Contents
Part 6: Quality Control in the Informed Consent Process
Part 7: Requirements for the Documentation of Informed Consent
Part 6: Quality Control in the Informed Consent Process 知情同意过程中的质量控制
Protection of human research participants is the primary goal of the IRB and the informed consent process. Failure to comply with general requirements for informed consent (45 CFR 46.116) and documentation of informed consent (45 CFR 46.117) may result in suspension of a study. Errors in the informed consent process are considered protocol violations and, as such, must be reported to the relevant IRBs, along with a description of the action taken to correct the error and prevent it from occurring again.
保护人类研究参与者是IRB和知情同意程序的主要目标。未遵守知情同意书（45 CFR 46.116）和知情同意书文件（45 CFR 46.117）的一般要求可能导致研究暂停。知情同意过程中的错误被视为违反协议，因此必须向相关IRB报告，并说明为纠正错误和防止错误再次发生而采取的措施。
If violations of the informed consent process are severe or continuing, penalties may be imposed and the IRB may report the problem to the regulatory authorities. It is therefore important to ensure that the process of obtaining informed consent from participants is carried out carefully and with due attention to every detail. This section describes common errors that can occur in the informed consent process and discusses how they can be prevented.
如果违反知情同意程序的情况严重或持续，可能会受到处罚，IRB可能会将问题报告给监管机构。因此，重要的是确保从参与者处获得知情同意的过程得到认真执行，并适当注意每一个细节。本节描述了知情同意过程中可能出现的常见错误，并讨论了如何预防这些错误。
Remember, mistakes will happen. The most important thing to remember is to deal with them openly and honestly and report them immediately upon identification. The study staff will help you identify methods to prevent them from happening again.
记住，错误总会发生。要记住的最重要的事情是公开和诚实地对待他们，并在确认身份后立即报告他们。研究人员将帮助您确定防止此类事件再次发生的方法。
The following are examples of some of the most common errors that can occur in the informed consent process.
以下是知情同意过程中可能出现的一些最常见错误的示例。
The Participant Signs the Informed Consent Form After Study Procedures Have Begun 研究程序开始后，参与者签署知情同意书
How did this happen?
Some studies may involve clients as they come into the clinic. An eager staff member sees that the person who usually conducts consent interviews is busy and tries to help by having the client “just fill out some forms” while waiting.
一些研究可能涉及到进入诊所的客户。一位热心的工作人员发现通常进行同意面谈的人很忙，并试图通过让客户在等待时“只填写一些表格”来提供帮助。
Another staff member later assumes, without checking and without seeing the completed forms, that the participant has already completed the informed consent documentation and proceeds to enroll the person into the study.
另一名工作人员随后在未检查和未查看填写的表格的情况下假设参与者已完成知情同意书文件，并继续将此人纳入研究。
How can this error be prevented?
Ⅰ、Never assume anything. Always check that a participant’s informed consent documentation is complete before beginning a study procedure.
Ⅱ、Never perform any study assessments on potential participants before informed consent has been obtained.
1、不要假设任何事情。在开始研究程序之前，务必检查参与者的知情同意文件是否完整。
2、在获得知情同意之前，不得对潜在参与者进行任何研究评估。
Corrective Action: Review the study and the consent form with the participant as soon as the failure is identified. Document all steps to correct the situation, attach them to the signed Informed Consent Form and notify your supervisor as soon as possible.
纠正措施：一旦发现失败，立即与参与者一起审查研究和同意书。记录纠正情况的所有步骤，将其附在已签署的知情同意书上，并尽快通知您的主管。
The Consent Form is Signed by the Participant But is Missing the Initials or Signature of the Investigator or Witness (if Applicable), or is Not Dated 同意书由参与者签署，但缺少研究人员或证人的姓名首字母或签名（如适用），或没有注明日期
How did this happen?
The investigator may have become distracted. Perhaps the phone rang or another client needed attention. Perhaps the participant asked a question about another aspect of the study and the investigator turned the page, forgetting to sign or initial the form as required or to check that the participant has written the date on the form next to his or her signature.
