Contents

Part 7: Using Incentives for Study Participation

Part 8: What to Do when a Participant Leaves a Study

Part 9: Summary of Key Points

Part 7: Using Incentives for Study Participation   为参与研究提供激励措施

Use Incentives for Study Participation

Research participants may be offered rewards such as monetary payments, free medical care, extra vacation time, food, and lodging. Such rewards are not considered benefits of study participation but rather incentives for participation.

研究参与者可能会得到一些奖励，如金钱报酬、免费医疗、额外的休假时间、食物和住宿。这种奖励并不被认为是参与研究的好处，而是对参与的奖励。

Receiving a monetary payment, or receiving something for free that would normally have to be paid for, is an inducement. Any inducement may be coercive or an undue influence on a potential study participant. People who are poor or needy may be induced to do something, possibly against their better judgment, by the offer of money or another reward.

获得货币支付，或免费获得通常需要支付的东西，是一种诱因。任何诱导可能是强制性的，或对潜在的研究参与者产生不正当的影响。穷人或需要帮助的人可能会被金钱或其他奖励诱导去做一些事情，这可能会违背他们更好的判断。

Because incentives for participation are potentially coercive, the amount and conditions of such incentives must be reviewed and approved by the IRB (See related material from the Institutional Review Boards module).

由于参与激励具有潜在的强制性，此类激励的金额和条件必须由IRB审查和批准（参见机构审查委员会模块中的相关材料）。

Is it ethical to offer incentives to alcohol or drug abusers to participate in research?   鼓励酗酒或吸毒者参与研究是否合乎道德？

Many potential participants in drug and alcohol research are unemployed or otherwise economically disadvantaged. Concerns about unduly influencing such participants have led some investigators to decline to offer any incentives for study participation. It is unfair, however, to assume that any remuneration that is given to abusers of alcohol or other drugs will serve as an undue influence.

许多药物和酒精研究的潜在参与者失业或处于经济不利地位。对过度影响这些参与者的担忧导致一些研究者拒绝提供任何参与研究的激励。然而，假设给予酒精或其他药物滥用者的任何报酬都会产生不当影响，这是不公平的。

Interactive: Study Recruitment - Criteria for Incentives   互动：研究招聘-激励标准

Users are instructed to complete the statements below with “should” or “should not” to make the criteria correct. Then consider the feedback.

用户被指示用“应该”或“不应该”来完成下面的陈述，以使标准正确。然后考虑反馈。

Ⅰ、Incentives offered to any potential research participants, including alcohol or other drugs, _______________ be valuable enough to: induce participants to enter or remain in a study against their better judgment.

1、向任何潜在研究参与者提供的激励措施，包括酒精或其他药物，其价值足以：诱导参与者进入或留在一项研究中，而不是他们更好的判断。

2、Incentives offered to any potential research participants, including alcohol or other drug abusers, _______________ be valuable enough to: enable recruitment of an adequate number of participants.

2、对任何潜在的研究参与者，包括酗酒者或其他药物滥用者，提供的激励措施应足够有价值:能够招募到足够数量的参与者。

Ⅲ、Incentives offered to any potential research participants, including alcohol or other drug abusers, _______________ be valuable enough to: compensate participants for the time and inconvenience of study participation.

3、向任何潜在研究参与者（包括酒精或其他药物滥用者）提供的奖励应足够有价值：补偿参与者参与研究的时间和不便。

Ⅳ、Incentives offered to any potential research participants, including alcohol or other drug _______________ be given for taking risks.

4、对任何潜在的研究参与者，包括酒精或其他药物，给予冒险的奖励。

Ⅴ、Incentives offered to any potential research participants, including alcohol or other drug _______________ be given for taking medications.

5、向任何潜在研究参与者提供的奖励，包括酒精或其他药物，应给予其服用药物的奖励。

Feedback 1: Which did you choose: Should or Should Not? The correct response is Should Not. Incentives should not be valuable enough to: induce participants to enter or remain in a study against their better judgment.

反馈1：你选择了哪一个：应该还是不应该？正确的回答是“不应该”。激励措施不应该有足够的价值：诱导参与者进入或留在一项研究中，而不是他们更好的判断。

Feedback 2: Which did you choose: Should or Should Not? The correct response is Should. Incentives should be valuable enough to: enable recruitment of an adequate number of participants.

反馈2：你选择了哪一个：应该还是不应该？正确的回答是应该。激励措施应该足够有价值：能够招募足够数量的参与者。

Feedback 3: Which did you choose: Should or Should Not? The correct response is Should. Incentives should be valuable enough to: compensate participants for the time and inconvenience of study participation.

反馈3：你选择了哪一个：应该还是不应该？正确的回答是应该。激励措施应该足够有价值：补偿参与者参与研究的时间和不便。

Feedback 4: Which did you choose: Should or Should Not? The correct response is Should Not. Incentives should not be given for taking risks.

反馈4：你选择了哪一个：应该还是不应该？正确的回答是“不应该”。不应该为冒险提供激励。

Feedback 5: Which did you choose: Should or Should Not? The correct response is Should Not. Incentives should not be given for taking medications.

反馈5：你选择了哪一个：应该还是不应该？正确的回答是“不应该”。不应该对服用药物给予奖励。

Guidelines for Establishing Appropriate Incentives for Study Participation    为研究参与制定适当激励措施的指南

Three issues must be considered in determining the appropriateness of incentives for participation in a study.

在确定参与研究的激励措施是否适当时，必须考虑三个问题。

Monetary Value   货币价值

The value of an incentive should reflect the burden posed by participation in the study. The value should not be so high that the incentive could be considered coercive or an excessive influence on an individual’s decision to participate in a study.

激励的价值应反映参与研究带来的负担。该值不应太高，以至于该激励可能被认为是强制性的，或对个人参与研究的决定产生过度影响。

Method and Timing of Payment   付款方式和时间

Incentive credits should accrue as the study progresses. Payment should not be conditional on the participant’s completion of the entire study. However, it may be acceptable to create a payment schedule that provides some incentive for the participant to complete the study. The completion bonus should not be large enough to induce participants to remain in the study when they would otherwise have withdrawn.

激励积分应随着研究的进展而累积。付款不应以参与者完成整个研究为条件。但是，可以创建一个付款计划，为参与者完成研究提供一些激励。完成奖金不应大到足以诱使参与者留在研究中，否则他们会退出。

In some circumstances, participants who withdraw from a study may be paid at the time they would have completed the study had they not withdrawn. For example, if a study lasts for only a few days, it may be acceptable to pay all participants on study completion, including those who withdrew.

在某些情况下，退出研究的参与者可能会在他们没有退出的情况下完成研究时获得报酬。例如，如果一项研究仅持续几天，则可以接受在研究完成时向所有参与者付款，包括退出的参与者。

Forms of Payment   付款方式

Forms of payment may include cash, store gift cards, money orders, or check cards. Some IRBs are reluctant to approve cash payments for certain populations, such as drug using populations out of concern that drug users might use study payments for drug purchases. On the other hand, avoiding cash payments can be viewed as paternalistic and disrespectful. Some forms of payments, such as money orders or check cards, may require the individual to show identification, which can be a potential problem for some populations, such as drug users. Payments over a certain amount may also be subject to taxes, and the participant should be made aware of this.

付款形式可能包括现金、商店礼品卡、汇票或支票卡。一些IRB不愿意批准某些人群的现金支付，例如吸毒人群，因为担心吸毒者可能会将研究付款用于购买药物。另一方面，避免现金支付可能被视为家长式作风和不尊重。某些形式的支付，如汇票或支票卡，可能要求个人出示身份证明，这对某些人群（如吸毒者）来说可能是一个潜在问题。超过一定金额的付款也可能需要纳税，参与者应了解这一点。

Part 8: What to do when a Participant Leaves a Study   当参与者退出研究时该怎么办

The study protocol should include criteria for withdrawal and procedures for when a participant voluntarily leaves a study, is withdrawn early from the study for safety concerns, or is discharged after completing a study. The protocol should specify:

研究方案应包括退出标准和参与者自愿退出研究、出于安全考虑提前退出研究或完成研究后出院的程序。议定书应规定：

Ⅰ、When and how to withdraw participants.

Ⅱ、What type of data, if any, will be collected for withdrawn participants.

Ⅲ、Whether follow-up of some or all participants that have been withdrawn from the study may occur.

1、何时以及如何退出参与者。

2、对于退出的参与者，将收集何种类型的数据（如有）。

3、是否对部分或全部退出研究的参与者进行随访。

Common end-of-study procedures include, but are not limited to, a closing interview, referral, and follow-up for a specified period of time.

常见的研究结束程序包括但不限于结束访谈、转介和特定时间段的随访。

CLOSING INTERVIEW   结束访谈

The closing interview is important because it is the final opportunity to obtain study data and likely the last contact the research team will have with the study participant. This interview also provides an opportunity to document any adverse events the participant experienced that may need follow-up after the study ends.

