院校检讨委员会

CC IRB实际上正在工作,直到另行通知. 请发邮件给主席Amanda Udis-Kessler audiskessler@daves-studio.com 提出问题或要求参加Zoom会议.

目的宣言

IRB支持没有或最小伤害的人体受试者研究, 良好的同意程序, 没有欺骗或盘问的欺骗, 机密性或匿名性, 使用公平选择的参与者,如果他们愿意,他们可以拒绝参与.

IRB的椅子

阿曼达·乌迪斯-凯斯勒博士.D.、椅子
719-227-8177
audiskessler@daves-studio.com

amanda-udiskessler.jpg 

IRB, 是机构审查委员会的简称, exists to protect the well-being of participants in human subjects re搜索 (re搜索 that takes people as the objects of study rather than, 说, 莎士比亚的戏剧, 病毒。, 或杰克逊·波拉克的作品). 大多数人类研究都是通过访谈进行的, 调查问卷, 焦点小组, 实验, 和实地考察. 虽然它通常在社会学等学科中进行, 人类学, 心理学, 业务, 政治科学, human subjects re搜索 may also be carried in departments such as Education or Human Biology and Kinesiology, 以及跨学科项目,如女权主义和性别研究, 比赛, 种族与移民研究, 和西南研究. 一些创业基金项目需要与内部审查委员会进行互动.

IRB法规于2019年1月19日更改. 许多变化已被纳入本网站的文本和表格中.

IRB有一个 标准操作程序手册.

If your re搜索 involves 科罗拉多大学 students and you will be providing them with any form of compensation or incentives, 你必须复习 激励子页 获取具有法律约束力的信息.

Below are the forms that you will use to either apply for IRB approval or request an exemption. Please be aware that re搜索ers cannot exempt their own re搜索 from IRB review; only the IRB can do that.

There is specific language to be used by faculty members in their emails of approval for student projects. 语言在申请表的第一页. 教师必须使用这种语言,以便学生的提案得到审查. 教师 members, please take note, and students, please remind your advisors about the language.

提交你的提案, complete proposals including copies of all necessary attachments and a confirming email from your faculty sponsor are due VIA EMAIL to the Chair of the IRB when they are fully prepared, 并将在全年(包括夏季)进行滚动审查, 不过请注意,夏季复习可能需要更长的时间。). You will usually be notified about the IRB decision regarding your proposal within several days of submitting your proposal. 一到两天的周转时间并不罕见,但不能保证.

对于研究人员来说,确保他们有足够的时间来完成申请的最好方法, 获得批准, and still have time to do re搜索 is to do an exemplary job of filling out the application and to send the proposal in as early as possible.

以正式和专业的方式对待与IRB主席的初次接触, 就像你把求职信随求职信一起寄出去一样. Sending an extremely casual or informal email to the IRB chair signals that you may be equally casual about your obligations to the participants in your study. 除非你认识主席本人, 请不要以“嘿, 阿曼达”或其他同样非正式的方式.

豁免及申请表格

如果你的项目是个人兴趣项目,不是为了成绩, 一门课程, 或者一篇论文, 并且不打算贡献概括的学术知识, 您的项目根本不需要与IRB进行交互, 因为这并不算联邦政府的研究. 如前所述, 一些风险基金需要内部审查委员会的互动.

如果您认为您的项目属于以下类别之一, 填写链接到该类别的MS Forms文档. 

  • 未定义为研究的项目: Your project may fall into a category of re搜索 that the federal government does not define as re搜索 and that therefore does not require you to fill out an IRB proposal. 这类项目包括新闻业, 口述历史, and other projects in which you are only studying individuals and are not drawing broader social or historical conclusions.

  • 教育研究如果你正在进行教育实践方面的研究, 即使涉及到孩子, 你可能有资格获得教育研究豁免. 这项豁免不包括对成人(教师)的采访或调查, 学校管理人员).

  • 相互作用研究: If you are carrying out re搜索 with adults limited only to one or more of three types of re搜索 (interviews, 调查, (在公共场所观察)或仅对儿童进行教育测试, 你可能有资格获得相互作用研究豁免.

