药学英语翻译_1

药学英语翻译_1 1.每一种药物都有其固有的药理作用特点。如果给药剂量，给药次数，给药途 径恰当，大多数病人可以产生预期的药理效应。但对具体的病人来说，药理效应 可有一定的甚至是非常明显的差异。病人体质，药物质量，病原微生物，以及各 种环境条件都可能影响药物作用。它们可以使药物效应减弱或增强。产生个体差 异的主要原因是药物的吸收，分布，生物转化和排泄的差异。要保证每个病人都 能达到最大疗效、最小不良反应的治疗目的，单纯根据药理作用选药和用药显然 是不够的，还必须掌握影响各种药物的因素，结合病人具体情况，决定适当的治 疗，并在用药过程中不断根据变化及时适当地作出调整，直至病人痊愈。 Each medicine has its inherent the pharmacological function characteristics. If the administration dosage, to therapy, delivery methods appropriate, most patients can produce the desired pharmacological effect. But to specific patients for, pharmacological effect can have certain even very clear differences. Patients constitution, drug quality, pathogenic microbes, and various environmental conditions may affect drug interactions. They can make the effects of drugs increase or decrease. Produce individual difference is the main reason of the drug absorption, distribution, biological transformation and excretion of differences. To ensure that every patient can achieve maximum efficacy, minimum adverse reaction of therapeutic purposes, pure according to choose medicine and pharmacology drug it is not enough, still must master the influence of the factors of different drugs, patients with specific situations, to determine the appropriate treatment, and in the process of drug use in time according to change constantly adjust properly, until the patient recover. 2、构成的解决方案 干燥固体颗粒从这些正是构成方案准备注射熊的标题形式(药品注射。由于这 些剂型构成的保健医生使用,测试和制定有关管理的解决方案是不包括在个 人专著在固体或液体无菌干精矿。然而,在保证质量的兴趣注射制剂作为他们实 际上是管理,以下无损检测提供了展示了合适的解决方案时,他们构成准备之前使 用。 CONSTITUTED SOLUTIONS Dry solids from which constituted solutions are prepared for injection bear titles of the form [DRUG] for Injection. Since these dosage forms are constituted at the time of use by the health care practitioner, tests and standards pertaining to the solution as constituted for administration are not included in the individual monographs on sterile dry solids or liquid concentrates. However, in the interest of assuring the quality of injection preparations as they are actually administered, the following nondestructive tests are provided for demonstrating the suitability of constituted solutions when they are prepared just prior to use. 3.当事人cosponsoring他们对这次会议re-affirmed增加国际协调,旨在保证良好 的质量、安全、有效的药物开发,注册于上海最有效率和最经济的方式。这些活 动均以消费者的利益和公共卫生,防止不必要的重复的人类临床试验,并尽量避免 妨碍使用动物试验没有妥协的规章的义务的安全性和有效性。The Parties cosponsoring this Conference re-affirmed their commitment to increased international harmonisation, aimed at ensuring that good quality, safe and effective medicines are developed and registered in the most efficient and cost-effective manner. These activities are pursued in the interest of the consumer and public health, to prevent unnecessary duplication of clinical trials in humans and to minimise the use of animal testing without compromising the regulatory obligations of safety and 。 4.我很高兴的宣布它将与认证标准开发组织(sdo)关联起来,以便利用发展我 e-Inititatives技术标准。这个决定遵循一系列的讨论结果在提高效率的过程,开始 我督导委员会会议于 2005年5月。另外,可能产生的标准都将会被吸收更多的non-ICH从而提高国 家和组织对全球标准。我标准在全球范围内扩大我实现我的标准的视觉的 future-development更有效率的过程和均匀性要求增加药物开发全球没有妥协的 质量、安全和疗效标准预计由医护人员和病人。