阅读讨论

1．阅读和讨论有关人体试验的伦理规范：①纽伦堡伦理规范（Nuremberg Code）;②赫尔辛基宣言（Declaration of Helsinki）。

纽伦堡伦理规范

●时间：1947年8月19日

●地点：德国纽伦堡市

●背景：对第二次世界大战23名德国战犯进行审判，其罪名是强迫战俘接受“人体实验”

Nuremberg Code

The Nuremberg code includes such principles as informed consent and absence of coercion; properly formulated scientific experimentation;and beneficence towards experiment participants.

The ten points of the Nuremberg Code：

1.The voluntary consent of the human subject is absolutely essential.This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him/her to make an understanding and enlightened decision.This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment.It is a personal duty and responsibility which may not be delegated to another with impunity.

2.The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

3.The experiment should be so designed and based on the results of animal experimentation and knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.

4.The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

5.No experiment should be conducted where there is a prior reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.

6.The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

7.Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

8.The experiment should be conducted only by scientifically qualified persons.The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.

9.During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.

10.During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

参考译文

1．接受试验者必须自愿同意参加，且必须具有法律能力和自由选择的能力来填写同意书，不受任何欺骗、胁迫、劝诱、恐吓或任何强迫手段的驱使；研究者有责任让受试者对试验的主题、时间、目的、方法、可能的伤害、不便、对健康或个人的影响等有充足的知识和了解，以便受试者作出决定。

2．人体试验必须是绝对必要的，对社会具有重要意义，且无法用其他方法取代。

3．人体试验必须有充分的理论基础。

4．人体试验必须在避免所有不必要身体及心理痛苦及伤害的原则下进行。

5．如果事先知道此试验将带来死亡或残疾，则此人体试验不可做，除非研究者本人也是被试验对象中的一员。

6．试验的危险程度绝对不可超过试验所能解决问题的重要程度。

7．试验必须有适当的准备和充足的人员、设备，保护受试者现在甚至将来免于受到任何伤害、残障或死亡的可能。

8．试验必须由合格的科研人员进行，受试者在整个试验过程中，必须得到最好的技术和照护。

9．在整个试验过程中，受试者必须都是自愿参与，如受试者在身体或心理方面无法继续，受试者可以决定退出该试验。

10．在试验进行中，如果试验者认为继续试验可能会引起受试者伤害、残疾或死亡时，必须随时准备终止研究。

在线学习——纽伦堡伦理规范（Record）

学习心得：____________________________________________________________________________________________________

赫尔辛基宣言

●《赫尔辛基宣言》全称为《世界医学会赫尔辛基宣言》

●首次通过时间：1964年。历经多次修改

●地点：芬兰赫尔辛基

●背景：第18届世界医学会

Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects（2013）

Preamble

1.The World Medical Association（WMA）has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

The Declaration is intended to be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs.

2.Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians.The WMA encourages others who are involved in medical research involving human subjects to adopt these principles.

General Principles

3.The Declaration of Geneva of the WMA 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 in the patient's best interest when providing medical care”.

4.It is the duty of the physician to promote and safeguard the health，well-being and rights of patients, including those who are involved in medical research. The physician's knowledge and conscience are dedicated to the fulfilment of this duty.

5.Medical progress is based on research that ultimately must include studies involving human subjects.

6.The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions（methods, procedures and treatments）.Even the best proven interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality.

7.Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights.

8.While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.

9.It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects.The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.

10.Physicians must consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards.No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.

11.Medical research should be conducted in a manner that minimises possible harm to the environment.

12.Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications.Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional.

13.Groups that are underrepresented in medical research should be provided appropriate access to participation in research.

14.Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.

15.Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.

Risks, Burdens and Benefits

16.In medical practice and in medical research, most interventions involve risks and burdens.

Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.

17.All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation.

Measures to minimise the risks must be implemented.The risks must be continuously monitored, assessed and documented by the researcher.

18.Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed.

When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify or immediately stop the study.

Vulnerable Groups and Individuals

19.Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm.

All vulnerable groups and individuals should receive specifically considered protection.

20.Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group.In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.

Scientific Requirements and Research Protocols

21.Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation.The welfare of animals used for research must be respected.

22.The design and performance of each research study involving human subjects must be clearly described and justified in a research protocol.

The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed.The protocol should include information regarding funding, sponsors, institutional affiliations, potential conflicts of interest, incentives for subjects and information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study.

In clinical trials, the protocol must also describe appropriate arrangements for posttrial provisions.

Research Ethics Committees

23.The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins.This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified.It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration.

The committee must have the right to monitor ongoing studies.The researcher must provide monitoring information to the committee, especially information about any serious adverse events.No amendment to the protocol may be made without consideration and approval by the committee.After the end of the study, the researchers must submit a final report to the committee containing a summary of the study's findings and conclusions.

Privacy and Confidentiality

24.Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.

Informed Consent

25.Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary.Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.

26.In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study.The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal.Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information.

After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject's freely-given informed consent, preferably in writing.If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.

All medical research subjects should be given the option of being informed about the general outcome and results of the study.

27.When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress.In such situations the informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship.

28.For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative.These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.

29.When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorised representative. The potential subject's dissent should be respected.

30.Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group.In such circumstances the physician must seek informed consent from the legally authorised representative.If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee.Consent to remain in the research must be obtained as soon as possible from the subject or a legally authorised representative.

31.The physician must fully inform the patient which aspects of their care are related to the research.The refusal of a patient to participate in a study or the patient's decision to withdraw from the study must never adversely affect the patient-physician relationship.

32.For medical research using identifiable human material or data, such as research on material or data contained in biobanks or similar repositories, physicians must seek informed consent for its collection, storage and/or reuse.There may be exceptional situations where consent would be impossible or impracticable to obtain for such research.In such situations the research may be done only after consideration and approval of a research ethics committee.

Use of Placebo

33.The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention（s）, except in the following circumstances：

Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or

Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.

Extreme care must be taken to avoid abuse of this option.

Post-Trial Provisions

34.In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial.This information must also be disclosed to participants during the informed consent process.

Research Registration and Publication and Dissemination of Results

35.Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.

36.Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting.Negative and inconclusive as well as positive results must be published or otherwise made publicly available.Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication.Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.

Unproven Interventions in Clinical Practice

37.In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorised representative, may use an unproven intervention if in the physician's judgement it offers hope of saving life, re-establishing health or alleviating suffering.This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy.In all cases, new information must be recorded and, where appropriate, made publicly available.

（来源：http://www.wma.net/en/30publications/10policies/b3/）

在线学习——赫尔辛基宣言（Record）

学习心得：____________________________________________________________________________________________________

2．阅读以下两篇有关伦理的论文，以小组为单位讨论其中的伦理问题并汇报。

（1）徐喜荣．论人体试验中受试者的知情同意权——从“黄金大米”事件切入[J]．河北法学，2013（11）:111-120.

（2）朱炜，王南．从科研人员多采血看知情同意权[J]．中国医学伦理学，2004（3）:17-18.