Contents
Part 3: Special Requirements Concerning Consent
Part 4: The Informed Consent Process
Part 3: Special Requirements Concerning Consent 关于同意的特殊要求
The information that must be provided in an informed consent document is specified in 45 CFR 46.116, 21 CFR 50.20, and ICH E6 GCP 4.8.10. In the following sections, we will take a closer look at how this information is presented in a sample informed consent document.
必须在知情同意书中提供的信息在45 CFR 46.116、21 CFR 50.20和 ICH E6 GCP 4.8.10中有明确规定。在下面的章节中，我们将进一步了解这些信息是如何在一份知情同意书样本中呈现的。
The consent document should include the following:
同意文件应包括以下内容：
Ⅰ、State that the study involves research.
Ⅱ、Briefly explain the purpose of the research, the reason(s) why the person is being invited to participate, and the expected duration of the person’s participation in the study.
Ⅲ、Describe the procedures or interventions to be carried out, identifying which procedures are investigational and which might be provided as standard care in another setting.
Ⅳ、Explain the use of research methods such as randomization and placebo controls.
Ⅴ、Describe any foreseeable risks or discomforts to the participant. Estimate how likely it is that these risks and discomforts will occur.
Ⅵ、Describe the steps that will be taken to prevent or minimize risks or discomforts to the participant.
Ⅶ、Acknowledge that participation in the study may pose unknown and unforeseeable risks.
Ⅷ、Describe any benefits to the participant or to others that the research may reasonably be expected to produce. Estimate how likely it is that these benefits will occur.
Ⅸ、Disclose any appropriate alternative procedures or courses of treatment that may benefit the participant.
Ⅹ、Describe the extent to which records will be kept confidential and provide examples of people or organizations that may have access to research records (e.g., hospital personnel, study sponsors, staff of the U.S. Food and Drug Administration).
Ⅺ、For research that involves more than minimal risk, explain and describe any compensation and any medical treatments that are available if participants are injured as a result of participation in the study, where further information can be obtained, and who should be contacted in the event of a research- related injury.
Ⅻ、Explain who should be contacted for answers to questions about the research and the participant’s rights (including the name and phone number of the principal investigator).
XIII、State that participation in the study is voluntary and that declining to participate or deciding to withdraw at any time will involve no penalty or loss of benefits to which the participant is otherwise entitled.
XIV、State that the participant’s signature will indicate that he or she has decided to participate in the study, having read and discussed the information presented to him or her about the research.
XV、Provide any other information that prospective participants might need to make an informed decision about whether or not to participate in the research study, such as any recently obtained information about the investigational drug’s toxicity in animals.
1、说明该研究涉及研究。
2、简要说明研究的目的、被邀请参与研究的原因以及该人参与研究的预期时间。
3、描述将要执行的程序或干预措施，确定哪些程序是研究性的，哪些程序可以在其他环境中作为标准护理提供。
4、解释研究方法的使用，如随机化和安慰剂对照。
5、向参与者描述任何可预见的风险或不适。估计这些风险和不适发生的可能性。
6、描述将采取的措施，以防止或减少参与者面临的风险或不适。
7、承认参与研究可能会带来未知和不可预见的风险。
8、描述研究可能合理预期给参与者或其他人带来的任何利益，估计这些好处发生的可能性。
9、披露任何可能对参与者受益的适当替代程序或疗程。
10、描述记录的保密程度，并提供可访问研究记录的人员或组织的示例（例如，医院人员、研究发起人、美国食品和药物管理局的工作人员）。
11、对于涉及最小风险以上的研究，解释和描述参与者因参与研究而受伤时可获得的任何赔偿和医疗，可从中获得更多信息，以及在发生研究相关伤害时应联系谁。
12、解释应联系谁来回答有关研究和参与者权利的问题（包括主要研究者的姓名和电话号码）
13、 声明参与本研究是自愿的，任何时候拒绝参与或决定退出本研究均不涉及参与者有权获得的惩罚或利益损失。
14、 说明参与者的签名将表明他或她已决定参与研究，并已阅读和讨论了提交给他或她的有关研究的信息。
15、 提供潜在参与者可能需要的任何其他信息，以便就是否参与研究做出知情决定，例如最近获得的关于试验药物在动物体内毒性的任何信息。
Informed Consent of Trial Participants (ICH GCP 4.8.10)
Both the informed consent discussion and the written informed consent form and any other written information to be provided to participants should include explanations of the following:
知情同意讨论和书面知情同意书以及向参与者提供的任何其他书面信息都应包括以下内容的解释：
Ⅰ、That the trial involves research.
Ⅱ、The purpose of the trial.
Ⅲ、The trial treatment(s) and the probability for random assignment to each treatment.