调查人员可能已经分心了。也许电话铃响了，或者另一个客户需要注意。可能受试者问了一个关于研究另一方面的问题，研究者翻了一页，忘记按要求在表格上签名或在表格上签名，或者检查受试者是否在表格上签名旁边写了日期。
It is important to remember that the principal investigator (PI) is accountable for the informed consent process. While the PI may delegate the task of reviewing or discussing informed consent to another research staff member, such as the research coordinator or clinician, the PI must provide oversight of the process and ensure that the participant is comfortable with the discussion.
重要的是要记住，首席研究员(PI)对知情同意过程负责。虽然PI可以将审查或讨论知情同意的任务委托给其他研究人员，如研究协调员或临床医生，但PI必须监督整个过程，并确保参与者对讨论感到舒适。
How can this error be prevented?
Ⅰ、Conduct consent interviews in a quiet, separate room.
Ⅱ、When reviewing a consent form with a participant, focus on that task. Don’t answer the phone or respond to distractions unless there is a genuine emergency.
Ⅲ、The person obtaining the participant’s consent must be present when the consent form is signed. Having the investigator sign the consent form later is unacceptable. Never backdate a consent form.
Ⅳ、Create and use a checklist to ensure that every detail in the informed consent process is completed.
1、在一个安静、单独的房间进行同意面谈。
2、当与参与者一起审阅同意书时，要把注意力集中在该任务上。除非有真正的紧急情况，否则不要接电话或回应干扰。
3、在签署同意书时，获得参加者同意的人必须在场。让调查员稍后签署同意书是不可接受的。不要在同意书上注明日期。
4、创建并使用清单，以确保知情同意过程中的每一个细节都已完成。
Whiteout is Used to Correct an Error on the Consent Form 涂改用于更正同意书上的错误
How did this happen?
Failure to follow Good Clinical Practice or Good Medical Record correction techniques is the only reason for this error. Whiteout should never be used on any research or medical record document.
未能遵循良好的临床实践或良好的病历更正技术是导致此错误的唯一原因。不得在任何研究或病历文件上使用涂改。
How can this error be prevented?
By following good documentation practices. If an error occurs while the consent form is being completed, use Good Clinical Practice or Good Medical Record correction techniques to correct it: Cross out the error without obscuring the original entry, initial and date the crossing-out, and enter the correct information. (See also Good Medical Record practices to observe when writing progress notes in the Documentation and Record- Keeping module.)
通过遵循良好的文档实践。如果在填写同意书的过程中出现错误，请使用良好的临床实践或良好的病历更正技术进行更正：在不模糊原始条目的情况下划掉错误，并在划掉的条目上签名和注明日期，然后输入正确的信息。（另请参见文档和记录保存模块中编写进度说明时要遵守的良好病历做法）
An Out-of-Date Version of the Consent Form is Used 使用同意表的过期版本
How did this happen?
Several versions of an Informed Consent Form may be developed before IRB approval is received. Or, if the study has been in progress for more than 1 year, a new version of the consent form (most likely with a different date stamp) will have been prepared. In either case, a staff member may mistakenly pull out and use an out-of-date version of the form.
在收到IRB批准之前，可以制定多个版本的知情同意书。或者，如果研究已经进行了1年以上，则将准备一份新版本的同意书（很可能有不同的日期戳）。在这两种情况下，工作人员都可能会错误地取出并使用过期版本的表格。
How can this error be prevented?
Ⅰ、Ensure that the current version of the consent form is readily identifiable (e.g., color coded, marked with a prominent date stamp).
Ⅱ、Keep copies of the current version of the consent form in a different place than older, archived versions. Destroy copies of old, unused consent forms and mark the old original as obsolete in the regulatory binder.
1、确保同意书的当前版本易于识别（例如，彩色编码，标有显著的日期戳）。
2、将当前版本的同意书副本保存在与旧版本存档版本不同的地方。销毁旧的、未使用的同意书副本，并在监管活页夹中将旧的原件标记为作废。
Corrective Action: When the issue is identified reconsent the participant using the appropriate Informed Consent Form. Attach a memo identifying the issue and the corrective action to the new consent form.
纠正措施：确定问题后，使用适当的知情同意书再次发送给参与者。在新的同意书中附上一份备忘录，说明问题和纠正措施。
A New Consent Form is Required, But Not All Participants Signed It 需要新的同意书，但并非所有参与者都签字
How did this happen?
