ICH-GCP中英文对照（完整） - 图文

3. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC) 机构审查委员会/独立的伦理委员会

3.1 Responsibilities 职责

3.1.1 An IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should

be paid to trials that may include vulnerable subjects. 3.1.1 IRB/IEC应当保护所有试验对象的权利、安全和健康。应当特别注意那些可能包括有弱势对象的试验。

3.1.2 The IRB/IEC should obtain the following documents: 3.1.2 IRB/IEC应当得到以下文件：

trial protocol(s)/amendment(s), written informed consent form(s) and consent form updates that the investigator proposes for use in the trial, subject recruitment procedures (e.g. advertisements), written information to be provided to subjects, Investigator's Brochure (IB), available safety information, information about payments and compensation available to subjects, the investigator’s current curriculum vitae and/or other documentation evidencing qualifications, and any other documents that the IRB/IEC may need to fulfil its responsibilities. 试验方案/修改，研究人员申请用于试验的书面知情同意书及其更新件，对象招募程序（如广告），提供给对象的书面材料，研究者手册（ＩＢ），可得到的安全性材料，对象可获得的付款和补偿，研究人员的最新简历/或其他证明其资格的文件，以及IRB/IEC履行其职责所需要的任何其他文件。

The IRB/IEC should review a proposed clinical trial within a reasonable time and document its views in writing, clearly identifying the trial, the documents reviewed and the dates for the following:

IRB/IEC应当在合理的时限内审查所提议的临床研究，提供书面审评意见，明确的确认试验、所审评的文件和日期如下：

? approval/ favourable opinion; ? 批准/赞成意见

? modifications required prior to its approval/favourable opinion; ? ? ? ?

在批准/赞成之前所需要的修改 disapproval / negative opinion; and 不批准/负面的意见；和

termination/suspension of any prior approval/favourable opinion.

? 中止/暂停先前的批准/赞成意见

3.1.3 The IRB/IEC should consider the qualifications of the investigator for the proposed trial, as documented

by a current curriculum vitae and/or by any other relevant documentation the IRB/IEC requests. IRB/IEC应当参照现行简历和/或IRB/IEC要求的其他相关文件考虑所提议试验的研究人员的资格。

3.1.4 The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree

of risk to human subjects, but at least once per year. IRB/IEC应当根据人类对象的危险度，间隔一定事件对正在进项的试验继续审评，但至少每年一次。

3.1.5 The IRB/IEC may request more information than is outlined in paragraph 4.8.10 be given to subjects

when, in the judgement of the IRB/IEC, the additional information would add meaningfully to the protection of the rights, safety and/or well-being of the subjects. 在IRB/IEC评价中，当补充资料对于保护对象的权利、安全和/或健康有意义时，IRB/IEC可能需要比4.8.10段概述的给予对象的更多资料。

3.1.6 When a non-therapeutic trial is to be carried out with the consent of the subject’s legally acceptable

representative (see 4.8.12, 4.8.14), the IRB/IEC should determine that the proposed protocol and/or other document(s) adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trials.

当一个将进行的非治疗试验是由对象的可接受的合法代表给出知情同意时（见4.8.12.4.8.14），IRB/IEC应当确定，所建议的方案和/或其他文件已经充分说明了相关的伦理学考虑，并符合这一类试验的适用管理要求。

3.1.7 Where the protocol indicates that prior consent of the trial subject or the subject’s legally acceptable

representative is not possible (see 4.8.15), the IRB/IEC should determine that the proposed protocol and/or other document(s) adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trials (i.e. in emergency situations). 试验方案指出试验对象或其合法的可接受的代表的不可能先给出知情同意时（见4.8.15），IRB/IEC应当确定所提议的方案和/或其他文件充分说明了相关的伦理学考虑，并符合这一类试验的适用管理要求。 3.1.8 The IRB/IEC should review both the amount and method of payment to subjects to assure that neither

presents problems of coercion or undue influence on the trial subjects. Payments to a subject should be prorated and not wholly contingent on completion of the trial by the subject. IRB/IEC应当审评支付给对象款项的数量和方式，以确认没有对试验对象的胁迫问题或不正当影响。给对象的支付应当按比例分配，而不是完全以对象完成试验而定。

3.1.9 The IRB/IEC should ensure that information regarding payment to subjects, including the methods,

amounts, and schedule of payment to trial subjects, is set forth in the written informed consent form and any other written information to be provided to subjects. The way payment will be prorated should be specified. IRB/IEC应当保证，关于支付给对象的资料，包括支付方式、数量和支付给试验对象的时间表已列于知情同意书和将提供给对象任何其他书面资料上，应注明按比例支付的方式。

3.2 Composition, Functions and Operations 组成 、职能和操作

3.2.1 The IRB/IEC should consist of a reasonable number of members, who collectively have the qualifications

and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. It is recommended that the IRB/IEC should include: IRB/IEC应由合理数目的成员组成，他们全体都有审评和评价科学、医学和和所提议试验的伦理学方面的资料和经验。建议IRB/IEC应包括：

a) At least five members.

至少5名成员

b) At least one member whose primary area of interest is in a nonscientific area. 至少一名成员关心的重要领域时非科学领域；

c) At least one member who is independent of the institution/trial site.

至少一名成员独立于研究机构/试验单位。

Only those IRB/IEC members who are independent of the investigator and the sponsor of the trial should vote/provide opinion on a trial-related matter.