Ⅳ、The trial procedures to be followed, including all invasive procedures.
Ⅴ、The participant’s responsibilities.
Ⅵ、Those aspects of the trial that are experimental.
Ⅶ、The reasonably foreseeable risks or inconveniences to the participant and, when applicable, to an embryo, fetus, or nursing infant.
Ⅷ、The reasonably expected benefits. When there is no intended clinical benefit to the participant, the participant should be made aware of this.
Ⅸ、The alternative procedure(s) or course(s) of treatment that may be available to the participant, and their important potential benefits and risks.
Ⅹ、The compensation and/or treatment available to the participant in the event of trial-related injury.
Ⅺ、The anticipated prorated payment, if any, to the participant for participating in the trial.
Ⅻ、The anticipated expenses, if any, to the participant for participating in the trial.
XIII、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.
XIV、That the monitor(s), the auditor(s), the IRB, and the regulatory authorities 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 legally acceptable representative is authorizing such access.
XV、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.
XVI、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.
XVII、The person(s) to contact for further information regarding the trial and the rights of trial participants, and whom to contact in the event of trial-related injury.
XVIII、The foreseeable circumstances and/or reasons under which the participant’s participation in the trial may be terminated.
XIX、The expected duration of the participant’s participation in the trial.
XX、The approximate number of participants involved in the trial.
1、试验涉及研究。
2、试验目的。
3、试验治疗和随机分配给每个治疗的概率。
4、应遵循的试验程序，包括所有侵入性程序。
5、参与者的责任。
6、试验的那些方面是实验性的。
7、对参与者和胚胎、胎儿或哺乳期婴儿（如适用）可合理预见的风险或不便。
8、合理预期收益。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。
9、参与者可能获得的替代治疗程序或疗程，及其重要的潜在利益和风险。
10、参与者在试验相关伤害事件中可获得的补偿和/或治疗。
11、预期按比例向参与试验的参与者支付的款项（如有）。
12、参与者参与试验的预期费用（如有）。
13、 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有权获得的利益。
14、在适用法律和法规允许的范围内，允许监测员、审计员、内部审计委员会和管理当局直接查阅参与者的原始医疗记录，以核实临床试验程序和/或数据，但不违反参与者的保密性，并且参与者或其法律上可接受的代表通过签署书面知情同意表格授权这种查阅。
15、 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。
16、 如果获得与参与者是否愿意继续参与试验相关的信息，将及时通知参与者或参与者的合法代表。
17、 有关试验和试验参与者权利的更多信息，以及在试验相关伤害事件中与谁联系的联系人。
18、 参与者可能终止参与试验的可预见情况和/或原因。
19、 参与者参与试验的预期持续时间。
20、 参与试验的大致人数。
Special Requirements Concerning the Consent of Pregnant Women 关于孕妇同意的特殊要求
When a research activity involves pregnant women as participants:
Ⅰ、Both mother and father must be informed about any potential impact of the research on the fetus.
Ⅱ、Both mother and father must consent to the woman’s participation in the research. However, the father’s consent is not required in the following circumstances:
i、The purpose of the research is to meet the health needs of the mother.
ii、The father’s identity or whereabouts cannot be determined.
iii、The father is not reasonably available.
iv、The pregnancy resulted from rape.
Ⅲ、If either parent is unable to consent because of availability, incompetence, or temporary incapacity, the informed consent of one parent will suffice provided the criteria in the previous bullet points are not met.
Ⅳ、Consent of a legally acceptable representative of either or both parents does not suffice for informed consent.
Additional protections for pregnant women involved as participants in research are set forth in 45 CFR 46 Subpart B.
当研究活动涉及孕妇作为参与者时：
1、必须告知母亲和父亲研究对胎儿的任何潜在影响。
2、母亲和父亲都必须同意妇女参与研究。但是，在下列情况下，不需要父亲的同意：
（1）研究的目的是满足母亲的健康需求。
（2）无法确定父亲的身份或下落。
（3）父亲不在合理范围内。
（4）怀孕是强奸造成的。
3、如果父母中的任何一方因可用性、不称职或暂时丧失行为能力而无法同意，只要不符合前面要点中的标准，父母中的一方的知情同意就足够了。
4、父母一方或双方法定代表人的同意不足以获得知情同意。
作为研究参与者参与的孕妇的额外保护在45 CFR 46 Subpart B中阐述。
Special Requirements Concerning the Consent of Children 关于儿童同意的特殊要求
The CFR defines children as:
“...persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” (45 CFR 46.402)
The legal age for consent in most states is 18; persons under age 18 are considered minors. However, in some jurisdictions, persons under age 18 can consent to treatment for substance abuse or dependence.
CFR将儿童定义为：
“……根据研究所在司法管辖区的适用法律，未达到同意参与研究的治疗或程序的法定年龄的人员。”（45 CFR 46.402）
大多数州的法定同意年龄为18岁；18岁以下的人被视为未成年人。然而，在一些管辖区，18岁以下的人可以同意接受药物滥用或依赖治疗。
Additional protections for children and minors involved as participants in research are set forth in 45 CFR 46 Subpart D.
When children or minors are involved in research, both the assent of the child or minor and the permission of his or her parent(s) are usually required.
Permission means the agreement of parent(s) or a legal guardian to the participation of their child or ward in research.
Assent means a child’s agreement to participate in research. Failure to object is not assent.
45 CFR 46子部分D中规定了对参与研究的儿童和未成年人的额外保护。
当儿童或未成年人参与研究时，通常需要儿童或未成年人的同意及其父母的许可。
许可是指父母或法定监护人同意其子女或监护人参与研究。
同意是指孩子同意参与研究。不反对不等于同意。
In most cases, both parents must give their permission for their child or minor’s participation in research. However, exceptions to this requirement are permitted in certain circumstances. An exception is also permitted in the case of an emancipated minor.
Although children may be legally incapable of giving informed consent, they may nevertheless be able to assent to or dissent from participation in research.
Out of respect for children as developing persons, children should be asked whether or not they wish to participate in the research, particularly if:
Ⅰ、The research does not involve interventions that are likely to benefit the participants, and
Ⅱ、The child can understand what it means to be a volunteer for the benefit of others.
在大多数情况下，父母双方都必须允许子女或未成年人参与研究。但是，在某些情况下，允许对该要求进行例外。对于被解放的未成年人，也允许有例外情况。
尽管儿童在法律上可能无法给予知情同意，但他们仍然可以同意或反对参与研究。
出于对儿童作为发展中人的尊重，应询问儿童是否愿意参与研究，特别是在以下情况下：
1、研究不涉及可能使参与者受益的干预措施，以及
2、孩子能够理解为他人的利益做志愿者意味着什么。
A child’s assent should be sought when the child is capable of providing such assent, taking into account his or her age, maturity, and psychological state. The age that a child needs to attain to give assent varies from state to state. In certain circumstances, the IRB may determine that research can proceed without the assent of the children involved.
考虑到儿童的年龄、成熟度和心理状态，当儿童能够提供此类同意时，应寻求儿童的同意。一个孩子获得同意所需的年龄因州而异。在某些情况下，IRB可能会决定研究可以在未经相关儿童同意的情况下进行。
Special Requirements Concerning the Consent of Prisoners 关于囚犯同意的特殊要求
Because of their incarceration, prisoners may be under constraints that potentially affect their ability to make a truly voluntary decision about whether or not to participate in a study.
由于他们的监禁，囚犯可能受到限制，这可能会影响他们做出真正自愿决定是否参加研究的能力。
45 CFR 46.303 defines a prisoner as:
“Any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.”
45 CFR 46.303将囚犯定义为：
“任何人不由自主地限制或被拘留在刑事机构。该术语旨在涵盖在刑事或民事规定下判处所属机构的个人，凭借律法或承诺程序在其他设施中拘留的个人提供刑事检控或在刑事诉讼中的刑事诉讼中的替代方案，以及被拘留的个人被拘留，试验或判决。“
Additional safeguards for the protection of prisoners involved in research (set forth in 45 CFR 46 Subpart C) include the following:
Ⅰ、The IRB must approve the study as prisoner research.
Ⅱ、The IRB that reviews and approves the study must include a prisoner or prisoner advocate in its membership.
Ⅲ、A majority of the IRB members (exclusive of prisoner members) must have no association with the prison(s) involved in the research, apart from their membership on the IRB.
Ⅳ、The study must present no more than minimal risk to the participants.
Ⅴ、The proposed research must involve the study of:
i、The possible causes, effects, and processes of incarceration and criminal behavior.
ii、Prisons as institutional structures or prisoners as incarcerated persons.
iii、Conditions that particularly affect prisoners (e.g., vaccine trials; research on hepatitis, which is more prevalent in prisons than elsewhere; research on social and psychological problems such as alcoholism, drug addiction and sexual assault).
iv、Practices intended to improve the health or well-being of the participants.