ICH is pleased to announce that it will collaborate with accredited Standards Development Organizations (SDOs) to leverage the development of technical standards for ICH e-Inititatives. This decision follows the outcome of a series of discussions on improving the efficiency of the ICH process that started at the Steering Committee meeting in May, 2005. Additionally it is likely that the resulting standards would be taken up by many more non-ICH countries and organizations thereby elevating ICH standards to global standards. Expanding ICH standards globally would fulfill ICH’s vision of the future—development of more efficient processes and increased uniformity of drug development requirements globally without compromising the quality, safety, and efficacy standards expected by practitioners and patients. 5.在美国所有的新药必须要得到联邦食品与药品管理局的批准才能上市。所有 药物都会有潜在的不良反应，所以，只有当某种药物的益处大于其风险时，它才 有可能被批准上市。但是，对新药审批的检查需要很长时间，因此联邦食品与药 品管理局在1987年出台一项规定，允许在一些有价值的试验期间药物用于危重 病人。同时他们也警告说若不经有的临床医生评估病情而随便使用这种尚未 被批准的药物，对这些患者反而有害无益。总之，即使是实验期间药品也必须符 合某个益处风险比例才可试用。In the United States all the drug must to get the federal food and drug administration approval to market. All drugs can have potential adverse effects, therefore, only when a certain drug benefits outweigh the risks, it is likely to be approved on the market. But, the examination and approval of new drug inspection needs a long time, so the federal food and drug administration in 1987 issued a regulation, allowed in some valuable during the tests of drugs for critically ill patient. At the same time they also warned that if not through experienced clinical doctors estimate to use this illness and has not yet been approved drugs, the patients but harmful. All in all, even during the drug also must comply with a good risk proportion to the trial. 6.本世纪 60 年代开始，美国国会赋予食品与药物管理局监督处方药广告的权 力。但有关药品及生物制品广告及宣传的规定在数量上很有限。书面规定的短缺 使 FDA 能够随时改变其政策及行为而不必对公众说明情况。制药业、广告商及 推广商对这种状况深表关注。他们认为在目前这种竞争激烈及信息密集的环境 下，制定有关他们所关心的问题的法规应该经过正式的行政程序，并且这个程序 应给予任何公司和个人对此项规定作出评论及请求改变的机会。目前的情况是这 些公司必须去遵守一些不成文的政策，而且这些政策的实施也没有公开，这就使 整个制药业都处于不利状态。因此，他们急切期望曰叭在药物广告及宣传的规定 及实施上有所改进。Since the’s, the United States congress granted the food and drug administration supervision and prescription drug advertising power. But about the drugs and biological products advertising and publicity of provisions in the number is very limited. Stipulated in writing the shortage of FDA can change its policies and actions to the public and don’t have to explain. The pharmaceutical industry, advertisers and promoter are deeply concerned about the situation. They think that in the current competitive information and dense environment, for they are concerned with the problems and regulations should be after formal administrative procedures, and the program should be given any companies and individuals to make a comment about this paragraph and request opportunity to change. The current situation is these companies have to keep some unwritten policies, and the implementation of these policies and no public, this makes the whole industry is in a bad state. Therefore, they were eager expectation yue in drug advertising and publicity seems the provisions on the implementation and improvement. 7.药品和生物制品是与人民生活密切相关的特殊商品，对这些产品的严格管理 是对人民健康负责的表现。现阶段在我国，越来越多的人选择去药房买药来治疗 一些小病，如发烧、感冒等。这些消费者的选择往往是那些从药品广告，特别是 电视广告中听来的药品。为确保这些广告不会使消费者误入歧途或自开药方，它 们被要求加入“请按医生处方购买”字样。但事实上，众多的消费者仍然忽视这个 忠告，因而一方面，制药业、广告商及市场开拓者需遵循有关法规，在其广告及 宣传资料中应详细说明该产品的优点及风险，以及所有相关信息，不论是对其有 利还是不利的。另一方面，有关部门也应重视对消费者的教育，教育他们要充分 认识到药品广告的局限性，以便能够判断什么是他们最佳的选择。 