Contents
Part 1: What is Informed Consent?
Part 2: The Informed Consent Document
Part 1: What is Informed Consent?
When most people hear the phrase “informed consent,” they think of the legal document that explains the study and contains the required dated signatures. However, informed consent is first and foremost a continuing process. This includes a person voluntarily agreeing to participate in a research study after being fully informed about it via verbal discussion with study staff, followed by documentation in a written, signed, and dated informed consent form. A participant’s consent will be continually sought during the course of the study, and the participant will be notified of any changes to the study, along with any other pertinent information that may influence their decision to remain in the study.
当大多数人听到“知情同意”一词时，他们会想到解释该研究并包含所需日期签名的法律文件。然而，知情同意首先是一个持续的过程。这包括通过与研究人员进行口头讨论，并随后以书面、签字和注明日期的知情同意书形式记录，自愿同意参与研究的人员。在研究过程中，将不断征求参与者的同意，并将研究的任何变更以及可能影响其继续参与研究决定的任何其他相关信息通知参与者。
While documentation of informed consent is required in most clinical studies, there are occasions when a waiver or alteration of written informed consent is obtained from the Institutional Review Board (IRB) for some or all study participants. The fundamental criteria for waivers and alterations of informed consent are located in 45 CFR 46.116(c) and 45 CFR 46.116(d). Please consult the local IRB for determining when it is appropriate to waive the requirement for written consent.
虽然在大多数临床研究中都需要知情同意书的文件记录，但在某些情况下，一些或所有研究参与者的书面知情同意书会从机构审查委员会（IRB）处获得弃权或变更。《美国联邦法规》第45卷第46.116（c）节和第45卷第46.116（d）节规定了放弃和变更知情同意书的基本标准。请咨询当地IRB，以确定何时适合放弃书面同意的要求。
The informed consent document should contain all of the information that the person needs to make an informed decision about taking part in the study. Many research teams use the consent document to guide the verbal explanation of the study to potential participants.
知情同意书文件应包含患者做出参与研究知情决定所需的所有信息。许多研究团队使用同意书来指导潜在参与者对研究进行口头解释。
The participant must sign and date the informed consent document before taking part in any study procedures. Signing the consent form is NOT the final step in the informed consent process. The participant may withdraw consent and decline to participate in the study at any time before or after signing the consent document until their participation in the study is completed.
参与任何研究程序前，参与者必须在知情同意书上签字并注明日期。签署同意书并不是知情同意过程的最后一步。参与者可在签署同意书之前或之后的任何时间撤回同意书并拒绝参与研究，直至其参与研究完成。
The general requirements for informed consent in federally funded research are spelled out in 45 CFR 46.116 and 21 CFR 50.20. Some states have enacted requirements for informed consent that go beyond federal regulations. This module reviews the requirements for informed consent that are set out in federal regulations and in the Good Clinical Practice guidelines of the International Council for Harmonization (ICH GCP 4.8.10). It is the principal investigator’s responsibility to know and abide by any additional state requirements.
联邦资助研究中知情同意的一般要求在45 CFR 46.116和21 CFR 50.20中有详细说明。一些州颁布了超出联邦法规的知情同意要求。本单元审查联邦法规和国际协调理事会良好临床实践指南（ICH GCP 4.8.10）中规定的知情同意要求。主要调查员有责任了解并遵守任何其他州要求。
All researchers must ensure that the process of obtaining informed consent from study participants not only conforms to federal, state, and local regulations but also respects each individual’s right to make a voluntary, informed decision.
所有研究人员必须确保获得研究参与者知情同意的过程不仅符合联邦、州和地方法规，而且尊重每个人做出自愿知情决定的权利。
Part 2 of this module deals with the informed consent document. Part 4 deals with the informed consent process.
本单元第2部分涉及知情同意书。第4部分涉及知情同意程序。
Part 2: The Informed Consent Document
Ⅰ、Study Purpose 研究目的
The consent document must state (ICH GCP 4.8.10):
i、That the trial involves research.
ii、The purpose of the trial.
