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受试者"预筛"和筛选有什么区别?

编辑:岁福医疗器械咨询 时间:2021-08-10 阅读量:
 

  预筛的定义,以及具体的操作方式,界限等在国内甚少被提及,但其实有一些globaltrial的方案中,会明确写出预筛的流程,也会设置Pre-ScreeningICF和Pre-ScreeningLog等。今天跟大家分享一篇UMBC大学发表的有关"Pre-Screening"和"Secreening"的文章。

  What is the difference between screening and pre-screening?
  筛选和预筛选有什么区别?

  “Pre-screening,” for IRB purposes, is the term used to describe activities before obtaining informed consent (i.e., before enrollment) to determine initial eligibility for and interest in a study. Pre-screening may be performed over the telephone, in-person or on-line and may not include any research procedures.
  基于伦理目的的“预筛选”是用于描述在获得知情同意之前(即筛选入组之前)确定患者有没有初步的资格和兴趣进入研究的术语。预筛选可以通过电话、面对面或在线进行,不得包括任何研究程序.

  “Screening” is the term used to describe activities performed after obtaining consent to ensure participants are qualified for the study. Screening activities include any interaction or intervention with potential participants to determine further eligibility that would not otherwise have been performed if not for the study, or collecting data directly from subjects through written screening tools or oral responses to questionnaire
  “筛选”一词用于描述在获得知情同意后进行的活动,以确保患符合入排。筛选活动包括与潜在受试者的任何互动或干预,以确定是否有参加下一步研究的资格,一般通过书面筛选工具或对问卷的口头答复等方式直接从受试者收集数据。

  Regardless of the strategy used, investigators must protect the privacy of the potential participant and the confidentiality of information collected about him/her.
  无论使用何种收集信息的策略,研究者都必须保护潜在受试者隐私以及收集到的有关他/她的信息的保密。

  Pre-screening
  预筛选

  What information can be collected during pre-screening?
  在预筛选过程中可以收集哪些信息?

  Questions appropriate for pre-screening address the specific inclusion/exclusion criteria for the study and other issues of suitability, for example, an individual’s ability to come to the research site multiple times. It is not appropriate to gather information that is not directly related to assessing eligibility and suitability. Administering eligibility tests is considered a research activity and may not be conducted during a pre-screening but rather only after the participant has been deemed eligible, agreed to participate, and has signed a consent form. Regardless of the setting, only information pertaining to the participant’s eligibility should be gathered during pre-screen. It may be acceptable to perform very limited protocol procedures as part of a pre-screen if they directly relate to eligibility determinations and an individual verbally consents to have them performed.
  适合预筛选的问题可以是涉及研究的具体入排和其他适用的问题,例如,个人多次到达研究中心的能力。收集与入排相关没有直接关系的信息是不合适的。提供与入排相关的检查被视为研究活动,不得在预筛选期间进行,而只能在潜在受试者被视为符合条件、同意参与并签署知情同意书后进行。无论问题如何设置,在预筛选期间只应收集与潜在受试者入选资格有关的信息。如果这是直接与潜在受试者入排相关的,并且潜在受试者已经口头同意,那么可以接受把实施有限的方案流程作为预筛的一部分。

  How should pre-screening over the telephone be done?
  如何通过电话进行预筛选?

  To begin a phone pre-screening conversation, a study team member should identify himself or herself as such. Then, potential participants should be:
  1、Informed of the nature and sensitivity of the questions,
  2、Told how long the phone call is expected to take,
  3、Asked whether there might be a better time for them to answer these questions, and offered the option of completing the pre-screening in person, if possible.
  开始电话预筛选对话时,研究团队成员应表明自己的身份。那么,潜在的受试者应该是:
  1、了解问题的性质和敏感性,
  2、被告知电话预计需要多长时间,
  3、询问他们是否有更好的时间来回答这些问题,以及如果可能,研究团队成员亲自当面完成预筛选