Pharmaceutical and biological products is closely related to people’s life and special goods, for these products strict management is responsible for the performance of the people’s health. At present in our country, more and more people choose to go to the pharmacy to buy medicines to treat some ailment, such as fever, colds, etc. These consumer choice is often those who from drug advertising, especially television ads to drug listened. To ensure that these ads consumers will not be put astray or from a prescription, they were asked to join "please press a doctor’s prescription to buy," the words. But in fact, many consumers still ignore the advice, so on the one hand, the pharmaceutical industry, advertisers and market the blazers have to follow the relevant laws and regulations, in its advertising and publicity material specified in the product and the advantages of risk, and all relevant information, whether for its positive or negative. On the other hand, the relevant departments have attention should be paid to the consumer education, education they should fully understand the limitations of the drug advertising, in order to be able to tell what is their best choice. 30 年间，制药业经历了巨大的变化，其中的一些变化是因为技术 8.在过去的 的进步而带来的结果，而另外一些变化则是因为组织结构上的变化而引起的。不 管怎么说，与从前相比，现在的研究和发展环境是大大地改善了。 首先是技术上的进步给科研提供了更多的便利:今天的科研人员拥有他们的前 辈在 30 年前所没有的技术装备。这些新技术使 30 年前已“过时”的随机筛选法 又获新生。 其次是生物技术以及制药业中与之相关部门的出现。这使得本行业中出现了很 多从事生物技术的小公司。而这些小公司的出现又在很大程度上改变了制药业的 构成。将来的情况是大的制药公司将主要致力于研制开发市场潜力巨大的产品， 小公司将作为大公司的补充，开发那些需求量虽小但却能发挥其技术优势的产 品。 In the past 30 years, the pharmaceutical industry has experienced great changes, some of these changes due to the progress of technology and will bring results, and some other change it is because of the change of organizational structure and cause. Anyway, compared with the former, now of the research and development environment is greatly improved. First are the technical progress to scientific research to provide a more convenient: today’s scientific research personnel have their predecessors in 30 years ago have no technical equipment. These new technology makes 30 years ago has "out of date" random screening method and normal life. Second is the biological technology and the pharmaceutical industry and the related departments in there. This makes the industry there are many biological technology in a small company. And these small company’s appearance and to a great extent changed the structure of the pharmaceutical industry. The future is big pharmaceutical companies will mainly devotes to research and development the market has great potential products, small company will as a big company of supplement, the demand for development is small but it can play its technical advantage of the products. 9.基础研究是科学进步的基础，也是一切工业发展的动力，但由于基础研究往 往是为追求真理本身而进行的( conducted in the pursuit of truth for its own sake ) ，不能象应用研究那样马上带来直接的经济效益，很多机构不愿意为其投 资。即使在美国这样的发达国家，每年用于基础研究的资金也只占全部科研资金 的 7 % ，因此，不难想象在众多的发展中国家情况还要糟得多。制药业的情况 或多或少也是一样的。制药公司愿意为研制某种新药投资而不愿为基础研究投 资，因为他们希望在短时间内获利。但可喜的是，本行业在近年来也已意识到这 是一种短视的做法。例如，人们已经意识到，如果不真正掌握癌症的致病原因， 那末所有的抗癌药物只能是缓解剂而非治疗剂。从长远来看，谁在基础研究上有 所突破，谁才能最终获利。这也许会成为制药业投资基础研究的动机吧。 