What is the difference between screening and pre-screening？
“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.
“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
Regardless of the strategy used, investigators must protect the privacy of the potential participant and the confidentiality of information collected about him/her.
What information can be collected during pre-screening？
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.
How should pre-screening over the telephone be done？
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.
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.
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.
How should pre-screening in person be done？
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.
Can pre-screening online be conducted on-line？
Can information be retained from individuals who are pre-screened but not enrolled？
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.
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.
What needs to be included in the application for IRB review？
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 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.
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.
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.
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.
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