzeichner kann die Protokolle ohne vorherige oder gleichzeitige Ratiflkation, Annahme oder Genehmigung des Ubereinkomrnens nicht ratiflzieren, annehmen oder genehmigen.

Kapitel XIII Anderungen des Ubereinkommens

Artikel32 Anderungen des Ubereinkommens

(1) Die Aufgaben, die dieser Artikel und Artikel 29 dem "AusschuB" iibertragen, werden yom LenkungsausschuB flir Bioethik (CDBI) oder von einem anderen yom Ministerkomitee hierzu bestimrnten AusschuB wahrgenomrnen.

(2) Nimrnt der AusschuB Aufgaben nach diesem Ubereinkomrnen wahr, so kann, vorbehaltlich des Artikels 29, jeder Mitgliedstaat des Europarats sowie jede Vertragspartei dieses Ubereinkomrnens, die nicht Mitglied des Europarats ist, im AusschuB vertreten sein und iiber eine Stimrne verfligen.

(3) Jeder in Artikel 33 bezeichnete oder nach Artikel 34 zum Beitritt zu diesem Ubereinkomrnen eingeladene Staat, der nicht Vertragspartei des Ubereinkomrnens ist, kann einen Beobachter in den AusschuB entsenden. 1st die Europiiische Gemeinschaft nicht Vertragspartei, so kann sie einen Beobachter in den AusschuB entsenden.

(4) Damit wissenschaftlichen Entwicklungen Rechnung getragen werden kann, iiberpriift der AusschuB dieses Ubereinkomrnen spiitestens flinf Jahre nach seinem Inkrafttreten und danach in den von ibm bestimrnten Abstanden.

(5) Jeder Vorschlag zur Anderung dieses Ubereinkomrnens und jeder Vorschlag fUr ein Protokoll oder zur Anderung eines Protokolls, der von einer Vertragspartei, dem AusschuB oder dem Ministerkomitee vorgelegt wird, ist dem Generalsekretiir


des Europarats zu ubermitteln; dieser leitet ihn an die Mitgliedstaaten des Europarats, die Europaische Gemeinschaft, jeden Unterzeichner, jede Vertragspartei, jeden nach Artikel 33 zur Unterzeichnung eingeladenen Staat und jeden nach Artikel 34 zum Beitritt eingeladenen Staat weiter.

(6) Der AusschuB proft den Vorschlag frohestens zwei Monate nach dem Zeitpunkt, zu dem der Generalsekretiir ihn nach Absatz 5 weitergeleitet hat. Der AusschuB unterbreitet den mit Zweidrittelmehrheit der abgegebenen Stimmen angenommenen Text dem Ministerkomitee zur Genehmigung. Nach seiner Genehmigung wird dieser Text den Vertragsparteien dieses Ubereinkommens zur Ratifikation, Annahme oder Genehmigung zugeleitet.

(7) Jede Anderung tritt fUr die Vertragsparteien, die sie angenommen haben, am ersten Tag des Monats in Kraft, der auf einen Zeitabschnitt von einem Monat nach dem Tag folgt, an dem fUnf Vertragsparteien, darunter mindestens vier Mitgliedstaaten des Europarats, dem Generalsekretar ihre Annahme der Anderung mitgeteilt haben.

Fur jede Vertragspartei, welche die Anderung spilter annimmt, tritt sie am ersten Tag des Monats in Kraft, der auf einen Zeitabschnitt von einem Monat nach dem Tag folgt, an dem die betreffende Vertragspartei dem Generalsekretiir ihre Annahme der Anderung mitgeteilt hat.

Kapitel XIV SchluObestimmungen

Artikel33 Unterzeichnung, Ratifikation und Inkrafttreten

(1) Dieses Ubereinkommen liegt fur die Mitgliedstaaten des Europarats, fUr die Nichtmitgliedstaaten, die an seiner Ausarbeitung beteiligt waren, und fUr die Europaische Gemeinschaft zur Unterzeichnung auf.

(2) Dieses Ubereinkommen bedarf der Ratifikation, Annahme oder Genehmigung. Die Ratifikations-, Annahme- oder Genehmigungsurkunden werden beim Generalsekretar des Europarats hinterlegt.

(3) Dieses Ubereinkommen tritt am ersten Tag des Monats in Kraft, der auf einen Zeitabschnitt von drei Monaten nach dem Tag folgt, an dem fUnf Staaten, darunter mindestens vier Mitgliedstaaten des Europarats, nach Absatz 2 ihre Zustimmung ausgedrockt haben, durch das Ubereinkommen gebunden zu sein.

464 Europarat

(4) Fili jeden Unterzeichner, der spiUer seine Zustimmung ausdriickt, durch dieses Ubereinkommen gebunden zu sein, tritt es am ersten Tag des Monats in Kraft, der auf einen Zeitabschnitt von drei Monaten nach Hinterlegung seiner Ratifikations-, Annahme- oder Genehmigungsurkunde folgt.

Artikel34 Nichtmitgliedstaaten

(1) Nach Inkrafttreten dieses Ubereinkommens kann das Ministerkomitee des Europarats nach Konsultation mit den Vertragsparteien durch einen BeschluB, der mit der in Artikel 20 Buchstabe d der Satzung des Europarats vorgesehenen Mehrheit und mit einhelliger Zustimmung der Vertreter der Vertragsparteien, die Anspruch auf einen Sitz im Ministerkomitee haben, gefaBt worden ist, jeden Nichtmitgliedstaat des Europarats einladen, dem Ubereinkommen beizutreten.

