Contents
Part 4: Advertising for Study Participants
Part 5: Retention
Part 6: Retention Strategies
Part 4: Advertising for Study Participants 为研究参与者做广告
Advertisements, fliers, and brochures that are prepared to inform potential participants about a study and recruit them are considered part of the informed consent process. As such, they must be reviewed and approved by the designated IRB.
为告知潜在参与者有关研究并招募他们而准备的广告、传单和小册子被视为知情同意过程的一部分。因此，它们必须经过指定的内部审计委员会的审查和批准。
Recruitment of participants may not begin until the IRB has approved the protocol, informed consent documents, and proposed recruitment and advertising materials.
在IRB批准方案、知情同意文件以及拟议的招募和广告材料之前，不得开始招募参与者。
The IRB reviews not only the wording of advertising materials but also the presentation and the intended mode of communication (e.g., print, radio, television). The purpose of the IRB’s review is to ensure that no aspect of the advertising materials might be considered coercive or misleading.
IRB不仅审查广告材料的措辞，还审查其展示和预期的沟通方式（如印刷、广播、电视）。IRB审查的目的是确保广告材料的任何方面都不会被视为具有强制性或误导性。
Interactive: Coercive or Non-Coercive Advertising 强制性广告与非强制性广告
Users are instructed to review each of the scenarios given and to answer the question: Would the IRB consider these scenarios Coercive or Non-Coercive ? The consider the feedback.
用户被要求回顾给出的每个场景，并回答以下问题:IRB认为这些场景是强制性的还是非强制性的?考虑反馈。
Scenarios 1: Only clients who agree to enroll in a study will continue to receive treatment.
情景1：只有同意参与研究的客户才能继续接受治疗。
Scenarios 2: An employer or counselor says, "I would really appreciate it if you signed up for this study."
情景2：一位雇主或顾问说，“如果你报名参加这项研究，我会非常感激。”
Scenarios 3: Study staff handing out fliers about a drug treatment study to passersby on the street.
情景3：研究人员向街上的路人分发关于药物治疗研究的传单。
Scenarios 4: Offer of payment that appears in an advertisement in larger or bolder type than other information about the study.
情景4：在广告中以比其他研究信息更大或更粗体的形式出现的付款要约。
Feedback 1: Would the IRB consider this scenario Coercive or Non-Coercive? Making study participation a condition of continued treatment is not ethical. Therefore, the correct response is Coercive.
反馈1：IRB会认为这种情况是强制性的还是非强制性的？将参与研究作为持续治疗的条件是不道德的。因此，正确的反应是强制性的。
Feedback 2: Would the IRB consider this scenario Coercive or Non-Coercive? Having a person of authority or influence suggest they would appreciate participation is not ethical. Therefore, the correct response is Coercive.
反馈2：IRB会认为这种情况是强制性的还是非强制性的？让有权威或影响力的人暗示他们会欣赏参与是不道德的。因此，正确的反应是强制性的。
Feedback 3: Would the IRB consider this scenario Coercive or Non-Coercive? This is a random and non-invasive way of recruiting potential study participants. Therefore, the correct response is Non-Coercive.
反馈3：IRB会认为这种情况是强制性的还是非强制性的？这是一种随机、非侵入性的招募潜在研究参与者的方法。因此，正确的回答是非强制性的。
Feedback 4: Would the IRB consider this scenario Coercive or Non-Coercive? Payment cannot be used to recruit study participants. Therefore, the correct response is Coercive.
反馈4：IRB会认为这种情况是强制性的还是非强制性的？付款不能用于招募研究参与者。因此，正确的反应是强制性的。
How might advertising for study participants be misleading? 针对研究参与者的广告是如何误导的呢?
The following are examples of statements or actions that might be considered misleading:
以下是一些可能被认为是误导的陈述或行为的例子:
Ⅰ、Saying that a study will involve no invasive procedures when, in fact, participants will be required to have blood drawn.
Ⅱ、Appearing to promise a favorable outcome by:
i、Using the terms "new treatment," "new medication," or "new drug" without explaining that the treatment is investigational.
ii、Suggesting that the drug or treatment is equivalent or superior to any other available drug or treatment.
iii、Offering "free medical treatment" instead of stating that participants will not be charged for participating in the study.
iv、Making a statement such as "We will cure you in six easy steps."
1、说一项研究将涉及没有侵入性程序，其实参与者需要血液绘制。
2、出现承诺有利的结果：
（1）使用“新治疗”的术语“新药”或“新药”而无需解释治疗是调查的。
（2）表明药物或治疗等同于或优于任何其他可用的药物或治疗。
（3）提供“免费医疗”，而不是指出参与参与研究的参与者。
（4）发表声明，如“我们将以六个简单的步骤治愈您”。
Part 5: Retention 保留
Why is retention of study participants important? 为什么保留研究参与者很重要？
Recruitment of an adequate number of participants, although essential, does not in itself assure the success of a study. Once participants are recruited into a study, they must complete the study to ensure their information/data can be included in the final analysis.
招募足够数量的参与者虽然至关重要，但其本身并不能保证研究的成功。一旦参与者被招募到研究中，他们必须完成研究，以确保他们的信息/数据可以包含在最终分析中。
Unless an adequate number of participants are retained for the duration of the study, investigators may not obtain enough data to answer the research question they posed, which was the reason for performing the study in the first place. Also, the cost (in time and resources) of retaining and managing a participant who is already enrolled is considerably less than the cost of recruiting a new participant.
除非在研究期间保留足够数量的参与者，否则研究人员可能无法获得足够的数据来回答他们提出的研究问题，这是进行研究的首要原因。此外，保留和管理已注册参与者的成本（时间和资源）大大低于招募新参与者的成本。
Retention means assuring that participants:
Ⅰ、Undergo study procedures at the required intervals.
