Institutional Review Board
IRBManager Renamed to OneAegis
Effective Monday, June 12, IRBManager was renamed to OneAegis. Two additional changes also occur on that date: 1) 的 dashboard was updated to a more modern layout, and 2) Emails generated from the system will now have a return address of “(电子邮件保护)”. (However, note that ORCI will receive any emails sent back to that address.) IRBManager URLs will automatically redirect to the new OneAegis URLs. Except for the new-look dashboard, the functionality of the system remains the same (including the submission forms).
的 Institutional Review Board (IRB)的实体 Office of Research Compliance and 完整性, ensures that the basic rights and welfare of research participants are fostered and protected. 的 IRB is comprised of GVSU faculty, 工作人员 and community members, who review proposed research studies involving living persons. 的 IRB supports researchers through its coordinated activities in education, regulatory compliance and oversight, and post approval-monitoring. All research involving human subjects performed at GVSU and/or by GVSU students, 工作人员, and/or faculty must be reviewed and authorized by the IRB prior to the beginning of the research.
寻找IRB表格?
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1. Click the OneAegis logo above.
2. Enter your GVSU network ID and password. This will take you to your OneAegis dashboard.
3. To start a brand new submission: Click "Start xForm" on the dashboard. Select the form you wish to submit.
4. 提交修正案, 继续复习, 可报告事件表单, or closure: On your dashboard, click on the protocol number of the desired study. This will open the study information page. Click "Start xForm" under the "Actions" menu (left side of page) on the dashboard. Select the form you wish to submit.
参考 OneAegis用户指南 for additional information on using the platform.
Looking for 花旗集团的培训?
Click on the CITI logo to go to instructions on logging into CITI, as well as further information related to using CITI at GVSU.
快速链接
Are you looking to conduct human research? 的 information below will quickly get you started.
指南
- Characteristics of Different Types of Projects
- IRB常见问题
- Research Compensation and Incentives [Video] (Credit: Jonathan McCabe, GVSU Class of 2024)
- 知情同意 [Video] (Credit: Jonathan McCabe, GVSU Class of 2024)
- 欺骗和. 不完整的信息披露 [Video] (Credit: Jonathan McCabe, GVSU Class of 2024)
知情同意 Document Templates
Below are informed consent document templates you can use for your IRB submission. 的 proper template to use will depend upon the level of review for your protocol (exempt or expedited/full board) and whether or not your study falls under the purview of the General Data Protection Regulation (GDPR). 如果你在收集 可识别的 information AND the data is being collected either electronically or in-person in a country belonging to the European Economic Area, your consent form must include GDPR language unless steps are taken to ensure participants are not providing data from a GDPR-regulated area. If you have any questions about which template to use, please contact the Office of Research Compliance and 完整性.
- Exempt Review without GDPR: 知情同意 Document Template
- Exempt Review with GDPR: 知情同意 Document Template
- Expedited/Full Board Review without GDPR: 知情同意 Document Template
- Expedited/Full Board Review with GDPR: 知情同意 Document Template
If you are conducting a clinical study, do not use the templates above. Please contact the Office of Research Compliance and 完整性 directly.
Application Forms and Other Forms
All IRB submission forms are housed in OneAegis, with the exception of the Individual Investigator Agreement Form and HIPAA forms listed below. Forms that are found in OneAegis include the New Protocol Submission Form, Research Determination Form, 持续覆核表格, 修订要求表格, 可报告事件表, 及结案表格. Please log into OneAegis to access those forms.
- Individual Investigator Agreement Form
- HIPAA Authorization to Use and Disclose Health Information for Research Purposes
If you are an external researcher seeking approval to recruit GVSU students, faculty or 工作人员 for participation in your research, complete the request form located on this webpage: