申请IRB审核

会议

内部审查委员会会议将在实际需要的基础上举行.

申请IRB审查:

提交提案的程序

  1. 调查人员必须填写一份 人体受试者研究计划.
  2. 调查人员必须包括调查等研究工具, 调查问卷, det365亚洲版稿, 操作协议, 汇报的形式, 等.
  3. 调查人员必须附上研究的知情同意文件和, 如果需要, 告知参与者研究程序的脚本, 调查, 面试, 等. 我们鼓励调查人员使用这种方法 知情同意书模板 as a starting point; substantial editing needs to be made to the document for each project as indicated by the sections in red.
  4. Investigators must include the following attachments as appropriate: evidence of permission from cooperating institutions (if any); b. relevant grant application(s); and non-disclosure or other agreements with owners of restricted data sets.
  5. Investigators must attach certificate(s) verifying that all investigators involved in the project have completed the CITI training program. 说明可在 培训 网页.
  6. 如果一个学生是调查员, 学院主管必须通过电子邮件将提案和证明文件提交给IRB主席 irb@skipscoop.com. 教务主管应附上一份声明，说明他/她已经阅读并批准了该提案.

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项目结束报告表

调查人员必须填写一份 项目结束报告表 在研究结束后发送邮件给IRB主席 irb@skipscoop.com.

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申请时间框架和批准决定

The IRB accepts applications for approval of research involving human subjects between the first and last day of class of each semester.

研究者必须在IRB预定会议前一周提交研究提案. 会议日期列在IRB网站上，并在本文件前面提到的“IRB会议日期”下列出. 调查人员应该允许一周的快速审查决定和最多三周的全面审查决定.

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寒假/暑假IRB审查

在寒假或暑假期间收到的申请将在下学期开始时进行审查. 在学期结束前通知IRB主席, 通过暑期研究计划进行的师生研究项目可能会例外. 其他夏季或冬季研究的例外情况只有在特殊情况下才可获得批准. 对于几乎所有的研究项目, 申请人应该期望IRB委员会只在每个学期审查申请.

An administrator or staff member will initiate research reviews and facilitate meetings during the winter and summer breaks according to the policy for accepting applications during these periods, 如委员会描述所述. 在这些时期, IRB主席或, 椅子不在的时候, a sufficiently qualified faculty member appointed by the Dean of the College will write and sign official IRB letters of approval or disapproval.

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通知调查人员IRB的行动

根据召集的内部审查委员会的行动, 主席将就调查人员的建议向他们发出行动通知. 诉讼通知将包括

  1. IRB行动的日期.
  2. 内部审查委员会采取的行动.
  3. 动作应用的时间段.
  4. 任何批准或豁免的条件.
  5. 指示立即向IRB主席报告提案的任何变更或涉及受试者的不良事件.
  6. 研究者联系IRB主席时使用的联系信息.
  7. 指示提交项目结束报告.
  8. 董事会指示的其他信息.

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提案决策类别

一旦提案提交并由IRB审查, 它将被指定为批准, 不批准, 或者有条件批准.

批准

主席将通过电子邮件向研究者发送注明日期的批准信. 它将说明研究者应及时向项目程序或人员报告变更, 以及在研究过程中遇到的任何意外问题或不良事件. 该信函将包括审查指定的类别和IRB批准的持续时间, 哪一个在最初批准之日起一年内结束. 如果项目超过一年，项目必须通过IRB重新批准. 研究者必须在研究结束时提交一份项目结束报告表.

研究者负责实施内部审查委员会(IRB)建议的所有细微变化.g. 改变调查中的一个词，澄清知情同意文件中的术语等.). The Board will not monitor progress on any of its suggestions for expedited projects or suggestions that do not affect the risk of the study. 在这种情况下, the IRB comments or suggestions are meant to draw attention to ways in which a project may be made even less stressful to the human participants.

不批准

如果董事会不批准项目或给予豁免, 它将提供理由和建议的方法，该项目可能被修改，以满足批准. 在这种情况下，修订后的提案必须与新的人类受试者研究提案一起重新提交.

有条件批准

内部审查委员会可以“有条件地批准”与人力资源管理项目指导方针相一致的研究提案. IRB有条件批准, OHRP means that at the time when the IRB reviews and approves a research study (or proposed changes to a previously approved research study), the IRB requires as a condition of approval that the investigator (a) make specified changes to the research protocol or informed consent document(s), (b) confirm specific assumptions or understandings on the part of the IRB regarding how the research will be conducted, 或(c)提交其他文件. The investigator must provide the IRB with a letter or email stating specifically how the conditions will be met before the project begins. The IRB Chair will respond as to whether the conditions have been satisfied and include a final approval letter with the conditions noted in “approved” above. 在这种情况下，通常不需要重新提交原始提案. 研究者必须在研究结束时提交一份项目结束报告表.