同意书必须说明（ICH GCP 4.8.10）：
（1）试验涉及研究。
（2）试验的目的。
Ⅱ、Study Treatment and Randomization 研究治疗和随机化
The consent document must state (ICH GCP 4.8.10): The trial treatment(s) and the probability for random assignment to each treatment (if a randomized clinical trial).
同意书必须说明（ICH GCP 4.8.10）： 试验治疗和随机分配给每个治疗的概率（如果是随机临床试验）。
Ⅲ、Study Procedures 研究程序
The consent document must state (ICH GCP 4.8.10):
i、The trial procedures to be followed, including all invasive procedures.
ii、The participant’s responsibilities.
iii、Those aspects of the trial that are experimental.
iv、The expected duration of the participant’s involvement in the trial.
同意文件必须声明(ICH GCP 4.8.10):
（1）应遵循的试验程序，包括所有侵入性程序。
（2）参与者的责任。
（3）试验的那些方面是实验性的。
（4）受试者参与试验的预期持续时间。
Ⅳ、 Risks of Taking Part in the Study 参与研究的风险
The consent document must state (ICH GCP 4.8.10): The reasonably foreseeable risks or inconveniences to the participant and, when applicable, to an embryo, fetus, or nursing infant.
同意书必须说明（ICH GCP 4.8.10）：对参与者和（如适用）胚胎、胎儿或哺乳期婴儿的合理可预见风险或不便。
Ⅴ、Benefits of Taking Part in the Study 参与研究的好处
The consent document must state (ICH GCP 4.8.10): The reasonably expected benefits. When there is no intended clinical benefit to the participant, the participant should be made aware of this.
同意文件必须说明（ICH GCP 4.8.10）：合理预期的利益。当参与者没有预期的临床益处时，应让参与者意识到这一点。
Ⅵ、 Alternatives to Taking Part in the Study 参与研究的替代方案
The consent document must state (ICH GCP 4.8.10): The alternative procedure(s) or course(s) of treatment that may be available to the participant, and their important potential benefits and risks.
Points to note: IRBs often want the informed consent document to list other therapies available for the condition under treatment in addition to other treatment options at the facility where the study is being conducted.
同意书必须说明（ICH GCP 4.8.10）：参与者可以使用的替代治疗程序或疗程，及其重要的潜在益处和风险。
需要注意的要点：IRB通常希望知情同意书中列出治疗条件下的其他治疗方法，以及正在进行研究的设施中的其他治疗方案。
Ⅶ、Costs of Participation and Compensation in the Event of Injury 发生伤害时的参与费用和赔偿费用
The consent document must state (ICH GCP 4.8.10):
i、The compensation and/or treatment available to the participant in the event of trial-related injury.
ii、The anticipated expenses, if any, to the participant for participating in the trial.
Points to note: When research involves more than minimal risk to the participant, the consent document must describe the treatment and compensation that will be provided in the event that a participant sustains a research-related injury. The language in the consent cannot appear to limit the participant’s rights in seeking damages related to injury in a trial.
Federal regulations do not limit the definition of “injury” to a physical injury. An injury may be psychological, social, financial, or of another nature.
同意书必须说明（ICH GCP 4.8.10）：
（1）在试验相关伤害事件中，参与者可获得的补偿和/或治疗。
（2）参与者参与试验的预期费用（如有）。
注意事项：当研究对参与者的风险超过最低限度时，同意书必须说明参与者遭受研究相关伤害时将提供的治疗和补偿。同意书中的语言似乎不能限制参与人在审判中要求损害赔偿的权利。
联邦法规没有将“伤害”的定义限制为身体伤害。伤害可能是心理、社会、经济或其他性质的。
Ⅷ、Payment for Taking Part in the Study 参加研究的费用
The consent document must state (ICH GCP 4.8.10): The anticipated prorated payment, if any, to the participant for participating in the trial.
Points to note: Payment to participants for their participation in a research study must never be coercive in either amount or method of distribution.