(2) Fili jeden beitretenden Staat tritt dieses Ubereinkommen am ersten Tag des Monats in Kraft, der auf einen Zeitabschnitt von drei Monaten nach Hinterlegung der Beitrittsurkunde beim Generalsekretar des Europarats folgt.

Artikel35 Hoheitsgebiete

(1) Jeder Unterzeichner kann bei der Unterzeichnung oder bei der Hinterlegung seiner Ratifikations-, Annahme- oder Genehmigungsurkunde ein Hoheitsgebiet oder mehrere Hoheitsgebiete bezeichnen. auf die dieses Ubereinkommen Anwendung findet. Jeder andere Staat kann bei der Hinterlegung seiner Beitrittsurkunde dieselbe Erklarung abgeben.

(2) Jede Vertragspartei kann jederzeit danach durch eine an den Generalsekretiir des Europarats gerichtete Erklarung die Anwendung dieses Ubereinkommens auf jedes weitere in der Erklarung bezeichnete Hoheitsgebiet erstrecken, flir dessen intemationale Beziehungen sie verantwortlich ist oder flir die sie befugt ist, Verpflichtungen einzugehen. Das Ubereinkommen tritt fur dieses Hoheitsgebiet am ersten Tag des Monats in Kraft, der auf einen Zeitabschnitt von drei Monaten nach Eingang der Erkliirung beim Generalsekretiir folgt.

(3) Jede nach den Absatzen 1 und 2 abgegebene Erklarung kann in bezug aufjedes darin bezeichnete Hoheitsgebiet durch eine an den Generalsekretiir gerichtete Notifikation zurUckgenommen werden. Die Riicknahme wird am ersten Tag des Monats wirksam, der auf einen Zeitabschnitt von drei Monaten nach Eingang der Notifikation beim Generalsekretar folgt.


Artikel36 Vorbehalte

(1) Jeder Staat und die Europaische Gemeinschaft konnen bei der Unterzeichnung dieses Ubereinkommens oder bei der Hinterlegung der Ratifikationsurkunde beziiglich bestimmter Vorschriften des Ubereinkommens einen Vorbehalt machen, soweit das zu dieser Zeit in ihrem Gebiet geltende Recht nicht mit der betreffenden Vorschrift iibereinstimmt. Vorbehalte allgemeiner Art sind nach diesem Artikel nicht zuHissig.

(2) Jeder nach diesem Artikel gemachte Vorbehalt muB mit einer kurzen Darstellung des betreffenden Rechts verbunden sein.

(3) Jede Vertragspartei, we1che die Anwendung dieses Ubereinkommens auf ein in der in Artikel 35 Absatz 2 aufgeftihrten Erklarung erwiihntes Hoheitsgebiet erstreckt, kann in bezug auf das betreffende Hoheitsgebiet einen Vorbehalt nach den Absatzen 1 und 2 machen.

(4) Jede Vertragspartei, die einen Vorbehalt nach diesem Artikel gemacht hat, kann ihn durch eine an den Generalsekretar des Europarats gerichtete Erklarung zurUcknehmen. Die Riicknahme wird am ersten Tag des Monats wirksam, der auf einen Zeitabschnitt von einem Monat nach dem Eingang beim Generalsekretar folgt.

Artikel37 Kiindigung

(1) Jede Vertragspartei kann dieses Ubereinkommen jederzeit durch eine an den Generalsekretar des Europarats gerichtete Notifikation kiindigen.

(2) Die Kiindigung wird am ersten Tag des Monats wirksam, der auf einen Zeitabschnitt von drei Monaten nach Eingang der Notifikation beim Generalsekretar folgt.

Artikel38 Notifikationen

Der Generalsekretar des Europarats notifiziert den Mitgliedstaaten des Rates, der Europaischen Gemeinschaft, jedem Unterzeichner, jeder Vertragspartei und jedem anderen Staat, der zum Beitritt zu diesem Ubereinkommen eingeladen worden ist,

a) jede Unterzeichnung, b) jede Hinterlegung einer Ratifikations-, Annahme-, Genehmigungs- oder

Beitrittsurkunde;

466 Europarat

c) jeden Zeitpunkt des Inkrafttretens dieses Ubereinkommens nach Artikel 33 oder 34;

d) jede Anderung und jedes Protokoll, die nach Artikel 32 angenommen worden sind, sowie das Datum des Inkrafttretens der A.nderung oder des Protokolls;

e) jede nach Artikel35 abgegebene ErkHirung; f) jeden Vorbehalt undjede Riicknahme des Vorbehalts nach Artikel36; g) jede andere Handlung, Notifikation oder Mitteilung im Zusammenhang mit

diesem Ubereinkommen.

Zu Urkund dessen haben die hierzu gehOrig befugten Unterzeichneten dieses Ubereinkommen unterschrieben.

Geschehen zu Oviedo (Asturien) am 4. April 1997 in englischer und franzosischer Sprache, wobei jeder Wortlaut gleichermaBen verbindlich ist, in einer Urschrift, die im Archiv des Europarats hinterlegt wird. Der Generalsekretiir des Europarats iibermittelt allen Mitgliedstaaten des Europarats, der Europaischen Gemeinschaft, den Nichtmitgliedstaaten, die an der Ausarbeitung dieses Ubereinkommens beteiligt waren, und allen zum Beitritt zu diesem Ubereinkommen eingeladenen Staaten beglaubigte Abschriften.

Documents

Teilnehmerverzeichnis / List of Participants - Springer978-3-642-57326-2/1.pdf · 370 TeilnehmerverzeichnisIList of Participants Professor Dr. Elmar Doppelfeld Vorsitzender des Arbeitskreises