Ⅰ、Some participants were absent from the clinic during the week when most participants signed new consent forms. When the absent participants returned the following week, the need for them to sign new consent forms was overlooked.
Ⅱ、A staff member assumes that a colleague already had the participant sign a new consent form.
1、在大多数参与者签署新的同意书的那一周，一些参与者缺席了诊所。当缺席的参与者在接下来的一周返回时，他们签署新的同意书的需要被忽略了。
2、工作人员假设同事已经让参与者签署了新的同意书。
How can this error be prevented?
Ⅰ、Again, never assume anything. When a new consent form is required, check on each participant’s next clinic visit to ensure that he or she has signed the new form.
Ⅱ、Devise a system for flagging the files of participants who have not yet signed new consent forms.
Ⅲ、Use a tracking spreadsheet.
Ⅳ、Ensure documentation of consent form is in the source notes.
1、永远不要假设任何事情。当需要新的同意书时，检查每个参与者下一次的诊所访问，以确保他或她已经签署了新的表格。
2、设计一个系统来标记尚未签署新的同意书的参与者的文件。
3、使用跟踪电子表格。
4、确保同意表格的文件在源文件中。
Corrective Action: When the issue is identified have the participant review, sign and date the new consent form. Document the reason for the delay and attach it to the new consent form.
纠正措施：确定问题后，让参与者审查、签署新的同意书并注明日期。记录延迟的原因，并将其附在新的同意书中。
The Original Consent Form Has Been Lost 原始同意书已丢失
How did this happen?
Ⅰ、A staff member may mislay a participant’s consent form among other papers on his or her desk.
Ⅱ、The form may have been filed incorrectly.
Ⅲ、The original of the consent form may have been given to the participant by mistake.
1、工作人员可能会将参与者的同意书与其他文件一起误放在其办公桌上。
2、表格可能归档不正确。
3、同意书原件可能错误地交给了参与者。
How can this error be prevented?
Ⅰ、Devise written procedures for the handling of informed consent documentation and train all staff in the use of these procedures.
1、制定处理知情同意书文件的书面程序，并培训所有员工使用这些程序。
Corrective Action: Report the loss of a consent form immediately to the IRB and/or the sponsor and get another signed as soon as possible. To avoid the appearance of fraud, carefully document the sequence of events that led to the loss of the first consent form.
纠正措施：立即向IRB和/或赞助商报告同意书的丢失情况，并尽快获得另一份签名。为避免出现欺诈，请仔细记录导致第一份同意书丢失的事件顺序。
Informed Consent Activity 知情同意活动
Users are instructed to choose the answer that best describes the action to correct the informed consent document as described. 指导用户选择最能描述纠正知情同意书所述行为的答案。
Ⅰ、As the research coordinator for a study at ABC Treatment Center, you discussed the informed process with the participant and she signed and dated the informed consent form. After re-reviewing the form later that day, you noticed that the study participant signed the informed consent form but added yesterday’s date and she has already left the clinic. What should you do? Choose the best answer from the options given below:
A. You cross out the wrong date and add the correct date.
B. Throw away the old consent form and start a new informed consent form when the participant comes in for the next visit.
C. Ask the PI to cross out the wrong date, add the correct date, then initial, and date the informed consent form with the current date.
D. On the next visit, ask the participant to cross out the wrong date, add the correct date, then initial, and date the informed consent form with the current date.
E. Do nothing. Yesterday’s date will suffice.
1、作为ABC治疗中心一项研究的研究协调员，您与参与者讨论了知情过程，参与者在知情同意书上签字并注明日期。当天晚些时候重新查看表格后，您注意到研究参与者签署了知情同意书，但添加了昨天的日期，并且她已经离开了诊所。你该怎么办？从以下选项中选择最佳答案：
（1）你划掉了错误的日期，加上了正确的日期。
（2）受试者下次来访时，扔掉旧的知情同意书，重新开始填写新的知情同意书。
（3）要求PI划掉错误的日期，添加正确的日期，然后在知情同意书的首字母上写上当前日期。
（4）下次来访时，要求参与者划掉错误的日期，添加正确的日期，然后签首字母，并以当前日期标注知情同意书的日期。
（5）什么都不做。昨天的日期就足够了。
Feedback: Which do you choose: A, B, C, D, or E? The best answer is: On the next visit, you should ask the participant to cross out the wrong date, add the correct date, then initial, and date the informed consent form with the current date. That would be multiple choice D.