同意书必须说明（ICH GCP 4.8.10）：参与试验的参与者的预期按比例付款（如有）。
注意事项：对参与研究的参与者的付款，无论是在金额上还是在分配方式上，都不能是强制性的。
Ⅸ、 Voluntary Nature of Study 学习的自愿性
The consent document must state (ICH GCP 4.8.10):
i、That the participant’s participation in the trial is voluntary and that the participant may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the participant is otherwise entitled.
ii、The foreseeable circumstances and/or reasons under which the participant’s participation in the trial may be terminated.
同意书必须说明（ICH GCP 4.8.10）：
（1）参与者参与试验是自愿的，参与者可以在任何时候拒绝参与或退出试验，而不会受到惩罚或损失参与者应有的利益。
（2）参与者可能终止参与试验的可预见情况和/或原因。
Ⅹ、Confidentiality of Personal Information 个人资料的保密
The consent document must state (ICH GCP 4.8.10):
i、That the monitor(s), the auditor(s), the IRB, and the regulatory authority(ies) will be granted direct access to the participant’s original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the participant, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the participant or the participant’s legal representative is authorizing such access.
ii、That records identifying the participant will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. If the results of the trial are published, the participant’s identity will remain confidential.
Points to note: Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to preventinvestigators from having to release (e.g., via a subpoena) names or other identifying information about research participants.
Certificates of Confidentiality provide additional protection for participants who are enrolled in studies in which information is being collected that, if disclosed, could have adverse consequences for participants or could damage their financial standing, employability, insurability, or reputation.
See related material from the Confidentiality and Privacy module for a summary of confidentiality requirements in research involving human participants.
同意书必须说明（ICH GCP 4.8.10）：
（1）监护仪、审计师、IRB和监管机构将被授予直接访问参与者原始医疗记录的权限，以验证临床试验程序和/或数据，而不违反参与者的保密性，在适用法律法规允许的范围内，且通过签署书面知情同意书，参与者或参与者的法定代表人授权此类访问。
（2）识别参与者的记录将保密，并且在适用法律和/或法规允许的范围内，不会公开提供。如果试验结果公布，参与者的身份将保密。
注意事项：国家卫生研究院（NIH）颁发保密证书，以防止调查人员不得不公布（例如通过传票）研究参与者的姓名或其他身份信息。
保密证书为参加正在收集信息的研究的参与者提供了额外的保护，这些信息如果被披露，可能会对参与者产生不利影响，或者可能损害他们的财务状况、就业能力、可保性或声誉。
有关涉及人类参与者的研究中的保密要求摘要，请参见保密和隐私模块中的相关资料。
Ⅺ、New Information that may Affect Study Participation 可能影响研究参与的新信息
The consent document must state (ICH GCP 4.8.10): That the participant or the participant’s legally acceptable representative will be informed in a timely manner if information becomes available that may be relevant to the participant’s willingness to continue participation in the trial.
同意书必须说明（ICH GCP 4.8.10）：如果获得可能与参与者继续参与试验的意愿相关的信息，将及时通知参与者或参与者的法定代表人。
Ⅻ、Study Contacts 研究联系人
The consent document must state (ICH GCP 4.8.10): The person(s) to contact for further information regarding the trial and the rights of trial participants in the event of trial-related injury.
同意书必须说明（ICH GCP 4.8.10）：在发生试验相关伤害的情况下，与试验和试验参与者权利相关的进一步信息联系的人员。
XIII、 Duration of Participation and Number of People Taking Part in the Study 参与时间和参与研究的人数
The consent document must state (ICH GCP 4.8.10):
i、The expected duration of the participant's participation in the trial.
ii、The approximate number of participants involved in the trial.
Points to note: A consent form should be written in non-technical language that participants would understand. Also, it should be written in language consistent with the participants educational level, cultural views, and familiarity with research.
同意书必须说明（ICH GCP 4.8.10）：
（1）参与者参与试验的预期持续时间。
（2）参与试验的大致人数。
注意事项：同意书应以参与者能够理解的非技术性语言书写。此外，报告的语言应与参与者的教育水平、文化观点和对研究的熟悉程度相一致。
