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? ?為參與研究提供激勵(lì)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.

研究參與者可能會(huì)得到一些獎(jiǎng)勵(lì)，如金錢報(bào)酬、免費(fèi)醫(yī)療、額外的休假時(shí)間、食物和住宿。這種獎(jiǎng)勵(lì)并不被認(rèn)為是參與研究的好處，而是對(duì)參與的獎(jiǎng)勵(lì)。

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.

獲得貨幣支付，或免費(fèi)獲得通常需要支付的東西，是一種誘因。任何誘導(dǎo)可能是強(qiáng)制性的，或?qū)撛诘难芯繀⑴c者產(chǎn)生不正當(dāng)?shù)挠绊?/b>。窮人或需要幫助的人可能會(huì)被金錢或其他獎(jiǎng)勵(lì)誘導(dǎo)去做一些事情，這可能會(huì)違背他們更好的判斷。

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).

由于參與激勵(lì)具有潛在的強(qiáng)制性，此類激勵(lì)的金額和條件必須由IRB審查和批準(zhǔn)（參見機(jī)構(gòu)審查委員會(huì)模塊中的相關(guān)材料）。

Is it ethical to offer incentives to alcohol or drug abusers to participate in research?? ?鼓勵(lì)酗酒或吸毒者參與研究是否合乎道德？

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.

許多藥物和酒精研究的潛在參與者失業(yè)或處于經(jīng)濟(jì)不利地位。對(duì)過(guò)度影響這些參與者的擔(dān)憂導(dǎo)致一些研究者拒絕提供任何參與研究的激勵(lì)。然而，假設(shè)給予酒精或其他藥物濫用者的任何報(bào)酬都會(huì)產(chǎn)生不當(dāng)影響，這是不公平的。

Interactive: Study Recruitment - Criteria for Incentives? ?互動(dòng)：研究招聘-激勵(lì)標(biāo)準(zhǔn)

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

用戶被指示用“應(yīng)該”或“不應(yīng)該”來(lái)完成下面的陳述，以使標(biāo)準(zhǔn)正確。然后考慮反饋。

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、向任何潛在研究參與者提供的激勵(lì)措施，包括酒精或其他藥物，其價(jià)值足以：誘導(dǎo)參與者進(jìn)入或留在一項(xiàng)研究中，而不是他們更好的判斷。

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、對(duì)任何潛在的研究參與者，包括酗酒者或其他藥物濫用者，提供的激勵(lì)措施應(yīng)足夠有價(jià)值:能夠招募到足夠數(shù)量的參與者。

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、向任何潛在研究參與者（包括酒精或其他藥物濫用者）提供的獎(jiǎng)勵(lì)應(yīng)足夠有價(jià)值：補(bǔ)償參與者參與研究的時(shí)間和不便。

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

4、對(duì)任何潛在的研究參與者，包括酒精或其他藥物，給予冒險(xiǎn)的獎(jiǎng)勵(lì)。

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

5、向任何潛在研究參與者提供的獎(jiǎng)勵(lì)，包括酒精或其他藥物，應(yīng)給予其服用藥物的獎(jiǎng)勵(lì)。

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.

反饋1：你選擇了哪一個(gè)：應(yīng)該還是不應(yīng)該？正確的回答是“不應(yīng)該”。激勵(lì)措施不應(yīng)該有足夠的價(jià)值：誘導(dǎo)參與者進(jìn)入或留在一項(xiàng)研究中，而不是他們更好的判斷。

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.

反饋2：你選擇了哪一個(gè)：應(yīng)該還是不應(yīng)該？正確的回答是應(yīng)該。激勵(lì)措施應(yīng)該足夠有價(jià)值：能夠招募足夠數(shù)量的參與者。

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.

反饋3：你選擇了哪一個(gè)：應(yīng)該還是不應(yīng)該？正確的回答是應(yīng)該。激勵(lì)措施應(yīng)該足夠有價(jià)值：補(bǔ)償參與者參與研究的時(shí)間和不便。

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

反饋4：你選擇了哪一個(gè)：應(yīng)該還是不應(yīng)該？正確的回答是“不應(yīng)該”。不應(yīng)該為冒險(xiǎn)提供激勵(lì)。

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

反饋5：你選擇了哪一個(gè)：應(yīng)該還是不應(yīng)該？正確的回答是“不應(yīng)該”。不應(yīng)該對(duì)服用藥物給予獎(jiǎng)勵(lì)。

Guidelines for Establishing Appropriate Incentives for Study Participation? ??為研究參與制定適當(dāng)激勵(lì)措施的指南

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

在確定參與研究的激勵(lì)措施是否適當(dāng)時(shí)，必須考慮三個(gè)問(wèn)題。

Monetary Value? ?貨幣價(jià)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.

激勵(lì)的價(jià)值應(yīng)反映參與研究帶來(lái)的負(fù)擔(dān)。該值不應(yīng)太高，以至于該激勵(lì)可能被認(rèn)為是強(qiáng)制性的，或?qū)€(gè)人參與研究的決定產(chǎn)生過(guò)度影響。

Method and Timing of Payment? ?付款方式和時(shí)間

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.

激勵(lì)積分應(yīng)隨著研究的進(jìn)展而累積。付款不應(yīng)以參與者完成整個(gè)研究為條件。但是，可以創(chuàng)建一個(gè)付款計(jì)劃，為參與者完成研究提供一些激勵(lì)。完成獎(jiǎng)金不應(yīng)大到足以誘使參與者留在研究中，否則他們會(huì)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.

