Contents
Part 5: Inviting Potential Participants to Enroll in a Research Study
Part 5: Inviting Potential Participants to Enroll in a Research Study 邀请潜在的参与者注册研究
Written documentation of Institutional Review Board approval of the study, consent document(s) and recruitment materials (where appropriate) must be obtained and provided to the sponsor. NIDA and the CTN Lead Investigator must give their approval before recruitment can begin at a study site.
必须获得研究机构审查委员会批准的书面文件、同意文件和招募材料（如适用），并将其提供给申办方。NIDA和CTN首席研究员必须在研究地点开始招募前给予批准。
Members of the research team may find it helpful to keep the following questions in mind as they go through the process of recruiting participants for a study:
研究团队成员可能会发现，在招募研究参与者的过程中，牢记以下问题很有帮助：
Is the participant capable of understanding information about the study and giving informed consent voluntarily? 参与者是否能够理解研究信息并自愿给予知情同意？
Adults have the capacity to consent when they possess sufficient mental capability to:
Ⅰ、Understand information given to them.
Ⅱ、Appreciate the relevance of the information to their circumstances.
Ⅲ、Make a reasoned decision about whether or not to participate in a particular study.
当成年人具备足够的心理能力时，他们有能力同意：
1、了解提供给他们的信息。
2、了解信息与他们的情况的相关性。
3、对是否参加某项研究做出合理的决定。
Capacity to consent may be affected by several factors, including:
Ⅰ、Age.
Ⅱ、Cognitive (mental) impairment.
Ⅲ、Illness.
Ⅳ、Treatments.
同意能力可能受到若干因素的影响，包括：
1、年龄。
2、认知（精神）障碍。
3、疾病。
4、治疗。
Capacity to consent is study-specific. A person may have sufficient capacity to carry out daily activities and make personal decisions, but he or she may not have sufficient capacity to appreciate the relevance of a given research study to his or her circumstances. On the other hand, a person may be incapacitated in daily activities but still have the capacity to consent to study participation.
同意能力是研究特有的。一个人可能有足够的能力开展日常活动和做出个人决定，但他或她可能没有足够的能力理解某项研究与他或她的情况的相关性。另一方面，一个人可能无法进行日常活动，但仍然有能力同意参与研究。
For some participants or groups of participants, the investigator or the IRB may decide to obtain an independent capacity assessment. This may involve consulting a psychiatrist or neurologist for a determination of an individual’s cognitive ability and ability to understand the details and implications of a study protocol.
对于某些参与者或参与者群体，研究者或IRB可能决定获得独立的能力评估。这可能涉及咨询精神科医生或神经科医生，以确定个体的认知能力以及理解研究方案细节和含义的能力。
If a person is unable to provide informed consent, a legal representative may give permission for the individual to participate in research in some circumstances. A legal representative may be:
Ⅰ、A parent (for minors only).
Ⅱ、A legal guardian, as determined by state law, who can make health care decisions for a person who is unable to consent.
Ⅲ、An individual who holds a valid durable power of attorney for health care. Because of variability in legal opinions about the authority of the holder of a durable power of attorney for health care, the investigator should clarify whether institutional and IRB policies permit the holder of a durable power of attorney for health care to give informed consent for participation in research on behalf of a study participant.
如果一个人无法提供知情同意，在某些情况下，法律代表可能会允许该个人参与研究。法定代表人可以是:
1、家长(仅限未成年人)。
2、州法律规定的合法监护人，可以为无法同意的人作出医疗保健决定。
3、持有有效、持久的医疗保健委托书的个人。由于关于医疗保健长期授权书持有人权限的法律意见存在差异，研究者应澄清机构和IRB政策是否允许医疗保健长期授权书持有人代表研究参与者对参与研究给予知情同意。
Has the participant been given sufficient, accurate information about the study? 参与者是否获得了关于该研究的充分、准确的信息？
To be informed means to have thorough knowledge of a matter. To be able to give informed consent, participants must have sufficient, accurate information about a study. This means that participants should be able to answer the following questions:
被告知意味着对一件事有透彻的了解。为了能够给予知情同意，参与者必须拥有关于研究的充分、准确的信息。这意味着参与者应该能够回答以下问题：
Ⅰ、What is the purpose of the research?
Ⅱ、Does the study involve an experimental treatment or procedure?
Ⅲ、Does the study involve random assignment to one treatment or another?
Ⅳ、What must I do as a study participant?
Ⅴ、What are the anticipated risks and benefits of participation in the study?
Ⅵ、What alternative treatments or procedures are available?
Ⅶ、Will participants in the study receive any compensation?
Ⅷ、Will I have any expenses for participating in the study?
Ⅸ、How long will my participation in the study last?
Ⅹ、Will my study records be kept confidential?
Ⅺ、Will I be informed in a timely manner about any issues that might affect my willingness to continue taking part in the study?
Ⅻ、Who is in charge of the study?
XIII、Will I receive treatment whether I participate in the study or not?
XIV、May I withdraw from the study at any time if I change my mind and no longer wish to take part?
1、研究的目的是什么？
2、研究是否涉及实验性治疗或程序？
3、该研究是否涉及随机分配到一种或另一种治疗？
4、作为研究参与者，我必须做什么？
5、参与研究的预期风险和收益是什么？
6、有哪些替代治疗或程序？
7、研究参与者是否会获得任何补偿？
8、我参加研究会有任何费用吗？
9、我参加这项研究将持续多长时间？
10、我的研究记录会保密吗？
11、是否会及时告知我任何可能影响我继续参与研究意愿的问题？
12、谁负责这项研究？
13、 无论我是否参与研究，我都会接受治疗吗？
14、 如果我改变主意，不再希望参加研究，我可以随时退出研究吗？
To ensure that a participant has been given sufficient, accurate information about a study, a member of the research team should:
为确保参与者已经获得了足够的，准确的关于研究的信息，研究团队的成员应该：
Ⅰ、Talk with the participant about the study’s purpose and requirements.
Ⅱ、Provide fliers or brochures that describe the study or provide general information about clinical research, if available.
Ⅲ、Invite the participant to ask questions and respond to questions asked by the participant.
Ⅳ、Give the participant plenty of time to read the informed consent document and ask questions about it.
Ⅴ、Give the participant a copy of the informed consent document to take home and read before signing it. Additionally, give the participant a copy of the consent form after he or she has signed it.
Ⅵ、Invite the participant to call with questions later and provide the names and phone numbers of people to call.
1、与参与者讨论研究的目的和要求。
2、提供描述研究的传单或小册子，或提供有关临床研究的一般信息（如有）。
3、邀请参与者提问并回答参与者提出的问题。
4、给参与者足够的时间阅读知情同意书并提出相关问题。
5、给参与者一份知情同意书副本，以便在签署前带回家阅读。此外，在参与者签署同意书后，给其一份副本。
6、邀请参与者稍后打电话提问，并提供要打电话的人的姓名和电话号码。
Potential study participants may have difficulty focusing for an extended period of time for various reasons. For example, in some study populations (e.g., substance use disorders), such difficulty could be related to co-occurring illness, chronic pain, or withdrawal from substance use. Information must be presented in a language they can understand, at a pace they can keep up with, and in a manner that invites questions.
由于各种原因，潜在的研究参与者可能难以长时间集中注意力。例如，在一些研究人群中（例如，物质使用障碍），这种困难可能与共同发生的疾病、慢性疼痛或停止使用物质有关。信息必须以他们能够理解的语言呈现，以他们能够跟上的速度呈现，并且以一种引发问题的方式呈现。
Sometimes information about a study may be presented to a group of potential participants. In this situation, it is important to meet with participants individually, ensuring that each person has the opportunity to ask questions in private.
有时候，关于一项研究的信息可能会呈现给一组潜在的参与者。在这种情况下，与参与者单独见面很重要，确保每个人都有机会私下提问。
Does the participant understand the information he or she has been given about the study? 参与者是否理解他或她收到的关于研究的信息？
The research team must be satisfied that the participant understands what he or she has been told about the study. Participants who are in withdrawal, depressed, manic, or otherwise psychiatrically or cognitively impaired may not be able to give informed consent.
研究团队必须确信参与者了解他或她所了解的研究内容。处于戒断状态、抑郁、躁狂或其他精神或认知障碍的参与者可能无法给予知情同意。
The best way to be sure that the participant understands the information he or she has been given about the study is to review the consent document with the participant, line-by-line. Then, ask the participant questions about the study to ascertain what information he or she has absorbed.
确保参与者理解他或她所获得的关于研究的信息的最佳方法是与参与者逐行审查同意书。然后，询问参与者有关研究的问题，以确定他或她吸收了哪些信息。
It may be helpful to prepare a quiz to test the participant’s understanding of the study. Such a quiz would have to be prepared in advance and submitted to the IRB for review and approval along with the other consent documents.
准备一个测验来测试参与者对研究的理解可能会有所帮助。此类测验必须提前准备，并与其他同意文件一起提交给IRB审查和批准。
There are instances when it is challenging to assess that participants understand the information they have been given. Consider the following conditions.
在某些情况下，评估参与者是否理解所提供的信息是一项挑战。考虑下面的条件。
A Participant has Limited Speaking Ability in English 参与者的英语口语能力有限
45 CFR 46.116 requires that:
“the information given to the participant or the representative shall be in language understandable to the participant or the representative.” In practice, most IRBs require the informed consent document to be translated for potential participants who have limited or no understanding of spoken English. Researchers must follow the procedure approved by the IRB for obtaining consent from these participants.