  Next, the study team member should explain that a set of questions will be asked to determine eligibility. Whenever possible, the potential participant should be asked to indicate if s/he appears to be eligible only after all questions have been asked. Sometimes this is not possible, for example, when pre-screening for specific levels of activity. The investigator should consider this carefully when designing pre-screening procedures.
  接下来,研究团队成员应向潜在受试者解释将询问一组问题来确定潜在受试者的入选资格。只要有可能,应要求潜在受试者在所有问题都问完后才表明他/她是否符合资格。但有时这是不可能做到的,例如针对特定活动水平进行的预筛选。研究者在设计预筛选程序时应仔细考虑这一点。

  In the interest of confidentiality, only the potential participant’s first name or initials should be recorded at the beginning of the pre-screening conversation. After the screening conversation, if s/he appears to be eligible and is interested in pursuing the study, contact/identifying information can be recorded – e.g., last name, address, birth date, and Social Security number.
  为保密起见,在预筛选对话开始时只应记录潜在受试者的first name或首字母缩写。在筛选对话之后,如果他/她大概符合资格并且有兴趣进行该研究,则可以记录联系信息/身份信息——例如,姓氏、地址、出生日期和社会安全号码。

  How should pre-screening in person be done?
  应如何亲自进行预筛选?

  Pre-screening is done in person usually when potential participants are finding out about research during routine, non-research activities. The guidelines for the conduct of pre-screening in person are the same as those for conducting prescreening over the telephone.
  当潜在受试者在常规的非临床研究活动中被发现时,通常研究团队成员会亲自当面进行预筛选。当面进行预筛选的准则与通过电话进行预筛选的准则相同。

  Can pre-screening online be conducted on-line?
  预筛选可以在网上进行吗?

  Yes. In many cases, potential participants prefer online pre-screening. The guidelines for the conduct are the same as those described above for other methods. However, because online survey tools have different privacy policies and terms of use, the investigator must provide reference documentation in the protocol application regarding privacy and confidentiality protections.
  是的。在许多情况下,潜在受试者者更喜欢在线online进行预筛选。行为准则与上述其他方法的准则相同。但是,由于在线调查工具具有不同的隐私政策和使用条款,研究人员必须在方案中提供有关隐私和保密保护的参考文件。

  Can information be retained from individuals who are pre-screened but not enrolled?
  是否可以保留已预先筛选但未入选的个人的信息?

  Yes, non-identifying information may be retained about individuals who are pre-screened for a study, but do not actually pursue the study or enroll.
  是的,可能会保留参加预筛选但最终并未进行筛选或入组的个人的非识别信息。

  Pre-screening sheets from individuals who did not provide identifying information can be retained with no further action. Pre-screening sheets with identifying information may also be retained in research files. Fields containing identifiable information must be blacked out or cut off as soon as it is clear that the individual will not be enrolled.
  可以保留未提供身份信息的个人的预筛选表,无需采取进一步行动。带有识别信息的预筛选表也可以保留在研究文件中。一旦明确潜在受试者将不会入组,包含可识别信息的字段必须被涂黑或移除。

  What needs to be included in the application for IRB review?
  预筛申请伦理审查需要包括哪些内容?

  Protocol: All pre-screening activities are considered part of the participant selection and recruitment process and must be reviewed and approved by the IRB prior to initiation. Pre-screening procedures should be described in the protocol document. In addition, the specific inclusion/exclusion criteria for the study should be stated. The IRB will compare the screening tools with these inclusion/exclusion criteria, to ensure that the questions asked during pre-screening are not beyond the scope of the criteria. Screening tools: The questionnaires, checklists, or other screening tools that will be used must be submitted for IRB review. If pre-screening is to be done over the telephone, investigators should provide a script for IRB review. The script should follow the points outlined above (How should pre-screening over the telephone be done? section). Consent form: Pre-screening does not need to be described in the consent form because it is done before the consent discussion and documentation of consent takes place.
  方案:所有预筛活动都被视为受试者招募过程的一部分,并且必须在开始前得到 IRB 的审查和批准。预筛选程序应在方案中描述。此外,应说明研究的具体纳入/排除标准。IRB 会将筛选工具与这些纳入/排除标准进行check,以确保预筛选期间提出的问题不超出入排标准的范围。筛选工具:预筛过程中使用的问卷、checklist或其他工具必须提交给 IRB 审查。如果通过电话进行预筛选,研究人员将screen script提供 给IRB 审查。screen script应遵循上述要点(如何通过电话进行预筛选部分)。知情同意书:不需要在同意书中描述预筛选,因为它是在同意讨论和同意文件之前完成的。