反馈：你选择哪一个：A、B、C、D还是E？最好的答案是：在下次就诊时，你应该要求参与者划掉错误的日期，添加正确的日期，然后在知情同意书上签名，并用当前日期标注日期。这将是多选D。
Now that you know how to correct the informed consent form when an error occurs, how could you prevent the problem from occurring again? ( Choose the best answer from the options given below.）既然您知道了在发生错误时如何更正知情同意书，那么如何防止问题再次发生？（从下面给出的选项中选择最佳答案。）
A. Have a list handy of key items to check when reviewing informed consent documents signed by study participants.
B. Highlight the initial, signature, and date lines in the actual consent form document so that as the form is discussed, these areas are clearly identified.
C. Be sure to review the signed informed consent form before the participant leaves the visit to ensure that all items are marked, signed, and dated appropriately.
D. Keep a calendar handy to check today’s date against the date provided by the participant in the form.
E. All of the above.
（1）在审阅研究参与者签署的知情同意文件时，手边准备一份关键项目清单，以便检查。
（2）在实际的同意表格文件中突出最初的、签名和日期线，以便在讨论表格时清楚地识别这些区域。
（3）在参与者离开之前，一定要查看已签署的知情同意书，以确保所有项目都有适当的标记、签名和日期。
（4）将日历放在手边，核对今天的日期与参与者在表格中提供的日期。
（5）以上所有。
Feedback: Which do you choose: A, B, C, D, or E? The best answer is: All of these strategies would help participants to complete accurately the informed consent form. That would be multiple choice E.
反馈：你选择哪一个：A、B、C、D还是E？最好的答案是：所有这些策略都有助于参与者准确填写知情同意书。那就是选择题E。
Part 7: Requirements for the Documentation of Informed Consent 知情同意书的文件要求
Requirements for the documentation of informed consent are set forth in 45 CFR 46.117, 21 CFR 50.27, and ICH GCP 4.8. In brief, these requirements are as follows.
45 CFR 46.117、21 CFR 50.27和ICH GCP 4.8中规定了知情同意书的文件要求。简言之，这些要求如下。
Informed Consent Shall be Documented by the Use of a Written Consent Form 知情同意书应以书面同意书形式记录
Ⅰ、The IRB must approve the consent form.
Ⅱ、The participant or the participant’s legally authorized representative must sign the current version of the IRB approved consent form.
Ⅲ、ICH GCP requires that the consent form should also be signed by the person conducting the informed consent discussion.
Ⅳ、A copy of the form must be given to the person who signs it. The study site must keep the original on file.
1、IRB必须批准该同意书。
2、参与者或参与者的合法授权代表必须签署现行版本的IRB批准的同意书。
3、ICH GCP要求进行知情同意讨论的人也应签署同意书。
4、必须将表格的副本交给签字的人。研究地点必须保留原始文件。
The Consent Form May Take One of Two Organizational Structures 同意书可采用两种组织结构之一
A written document that embodies the elements of informed consent required by 45 CFR 46.116. This form may be read to the participant or the participant’s representative. The investigator should give the participant or representative ample time to absorb the content of the form before signing it.
包含45 CFR 46.116要求的知情同意要素的书面文件。本表格可向参与者或参与者代表阅读。研究人员应给参与者或代表足够的时间，让他们在签字前吸收表格的内容。
A short-form written document stating that the elements of informed consent were presented orally to the participant or the participant’s representative. When the short form document is used:
Ⅰ、A witness must be present at the oral presentation.
Ⅱ、The IRB must approve a written summary of what is to be said to the participant or representative.
Ⅲ、The participant or representative must sign only the short form itself.
Ⅳ、The witness must sign both the short form and a copy of the summary.
Ⅴ、The person obtaining the participant’s consent must also sign a copy of the summary.
Ⅵ、A copy of the summary, in addition to a copy of the short form, must be given to the participant or the participant’s representative.