结束访谈很重要，因为这是获得研究数据的最后机会，也是研究团队与研究参与者的最后一次接触。本次访谈还提供了一个记录参与者在研究结束后可能需要随访的任何不良事件的机会。

REFERRALS   转介

The research team is responsible for ensuring that a participant who leaves the study has any referrals that he or she needs to obtain services or help elsewhere, if desired.

研究团队负责确保退出研究的参与者获得他或她需要的任何转介，以便在其他地方获得服务或帮助（如果需要）。

FOLLOW-UP   随访

Some protocols include a requirement for a follow-up interview to be conducted at a predetermined time point (e.g., one month) after the participant is discharged from the active treatment phase of the study. It may be helpful to remind the participant of this requirement during the closing interview and, if possible, to schedule the day and time of the follow-up interview. Also, review the participant's locator form to ensure that all contact information is up-to-date.

一些方案包括要求在参与者退出研究的积极治疗阶段后的预定时间点（例如，一个月）进行后续访谈。在结束访谈时提醒参与者这一要求可能会有所帮助，如果可能的话，安排后续访谈的日期和时间。此外，检查参与者的定位表，确保所有联系信息都是最新的。

Most trial participants view the experience positively and would be open to participating in another trial if asked. Gaining acceptance to contact a participant for future studies is often part of the informed consent document and process. In order not to squander this potential resource, keep participants who have completed a study informed to the extent possible of the study’s status and findings and let them know that their participation was valuable. Such efforts can also serve as “word-of-mouth” advertising. A thank-you card or certificate of appreciation can indirectly serve as a recruitment tool for the study, as well as for future studies.

大多数试验参与者对体验持肯定态度，如果被要求，他们愿意参加另一个试验。知情同意书文件和流程通常包括接受与参与者联系进行未来研究。为了不浪费这一潜在资源，尽可能让完成研究的参与者了解研究的状态和发现，并让他们知道他们的参与是有价值的。这些努力也可以作为“口碑”广告。感谢卡或感谢证书可以间接地作为本次学习以及未来学习的招聘工具。

Part 9: Summary of Key Points

Ⅰ、Recruitment and retention of participants are key to the success of any clinical study.

1、招募和保留参与者是任何临床研究成功的关键。

Ⅱ、A successful recruitment and retention strategy requires informed and detailed planning, commitment of adequate resources, careful monitoring, and timely identification and resolution of problems.

2、成功的招聘和保留战略需要知情和详细的规划、充足的资源投入、仔细的监控以及及时发现和解决问题。

Ⅲ、Recruitment of participants may not begin until the Institutional Review Board (IRB) has approved the protocol, informed consent documents, and proposed recruitment and retention strategies.

3、在机构审查委员会（IRB）批准方案、知情同意文件以及拟议的招募和保留策略之前，不得开始招募参与者。

Ⅳ、Advertisements, fliers, and brochures that are prepared to recruit potential participants and inform them about a study are considered part of the informed consent process. As such, they must be reviewed and approved by the IRB (see ICH GCP 3.1.2).

4、准备招募潜在参与者并告知他们研究情况的广告、传单和小册子被视为知情同意过程的一部分。因此，必须由IRB审查和批准（见ICH GCP 3.1.2）。

Ⅴ、Recruitment for a study has two major elements:

   i、Defining a population of appropriate participants to answer the research question.

   ii、Recruiting appropriate participants in an ethical manner.

5、研究招募有两大要素：

（1）确定合适的参与者群体以回答研究问题。

（2）以合乎道德的方式招募合适的参与者。

Ⅵ、Recruitment of an adequate number of participants, although essential, does not in itself assure the success of a study. Unless an adequate number of participants are retained for the duration of the study, investigators will not obtain enough data to answer the research question they posed, which was the reason for performing the study in the first place.

6、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。除非在研究期间保留足够数量的参与者，否则研究人员将无法获得足够的数据来回答他们提出的研究问题，而这正是进行研究的首要原因。

Ⅶ、Research participants may be offered rewards such as monetary payments or medical care at no cost. Such rewards are not considered benefits of study participation but rather incentives for participation.

7、研究参与者可能会得到奖励，如金钱支付或免费医疗。这些奖励并不被认为是参与研究的好处，而是参与研究的激励。

Ⅷ、Because incentives for participation are potentially coercive, the amount, form, and conditions of such incentives must be reviewed and approved by the IRB (see ICH GCP 3.1.8).

8、由于参与激励具有潜在的强制性，此类激励的金额、形式和条件必须经IRB审查和批准（见ICH GCP 3.1.8）