Contents

Part 1: Introduction

Part 2: Recruitment

Part 3: Recruitment Strategies

Part 1: Introduction

Why are recruitment and retention important?? ?為什么招聘和留住員工很重要？

The purpose of a clinical study is to answer a research question. To do this, researchers must:

Ⅰ浩聋、Recruit an adequate number of appropriate participants.

Ⅱ棍郎、Retain as many of those participants as possible for the time period specified in the study protocol.

臨床研究的目的是回答一個研究問題。為此膛檀，研究人員必須：

1芒粹、招募足夠數(shù)量的適當參與者盈蛮。

2废菱、在研究方案規(guī)定的時間內，盡可能多地保留這些參與者。

Overly optimistic recruitment and retention projections are common in clinical studies. If either recruitment or retention falls short, a study may fail to achieve its objective. The researchers may be unable to answer the research question they posed and participants who were recruited to the study may have been placed at risk for no purpose. Thus, recruitment and retention of participants are key to the success of any clinical study.

在臨床研究中殊轴，過度樂觀的招募和保留預測是常見的衰倦。如果招募或保留不足，一項研究可能無法實現(xiàn)其目標旁理。研究人員可能無法回答他們提出的研究問題樊零，被招募到研究中的參與者可能被置于毫無目的的風險之中。因此孽文，招募和保留參與者是任何臨床研究成功的關鍵驻襟。

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

成功的征聘和保留戰(zhàn)略需要知情和詳細的規(guī)劃、承諾充足的資源芋哭、認真監(jiān)測以及及時查明和解決問題沉衣。

Recruitment and retention strategies, including the wording, presentation and the mode of communication of advertising materials, must be approved by the designated Institutional Review Board (IRB) prior to implementation.

招聘和保留策略，包括廣告材料的措辭楷掉、展示和溝通方式厢蒜，必須在實施前獲得指定機構審查委員會（IRB）的批準。

Recruitment and retention are challenges that involve much time and effort on the part of both clinicians and researchers. This module discusses the issues to be considered in the recruitment and retention of participants to studies. Part 1 deals with recruitment and Part 2 addresses retention.

招募和保留是一項挑戰(zhàn)烹植，需要臨床醫(yī)生和研究人員花費大量時間和精力。本單元討論招募和保留研究參與者時需要考慮的問題愕贡。第1部分涉及招聘草雕，第2部分涉及保留。

Part 2: Recruitment? ?招聘

What are the major elements of recruitment?? ?招聘的主要內容是什么固以？

Recruitment to a study has two major elements:

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

Ⅱ、Recruiting appropriate participants in an ethical manner.

研究招募有兩個主要因素：

1憨琳、確定合適的參與者群體以回答研究問題诫钓。

2、以合乎道德的方式招募合適的參與者篙螟。

Issues to Consider in Defining a Population of Participants for a Study? ?定義研究對象的人群需要考慮的問題

Defining the participant population for a clinical study involves consideration of various issues, as described below.

定義臨床研究的參與者群體包括考慮各種問題菌湃，如下所述。

Purpose of the Study? ?研究的目的

The purpose of a study will often define the appropriate participant population for the study. For example, the purpose of a study may be to test an intervention that is aimed at pregnant women with gestational hypertension, runaway teenage girls who are involved in the criminal justice system, military veterans who use tobacco products, or another defined population subgroup.

研究的目的通常會為研究確定適當?shù)膮⑴c者群體遍略。例如惧所，一項研究的目的可能是測試一種干預措施，該干預措施針對的是患有妊娠期高血壓的孕婦绪杏、參與刑事司法系統(tǒng)的離家出走少女下愈、使用煙草產品的退伍軍人，或其他確定的人口亞群蕾久。

Generalizability of Results? ?結果的普遍性

It is important that findings from a clinical study be relevant to people who were not in the study but have the same characteristics as the study participants. This is called generalizability . The number of participants must be adequate so that the study’s results can be applied to the general population that might benefit from the research.

重要的是势似，臨床研究的結果與未參與研究但與研究參與者具有相同特征的人相關。這就是所謂的普遍性。參與者的數(shù)量必須足夠履因，以便研究結果能夠應用于可能從研究中受益的普通人群障簿。

Considerations of Fairness? ?對公平的考慮

The 1979 Belmont Report established the three key principles on which the current system of human research protections rests: respect for persons, beneficence, and justice.

1979年的《貝爾蒙特報告》確立了目前保護人類研究的制度所依據的三個關鍵原則:尊重個人、慈善和正義搓逾。

The principle of justice requires that participants be selected fairly. Researchers must attempt at all times to distribute the risks and benefits of participation in a study fairly and without bias across the population.