一份简短的书面文件，说明知情同意的要素已口头提交给参与者或参与者的代表。当使用简式文档时:
1、口头陈述必须有证人在场。
2、IRB必须批准对参与者或代表所说内容的书面总结。
3、参与者或代表只能在简短的表格上签字。
4、证人必须在简表和摘要副本上签字。
5、获得参与者同意的人员还必须签署一份总结。
6、除了一份简短表格外，还必须向参与者或参与者代表提供一份摘要副本。
Researchers Must Not Waive or Appear to Waive Any Legal Rights of Participants 研究人员不得放弃或似乎放弃参与者的任何合法权利
For example, care must be taken when describing what compensation (beyond the provision of immediate or therapeutic intervention) the institution is voluntarily willing to provide in an event such as a research-related injury.
例如，在描述机构在发生研究相关伤害等事件时自愿提供的补偿（除提供即时或治疗干预外）时，必须谨慎。
Participants should understand that, regardless of what the institution may agree to provide as compensation for a research-related injury, they retain the right to take legal action against the institution and/or those responsible for the injury.
参与者应理解，无论机构可能同意提供什么作为研究相关损害的赔偿，他们保留对机构和/或对损害负有责任的人采取法律行动的权利。
The Consent Form Must be Revised When New Information Becomes Available that May Be Relevant to the Participant’s Consent 当获得可能与参与者同意相关的新信息时，必须修改同意书
If a new adverse event appears to be related to the study medication (e.g., a severe allergic reaction that occurs shortly after a medication is given), this risk should be added to a revised consent form.
Ⅰ、The revised consent form must be approved by the IRB.
Ⅱ、The participant must be informed of the new information in a timely manner.
Ⅲ、The communication of the new information to the participant must be documented.
如果一个新的不良事件似乎与研究用药有关(例如，在用药后不久发生严重的过敏反应) ，这个风险应该加入到修订的同意书中。
Ⅰ、经修订的同意书必须得到 IRB 的批准。
Ⅱ、参与者必须及时被告知新的信息。
Ⅲ、必须记录与参与者沟通的新信息。
Other considerations for the Informed Consent Process 关于知情同意进程的其他考虑因素
The investigator must document the informed consent process in the participants’ source notes. When new information becomes available which results in a revised informed consent form, the participant must be informed in a timely manner and the communication of this information must be documented in the source notes.
研究者必须在参与者的资料来源记录中记录知情同意过程。当获得新信息并产生修订的知情同意表格时，必须及时通知参与者，并在来源说明中记录该信息的交流。
In obtaining and documenting the informed consent, the investigator should comply with ethical principles that have their origin in the Declaration of Helsinki, ICH GCP, CFR and applicable regulatory requirements.
在获取和记录知情同意书时，研究人员应遵守赫尔辛基宣言、ICH GCP、CFR和适用监管要求中的伦理原则。
Non-therapeutic trials should be conducted in subjects who are capable of personally giving consent and signing and dating the consent form.(ICH GCP 4.8.13)
非治疗性试验应在能够亲自同意并签署同意书并注明日期的受试者中进行。（ICH GCP 4.8.13）
Non-therapeutic trials may be conducted with consent from a legal representative if the following conditions are met:
Ⅰ、The objectives of the trial cannot be met by a participant that can personally give consent.
Ⅱ、The foreseeable risks to the participants are low.
Ⅲ、Any negative impact on the participants’ well-being is minimized.
Ⅳ、The trial is not prohibited by law.
Ⅴ、The approval of the IRB is expressly sought on the inclusion of such participants and is documented in a written approval letter.
非治疗性试验可在符合以下条件的情况下，经法定代表人同意后进行:
1、试验的目标不可能由参与者个人同意来实现。
2、参与者可预见的风险很低。
3、任何对参与者幸福感的负面影响都被最小化。
4、法律不禁止审判。
5、IRB的批准是明确要求包括这些参与者，并记录在书面批准信中。
These type of non-therapeutic trials should be conducted in patients having a disease or condition for which the investigational product is intended and they should be closely monitored.
此类非治疗性试验应在患有试验药物拟用于治疗的疾病或状况的患者中进行，并应密切监测。
Further Information 更多信息
45 CFR 46.116
ICH E6 GCP 4.8 — ICH GCP Guidelines
45 CFR 46 Subpart B — Research Involving Pregnant Women
45 CFR 46.408 — Research Involving Children
45 CFR 46.303 — Research Involving Prisoners
