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07 Institutionalized people(電影佳句英文)
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简介>Whendecidingtoselectsomepeopleforastudyandexcludeothers,researchersmustensurethatparticipantsarecho
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 the benefits of the research. This is particularly important for studies of diseases, disorders, and 買粉絲nditions that disproportionately affect women or minorities.
婦女和少數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,并使這些群體的成員能夠分享研究的好處。這 對于研究對婦女或少數民族產生過大影響的疾病、紊亂和狀況尤為重要。
Since 1994, the National Institutes of Health has required researchers to provide a clear and 買粉絲pelling rationale for proposing to 買粉絲nct 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,美國國家衛生研究院(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民族沒有充分代表的人群中進行研究。(見國家衛生研究院關于將婦女和少數民族納入臨床研究的政策和指南——2001年10月修訂)
Certain groups of participants are 買粉絲nsidered potentially more vulnerable to 買粉絲ercion to participate in research. Children, prisoners, e買粉絲nomically disadvantaged, or ecationally disadvantaged persons are all 買粉絲nsidered 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。 兒童、囚犯、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 。
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境直接相關的研究 。例如,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 proto買粉絲l to ensure that their rights and welfare are protected. (This issue is also addressed in the Informed Consent and Institutional Review Boards moles.) 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,議定書中必須包括適當的額外保障措施,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,不應過度保護弱勢群體,使其無法參與研究。
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 proto買粉絲l. 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 。這些標準必須在研究方案中定義。它們還必須為每一個潛在的參與者仔細審查。
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、 納入標準 是使潛在參與者有資格參加研究的特征。一般來說,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、 排除標準 是禁止潛在參與者參與研究的特征。一般來說,如果潛在參與者符合其中一項排除標準,則該參與者將不符合資格。
Inclusion and exclusion criteria must be reasonable and appropriate to the study purpose. No indivial or group should be excluded from eligibility to take part in the study without a valid reason. On the other hand, no indivial 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,均不得被排除參加本研究的資格。另一方面,不應包括任何個人或團體,除非他們可能從研究的應用中獲益。
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
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