The basic research is the foundation of scientific progress, is all the power for the development of the industry, but due to the basic research is often seek truth itself for the (conducted in the pursuit of truth for its own sake), can not be like application research that immediately bring direct economic benefit, many institutions are reluctant to for their investment. Even in developed countries such as the U.S., every year for the basic research of the capital account for just 7% of all research funds, therefore, it is not difficult to imagine in many of the developing countries worse situation. The pharmaceutical industry situation more or less is the same. Pharmaceutical companies are willing to develop a new drug for investment rather than for the basic research investment, because they want to profit in a short time. But the good news is this industry in recent years have already aware that this is a short-sighted approach. For example, people have realized, if not master the causes of cancer, then all of the cancer drugs can only is to alleviate the agent and not therapeutic agent. In the long run, who has achieved in basic research, who can eventually profit. This may be the motive of the pharmaceutical industry investment basis? 应当由有资格的人员定期进行培训，至少应当包括员工所从事的特定操作和与 其职能有关的GMP。培训记录应当保存，并且应定期对培训进行评估。By a qualified personnel shall be regular training shall at least include the employees engaged in the specific operating and its function of the GMP. Training records shall be kept, and should be regularly for the training for the evaluation. 中间体或原料药生产和控制的顾问应当有足够的学历，受训和经验，能胜任所 承担的工作。 Intermediate or API production and control of the consultants shall have enough education, training and experience, can be competent for the job. 实验室区域/操作通常应当与生产区隔离。有些实验室区域，特别是用于中间控 制的，可以位于生产区内，只要生产工艺操作对实验室测量的准确性没有负面影 响，而且实验室及 其操作对生产过程，或中间体，或原料药也没有负面影响。Laboratory area/operation and production areas shall be usually isolation. Some laboratory area, especially used in the middle control, located in production area can be, as long as production process operation on the measuring accuracy of the laboratory no negative effects, and laboratory and its operation on the production process, or intermediates, or an API and no negative effects. 剧毒的非药用物质，如除草剂，杀虫剂的任何生产活动(包括称重，研磨或包 装)都不应当使用生产原料药的厂房和/或设施。这类剧毒非药用物质的处理和 贮存都应当与原料药分开。The medicinal material not poisonous, such as herbicides, pesticide any production activities (including weighing, grinding or packaging) should use active pharmaceutical ingredients (apis) workshop and/or facilities. This kind of medicinal substance poisonous handling and storage should be separated with API. 进入和流出厂房以及临近区域的污水，垃圾和其他废物(如生产中的固态，液态 或气态的副产物)，应当安全，及时，卫生地处理。废物的容器和/或管道应当显 著地标明。 Into and out of the area near the factory and sewage, trash and other waste (such as the production of the solid, liquid or gaseous by-products), shall be safe, timely, health to deal with. Waste containers and/or pipe shall be as significant. 世界医学会制定赫尔辛基宣言,作为报表的伦理原则,以期指导医师及医学研究 人员在对涉及人类的科目。涉及人体试验之医学研究包括研究人类的材料或可辨 认的数据。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. 医师之职责,促进和保障人民的健康。医生的知识和良知应奉献于此一使命完 成。It is the duty of the physician to promote and safeguard the health of the people. The physician’s knowledge and conscience are dedicated to the fulfillment of this duty. 《独立宣言》的日内瓦的世界医学会使医生说:“我的病人的健康将是我的第一 次考虑,“国际代码医学伦理学的声明:“医生应当只在病人的利益提供医疗护理可 能的作用削弱了生理和心理状态的病人。”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." 医学之进步奠基于科学研究,而此研究终究必须有部份仰赖其他有关人体试验。 Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects. 在医学研究中对人类研究对象,考虑相关的人类主体的幸福应该优先于科学与 社会的利益。In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society. 医学研究的主要目的是改善有关人体试验的预防、诊断和治疗的程序和成因之 瞭解及致病机转的疾病。即使是最好的行之有效的预防、诊断及治疗之方法,通 过研究应不断地挑战为他们的有效性、效率、可得性和质量。