公平原則要求公平地選擇參與者卷谈。研究人員必須在任何時候都嘗試在人群中公平、無偏見地分配參與研究的風險和收益霞篡。

When deciding to select some people for a study and exclude others, researchers must ensure that participants are chosen for reasons that are directly related to the problem being studied and not simply because of their availability, their compromised position, or their vulnerability.

當決定選擇一些人參與一項研究而排除其他人時世蔗，研究人員必須確保選擇參與者的原因與所研究的問題直接相關，而不僅僅是因為他們的可用性朗兵、他們的妥協(xié)立場或他們的脆弱性污淋。

Unless there is a clear justification for doing so, research should not involve persons from groups that are unlikely to benefit from subsequent applications of the research. For example, it would be unethical to select as study participants only persons on welfare, institutionalized persons, or members of a specific racial or ethnic group unless the intervention being studied was intended to directly benefit that group of people.

除非有明確的理由，否則研究不應涉及不太可能從研究的后續(xù)應用中受益的群體余掖。例如寸爆，如果只選擇靠福利生活的人、被機構收容的人或特定種族或族裔群體的成員作為研究參與者是不道德的盐欺，除非所研究的干預措施旨在直接使這一群體受益赁豆。

Adequate Representation of Women and Minorities? ?婦女和少數(shù)群體的適當代表性

Women and minorities should be adequately represented in the study population so that the research findings will be meaningful for these groups and so that members of these groups can share in the benefits of the research. This is particularly important for studies of diseases, disorders, and conditions that disproportionately affect women or minorities.

婦女和少數(shù)民族應在研究人群中有充分的代表性，以便研究結果對這些群體有意義冗美，并使這些群體的成員能夠分享研究的好處魔种。這對于研究對婦女或少數(shù)民族產生過大影響的疾病、紊亂和狀況尤為重要粉洼。

Since 1994, the National Institutes of Health has required researchers to provide a clear and compelling rationale for proposing to conduct a study in a population in which women and minorities are not adequately represented. (See NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research – Amended October 2001.)

自1994年以來节预，美國國家衛(wèi)生研究院（National Institutes of Health）要求研究人員提供一個明確且令人信服的理由，以建議在婦女和少數(shù)民族沒有充分代表的人群中進行研究属韧。（見國家衛(wèi)生研究院關于將婦女和少數(shù)民族納入臨床研究的政策和指南——2001年10月修訂）

Protection of Vulnerable Participants? ?保護弱勢參與者

Certain groups of participants are considered potentially more vulnerable to coercion to participate in research. Children, prisoners, economically disadvantaged, or educationally disadvantaged persons are all considered to be vulnerable populations.

某些參與者群體被認為可能更容易受到強迫而參與研究安拟。兒童、囚犯宵喂、經濟上處于不利地位的人或教育上處于不利地位的人都被認為是弱勢群體糠赦。

Generally, participants from vulnerable populations should be enrolled only in studies that pertain directly to their circumstances. For example, pregnant women should be enrolled only in studies in which pregnancy is pertinent to the research question (e.g., investigating if one treatment strategy is more effective than another in pregnant substance abusers).

一般來說，來自弱勢群體的參與者只應參加與其環(huán)境直接相關的研究樊破。例如愉棱，孕婦只應參加與研究問題有關的妊娠研究（例如，調查一種治療策略是否比另一種治療策略對懷孕藥物濫用者更有效）

When participants from vulnerable populations are to be recruited for a study, appropriate additional safeguards must be included in the protocol to ensure that their rights and welfare are protected. (This issue is also addressed in the Informed Consent and Institutional Review Boards modules.) However, vulnerable populations should not be overprotected to the extent that they are excluded from participating in research.

當從弱勢群體招募參與者進行研究時哲戚，議定書中必須包括適當?shù)念~外保障措施奔滑，以確保他們的權利和福利得到保護。（這一問題也在知情同意和機構審查委員會模塊中討論）然而顺少，不應過度保護弱勢群體朋其，使其無法參與研究王浴。

Reasonable Inclusion and Exclusion Criteria? ?合理的納入和排除標準

The inclusion and exclusion criteria define precisely who is eligible to participate in the study and who is not. These criteria must be defined in the study protocol. They must also be carefully reviewed for every potential participant.

納入和排除標準精確地定義了哪些人有資格參與研究，哪些人沒有資格梅猿。這些標準必須在研究方案中定義氓辣。它們還必須為每一個潛在的參與者仔細審查。

Ⅰ袱蚓、Inclusion criteria are the characteristics that make a potential participant eligible to enroll in a study. Generally, every potential participant must meet all inclusion criteria in order to be eligible.

Ⅱ钞啸、Exclusion criteria are the characteristics that prohibit a potential participant from enrolling in a study. Generally, a potential participant will be ineligible if he or she meets one of the exclusion criteria.

