第1个回答 2022-06-15
Part 8: Scenario
Part 9: Summary of Key Points
The three investigators below are planning clinical trials that involve substance abuse treatment. Read about each of their trials, and then make a decision: Who did NOT obtain the informed consent necessary for the individual to participate in the trial? After making your selection, consider the feedback provided.
下面的三位研究人员正在计划进行涉及药物滥用治疗的临床试验。阅读他们的每项试验，然后做出决定：谁没有获得参与试验所需的知情同意？在做出选择后，考虑提供的反馈。
Scenario: Three investigators are planning clinical trials that involve substance abuse treatment. Read about each of their trials, and then make a decision: Who did NOT obtain the informed consent necessary for the individual to participate in the trial?
情景： 三名研究人员正在计划进行涉及药物滥用治疗的临床试验。阅读他们的每项试验，然后做出决定：谁没有获得参与试验所需的知情同意？
Marc has been using cocaine for nearly ten years and is interested in seeking treatment. Dr. Johnson is leading a clinical trial on a pharmacological treatment for cocaine addiction.
After receiving details about the study and having all of his questions answered, Marc decides to think about it for a few days and talk it over with some friends and family members. He comes back later that week, asks Dr. Johnson some additional questions, and after hearing the responses signs and dates his consent to participate in the study, and Dr. Johnson proceeds with enrollment. Did Dr. Johnson obtain the necessary informed consent?
Marc一直在使用可卡因近十年，并有兴趣寻求治疗。约翰逊博士在可卡因成瘾的药理学治疗上领导临床试验。
在收到关于研究的详细信息并获得所有问题后，Marc决定在几天内思考它并与一些朋友和家庭成员交谈。他在那个星期晚些时候回来了，询问约翰逊博士一些额外的问题，并听到回应的签署并遵守他同意参加该研究，约翰逊博士进行报名。约翰逊博士获得了必要的知情同意吗？
Dr. Band is researching the effects of buprenorphine/naloxone (BUP/NX) for participants dependent on prescription opioid analgestics. Alicia— a 38 year old prescription opioid user— is interested in the study.
Dr. Band leaves the consent form for Alicia to read over, but she has a difficult time understanding the medical terms and can’t answer any of the consent quiz questions correctly. In the interest of saving time Dr. Band has her sign and date the consent form and enrolls her and promises to review the study procedures in detail at their next visit. Did Dr. Band obtain the necessary informed consent?
Band博士正在研究丁丙诺啡/纳洛酮（BUP/NX）对依赖处方类阿片镇痛剂的参与者的影响。38岁的处方类阿片使用者Alicia对这项研究感兴趣。
班德博士将同意书留给艾丽西亚阅读，但她很难理解医学术语，无法正确回答任何同意书问答题。为了节省时间，Band博士让她在同意书上签字并注明日期，为她登记，并承诺在下次就诊时详细审查研究程序。班德博士是否获得了必要的知情同意书？
Ada has been trying to stop her heroin use on her own, but muscle and bone pain, insomnia, vomiting, and other withdrawal symptoms have caused her to repeatedly relapse. Dr. Hirsch is holding a clinical trial combining pharmacological and behavioral interventions for the treatment of heroin. The doctor explains the trial and the possible effects.
Ada asks questions about the study, demonstrates her understanding of the procedures, signs and dates the consent form for the study. Did Dr. Hirsch obtain the necessary informed consent?
Ada一直试图阻止她自己的海洛因使用，但肌肉和骨痛，失眠，呕吐等戒断症状导致她反复复发。Hirsch博士在临床试验结合药理学和行为干预措施治疗海洛因。医生解释了试验和可能的影响。
ADA提出了关于该研究的问题，表明了她对该研究的同意书的程序，签署和日期的理解。Hirsch博士获得了必要的知情同意吗？
Feedback : Dr. Johnson provides the appropriate information about the study and answers all of Marc’s questions. He allows Marc to absorb the information, discuss with others, and be comfortable and confident with his decision before signing the consent form. Sorry, A is not the correct answer. The necessary informed consent was obtained in this case.
反馈 ：约翰逊博士提供了有关该研究的适当信息，并回答了马克的所有问题。他允许马克吸收信息，与他人讨论，并在签署同意书之前对自己的决定感到舒适和自信。对不起，A不是正确答案。在这种情况下，获得了必要的知情同意。
Feedback : Dr. Band leaves the consent for Alicia to read and does not explain any of the information. He enrolls Alicia in the study without her fully understanding the study information, and requests that she sign the consent despite knowing that she does not demonstrate an understanding of the study. A consent form should be written in nontechnical language that potential participants would understand, in language consistent with the proposed participants' educational level, cultural views, and familiarity with research. If you chose B, you are correct. In this case, he did NOT obtain the informed consent necessary for the individual to participate in the trial.