保护参与研究的囚犯的额外保障措施（见45 CFR 46子部分C）包括：
1、IRB必须批准该研究作为囚犯研究。
2、审查和批准研究的IRB成员必须包括囚犯或囚犯辩护律师。
3、大多数IRB成员（不包括囚犯成员）不得与参与研究的监狱有任何关联，除了他们是IRB的成员。
4、研究对参与者的风险不得超过最低限度。
5、拟定研究必须涉及以下方面的研究：
（1）监禁和犯罪行为可能的原因、影响和过程。
（2）作为体制结构的监狱或作为被监禁者的囚犯。
（3）特别影响囚犯的情况（例如，疫苗试验；关于肝炎的研究，这在监狱中比其他地方更为普遍；关于社会和心理问题的研究，如酗酒、吸毒成瘾和性攻击）。
（4）旨在改善参与者健康或福祉的实践。
Part 4: The Informed Consent Process
Elements of the Informed Consent Process 知情同意进程的要素
Part 1 of this module examined the informed consent document in detail. Part 4 will examine the process of obtaining informed consent from potential study participants.
To be valid, informed consent must be based on the following:
本单元第1部分详细研究了知情同意书文件。第4部分将探讨从潜在研究参与者处获得知情同意的过程。
为了有效，知情同意必须基于以下内容：
Capacity to Give Informed Consent 给予知情同意的能力
Before the informed consent process can begin, the potential participant must be deemed capable of understanding his or her actions and making a reasoned decision. If the person lacks capacity because he or she is a minor, is ill, or for any other reason, special provisions must apply (such as a life-threatening emergency), or the person may not be included in the study.
在知情同意程序开始之前，必须认为潜在参与者能够理解其行为并做出合理的决定。如果此人因未成年人、生病或任何其他原因而缺乏行为能力，则必须适用特殊规定（如危及生命的紧急情况），否则此人可能不会被纳入研究。
A person who has a court-appointed legal guardian or who has been determined by a court to be legally incompetent cannot sign an Informed Consent Form even if he or she has the capacity to make a decision. This determination is made by the legal system and not by clinicians.
有法院指定的法定监护人或被法院判定为无法律行为能力的人，即使他或她有能力作出决定，也不能签署知情同意书。这一决定是由法律制度而不是由临床医生作出的。
Disclosure of all Relevant Information 披露所有相关信息
The research team must disclose all relevant information about the study to the potential participant. The information disclosed must be sufficient to enable the potential participant to make an informed reasoned decision about whether to participate. This information generally includes:
研究团队必须向潜在参与者披露研究的所有相关信息。所披露的信息必须足以使潜在参与者就是否参与做出知情、合理的决定。这些信息通常包括：
Ⅰ、The purpose of the study.
Ⅱ、The nature of the procedure or intervention that is being studied.
Ⅲ、Reasonable alternatives to participation in the study.
Ⅳ、The potential risks and benefits as well as the uncertainties of study participation.
Ⅴ、The participants obligations for the duration of the study.
1、研究目的。
2、正在研究的程序或干预的性质。
3、参与研究的合理替代方案。
4、学习参与的潜在风险和收益以及不确定性。
5、研究期间参与者的义务。
Comprehension by the Participant 参与者的理解
The potential participant must understand the information disclosed to him or her about the research study. The participant is free to ask questions to the study team as well as take additional time to make a decision regarding participation. The research team must be able to evaluate the potential participant’s ability to understand what his or her participation in the study would involve. The informed consent document might include a quiz or other documented assessment to assess whether the participant truly understands the study.
潜在参与者必须了解向其披露的有关研究的信息。参与者可以向研究团队自由提问，也可以花更多的时间来决定是否参与。研究团队必须能够评估潜在参与者理解其参与研究所涉及内容的能力。知情同意书文件可能包括测验或其他书面评估，以评估参与者是否真正理解研究。
Voluntary Agreement by the Participant 参与者的自愿协议
The participant must agree to participate in the research study and his or her agreement must be voluntary and free from coercion or undue influence.
参与者必须同意参与研究，且其同意必须是自愿的，不得受到胁迫或不当影响。
Right to Withdraw 撤回的权利
The participant must be informed that he or she has a right to withdraw from the study at any time and for any reason, without penalty or loss of benefits that he or she would otherwise be entitled to receive.
必须告知参与者，他或她有权在任何时候出于任何原因退出研究，而不会受到惩罚或失去他或她本来有权获得的福利。
If a participant wishes to withdraw from a study in which an experimental drug is being tested, he or she must be informed of any procedures that are recommended to ensure safe withdrawal from the study drug. The participant must also be advised of any consequences of withdrawal, such as the inability to continue taking the study medication. No further data will be collected on the participant, but the participant will be informed that data already collected can be used for study analysis.
如果参与者希望退出正在测试实验药物的研究中，他或她必须被告知建议确保研究药物安全退出的任何程序。还必须告知参与者退出的任何后果，例如无法继续服用研究药物。将不再收集关于参与者的进一步数据，但将告知参与者已收集的数据可用于研究分析。
The research team or principal investigator may terminate participation in a study if it is in the best interest of the participant.
如果符合参与者的最佳利益，研究团队或主要研究者可以终止参与研究。