Ⅱ、Complete questionnaires or responses to interviewers’ questions.
Ⅲ、Participate in any other activities required by the study protocol.
Ⅳ、Attend follow-up visits as required.
留存意味着确保参与者:
1、按照要求的时间间隔进行研究程序。
2、完成问卷或回答面试官的问题。
3、参加研究方案要求的任何其他活动。
4、根据需要参加后续访问。
Part 6: Retention Strategies 保留策略
Elements of a Successful Retention Strategy 成功保留战略的要素
Successful retention involves:
Ⅰ、Treating the participant with respect.
Ⅱ、Being considerate of the participant’s time.
Ⅲ、Identifying and overcoming barriers to retention.
Ⅳ、Including retention strategies in the budget.
Ⅴ、Identifying and resolving problems in a timely manner.
成功的保留包括：
1、尊重参与者。
2、考虑参与者的时间。
3、识别和克服保留障碍。
4、将保留策略纳入预算。
5、及时发现和解决问题。
When devising a retention strategy, the following issues should be considered.
在设计留存策略时，需要考虑以下问题。
Retention Begins with the Participant’s First Visit 保留从参与者第一次访问开始
During the first visit, while the participant is going through the informed consent process ensure the participant understands the time and procedures involved and talk about why it is important to complete all the required study procedures and visits. Often, study templates or electronic CRFs are created to record a participant’s contact information, also called locator forms. Using a locator form, the study staff may record the participant’s address, phone number, and contact information for friends and family members who may be called, of course, with the consent of the participant. This information will help the clinic to locate the participant later if he or she misses a visit.
在首次访视期间，当参与者正在进行知情同意程序时，确保参与者了解所涉及的时间和程序，并说明为什么完成所有必要的研究程序和访视是重要的。通常，创建研究模板或电子CRF来记录参与者的联系信息，也称为定位表。通过使用定位表，研究人员可以记录参与者的地址、电话号码以及朋友和家人的联系信息，当然，在参与者同意的情况下，可以给他们打电话。这些信息将有助于诊所在参与者错过就诊后找到他或她。
Retention is an Ongoing Process 保留是一个持续的过程
Do not wait until the last participant is enrolled before starting to think about retention. Devise retention strategies during the study design phase. Depending on the population being studied, it may be beneficial to review the participant’s contact information with him or her at every visit. For example, many drug-dependent individuals change their home address or job frequently. Ensure that up-to-date contact information is always on file for every participant.
不要等到最后一个参与者注册后才开始考虑保留问题。在研究设计阶段设计保留策略。根据所研究的人群，在每次就诊时查看参与者与他或她之间的联系信息可能是有益的。例如，许多药物依赖者经常改变家庭住址或工作。确保每个参与者的最新联系信息始终存档。
Retention is Everyone’s Responsibility
保留是每个人的责任
All clinic staff should be trained to understand the importance of maintaining up-to-date contact information for all participants. A participant may casually mention at any time that he or she is about to move, change jobs, or change his or her marital status. This information should be recorded in the participant’s file and communicated to all members of the research team.
所有诊所工作人员都应接受培训，以了解为所有参与者保留最新联系信息的重要性。参与者可以随时随意提及他或她将要搬家、换工作或改变婚姻状况。这些信息应记录在参与者的档案中，并传达给研究团队的所有成员。
Specific Strategies for Retaining Participants in a Clinical Study 临床研究中留住参与者的具体策略
Ⅰ、Stress the importance of compliance during the informed consent interview and throughout the study.
Ⅱ、Establish rapport with participants.
Ⅲ、If a participant cannot be found and has not withdrawn consent, use the participant's contact information to try to find him or her. Telephone the participant’s home, telephone his or her contacts, or (if the participant has given consent for home visits) visit the participant’s home.
Ⅳ、Use public information to try to locate the participant. For example, in some states, the motor vehicle administration and other government agencies will release an individual’s contact information if it is considered to be part of the public record.
Ⅴ、Consider amending the protocol to ease or eliminate assessments or other procedures that participants find disagreeable and that may deter retention.
Ⅵ、Use regular teleconferences to brainstorm retention strategies with local and national project staff.
Ⅶ、Send reminder notes to let the participant know you will be calling shortly to perform or schedule their next assessment.
Ⅷ、Conduct research interviews at a location convenient for the participant.
Ⅸ、Offer participants transportation to and from the study site.
Ⅹ、Be persistent and document all attempts to contact participants — keep trying.
Ⅺ、Ensure that all of these efforts preserve the privacy of the participant.
1、强调在知情同意访谈和整个研究过程中遵守的重要性。
2、与参与者建立融洽的关系。
3、如果无法找到与会者且未撤回同意，请使用与会者的联系方式查找。给参与者的家打电话，给他或她的联系人打电话，或者(如果参与者同意进行家访)到参与者家拜访。
4、利用公共信息试图定位参与者。例如，在一些州，机动车管理局和其他政府机构将公布个人的联系信息，如果该信息被视为公共记录的一部分。
5、考虑修改议定书，以减轻或消除参与者认为不愉快并可能阻止保留的评估或其他程序。
6、定期召开电话会议，与当地和国家项目员工集体讨论保留策略。
7、发送提醒说明，让参与者知道您将很快打电话执行或安排他们的下一次评估。
8、在参与者方便的地点进行研究访谈。
9、为参与者提供往返研究现场的交通工具。
10、坚持不懈，记录所有与参与者联系的尝试——继续尝试。
11、确保所有这些努力都能保护参与者的隐私。