The primary purpose of medical research involving human subjects is to improve prophylactic, diagnostic and therapeutic 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. 在当前的医疗实践和医学研究中,大多数的预防、诊断及治疗程序都涉及风险和 负担。In current medical practice and in medical research, most prophylactic, diagnostic and therapeutic procedures involve risks and burdens. 医学研究伦理标准必须发扬尊重所有的人类和保护他们的健康和权利。一些研 究人口脆弱,需要特别保护。特定的需求和医学弱势经济必须被认可。也需要特 别注意那些不能给自己或拒绝同意,那些将会受到答应被胁迫,对于那些将不利于 个人从研究和那些为谁研究结合护理。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. 研究人员应该知道之伦理、法律和法规的要求,为研究人类主体在他们自己的国 家以及适用的国际需求。没有全国性的伦理、法律、法规的要求应该被允许减少 或消除任何保护人类受试者中所述的这一宣言。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. 医师之职责医学研究中保护生命、健康、个人隐私和尊严受试验者之。It is the duty of the physician in medical research to protect the life, health, privacy, and dignity of the human subject. 有关人体试验的医疗研究必须符合公认的科学原则,全面了解的基础上的科学 文献,其他相关的信息来源,及适当的实验室,并在适当的情况下,动物实验。 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 on adequate laboratory and, where appropriate, animal experimentation. 都必须谨慎实施过程中可能影响环境之研究,动物福利所用于研究必须要被尊 重。 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. 每一个设计、性能指标进行人体实验程序应该明确制定实验协议。本议定书应 提交的考虑、意见、指导,并在适当的地方,一个特别指定审批伦理审查委员会, 必须独立的调查员,赞助或者其它类型的不良影响。这个独立委员会应是符合法 律、法规的国家进行实验研究。该委员会有权监督正在进行的试验。研究者有义 务向委员会提供监测信息,尤其是任何严重不良事件。研究者还应向委员会审查, 有关资金、赞助商、制度背景,其他潜在的利益冲突、奖励的科目。The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol. This protocol should be submitted for consideration, comment, guidance, and where appropriate, approval to a specially appointed ethical review committee, which must be independent of the investigator, the sponsor or any other kind of undue influence. This independent committee 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. 试验计画书应该包含一个相关伦理考量的声明表明,应符合本宣言所揭橥之原 则。The research protocol should always contain a statement of the ethical considerations involved and should indicate that there is compliance with the principles enunciated in this Declaration. 有关人体试验的医疗研究应该进行人才,只有科学的监督下,临床医学主管人。 人类的责任主体必须总要休息资格的人员和医学无法休息主题的研究,即使这个 课题给予同意。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 consent. 每一个有关人体试验的医疗研究,事前须审慎评估可能的风险、责任、以及 可预见的利益相比,对受试验者或其他人。这并不妨碍健康志愿者参与的医学研 究。所有研究的设计应该公开的方式。Every 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. 医生应避免从事有关人体试验的研究计划,除非他们有信心的风险已充份评估 可以很好地管理。医生应停止其研究发现,如果风险超过潜在的利益或如果有确 凿证据积极有益的结果。Physicians should abstain from engaging in research projects involving human subjects unless they are confident that the risks involved have been adequately assessed and can be satisfactorily managed. Physicians should cease any investigation if the risks are found to outweigh the potential benefits or if there is conclusive proof of positive and beneficial results. 涉及人体试验之医学研究才可以进行如果在研究目的之重要性大于其固有的 风险负担的话题。这是特别重要的是当人体健康志愿者。Medical research involving human subjects should only be conducted if the importance of the objective outweighs the inherent risks and burdens to the subject. This is especially important when the human subjects are healthy volunteers. 医学研究唯有被的族群可能的研究才有其执行成果中获益的研究。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. 受 试者必须是志愿参加,并告知参与该项研究计划。The subjects must be volunteers and informed participants in the research project. 在治疗病人,在证明预防、诊断和治疗的方法不存在或已经无效的,医生,与患者 知情同意,必须自由地使用新的或新的预防、诊断和治疗措施,如果在医生的判断, 它提供了希望拯救生命,还健康或减轻痛苦。如果可能,这些措施应该使研究对象, 旨在评估他们的安全性和有效性。在所有病例中,新信息应该被记录,并在适当的 情况下,出版了。其他有关规定申报应该被执行。