ヘルシンキ宣言第６版（2000年10月7日、英国エディンバラで行われた第52回世界医師会総会にて採択）の、第５版からの改訂箇所

（2000年10月22日土屋貴志作成）

＊削除箇所は<　　>、追加ないし訂正箇所は[　　]で示し、訂正の場合は[　　]内に訂正前の第5版の文言を記す。また、移動の場合は[　　]内に移動前の箇所のナンバリングを記す（ただし「Introduction」は第5版ではナンバリングのない8つの段落からなっているので、何番目の段落にあたるかを記した）。

World Medical Association Declaration of Helsinki:

<Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects>

[Ethical Principles for Medical Research Involving Human Subjects]

Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964

and amended by the

29th WMA General Assembly, Tokyo, Japan, October 1975

35th WMA General Assembly, Venice, Italy, October 1983

41st WMA General Assembly, Hong Kong, September 1989

<and the>

48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996

[and the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000]

A. Introduction

1. [第8段落前半] <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.> [The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. 　Medical research involving human subjects includes research on identifiable human material or identifiable data.]

2. [第1段落] It is the <mission> [duty] of the physician to [promote and] safeguard the health of the people. <His or her> [The physician's] knowledge and conscience are dedicated the fulfillment of this <mission> [duty].

3. [第2段落] The Declaration of Geneva of the World Medical Assembly 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."

4. [第5段落] Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects.

5. [I-5後半] [In medical research on human subjects,] <Concern for the interest> [considerations related to the well-being] of the [human] subject <must always prevail> [should take precedence over the interests of science and society].

6. [第3段落] The [primary] purpose of <biomedical> [medical] research involving human subjects must be to improve diagnostic, therapeutic and prophylactic procedures and the understanding of the aetiology and pathogenesis of disease. [Even the best proven prophylactic, diagnostic, and therapeutic methods must continuously be challenged through research for their effectiveness, efficiency, accessibility and quality.]

7. [第4段落] In current medical practice [and in medical research, most prophylactic,] diagnostic<,> [and] therapeutic <or prophylactic> procedures involve <hazards> [risks and burdens]. <This applies especially to biomedical research.>

[第6段落＝全文削除] <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.>

8. [Medical research is subject to ethical standards that promote respect for all human beings and protect their health and rights. Some research populations are vulnerable and need special protection. The particular needs of the economically and medically disadvantaged must be recognized. Special attention is also required for those who cannot give or refuse consent for themselves, for those who may be subject to giving consent under duress, for those who will not benefit personally from the research and for those for whom the research is combined with care.]

9. [第8段落後半] <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, civic and ethical responsibilities under the laws of their own countries.> [Research Investigators should be aware of the ethical, legal and regulatory requirements for research on human subjects in their own countries as well as applicable international requirements. No national ethical, legal or regulatory requirement should be allowed to reduce or eliminate any of the protections for human subjects set forth in this Declaration.]

B. [I.] Basic Principles [for All Medical Research]

10. [III-1.] <In the purely scientific application of medical research carried out on a human being,> It is the duty of the physician [in medical research] to <remain the protector of the life and health of that person on whom biomedical research is being carried out> [protect the life, health, privacy, and dignity of the human subject].

11. [I-1.] <Biomedical> [Medical] 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 [, other relevant sources of information, and on adequate laboratory and, where appropriate, animal experimentation].

12. [第7段落] <Special> [Appropriate] 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.

13. [I-2.] The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol <which>[.] [This protocol] should be <transmitted> [submitted] for consideration, comment and guidance [, and where appropriate, approval] to a specially appointed [ethical review] committee [, which must be] independent of the investigator [,] and the sponsor [or any other kind of undue influence.] <provided that t> [T]his independent committee <is> [should be] in conformity with the laws and regulations of the country in which the research experiment is performed. [The committee has the right to monitor ongoing trials. The researcher has the obligation to provide monitoring information to the committee, especially any serious adverse events. The researcher should also submit to the committee, for review, information regarding funding, sponsors, institutional affiliations, other potential conflicts of interest and incentives for subjects.]

14. [I-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> [there is compliance with the principles enunciated in this Declaration].

15. [I-3.] <Biomedical> [Medical] 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.

16. [I-5前半] Every <biomedical> [medical] research [project] involving human subjects should be preceded by careful assessment of predictable risks [and burdens] in comparison with foreseeable benefits to the subject or to others. [This does not preclude the participation of healthy volunteers in medical research. The design of all studies should be publicly available.]

17. [I-7.] Physicians should abstain from engaging in research projects involving human subjects unless they are <satisfied> [confident] that the <hazards> [risks] involved <are believed to be predictable> [have been adequately assessed and can be satisfactorily managed]. Physicians should cease any investigation if the <hazards> [risks] are found to outweigh the potential benefits [or if there is conclusive proof of positive and beneficial results].