  Screening
  筛选

  Screening activities include any interaction or intervention with potential subjects to determine eligibility that is performed following a participant’s consent to continue with the research. The IRB protocol application should describe activities in the recruitment process including:
  1、The screening instruments to be used and script followed to perform the procedures
  2、How subjects will respond –  e.g., calling in response to advertisements, referrals from other participants,  etc.
  3、A description of the data, if any, that will be collected..
  4、How the data collected during the screening procedures will be stored.
  5、Whether the investigator intends to retain or destroy data collected from subjects who are deemed ineligible upon completion of the screening process.
  筛选活动包括与潜在受试者的任何interaction或intervention,以确定受试者同意继续确认他有是否符合入排。IRB 申请资料中应描述招募过程中的行动,包括:
  1、要使用的筛选工具和执行程序所遵循的script
  2、受试者将如何响应——例如,响应广告、其他受试者的推荐,电话等。
  3、对将要收集的数据的描述。
  4、在筛选过程中收集的数据将如何存储。
  5、研究者是否打算保留或销毁从筛选过程完成后被认为不合格的受试者收集的数据。

  Screening Script
  自行理解其意义

  The script must include an introductory statement that informs participants of the purpose of the questions and that they do not have to answer any questions they do not want to answer and must be in language understandable to the population under study.
  Script必须包括一个介绍性陈述,告知参与者问题的目的,并且他们不必回答任何他们不想回答的问题,并且必须使用受试者可以理解的语言。

  When appropriate, the script must include an introductory statement warning the subjects of the sensitive nature of the questions that might make the subject uncomfortable, and preferably include an example (for instance, “We are going to ask you about drug or alcohol use.”) The script must not describe the type of questions that will be asked as “confidential;” i.e., rather than saying “we would like to ask you some confidential questions,” say “we would like to ask you some questions.” It is acceptable to say “personal questions” or “sensitive questions.” The purpose of this policy is to prevent any possible misunderstanding that the answers will be held in complete confidence.
  在适当的情况下,Script必须包括一个介绍性的陈述,警告受试者可能使受试者不舒服的问题的敏感性,最好包括一个例子(例如,“我们将询问您有关药物或酒精使用的问题。” ) Script不得描述将作为“机密”提出的问题类型;即,与其说“我们想问你一些机密问题”,不如说“我们想问你一些问题”。可以说“个人问题”或“敏感问题”。本政策的目的是防止任何可能的误解,即答案将完全保密。

  The body of the screening script should the actual questions that will be asked, not just a general statement such as “inclusion/exclusion criteria addressed.” The script must include a closing statement informing participants of whether or not they have met the preliminary screening requirements. If they do, the closing statement whether the information received from the subject will be destroyed immediately, or whether it will be stored, and if so for how long and where.
  Screen Script的正文应该是将要提出的实际问题,而不仅仅是诸如“是否满足纳入/排除标准”之类的一般性陈述。Script必须包括结束语,告知受试者他们是否满足初步筛选要求。如果他们这样做,结束声明是否会立即销毁从受试者收到的信息,或者是否将其存储,如果是,则存储多长时间和储存在哪里。

  Note: the IRB realizes that the script may not be followed verbatim, as subjects may ask additional questions or stray from the topic. This is acceptable, but it is expected that the interviewer will keep as closely as possible to the spirit and letter of the script. If a participant refuses to participate in the proposed research, it is recommended that the script detail what information will be obtained and retained. Informed consent may still be required.
  注意:IRB 明白实际过程可能不会逐字遵循script,因为受试者可能会提出其他偏离主题的问题。这是可以接受的,但希望研究者尽可能的贴近Script的精神和文字。如果受试者拒绝参与该研究,建议Script详细说明将获得和保留哪些信息。可能仍需要知情同意。

  全文手翻,或有错误,还是建议看英文原文理解~
  来源:UMBC

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