在某些情況下，退出研究的參與者可能會(huì)在他們沒(méi)有退出的情況下完成研究時(shí)獲得報(bào)酬。例如，如果一項(xiàng)研究?jī)H持續(xù)幾天，則可以接受在研究完成時(shí)向所有參與者付款，包括退出的參與者。

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.

付款形式可能包括現(xiàn)金、商店禮品卡、匯票或支票卡。一些IRB不愿意批準(zhǔn)某些人群的現(xiàn)金支付，例如吸毒人群，因?yàn)閾?dān)心吸毒者可能會(huì)將研究付款用于購(gòu)買藥物。另一方面，避免現(xiàn)金支付可能被視為家長(zhǎng)式作風(fēng)和不尊重。某些形式的支付，如匯票或支票卡，可能要求個(gè)人出示身份證明，這對(duì)某些人群（如吸毒者）來(lái)說(shuō)可能是一個(gè)潛在問(wèn)題。超過(guò)一定金額的付款也可能需要納稅，參與者應(yīng)了解這一點(diǎn)。

Part 8: What to do when a Participant Leaves a Study? ?當(dāng)參與者退出研究時(shí)該怎么辦

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:

研究方案應(yīng)包括退出標(biāo)準(zhǔn)和參與者自愿退出研究、出于安全考慮提前退出研究或完成研究后出院的程序。議定書應(yīng)規(guī)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、何時(shí)以及如何退出參與者。

2、對(duì)于退出的參與者，將收集何種類型的數(shù)據(jù)（如有）。

3、是否對(duì)部分或全部退出研究的參與者進(jìn)行隨訪。

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

常見的研究結(jié)束程序包括但不限于結(jié)束訪談、轉(zhuǎn)介和特定時(shí)間段的隨訪。

CLOSING INTERVIEW? ?結(jié)束訪談

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.

結(jié)束訪談很重要，因?yàn)檫@是獲得研究數(shù)據(jù)的最后機(jī)會(huì)，也是研究團(tuán)隊(duì)與研究參與者的最后一次接觸。本次訪談還提供了一個(gè)記錄參與者在研究結(jié)束后可能需要隨訪的任何不良事件的機(jī)會(huì)。

REFERRALS? ?轉(zhuǎn)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.

研究團(tuán)隊(duì)負(fù)責(zé)確保退出研究的參與者獲得他或她需要的任何轉(zhuǎn)介，以便在其他地方獲得服務(wù)或幫助（如果需要）。

FOLLOW-UP? ?隨訪

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參與者退出研究的積極治療階段后的預(yù)定時(shí)間點(diǎn)（例如，一個(gè)月）進(jìn)行后續(xù)訪談。在結(jié)束訪談時(shí)提醒參與者這一要求可能會(huì)有所幫助，如果可能的話，安排后續(xù)訪談的日期和時(shí)間。此外，檢查參與者的定位表，確保所有聯(lián)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.

大多數(shù)試驗(yàn)參與者對(duì)體驗(yàn)持肯定態(tài)度，如果被要求，他們?cè)敢鈪⒓恿硪粋€(gè)試驗(yàn)。知情同意書文件和流程通常包括接受與參與者聯(lián)系進(jìn)行未來(lái)研究。為了不浪費(fèi)這一潛在資源，盡可能讓完成研究的參與者了解研究的狀態(tài)和發(fā)現(xiàn)，并讓他們知道他們的參與是有價(jià)值的。這些努力也可以作為“口碑”廣告。感謝卡或感謝證書可以間接地作為本次學(xué)習(xí)以及未來(lái)學(xué)習(xí)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、招募和保留參與者是任何臨床研究成功的關(guān)鍵。

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、成功的招聘和保留戰(zhàn)略需要知情和詳細(xì)的規(guī)劃、充足的資源投入、仔細(xì)的監(jiān)控以及及時(shí)發(fā)現(xiàn)和解決問(wèn)題。

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、在機(jī)構(gòu)審查委員會(huì)（IRB）批準(zhǔn)方案、知情同意文件以及擬議的招募和保留策略之前，不得開始招募參與者。

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、準(zhǔn)備招募潛在參與者并告知他們研究情況的廣告、傳單和小冊(cè)子被視為知情同意過(guò)程的一部分。因此，必須由IRB審查和批準(zhǔn)（見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、研究招募有兩大要素：

（1）確定合適的參與者群體以回答研究問(wèn)題。

（2）以合乎道德的方式招募合適的參與者。

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、招募足夠數(shù)量的參與者雖然至關(guān)重要，但其本身并不能保證研究的成功。除非在研究期間保留足夠數(shù)量的參與者，否則研究人員將無(wú)法獲得足夠的數(shù)據(jù)來(lái)回答他們提出的研究問(wèn)題，而這正是進(jìn)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、研究參與者可能會(huì)得到獎(jiǎng)勵(lì)，如金錢支付或免費(fèi)醫(yī)療。這些獎(jiǎng)勵(lì)并不被認(rèn)為是參與研究的好處，而是參與研究的激勵(lì)。

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、由于參與激勵(lì)具有潛在的強(qiáng)制性，此類激勵(lì)的金額、形式和條件必須經(jīng)IRB審查和批準(zhǔn)（見ICH GCP 3.1.8）