45 CFR 46.116要求：
“提供给参与者或代表的信息应采用参与者或代表可以理解的语言。”在实践中，大多数IRB要求为对英语口语理解有限或不了解的潜在参与者翻译知情同意书。研究人员必须遵循IRB批准的程序获得这些参与者的同意。
It is also important to be aware of specific language differences that may be confusing to participants who are not fluent in English. For example, in Spanish, the word “once” means the number 11. An instruction to “take this medication once daily” might be confusing to a Spanish-speaking participant.
同样重要的是要注意可能会让英语不流利的参与者感到困惑的特定语言差异。例如，在西班牙语中，“once”一词表示数字11。“每天服用一次这种药物”的说明可能会让讲西班牙语的参与者感到困惑。
A Participant has Limited Reading Ability 参与者的阅读能力有限
45 CFR 46.117 states:
“[the consent] form may be read to the participant or the participant’s legally authorized representative, but in any event, the investigator shall give either the participant or the representative adequate opportunity to read it before it is signed.” The participant may take the consent home and return at a later date with a decision.
45 CFR 46.117规定：
“[同意书]可向参与者或参与者的法定授权代表宣读，但无论如何，研究人员应在签署前给予参与者或其代表充分的阅读机会。”参与者可将同意书带回家，并在日后做出决定后返回。
Both 45 CFR 46.117 and ICH E6 GCP 4.8.9 state that if a participant is unable to read, a witness must be present throughout the informed consent discussion and must sign the consent form(s).
45 CFR 46.117和ICH E6 GCP 4.8.9说明如果参与者无法阅读，则在知情同意书讨论过程中必须有证人在场，并且必须在同意书上签字。
Is the participant’s decision to participate in the study entirely voluntary or has he or she been coerced or influenced in any way (e.g., by circumstances or by other people)? 参与者参与研究的决定是否完全是自愿的，或者他或她是否受到任何方式的胁迫或影响（例如，环境或其他人）？
Coercion occurs if an individual perceives that he or she could be harmed or punished for refusing to take part in a study, or if he or she feels compelled due to financial circumstances.
如果个人认为他或她可能因拒绝参加研究而受到伤害或惩罚，或者他或她因经济状况而感到被迫，则会发生强迫行为。
Historically, individuals in relationships of dependence or unequal power have been particularly vulnerable to coercion. Coercion occurred in the 1960s at Willowbrook State School when some parents could not admit their child to the school unless they agreed to the child’s participation in studies in which children were deliberately infected with hepatitis.
从历史上看，处于依赖或不平等权力关系中的个人特别容易受到胁迫。20世纪60年代在Willowbrook州立学校发生了强迫行为，当时一些家长不允许他们的孩子入学，除非他们同意让孩子参加故意让孩子感染肝炎的研究。
Blatant coercion such as this, as well as coercive financial incentive, is rare today because of the vigilance of research teams and IRBs. However, in some cases, coercion may occur subtly and unintentionally. This kind of coercion can be more difficult to detect.
由于研究团队和内部审查委员会的警惕，像这样明目张胆的强制，以及强制性的财政激励，在今天是罕见的。然而，在某些情况下，强制可能会微妙地和无意地发生。这种强制更难以察觉。
Does the participant understand that signing the informed consent document indicates agreement to participate in the study? 参与者是否明白签署知情同意文件表明协议参与该研究？
In most cases, the dated signature of the participant, or his or her legally authorized representative, on the informed consent document indicates that the participant understands the study and is willing to participate. Signing the informed consent document should be the final step in the informed consent process.
在大多数情况下，受试者或其合法授权代表在知情同意书文件上注明日期的签名表明受试者理解研究并愿意参与。签署知情同意书应该是知情同意过程的最后一步。
A member of the research team must sign the consent form to confirm that:
Ⅰ、To the best of the team member’s knowledge, the participant has understood the information given to him or her about the study and is volunteering without coercion.
Ⅱ、The informed consent process followed the procedures authorized by the local IRB.
研究团队成员必须签署同意书，以确认：
1、就团队成员所知，参与者已理解向其提供的有关研究的信息，并且在没有强迫的情况下自愿参与。
2、知情同意程序遵循当地IRB授权的程序。
ICH GCP requires that the person conducting the informed consent discussion sign the form.
The participant should be given a copy of the signed consent document. The original must be kept on file in the research offices per local IRB guidelines.
ICH GCP要求进行知情同意讨论的人在表格上签名。
应向参与者提供一份已签署同意书的副本。原件必须按照当地IRB指南在研究办公室存档。