1、納入標準是使?jié)撛趨⑴c者有資格參加研究的特征喇潘。一般來說体斩，每個潛在參與者都必須符合所有入選標準才能符合資格。

2颖低、排除標準是禁止?jié)撛趨⑴c者參與研究的特征絮吵。一般來說，如果潛在參與者符合其中一項排除標準忱屑，則該參與者將不符合資格蹬敲。

Inclusion and exclusion criteria must be reasonable and appropriate to the study purpose. No individual or group should be excluded from eligibility to take part in the study without a valid reason. On the other hand, no individual or group should be included unless they are likely to benefit from applications of the research.

納入和排除標準必須合理和適合研究目的。任何個人或團體在沒有正當理由的情況下莺戒，均不得被排除參加本研究的資格伴嗡。另一方面，不應包括任何個人或團體从铲，除非他們可能從研究的應用中獲益闹究。

Inclusion and exclusion criteria that are too stringent may make it difficult to recruit an adequate number of participants into the study. Modification of overly stringent admission criteria for a study can have a profoundly positive effect on recruitment. On the other hand, inclusion and exclusion criteria that are too broad may make it more difficult for the study to reach meaningful conclusions and may also result in increased safety concerns.

過于嚴格的納入和排除標準可能導致難以招募足夠數(shù)量的參與者參與研究。修改一項研究過于嚴格的入學標準會對招募產生深遠的積極影響食店。另一方面，過于寬泛的納入和排除標準可能使研究更難得出有意義的結論赏寇，也可能導致安全問題增加吉嫩。

Part 3: Recruitment Strategies? ?招聘策略

Elements of a Successful Recruitment Strategy? ?成功招聘戰(zhàn)略的要素

Elements of a successful recruitment strategy include the following:

成功招聘戰(zhàn)略的要素包括：

Ⅰ、Avoid specifying unnecessarily restrictive inclusion and exclusion criteria in the protocol.

Ⅱ嗅定、Develop a compensation strategy that adequately reimburses participants for their time and expenses without being coercively generous.

Ⅲ自娩、Develop a recruitment plan during the protocol planning stage.

Ⅳ、Have the necessary recruitment budget for start-up training, advertising, staff time, and other expenses.

Ⅴ渠退、Develop a profile of prospective study participants:

? ?i忙迁、What would motivate prospects to join the study?

? ?ii、From what sources do they obtain information?

? ?iii碎乃、What radio and television stations and programs do they listen to and watch?

? ?iv姊扔、Where do they live, work, shop, and play?

? ?v、In what media outlets would it be appropriate to place recruitment advertisements?

? ?vi梅誓、Which caregivers and relatives might serve as referral sources?

Ⅵ恰梢、Review recruitment rates, dropout rates, and screening success rates from previous studies. Identify and implement strategies that build on previous successes and incorporate lessons learned.

Ⅶ佛南、Choose appropriate staff members to conduct recruitment.

Ⅷ、Develop a system to track the number of participants enrolled per recruiter per site.

Ⅸ嵌言、Monitor recruitment carefully and intervene quickly to change recruitment techniques that are proving unsuccessful.

Ⅹ嗅回、Identify barriers to recruitment.

1、避免在協(xié)議中指定不必要的限制性的納入和排除標準摧茴。

2绵载、制定一個補償策略，充分補償參與者的時間和花費苛白，而不是強制慷慨娃豹。

3、在方案計劃階段制定招聘計劃丸氛。

4培愁、有必要的招聘預算，用于啟動培訓缓窜，廣告定续，員工時間和其他費用。

5禾锤、建立前瞻性研究參與者的簡介:

（1）什么因素會促使申請者加入這項研究?

（2）他們從哪些來源獲得信息?

（3）他們收聽和觀看哪些廣播電臺私股、電視臺和節(jié)目?

（4）他們在哪里生活、工作恩掷、購物和娛樂?

（5）在哪些媒體投放招聘廣告是合適的?

（6）哪些照顧者和親屬可以作為轉診來源?

6倡鲸、回顧以往研究的招募率、輟學率和篩查成功率黄娘。確定并實施建立在以往成功基礎上的戰(zhàn)略峭状，并吸取經驗教訓。

7逼争、選擇合適的員工進行招聘优床。

8、開發(fā)一個系統(tǒng)來跟蹤每個網站每個招聘人員的參與人數(shù)誓焦。

9胆敞、仔細監(jiān)督招聘，并迅速干預杂伟，以改變被證明不成功的招聘技術移层。

10、識別招聘障礙赫粥。

In general, recruitment strategies are most effective when they are used together in a coordinated fashion.

總的來說观话，當招聘策略以協(xié)調的方式一起使用時，招聘策略最為有效傅是。

Specific Strategies for Recruiting Participants into Clinical Studies? ?招募臨床研究參與者的具體策略

Ⅰ匪燕、Contact interested prospects as soon as possible. The longer a prospective participant has to wait before hearing back from study staff, the less likely it is that he or she will ultimately enroll in the study.

Ⅱ蕾羊、Cultivate potential sources of referrals to the study, network with clinic staff who are not working on the study, as well as with other local health care providers. Send direct mailings to selected health care providers.

Ⅲ、Give presentations about the study for clinic staff and provide periodic updates on the study’s progress.

Ⅳ帽驯、Participate in health fairs, speaking engagements, support groups, television and radio interviews, and other forums.

Ⅴ龟再、Ask for public service announcements on radio and television.

1、請盡快與感興趣的客戶聯(lián)系尼变。潛在參與者在收到研究人員的反饋之前等待的時間越長利凑，他或她最終加入研究的可能性就越小。

2嫌术、培養(yǎng)轉介到研究的潛在來源哀澈，與不參與研究的診所工作人員以及其他當?shù)蒯t(yī)療服務提供者建立網絡。直接郵寄給選定的醫(yī)療保健提供者度气。

3割按、為臨床工作人員做研究報告，并定期提供研究進展的更新磷籍。

4适荣、參加健康博覽會、演講活動院领、支持團體弛矛、電視和電臺采訪以及其他論壇。

5比然、請求廣播和電視上的公共服務公告丈氓。

Special Considerations in the Recruitment of Alcohol or Drug Abusers into Clinical Studies? ?酒精或藥物濫用者參與臨床研究的特殊考慮

Researchers wishing to recruit alcohol or drug abusers into clinical studies must ensure that potential participants are not taken advantage of.

希望招募酒精或藥物濫用者參與臨床研究的研究人員必須確保潛在參與者不會被利用。

The National Advisory Council on Alcohol Abuse and Alcoholism has issued guidelines for studies involving alcohol-abusing participants. These guidelines apply equally well to studies involving participants who abuse drugs other than alcohol. With regard to the recruitment of alcohol- or drug-abusing participants, the guidelines state:

國家酒精濫用和酒精中毒咨詢委員會發(fā)布了涉及酗酒參與者的研究指南强法。這些指南同樣適用于涉及濫用除酒精以外的藥物的參與者的研究万俗。關于招募酗酒或吸毒的參與者，準則規(guī)定：

Ⅰ饮怯、Alcohol or drug abusers should not be recruited as participants merely because of their easy availability, low social or economic status, or limited capacity to understand the nature of the research.

Ⅱ该编、The proposed population for any study must be appropriate in terms of age, sex, familial or genetic background, prior alcohol use, other drug use, and general medical and psychological condition, including, if appropriate, alcoholism recovery status.

1、不應僅僅因為酒精或藥物濫用者容易獲得硕淑、社會或經濟地位低或理解研究性質的能力有限而招募他們作為參與者。

2嘉赎、任何研究的建議人群必須在年齡置媳、性別、家庭或遺傳背景公条、以前飲酒拇囊、其他藥物使用情況以及一般醫(yī)療和心理狀況方面都是合適的，如有必要靶橱，還包括酗酒康復狀況寥袭。

Ethically Acceptable Strategies for Recruiting Participants into Clinical Studies? ?招募臨床研究參與者的倫理上可接受的策略

Most study participants are recruited in one of three ways:

大多數(shù)研究參與者是通過以下三種方式之一招募的：

Ⅰ路捧、Clients already receiving treatment at a research site that are asked to consider enrolling in appropriate studies.

Ⅱ、Other health care providers will refer clients who are potential study participants.

Ⅲ传黄、Individuals interested in participating in a study will respond to advertisements placed in newspapers or flyers as well as advertisements announced on the radio or over the television.

1杰扫、已經在研究站點接受治療的客戶被要求考慮參加適當?shù)难芯俊?/p>

2、其他醫(yī)療服務提供者將推薦潛在的研究參與者膘掰。

3章姓、對參與研究感興趣的個人會對報紙或傳單上的廣告以及廣播或電視上的廣告作出反應。

Studies can also use websites to recruit and screen participants. This approach can be especially useful when recruiting for studies concerned with socially embarrassing diseases or conditions.

研究還可以利用網站招募和篩選參與者识埋。這種方法在招募與社會尷尬疾病或狀況相關的研究人員時特別有用凡伊。

All recruitment strategies must be approved by the designated Institutional Review Board (IRB) before recruitment for a study may begin. In particular, certain rules apply when participants are recruited through advertising; these rules are discussed in the next section.

在開始招募研究人員之前，所有招募策略必須得到指定機構審查委員會（IRB）的批準窒舟。特別是系忙，當參與者通過廣告招募時，某些規(guī)則適用惠豺；下一節(jié)將討論這些規(guī)則银还。