只有那些独立于试验研究者和申办者的IRB/IEC成员才能对一个试验的相关事项投票/提出建议。

A list of IRB/IEC members and their qualifications should be maintained. 应当提供一份IRB/IEC成员的名单和他们的资格表。

3.2.2 The IRB/IEC should perform its functions according to written operating procedures, should maintain

written records of its activities and minutes of its meetings, and should comply with GCP and with the applicable regulatory requirement(s). IRB/IEC应但按照书面的操作程序完成其职责，应当保存其活动的书面记录和会议记录，并应当遵守ＧＣＰ和适用的管理要求。

3.2.3 An IRB/IEC should make its decisions at announced meetings at which at least a quorum, as stipulated in

its written operating procedures, is present. IRB/IEC应当在达到其书面操作程序中规定的法定人数的正式会议上作出决定。

3.2.4 Only members who participate in the IRB/IEC review and discussion should vote/provide their opinion

and/or advise. 只有参加IRB/IEC评审和讨论的成员才可投票/提出他们的评价和/或意见。

3.2.5 The investigator may provide information on any aspect of the trial, but should not participate in the

deliberations of the IRB/IEC or in the vote/opinion of the IRB/IEC. 研究者应当提供试验各方面的资料，但不应当参加IRB/IEC的审议或IRB/IEC的投票/意见。

3.2.6 An IRB/IEC may invite nonmembers with expertise in special areas for assistance. IRB/IEC可邀请在特别领域有专门知识的非成员来帮助。

3.3 Procedures 程序

The IRB/IEC should establish, document in writing, and follow its procedures, which should include: IRB/IEC应当建立书面文件和遵循其程序，程序应包括：

3.3.1 Determining its composition (names and qualifications of the members) and the authority under which it

is established.

确定其组成（成员单娥姓名和资格）和授权。

3.3.2 Scheduling, notifying its members of, and conducting its meetings. 安排时间，通知其成员，举行会议

3.3.3 Conducting initial and continuing review of trials. 对试验进行初始审评和继续审评

3.3.4 Determining the frequency of continuing review, as appropriate. 酌情确定继续审评的频度

3.3.5 Providing, according to the applicable regulatory requirements, expedited review and

approval/favourable opinion of minor change(s) in ongoing trials that have the approval/favourable opinion of the IRB/IEC. 依照适用的管理要求，为已经获得IRB/IEC批准/赞成的正在进行的试验的较小修改提供快速审评和批准/赞成意见。

3.3.6 Specifying that no subject should be admitted to a trial before the IRB/IEC issues its written

approval/favourable opinion of the trial. 说明在IRB/IEC书面签署对试验的批准/赞成意见之前不得接纳对象进入试验

3.3.7 Specifying that no deviations from, or changes of, the protocol should be initiated without prior written

IRB/IEC approval/favourable opinion of an appropriate amendment, except when necessary to eliminate immediate hazards to the subjects or when the change(s) involves only logistical or administrative aspects of the trial (e.g., change of monitor(s), telephone number(s)) (see 4.5.2). 说明在方案的适当修改预先得到IRB/IEC的书面批准/赞成之前，不能偏离或改变试验方案，除非有必要排除对于对象的直接危害，或方案的改变只涉及试验的后勤或管理方面（如更换监察员，改变电话号码）（见4.5.2）。 3.3.8 Specifying that the investigator should promptly report to the IRB/IEC: 说明研究人员应当立即报告IRB/IEC的事项：

a) Deviations from, or changes of, the protocol to eliminate immediate hazards to the trial subjects (see

3.3.7, 4.5.2, 4.5.4). 偏离或改变方案以消除试验对象的直接危害（见3.3.7，4.5.2，4.5.4）；

b) Changes increasing the risk to subjects and/or affecting significantly the conduct of the trial (see 4.10.2). 增加对象风险的改变和/或明显影响试验实施的改变（见4.10.2） c) All adverse drug reactions (ADRs) that are both serious and unexpected. 所有严重的和非预期的药品不良反应（ＡＤＲ）

d) New information that may affect adversely the safety of the subjects or the conduct of the trial.

对试验的进行或对象的完全可能不利影响的新资料。

3.3.9 Ensuring that the IRB/IEC promptly notify in writing the investigator/institution concerning: 确保IRB/IEC迅速通知研究者/研究机构的事项： a) Its trial-related decisions/opinions. 与试验有关的决定/建议

b) The reasons for its decisions/opinions.

IRB/IEC决定/意见的理由

c) Procedures for appeal of its decisions/opinions. 请求IRB/IEC决定/意见的程序

3.4 Records 记录

The IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for a period of at least 3 years after completion of the trial and make them available upon request from the regulatory authority(ies).

IRB/IEC应当保留全部有关记录（如书面的程序，成员名单，成员的职业/联系表，提交的文件，会议记录，以及往来信件）至完成试验后至少3年，并在管理当局需要时可以提供其书面程序和成员名单。 The IRB/IEC may be asked by investigators, sponsors or regulatory authorities to provide its written procedures and membership lists.

研究者、申办者和管理当局可向机构审查委员会/伦理委员会要求其提供书面运作程序和成员名单。

4. INVESTIGATOR 研究者

4.1 Investigator's Qualifications and Agreements 研究者的资格和协议

4.1.1 The investigator(s) should be qualified by education, training, and experience to assume responsibility for

the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/IEC, and/or the regulatory authority(ies).

研究者应当在受教育、培训和经验方面有资格承担实施试验的责任，应当符合适用的管理要求所说明的所有条件，并应当通过现时的个人简历/或申办者、IRB/IEC和/或管理当局要求的其他相关文件提供这种资格证明。

4.1.2 The investigator should be thoroughly familiar with the appropriate use of the investigational product(s),

as described in the protocol, in the current Investigator's Brochure, in the product information and in other information sources provided by the sponsor.