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核准研究的修订

研究活动的任何变化，包括研究计划, 同意程序及表格, 他们的研究, 其他研究人员, 和/或受试者招募方法, after IRB approval of the research study must be submitted to the IRB Chair for re-approval before continuing with the project. 例外情况包括必须消除对受试者明显的直接危害. 一般, 一个小的修改(如增加一个新的), 与调查相关的问题)可以通过加速流程批准. 有任何研究变化的新提案应在开始数据收集前至少一周提交.

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小变更的快速审核

为了使IRB将注意力集中在对人类受试者的保护上, 内部审查委员会授权其主席批准对先前审查的研究进行微小修改. 主席应以书面形式(通常是电子邮件)将批准通知调查员. 小变化的例子包括调查问题措辞的小变化, 更正小错误(例如列出错误的电话号码或电子邮件地址), 对参考文献或引文的更正, 等. 如上所述, the Chair is also authorized to review and approve changes made in accordance with the conditions of approval made by the IRB.

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学生作为调查员

365亚洲版学院的政策是允许学生成为研究活动的调查者. 即使学生是研究者，也需要一名指导老师来监督学生的研究. 而教师顾问和IRB将对提案进行审查并采取行动, 作为研究人员的学生有责任保护他们研究的人类受试者. Student-led investigations may require a faculty advisor to serve as a co-investigator in research projects that are deemed more than minimal risk. “Minimal risk” means that the “probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests,根据… 卫生和人类服务部联邦法规45 CFR 46.102(i). A proposal that collects information on illegal activity is more than minimal risk and likely would require greater faculty advisor oversight. 其他可能使风险水平超过最小风险的因素包括对声誉的威胁, 经济状况或就业能力. Questions that elicit responses to life events that are so upsetting that they may cause significant distress might also increase the level of risk.

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外部(非365亚洲版学院)研究人员的请求

All requests from external researchers are subject to administrative review as well as needing Randolph College IRB approval. Studies originating from other schools must first receive approval from their own human subjects review board before seeking permission to use Randolph College students or employees  as research subjects. 申请人须将申请机构内部审查委员会的批准信连同项目建议书一并提交给委员会.

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让其他学院/机构的学生参与365亚洲版学院的研究

Randolph College investigators should obtain IRB approval from Randolph College and all institutions where students would be engaged in the project. 在没有内部审查委员会的情况下，需要执行董事(或类似职位)的批准. 学生调查员必须有一名365亚洲版学院的指导老师.

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互联网研究及调查

IRB认识到，基于互联网或在线的调查使同意文件等问题复杂化, 未成年参与者的身份识别, 还有其他问题. The IRB encourages investigators (especially students) to conduct only minimal risk research when using internet 调查. The IRB does not recommend the use of open-ended responses on minimal risk 调查 because of the risk of subjects providing information that could raise the risk level of the research. The IRB will generally disapprove any internet research involving the use of personally identifiable information because confidentiality cannot be guaranteed. 最小风险研究, the IRB will allow investigators to certify age and consent by including the basic elements of consent in a statement at the beginning of the survey. The required elements of consent can be found in the guidelines for informed consent found in the 提交提案的程序 above.

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报告研究中的意外事件和不良事件

一个侦探, 或者任何知道意外问题的人, 必须立即向IRB主席报告, 或在主席不在的情况下由其他IRB成员提出申请, the unanticipated problems as well as any adverse events that involved physical and psychological harm to a participant. 主席将召集内部审查委员会, 如果有必要的话, 妥善处理未预料到的严重问题. 保护研究方案中的参与者免受进一步的不良事件是至关重要的.

如果在研究项目期间发生不良事件，研究者必须完成一份报告 主要调查人员不良事件报告表，每个参与者必须完成一份 受试者不良事件报告表.

当审阅不良事件的报告时, the IRB should consider whether the affected research protocol still satisfies the requirements for current IRB approval, 或者如果研究需要改变评论类型. The IRB Chair will inform the Vice 总统 for Academic Affairs who subsequently will notify any necessary supporting agency official, 并通知人类研究保护办公室的有关当局.

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