  • 良性行为研究: If you are carrying out psychological or marketing re搜索 with adults that involves no deception (or that involves deception that you can provide minimal information about in the consent process), 你可能有资格获得良性行为干预研究豁免. Note that this exemption has a special consent form with the same title that you must use with this exemption. 在填写此表格之前,你必须复习一下 BBI豁免信息表 我们鼓励你们打印一份,并随身携带以完成表格.

  • 二次研究: If you are carrying out secondary re搜索 involving information that has already been collected for someone else's re搜索 or non-re搜索 project, 或者你以前为一个不同的研究或非研究项目收集的数据, 你可能有资格获得二级研究豁免.

IRB申请表格: Please fill out and submit this form only if your project is defined as re搜索 according to the federal government AND you are not eligible for any of the above exemptions.

(Please note that I have re-added the earlier Word versions of these and some other documents below on this page. 你可以用这些来起草申请, 豁免的请求, 以及其他材料, 但请不要提交这些版本. 请只使用上述MS表格功能向税务局提交申请. 也, please note that there are some differences between the Word documents and the MS Forms versions, 因此,如果您要将Word文档复制到表单中,请谨慎操作.)

知情同意及相关模板

You MUST use a consent form unless you have submitted the request for a waiver or alteration of the consent process and have had your request approved by the IRB. You must use one of the below templates unless the IRB has approved your using a different consent form.

招聘材料模板

  • 招聘邮件模板 - use if you are recruiting participants via email; the template is structured to include all the legal information you need to provide to potential participants)

  • 招聘信模板 - use if you are recruiting participants via letter; the template is structured to include all the legal information you need to provide to potential participants)

虽然IRB没有设计招聘传单模板, please note that however your flyer is designed it must include the following informational elements to be approved by the IRB:

  • 说明你的项目是研究
  • 研究的目的
  • 参与者将参与的任何活动
  • 他们参与的时间
  • 参与者可能面临的风险
  • 参与者将(或可能)获得的任何福利
  • 他们的参与是自愿的
  • 您的姓名及联络资料(电话号码、电邮地址)
如果相关, your flyer must also include information about eligibility criteria regarding who should and who should not participate in the study. Your recruitment flyer must not contain any misleading information about the study or overemphasize incentives or compensation (e.g.,用大号或粗体字).

额外的形式

核准项目变更申请

批准项目不良事件报告表

 

你可以使用上述表格的以下Word版本来起草申请, 豁免的请求, 不良事件报告, 修改应用程序, 或要求放弃或更改知情同意程序, 但请不要将Word版本提交给IRB, 因为他们不会被审查. 他们只是帮你准备材料. 如上所述, 这些文件和上面的表格有些不同, 因此,在将草稿材料从Word文档转移到其中一个表单时要小心.

良性行为干预研究豁免判定形式文字版

教育研究豁免裁定表Word版

交互研究豁免判定表Word版

二次研究豁免判定表文字版

IRB申请表格Word版本

请求放弃或更改知情同意程序文字版

核准项目修改申请书Word版

核准项目不良事件报告表Word版

拒绝的理由

IRB不会, 在任何情况下, 批准一个已经进行过研究的项目. 在研究开始之前,提案必须得到批准.

你的建议将 如果缺少以下任何一项,应进行审查:

  • 教师 sponsor's email of approval (unless it is a Venture Grant project that is 不 f或者一篇论文; those are reviewed without faculty sponsor input. 如果你的创业基金将用于收集高级论文数据, 你的论文指导老师确实需要批准IRB提案)

  • A debriefing form or script if you will be using deception (most common in 心理学 and marketing studies)

  • 您的同意书或脚本,使用以下模板之一构建

  • 你的面试问题, 调查工具, 实验过程, 或者其他材料,清楚地显示参与者会遇到什么,他们会做什么

  • 研究计画的开始及预期结束日期

  • 事故报告计划,如果发生伤害. 没有例外,即使你确定不会发生伤害. A typical and good answer is that you would report an incident of harm to your advisor and to the chair of the IRB.
报告问题 - 最后更新: 08/29/2023