人体受试者保护机构审查委员会(IRB)

Institutional Review Board

The Marquette University Institutional Review Board reviews and approves research involving human subjects under the jurisdiction of the university. 由葡京游戏在线网址学院进行的所有涉及人类受试者的研究活动, staff and students must be approved by the Marquette IRB prior to any study-related activities taking place.

News and Announcements

Expand all   |   Collapse all  

Current and previous announcements

08/15/2020 Kuali 葡京游戏在线网址新的基于网络的数据输入和IRB申请管理系统是什么. Beginning September 1, 2020, all IRB submissions (新的,修订,持续的审查,和可报告的事件)在Kuali提交. 新的协议提交未使用Kuali by完成 October 1, 2020 will not be accepted.

06/15/2020 Updates to the MU IRB COVID-19 website have been made. Please visit to learn more about the steps towards resuming human subjects research at Marquette.

01/10/2020 —从今年春天开始,IRB将开始使用 Kuali for all IRB submissions. Kuali is the new online system for the submission, review and approval of human subject research. IRB正在寻找对测试该系统感兴趣的研究人员.  如果你打算在接下来的几个月内向IRB提交一份新的方案, IRB愿意接受Kuali表格代替传统表格. Please contact Jessica Rice for details.

07/13/2018- The Office of Human Research Protections has made several revisions to the regulations governing human research protections. A few minor changes will be implemented as of 07/19/2018 and the remaining changes will be implemented on 1/20/2019. For more information, please see the FAQ document the IRB office has created. 任何问题都可以向IRB经理杰西卡·赖斯(Jessica Rice)提出.

**持续覆核提交表格已更新,以反映新规例 required 所有在2018年07月19日之后提交的持续评审报告. Please see our forms and templates page for the new form***

03/15/2018 - A revised protocol form has been created. 此表格适用于任何学习类型(豁免、加速或全班). 还开发了一种新的修订表格. 这两份修改后的表格都可以在正规葡京游戏平台的 forms and templates page.

08/28/2017 - Beginning August 2017, IRB将使用Kuali研究软件进行IRB办公室记录管理. If the PI is an undergraduate student, the student must complete the 更新Kuali研究学生组:本科生 form and submit it to the Office of the Registrar in order to grant permission to allow undergraduate student information to be stored in the research software.

04/27/2017 -提供新的指导文件,为研究人员提供有用的信息. Visit the Useful Links 关于在研究中使用在线调查的指导文件页面, 有关基因检测的问题和如何识别您的数据集的有用提示.

09/08/2016 - New human subjects training available. IRB已经从NIH的在线培训模块切换到CITI. Visit the Training & Education page for more information.

06/14/2016 - Marquette School of Dentistry (MUSoD) approval required for all new IRB submissions where MUSoD students and patients will be research subjects. Complete the MUSoD IRB Approval Form 并在提交IRB之前获得MUSoD批准. IRB提交的文件中必须包含一份批准文件的副本. Contact Dr. Andrew Dentino for more information.

Frequently Asked Questions (FAQs)

跟随下面的链接了解Kuali特定的常见问题

How do I know if I need IRB approval?

If a project involves Marquette personnel "engaged" in "research" involving "human subjects,“Marquette IRB需要提交和审查. If there is uncertainty regarding a project meeting the three basic criteria for when a project will require IRB submission, use the Determination of MU IRB Submission as a guide.

我的研究需要提交什么类型的报告,需要多长时间才能得到IRB的批准?

The time from IRB submission to approval varies depending upon the type of review conducted by the IRB. 下面是对三种评审类型、它们的过程和预期的持续时间的描述.

  1. Exempt: Under federal regulations, certain types of research may be exempt from further IRB review if the study involves no more than “minimal risk” and falls into one or more of six exempt categories. For example: surveys; questionnaires or interviews; benign behavioral interventions; research use of data protected by HIPAA; and research on teaching or instruction. 调查人员不得作出豁免的决定. 一旦提交,允许大约1周的审查. Either (a) determination of exemption, (b) request for revisions, 或(c)有关项目不符合豁免条件的通知, will be sent by email. If the protocol does not qualify for exemption it will be processed for either expedited or full board review.
  2. Expedited: The IRB may use an expedited review procedure when the research involves no more than “minimal risk” to the subjects and where the only involvement of human subjects will be in one or more of the expedited categories. For example: blood draws; non-invasive specimen samples; data collected from running on a treadmill; sensitive identified interviews; and secondary data analysis from non-public sources. Once submitted, expect approximately 3 weeks for initial review by a designated member of the IRB. (a)决定加速批准, (b) request for revisions, 或(c)项目不符合加速审查条件的通知, will be sent by email. If the protocol does not qualify for expedited status it will be processed for either exempt or full board review.
  3. Full Board: 包含“最小风险”以上内容的提交,不符合豁免或加速审查的条件, 或未能获得豁免地位或快速批准, are sent to a convened IRB for review. For example: invasive clinical procedures; use of FDA regulated drugs or devices; maximal stress tests; and use of X-ray equipment. Investigators planning to submit a full review protocol should contact the ORC and review information and deadlines related to IRB Meeting Dates. 在召开的会议上进行审查后,可以(a)决定是否批准, (b) request for revisions, 或(c)不批准通知书将以电子邮件发出.

What does a typical IRB submission contain?

The submission should include the following. * Denotes required documents.

    • *IRB Review Form
    • Proof of human subjects training (e.g., CITI, NIH, etc.)
    • Consent/Assent forms
    • Recruitment materials (e.g., flyers, advertisements, scripts, etc.)
    • Data collection instruments (e.g.、调查、访谈问题、二级资料表等.)
    • Grant application if federally funded

协议提交给IRB后会发生什么?

一旦提交,IRB的工作人员将审查提交的完整性(e.g., consent forms, questionnaires, recruitment materials, 数据收集仪器)和适当的审查类型(除外, expedited, full board). Expedited studies are sent to an available IRB member; when possible protocols are sent to the member whose expertise most closely matches the research topic. 豁免研究可由IRB成员、IRB工作人员或指定的审查员进行审查. 全面的董事会研究经历一个预审过程,允许在审查前进行修订 convened board meeting批准或修改的通知将通过电子邮件发送.

What about after IRB approval?

一旦被IRB批准,以下要求以后提交给IRB. 所有更新、修改、需报告的事件和完成/结束必须提交 Kuali.

    • Renewal or Continuation: Federal regulations require expedited and full board studies be reviewed no less than once per year.
    • Amendments: Any modifications to the planned research must be reviewed and approved prior to implementation as they may affect the treatment of human subjects.
    • 可报告的事件:事件可能包括受试者的不良事件/反应, subject complaints, 协议偏差和不遵守的发生率.
    • Study Completions/Closeouts: A research project no longer involves human subjects once the investigators have finished obtaining data through interaction or intervention with subjects or obtaining identifiable private information about the subjects, which includes using, 研究或分析可识别的私人信息. 一旦irb批准的方案中描述的所有这些活动完成, 研究项目不再需要进行持续的审查. For example, when the only remaining activity of a research project involves the analysis of aggregate data sets without individual subject identifiers, no further continuing review is necessary. Similarly, 简单地维护个人可识别的私人信息而不使用, studying, or analyzing such information is not human subjects research and thus does not require continuing review. 一旦研究完成,必须提交最终报告、研究完成表或研究结束表.

学生的课堂研究项目需要IRB审查吗?

Many research methods and other research courses on Marquette's campus require students to complete a research project. The IRB is charged with reviewing projects involving human subjects that meet the federal definition of "research" involving "human subjects" (see No. 3). Some of these classroom projects require review and approval by the IRB; however, most do not.

Visit the page on Students Conducting Class Projects for more information.

如果对项目是否需要IRB审查和批准有任何疑问, 请致电(414)288-7570或 orc@mu.edu. Please note that there are no provisions for retrospective approval under the federal research regulations.

什么是葡京游戏在线网址的联邦保险公司?

A Federalwide Assurance is an agreement with the Office of Human Research Protections and the Department of Health and Human Services. The FWA represents a commitment to the protection of human subjects and specifies the ethical principles under which the research will be conducted. Marquette has its own FWA (FWA00005844) for research conducted by Marquette.