Institutional Review Board
Revised Common Rule Changes
The Department of Health and Human Services (DHHS) revised Federal Policy for the Protection of Human Subjects (a.k.a. the “Revised Common Rule”) are now in effect.
GVSU's Revised Common Rule webpage also provides further information regarding these changes.
To submit documents to the IRB:
1. Click the IRBManager logo above.
2. Enter your GVSU network ID and password. This will take you to your IRBManager dashboard.
3. To start a brand new submission: Click "Start xForm" under the "Actions" menu (left side of page) on the dashboard. Select the form you wish to submit.
4. To submit an amendment, continuing review, reportable event form, or closure: On the bottom of 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.
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 supports researchers through its coordinated activities in education, regulatory compliance 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.
The IRB is comprised of GVSU faculty, staff and community members, who review proposed research studies involving living persons.
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
If you are looking for application forms, they are now housed on IRBManager, with the exception of the Individual Investigator Agreement Form and HIPAA forms listed below. Forms that are found in IRBManager include the New Protocol Submission Form, Research Determination Form, Continuing Review Form, Amendment Request Form, Reportable Event Form, and Closure Form. Please log into IRBManager to access those forms.