Part 1: Introduction
Part 2: Recruitment
Part 3: Recruitment Strategies
The purpose of a clinical study is to answer a research question. To do this, researchers must:
Ⅰ、Recruit an adequate number of appropriate participants.
Ⅱ、Retain as many of those participants as possible for the time period specified in the study protocol.
临床研究的目的是回答一个研究问题。为此，研究人员必须：
1、 招募足够数量的适当参与者 。
2、在研究方案规定的时间内， 尽可能多地保留这些参与者 。
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.
在临床研究中， 过度乐观的招募和保留预测是常见的 。如果招募或保留不足，一项研究可能无法实现其目标。研究人员可能无法回答他们提出的研究问题，被招募到研究中的参与者可能被置于毫无目的的风险之中。因此， 招募和保留参与者是任何临床研究成功的关键 。
A successful recruitment and retention strategy requires informed and detailed planning, commitment of adequate resources, careful monitoring, and timely identification and resolution of problems.
成功的征聘和保留战略需要知情和详细的规划、承诺充足的资源、认真监测以及及时查明和解决问题。
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 广告材料的措辞 、 展示和沟通方式 ，必须在实施前获得指定机构审查委员会（IRB）的批准。
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.
招募和保留是一项挑战，需要临床医生和研究人员花费大量时间和精力。本单元讨论招募和保留研究参与者时需要考虑的问题。第1部分涉及招聘，第2部分涉及保留。
Recruitment to 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.
研究招募有两个主要因素：
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。
Defining the participant population for a clinical study involves consideration of various issues, as described below.
定义临床研究的参与者群体包括考虑各种问题，如下所述。
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.
研究的目的通常会为研究确定适当的参与者群体 。例如，一项研究的目的可能是 测试一种干预措施 ，该干预措施针对的是患有妊娠期高血压的孕妇、参与刑事司法系统的离家出走少女、使用烟草产品的退伍军人，或其他确定的人口亚群。
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， 临床研究的结果 与 未参与研究但与研究参与者具有相同特征的人相关 。这就是所谓的普遍性。参与者的数量必须足够，以便研究结果能够应用于可能从研究中受益的普通人群。
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 《贝尔蒙特报告》 确立了目前保护人类研究的制度所依据的三个关键原则: 尊重个人、慈善和正义。
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.
公平原则要求公平地选择参与者 。研究人员必须在任何时候都尝试在人群中公平、无偏见地分配参与研究的风险和收益。
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.
当决定选择一些人参与一项研究而排除其他人时， 研究人员必须确保选择参与者的原因与所研究的问题直接相关，而不仅仅是因为他们的可用性、他们的妥协立场或他们的脆弱 性。
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.
除非有明确的理由，否则 研究不应涉及不太可能从研究的后续应用中受益的群体 。例如，如果只选择靠福利生活的人、被机构收容的人或特定种族或族裔群体的成员作为研究参与者是不道德的，除非所研究的干预措施旨在直接使这一群体受益。
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.
妇女和少数民族应在研究人群中有充分的代表性 ，以便研究结果对这些群体有意义，并使这些群体的成员能够分享研究的好处。这 对于研究对妇女或少数民族产生过大影响的疾病、紊乱和状况尤为重要。
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年以来，美国国家卫生研究院（National Institutes of Health）要求研究人员提供一个明确且令人信服的理由，以建议在妇女和少数民族没有充分代表的人群中进行研究。（见国家卫生研究院关于将妇女和少数民族纳入临床研究的政策和指南——2001年10月修订）
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.
某些参与者群体被认为可能更容易受到强迫而参与研究。 儿童、囚犯、经济上处于不利地位的人 或 教育上处于不利地位的人 都被认为是 弱势群体 。
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).
一般来说， 来自弱势群体的参与者只应参加与其环境直接相关的研究 。例如，孕妇只应参加与研究问题有关的妊娠研究（例如，调查一种治疗策略是否比另一种治疗策略对怀孕药物滥用者更有效）
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.
当从弱势群体招募参与者进行研究时，议定书中必须包括适当的额外保障措施，以确保他们的权利和福利得到保护。 （这一问题也在知情同意和机构审查委员会模块中讨论）然而，不应过度保护弱势群体，使其无法参与研究。
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.
纳入和排除标准精确地定义了哪些人有资格参与研究，哪些人没有资格 。这些标准必须在研究方案中定义。它们还必须为每一个潜在的参与者仔细审查。
Ⅰ、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、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、 纳入标准 是使潜在参与者有资格参加研究的特征。一般来说，每个潜在参与者都必须符合所有入选标准才能符合资格。
2、 排除标准 是禁止潜在参与者参与研究的特征。一般来说，如果潜在参与者符合其中一项排除标准，则该参与者将不符合资格。
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.
纳入和排除标准必须合理和适合研究目的 。任何个人或团体在没有正当理由的情况下，均不得被排除参加本研究的资格。另一方面，不应包括任何个人或团体，除非他们可能从研究的应用中获益。
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.
过于严格的纳入和排除标准可能导致难以招募足够数量的参与者参与研究 。修改一项研究过于严格的入学标准会对招募产生深远的积极影响。另一方面， 过于宽泛的纳入和排除标准可能使研究更难得出有意义的结论，也可能导致安全问题增加 。
Elements of a successful recruitment strategy include the following:
成功招聘战略的要素包括：
Ⅰ、Avoid specifying unnecessarily restrictive inclusion and exclusion criteria in the protocol.
Ⅱ、Develop a compensation strategy that adequately reimburses participants for their time and expenses without being coercively generous.
Ⅲ、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、Develop a profile of prospective study participants:
i、What would motivate prospects to join the study?
ii、From what sources do they obtain information?
iii、What radio and television stations and programs do they listen to and watch?
iv、Where do they live, work, shop, and play?
v、In what media outlets would it be appropriate to place recruitment advertisements?
vi、Which caregivers and relatives might serve as referral sources?
Ⅵ、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、Choose appropriate staff members to conduct recruitment.
Ⅷ、Develop a system to track the number of participants enrolled per recruiter per site.
Ⅸ、Monitor recruitment carefully and intervene quickly to change recruitment techniques that are proving unsuccessful.
Ⅹ、Identify barriers to recruitment.
1、避免在协议中指定 不必要的限制性的纳入和排除标准 。
2、制定一个 补偿策略 ，充分补偿参与者的时间和花费，而不是强制慷慨。
3、在 方案计划阶段制定招聘计划 。
4、有必要的 招聘预算 ，用于启动培训，广告，员工时间和其他费用。
5、建立 前瞻性研究 参与者的简介:
（1）什么因素会促使申请者加入这项研究?
（2）他们从哪些来源获得信息?
（3）他们收听和观看哪些广播电台、电视台和节目?
（4）他们在哪里生活、工作、购物和娱乐?
（5）在哪些媒体投放招聘广告是合适的?
（6）哪些照顾者和亲属可以作为转诊来源?
6、 回顾以往研究的招募率、辍学率和筛查成功率 。确定并实施建立在以往成功基础上的战略，并 吸取经验教训 。
7、选择 合适的员工 进行招聘。
8、开发一个系统来 跟踪每个网站每个招聘人员的参与人数 。
9、仔细 监督招聘，并迅速干预 ，以改变被证明不成功的招聘技术。
10、 识别招聘障碍 。
In general, recruitment strategies are most effective when they are used together in a coordinated fashion.
总的来说，当招聘策略以协调的方式一起使用时， 招聘策略最为有效 。
Ⅰ、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、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、Participate in health fairs, speaking engagements, support groups, television and radio interviews, and other forums.
Ⅴ、Ask for public service announcements on radio and television.
1、请 尽快与感兴趣的客户联系 。潜在参与者在收到研究人员的反馈之前等待的时间越长，他或她最终加入研究的可能性就越小。
2、 培养转介到研究的潜在来源 ， 与不参与研究的诊所工作人员以及其他当地医疗服务提供者建立网络 。直接邮寄给选定的医疗保健提供者。
3、为临床工作人员做 研究报告 ， 并定期提供研究进展的更新 。
4、参加健康博览会、演讲活动、支持团体、电视和电台采访以及其他论坛。
5、请求广播和电视上的公共服务公告。
Researchers wishing to recruit alcohol or drug abusers into clinical studies must ensure that potential participants are not taken advantage of.
希望招募酒精或药物滥用者参与临床研究的研究人员必须 确保潜在参与者不会被利用 。
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:
国家酒精滥用和酒精中毒咨询委员会发布了涉及酗酒参与者的研究指南。这些指南同样适用于涉及滥用除酒精以外的药物的参与者的研究。关于招募酗酒或吸毒的参与者，准则规定：
Ⅰ、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、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、不应仅仅因为 酒
苏州马小云
分享好知识！