反馈 ：Band博士同意Alicia阅读，不解释任何信息。他在Alicia未完全理解研究信息的情况下将其纳入研究，并要求她在同意书上签字，尽管他知道她没有证明对研究的理解。同意书应以潜在参与者能够理解的非技术性语言书写，语言应与拟定参与者的教育水平、文化观点和对研究的熟悉程度相一致。如果你选择B，你是正确的。在本案中，他没有获得该个人参加试验所需的知情同意。
Feedback : Dr. Hirsch explains the procedures and information regarding the study, answers Ada’s questions and asks her questions to ascertain her understanding of the trial. Only then does she sign and date the consent and enroll in the study. Sorry, C is not the correct answer. The necessary informed consent was obtained in this case.
反馈 ：Hirsch博士解释了研究的程序和信息，回答了Ada的问题，并向她提问，以确定她对试验的理解。只有到那时，她才会签署同意书并注明日期，然后加入研究。对不起，C不是正确答案。在这种情况下，获得了必要的知情同意。
Ⅰ、Informed consent is a process by which a person voluntarily agrees to participate in a research study after being fully informed about it.
1、知情同意是指 一个人在完全知情后自愿同意参与研究的过程 。
Ⅱ、The informed consent document should contain all of the information that the participant needs to make an informed decision about participating in the study.
2、知情同意书应 包含参与者就参与研究做出知情决定所需的所有信息 。
Ⅲ、The participant’s signature on the informed consent document confirms his or her voluntary agreement to take part in the study.
3、受试者在知情同意书上的 签名确认其自愿参与 研究。
Ⅳ、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.
4、《美国联邦法规汇编》第45卷第46.116节和第21卷第50.20节阐述了联邦资助研究中知情同意的一般要求。一些州颁布了超出联邦法规的知情同意要求。
Ⅴ、All researchers have a responsibility to ensure that the process of obtaining informed consent or assent from study participants not only conforms to federal, state, and local regulations but also respects each individual’s right to make an informed decision voluntarily.
5、所有研究人员都有责任确保获得研究参与者 知情同意 或 同意的过程 不仅 符合联邦、州和地方法规 ，而且 尊重每个人自愿做出知情决定的权利 。
Ⅵ、The first step in the process of informed consent is preparing the consent document and supporting documents for presentation to the Institutional Review Board that must review and approve the study and consent document. The IRB must review and approve the consent document before the study can begin.
6、知情同意进程的第一步是 准备同意文件和辅助介绍的文件 ，以便向必须审查和批准研究和同意文件的机构审查委员会。在研究开始之前，IRB必须 审查并批准同意文件 。
Ⅶ、Consent documents should be written in nontechnical language that the proposed participants would understand. The language should be consistent with the proposed participants’ educational level, cultural views, and familiarity with research.
7、同意书文件应使用 非技术性语言编写 ，且提议的参与者能够 理解 。语言应与拟议参与者的教育水平、文化观点和对研究的熟悉程度保持一致。
Ⅷ、The information that must be provided in an informed consent document is specified in 45 CFR 46.116, 21 CFR 50.20, and ICH GCP 4.8.10.
8、 知情同意文件中必须提供的信息 在45 CFR 46.116、21 CFR 50.20和ICH GCP 4.8.10中有明确规定。
Ⅸ、The legal age for consent in most states is 18; persons under age 18 are considered minors. Additional protections for children involved as participants in research are set forth in 45 CFR 46 Subpart D. In most cases, both parents must provide permission and the child himself or herself must assent to the child’s participation in research.
9、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。45 CFR 46子部分D中规定了 对参与研究的儿童的额外保护 。在大多数情况下，父母双方必须提供许可， 儿童本人必须同意儿童参与研究 。
Ⅹ、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. Only one person gives consent. If the participant is capable and is not court ordered legally incompetent, then he or she should sign. If the participant is not capable or is legally incompetent, then the legal representative or guardian should sign. A child and the parents sign, but minor children assent, parents provide permission, and legal guardians consent.
10、如果一个人不能提供知情同意， 在某些情况下，法定代表人可以允许该个人参与研究 。只有一个人同意。如果参与者有能力且不是法院命令的法律上不称职的，则他或她应签字。如果参与者没有能力或在法律上不称职，则应由法定代表人或监护人签字。孩子和父母签字，但未成年子女同意，父母提供许可，法定监护人同意。
Ⅺ、Participants must not be coerced or unduly influenced. Coercion occurs if an individual perceives that he or she could be harmed or punished for refusing to take part in a study. In some cases, coercion may occur subtly and unintentionally.
11、 参与者不得受到胁迫或不当影响 。如果一个人认为他或她可能因拒绝参与研究而受到伤害或惩罚，就会发生强迫行为。在某些情况下，胁迫可能会微妙地或无意地发生。
Ⅻ、The value of an incentive for participation in a study should not be so high that it could be considered an undue influence on an individual’s decision to participate.
12、参与 研究的激励价值 不应太高，否则可能会被视为对个人参与决定的不当影响。
XIII、It is important to ensure that the process of obtaining informed consent from human participants is carried out carefully and with vigilant attention to every detail. 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 as well as fines and penalties.
13、 重要的是要确保从人类参与者那里获得知情同意的过程得到认真执行，并警惕地关注每一个细节。 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以及罚款和处罚。