In the treatment of 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 new prophylactic, diagnostic and therapeutic measures, if in 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. 研究结果表明,每一个患者进入书房应该是保证获得最优秀的证明的预防、诊断 和治疗的方法被研究。医生应充分告知病患,那些方面的医疗照护与研究。病人 拒绝参加研究必须不影响医患关系。At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study. The physician should fully inform the patient which aspects of the care are related to the research. The refusal of a patient to participate in a study must never interfere with the patient-physician relationship. 医师可以结合医学研究与医疗照护,只有不同的研究有潜在的预防、诊断或治疗 的价值。当医学研究结合医疗照护时,额外的准则来保护这些患者作为研究对象。 收益、风险、责任和效果的一种新方法需要被测试目前最佳的预防、诊断和治疗 方法。这并不排除使用安慰剂或不治疗,还没有证明研究预防、诊断或治疗的方 法。The physician may combine medical research with medical care, only to the extent that the research is justified by its potential prophylactic, diagnostic or therapeutic value. When medical research is combined with medical care, additional standards apply to protect the patients who are research subjects. The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists. 研究对象的权利保护其完整性必须得到尊重。应采取各种措施尊重隐私主体、 保密的病人的信息以及减少负面影响研究的主体的身心健全及人格的主题。在任 何研究人类,每个潜在的主体必须充分了解的目的、方法、资金来源,任何可能的 利益冲突、制度归属的研究员,预期效益和潜在风险的研究和不安可能需要。主 体的权利应该被告知要禁戒参与学习或撤回同意参加任何时间,而不会报复。在 确保这个课题的理解信息,医师应最终获得主体的freely-given知情同意,最好是 书面的同意。如果无法取得书面同意,撰写必须正式同意记载和证据。 The right of research subjects to safeguard their integrity must always be respected. Every precaution should be taken to respect the privacy of the subject, the confidentiality of the patient’s information and to minimize the impact of the study on the subject’s physical and mental integrity and on the personality of the subject. 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 risks of the study and the discomfort it may entail. The subject should be informed of 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, the 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. 在获取知情同意研究项目医师应特别注意主题有依赖关系,医师或被胁迫同意。 在那种情况下,知情同意应该得到了消息灵通的医生,他没有参与调查和谁是完全 独立于这一关系。为研究对象法律无能,身体上的还是精神上无法答应或者是一 个法律上无能的未成年人,研究者必须得到其法定代理人同意依照可适用的 法律。这些团体不应被包括在研究是非常必要的,除非研究促进大众健康,代表和 本研究代替不用于合法的主管人。When obtaining informed consent for the research project the physician should be particularly cautious if the subject is in a dependent relationship 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 relationship. 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 from the legally authorized representative in accordance with applicable law. 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. 当一个主题被视为无法律无能,如一个未成年的孩子,会给同意对参与研究的决 定时,研究人员必须获得批准,除了其法定代理人同意。研究从谁不是个人春意取 ,只有当他应该做的身心状况,防止受试同意书是得同意,包括代理radvance同意 一个必要特征的研究人口。具体的原因,包括研究对象的情况下,也会使他们变得 无法告知应规定审核和批准实验协议的审查委员会。该方案要声明同意留在研究 应尽快获得从个人还是一个经合法授权的代理。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. Research on individuals from whom it is not ossible to obtain consent, including proxy radvance consent, should be done only if he physical/mental condition that prevents obtaining informed consent is a necessary characteristic of the research population. The specific reasons for involving research subjects with a condition that renders them unable to give informed consent should be stated in the experimental protocol for 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. 两个作者和出版商有道德责任。在发表的研究成果,研究人员必须保存结果的精 度。消极和积极的结果就会出版或其它公众开放。资金来源、制度背景和任何可 能的利益冲突应该定义在出版发行。实验报告不符合原则躺在此声明不应该接受 发表。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.