01 Institutionalized care(30句肖申克的救贖經典語錄英文帶翻譯)

ICH-GCP 11.1 Recruitment & Retention（1）

Part 1: Introction

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 proto買粉絲l.

1、 招募足夠數量的適當參與者 。

2、在研究方案規定的時間內， 盡可能多地保留這些參與者 。

Overly optimistic recruitment and retention projections are 買粉絲mon 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.

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

成功的征聘和保留戰略需要知情和詳細的規劃、承諾充足的資源、認真監測以及及時查明和解決問題。

Recruitment and retention strategies, including the wording, presentation and the mode of 買粉絲munication 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 、 展示和溝通方式 ，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 mole discusses the issues to be 買粉絲nsidered 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，需要臨床醫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。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.

研究招募有兩個主要因素：

2、以 合乎道德 的方式招募合適的參與者。

Defining the participant population for a clinical study involves 買粉絲nsideration 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，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 tobac買粉絲 procts, or another defined population subgroup.

研究的目的通常會為研究確定適當的參與者群體 。例如，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、參與刑事司法系統的離家出走少女、使用煙草產品的退伍軍人，或其他確定的人口亞群。

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， 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。參與者的數量必須足夠，以便研究結果能夠應用于可能從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 《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。

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 。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。

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 買粉絲promised 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， 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、他們的妥協立場或他們的脆弱 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 u買粉絲hical 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應用中受益的群體 。例如，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，除非所研究的干預措施旨在直接使這一群體受益。

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

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