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) The dashboard was updated to a more modern layout, and 2) Emails generated from the system will now have a return address of “[email protected]”. (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).
The Institutional Review Board (IRB), an entity of the Office of Research Compliance and Integrity, ensures that the basic rights and welfare of research participants are fostered and protected. The IRB is comprised of GVSU faculty, staff and community members, who review proposed research studies involving living persons. The 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, staff, and/or faculty must be reviewed and authorized by the IRB prior to the beginning of the research.
OneAegis Quickstart
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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. To submit an amendment, continuing review, reportable event form, 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.
Refer to the OneAegis User Guide for additional information on using the platform.
Looking for CITI training?
Click on the CITI logo to go to instructions on logging into CITI, as well as further information related to using CITI at GVSU.
Quick Links
Are you looking to conduct human research? The information below will quickly get you started.
Informed Consent Document Templates
Below are informed consent document templates you can use for your IRB submission. The 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). If you are collecting identifiable 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 Integrity.
- Exempt Review without GDPR: Informed Consent Document Template
- Exempt Review with GDPR: Informed Consent Document Template
- Expedited/Full Board Review without GDPR: Informed Consent Document Template
- Expedited/Full Board Review with GDPR: Informed Consent Document Template
If you are conducting a clinical study, do not use the templates above. Please contact the Office of Research Compliance and Integrity 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, Continuing Review Form, Amendment Request Form, Reportable Event Form, and Closure Form. 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 staff for participation in your research, complete the request form located on this webpage: