院校检讨委员会

概述

The Marian University 院校检讨委员会 (IRB) ensures that research conducted at or sponsored by Marian University that involves human participants complies 与 the ethical standards set by the federal Office for Human Research Protections (OHRP), 它隶属于卫生与公众服务部(DHHS). Protocols for biomedical or behavioral research to be conducted at or supported by Marian University are subject to review by the IRB and such research may not be conducted 与out IRB approval.

If your research results in generalizable knowledge and you intend to publish those results in a journal article or presentation, 您的项目符合Research资格,如果您使用人类受试者,则需要接受IRB审查. If you are a principal investigator (PI) from outside of the university who wishes to recruit Marian University faculty, 工作人员, 或者学生作为Research对象, the Marian University IRB may accept primary IRB review and approval from a federally registered IRB 与 Federal Wide Assurance (FWA).

十大电子游戏注册内部审查委员会的结构和治理

The Marian University 院校检讨委员会 is federally registered 与 an FWA and is empowered by the Provost to review all research protocols involving human subjects to be conducted at or supported by Marian University. 委员会主席向教务长汇报工作.

The Marian University IRB has two subcommittees( Biomedical Research and Social/Behavioral Research), 每个委员会由一名主席和至少五名成员组成. Board membership includes representative faculty from every aspect of Marian University as well as an external community member not officially affiliated 与 Marian University to serve on each subcommittee.

内部审查委员会遵守符合的政策和程序(见下文) 联邦法规第46部分第45篇 (“共同规则”),并已获得IRB主席和教务长的批准.  

如何继续

在向您报告IRB决定之前,您不得开始人体受试者Research.

如果您正在进行一项涉及人类受试者的Research,请下载并完成 MU IRB表格1 (按此下载),然后将填妥的表格上传到我们的 在线提交网站 (点击进入网上提交网站). 收到你提交的表格1后, the IRB Chair will conduct an initial screening to determine if your research fulfills the criteria for exemption from further IRB review. 如果是这样,您将通过电子邮件收到通知,您可以继续学习. 
如果您的协议不符合豁免状态, 您将收到一份完整的IRB申请,并通过电子邮件提交至 IRB@bube-berlin.com. 在收到完整的申请表后, the protocol will receive either 'expedited review' or 'full committee review' by the relevant subcommittee. 为了完成审议,内部审查委员会可能需要要求提供更多信息. 一旦获得批准, a determination letter will be sent to you indicating that you are allowed to begin data collection. 对于非豁免协议, you and any affiliated researchers will also be required to complete a CITI training course or present a current completion certificate indicating that you have completed the required CITI training.
 
填写表格一申请表时, 您将被要求描述您的Research方案(长度约300字). Provide a brief explanation of the aims and purpose of the project but focus especially on the methodology you plan to use. 详细地描述, 人类受试者将如何参与, 有什么(如果有任何风险)的参与者, and what steps are being taken to adhere to the ethical guidelines governing human-subjects research.
 
如果你在准备提交之前有任何问题,你可以发电子邮件 IRB@bube-berlin.com.

申请截止日期和会议时间

应提交申请(理想情况下) 2个月 在提交拨款之前或招募人类受试者的预定开始日期之前.  因为许多申请都有资格获得豁免或加急, 不需要召开内部审查委员会会议, 内部审查委员会会议是根据需要召开的.  因此,尽早提交允许IRB管理员安排审查会议.

The IRB serves the public to ensure protection of human subjects and the scientific value of studies, 并设法迅速满足调查员的需要.  有关申请程序或协助申请的问题,欢迎致电 IRB@bube-berlin.com.

花旗集团的培训

Marian University has an institutional subscription to the online Collaborative Institutional Training Initiative (CITI) program. This training is mandatory for all researchers working 与 human subjects whose research protocol is subject to review by Marian University's IRB. 这一要求包括学生进行的Research,受IRB审查. Completion of the CITI program fulfills the federal government's requirements for ethics training for researchers working 与 human subjects.

如果您以前从未注册过(您没有花旗计划的用户名),请转到 http://www.citiprogram.org and register an account in the system by clicking on the "Register" button under "Create an account" from the homepage. 从动态下拉列表中输入并选择您的机构后, 按照提示创建您的帐户. 请注意,下拉列表中列出了两个“十大电子游戏注册”. 我们是“十大电子游戏注册-印第安纳波利斯”,另一所学校在威斯康星州.

如果您已经拥有花旗计划的用户名, 请登录您的帐户, 转到主菜单, 并点击“点击此处与其他机构建立联系”链接. 通过动态下拉列表键入并定位您的机构. Researchers who have completed CITI training at another institution and can produce their completion certificate validated from 与in the past four years do not need to complete the course until their previous certificate expires.

新学习者指南可在http://citiprogram上找到.桌子上.com/customer/portal/articles/1231781-new-learner-account-registration-2-0.

There are different CITI courses based on whether you primarily conduct biomedical or social/behavioral human subjects research. The biomedical human subjects course is listed as "Group 1: Biomedical Researchers" and the social/behavioral human subjects research course is listed as "Group 2: Social-Behavioral-Educational Researchers". Note that there is also a course named "Group 1: Biomedical Lab Researcher" which does not pertain to human subjects research. Select the course which best fits your research profile; 然而, 如果你的Research有时跨越领域,完成这两门课程就足够了. 因此, a researcher who primarily conducts biomedical research should enroll in that course and does not need to also complete the social/behavioral course, 即使他们偶尔进行或参与社会/行为Research, 反之亦然.

一旦你完成了课程的“必修”模块, there are a number of *elective* courses of which you must complete a minimum number (4) in order to receive a completion certificate. 你可能, 然而, complete additional elective modules as well as any of the *supplemental* courses that may be listed.

Elective courses should be chosen based on the topics that are most pertinent to the type of research one typically conducts. E.g., a faculty researcher who typically conducts educational research 与 children and sometimes mentors undergraduate students in research should enroll in the social/behavioral course and complete the following electives: Research 与 Children – SBE, 公立中小学Research- SBE, and Students in Research; for the fourth elective, 他们可能希望完成Research中的文化能力.

一旦你完成了所需的和最少数量的选修模块, 您将收到一份完成报告,该报告也将报告给IRB主席. No research protocols will be approved by the IRB unless all of the researchers involved – including faculty mentors in the case of student research – have completed CITI training. Your completion certificate will be valid for four years, when a refresher course will be required.

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