18. [I-4.] <Biomedical> [Medical] research involving human subjects <cannot legitimately be carried out unless> [should only be conducted if] the importance of the objective <is in proportion to> [outweighs] the inherent risk [and burdens] to the subject. [This is especially important when the human subjects are healthy volunteers.]

19. [III-4?] <In research on man, the interest of science and society should never take precedence over considerations related to the well being of the subject.> [Medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research.]

20. [III-2.] The subject <should> [must] be volunteers [and informed participants in the research project] <- either healthy persons or patients for whom the experimental design is not related to the patient's illness>.

21. [I-6.] The right of the research subject to safeguard <his or her> [their] integrity must always be respected. Every precaution should be taken to respect the privacy [, the confidentiality of the patient's information] <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.

22. [I-9.] In any research on human beings, each potential subject must be adequately informed of the aims, methods [, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the] anticipated benefits and potential hazards of the study and the discomfort it may entail. <He or she> [The] subject should be informed <that he or she is a 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. T> [the right to abstain from participation in the study or to withdraw consent to participate at any time without reprisal. After ensuring that the subject has understood the information, t]he physician should then obtain the subject's freely-given informed consent, preferably in writing. [If the consent cannot be obtained in writing, the non-written consent must be formally documented and witnessed.]

23. [I-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> [with the physician] or may consent under duress. In that case the informed consent should be obtained by a [well-informed] physician who is not engaged in the investigation and who is completely independent of this <official> relationship.

24. [I-11前半] <In case of legal incompetence> [For a research subject who is legally incompetent, physically or mentally incapable of giving consent or is a legally incompetent minor, the investigator must obtain] informed consent <should be obtained> from the <legal guardian> [legally authorized representative] in accordance with <national legislation> [applicable law]. <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.> [These groups should not be included in research unless the research is necessary to promote the health of the population represented and this research cannot instead be performed on legally competent persons.]

25. [I-11後半] <Whenever the minor child is in fact able to give consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian.> [When a subject deemed legally incompetent, such as a minor child, is able to give assent to decisions about participation in research, the investigator must obtain that assent in addition to the consent of the legally authorized representative.]

26. [II-5.] [Research on individuals from whom it is not possible to obtain consent, including proxy or advance consent, should be done only if the physical/mental condition that prevents obtaining informed consent is a necessary characteristic of the research population.] <If the physician considers it essential not to obtain informed consent, t> [The specific reasons for] <this proposal> [involving research subjects with a condition that renders them unable to give informed consent] should be stated in the experimental protocol for <transmission to the independent committee (I,2)> [consideration and approval of the review committee. The protocol should state that consent to remain in the research should be obtained as soon as possible from the individual or a legally authorized surrogate.]

27. [I-8.] [Both authors and publishers have ethical obligations.] In publication of the results of research, the investigators are obliged to preserve the accuracy of the results. [Negative as well as positive results should be published or otherwise publicly available. Sources of funding, institutional affiliations and any possible conflicts of interest should be declared in the publication.] Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication.

C. [II.] [Additional Principles for] Medical research combined with clinical care <(Clinical research)>

28. [II-6.] The physician <can> [may] combine medical research with <professional> [medical] care, <the objective being the acquisition of new medical knowledge,> only to the extent that <medical> the research is justified by its potential [prophylactic,] diagnostic or therapeutic value <for the patient>. [When medical research is combined with medical care, additional standards apply to protect the patients who are research subjects.]

29. [II-2＋II-3後半] The <potential> benefits, <hazards and discomfort> [risks, burdens and effectiveness] of a new method should be <weighed> [tested] against <the advantages> [those] of the best current [prophylactic,] diagnostic[,] and therapeutic methods. This does not exclude the use of <inert> placebo [, or no treatment,] in studies where no proven [prophylactic,] diagnostic or therapeutic method exists.

30. [II-3前半] <In any medical> [At the conclusion of the] study, every patient <-- including those of a control group, if any-- > [entered into the study] should be assured of [access to] the best proven [prophylactic,] diagnostic and therapeutic method [identified by the study].

31. [II-4.] [The physician should fully inform the patient which aspects of the care are related to the research.] The refusal of the patient to participate in a study must never interfere with the physician- patient relationship.

32. [II-1.] In the treatment of <the sick person> a patient, [where proven prophylactic, diagnostic and therapeutic methods do not exist or have been ineffective, the physician, with informed consent from the patient,] must be free to use [unproven or] <a> new [prophylactic,] diagnostic and therapeutic <measure> measures, if in <his or her> the physician's judgement it offers hope of saving life, re-establishing health or alleviating suffering. [Where possible, these measures should be made the object of research, designed to evaluate their safety and efficacy. In all cases, new information should be recorded and, where appropriate, published. The other relevant guidelines of this Declaration should be followed.]

<III. Non-therapeutic biomedical research involving human subjects (Non-clinical biomedical research)>

<III-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.>