The New Protocol Submission Form is used for new projects, transferring projects to GVSU for the first time, and three-year de novo review. If it is not clear if the proposed activities require IACUC review, please visit the Determination section or contact the Office of Research Compliance and Integrity at [email protected] or (616) 331-3197.

Submission Process

1. Go to OneAegis.

2. Enter your GVSU network ID and password.  This will take you to your OneAegis dashboard.

3. To start a new application, select the "Start xForm" button in the white bar under the navigation tabs.

4. A new window will open.  Select, "IACUC New Protocol Submission Form."

PHS Policy requires the IACUC to conduct continuing review of each previously approved, ongoing activity at appropriate intervals as determined by the IACUC. At GVSU, the IACUC may require a report on the status of each protocol annually. In doing so, the PI verifies that completed activities were conducted in accordance with the approved protocol, describes any proposed departures from the approved protocols, and provides information about activities projected for the upcoming year. In addition, the number of animals used over the course of the previous protocol year is provided.

Protocols with approval periods that exceed one year may require a Continuing Review report on an annual basis (note: your approval period begins with the approved start date and ends on the protocol expiration date). Your continuing review report is due exactly one year from your approved start date.

The protocol is considered active and experiments can be conducted while the continuing review is under review by the IACUC.

Submission Process

1. Go to OneAegis.

2. Enter your GVSU network ID and password.  This will take you to your OneAegis dashboard.

3. Select the study from the "My Studies" table on the screen.

4. You are now at the study-specific screen. Select the "Start xForm" button in the bare under the navigation tabs. 

5. A new window will open.  Select, "IACUC Continuing Review Form."

Under PHS Policy, the IACUC can approve protocols for a maximum of three years. To continue a protocol beyond a three-year approval period, an initial application for complete de novo review by the IACUC is required. We encourage researchers to submit renewal requests at least 60 calendar days prior to the expiration date to avoid a lapse in approval.

Submission Process

1. Go to OneAegis.

2. Enter your GVSU network ID and password.  This will take you to your OneAegis dashboard.

3. To start a new application, select the "Start xForm" button in the bar under the navigation tabs.

4. A new window will open.  Select, "IACUC New Protocol Submission Form." 

5. The first question asks if this is a renewal of an existing protocol.  Select Yes and include the IACUC # of the original protocol.  

6. Proceed with completing the form.

Any change to previously approved materials must be approved by the IACUC prior to implementation. If you need to make any changes to your protocol you must submit an Amendment request for IACUC review and approval before any changes are implemented. Changes include, but are not limited to, changes in procedure, key personnel, or sample size.

Significant Changes

Significant changes to an IACUC-approved protocol must be reviewed and approved by the IACUC before they are initiated (PHS Policy IV.C.1., and AWR §2.31[d][1]). The GVSU IACUC interprets significant changes to mean those that have the potential to impact substantially and directly on the health and well-being of the experimental animals. Examples of significant changes include, but are not limited to, changes:

• in the methods of animal use;
• in the objectives of a study;
• from non-survival to survival surgery;
• resulting in greater discomfort or a greater degree of invasiveness;
• in the species or in approximate number of animals used;
• in PI;
• in anesthetic agent(s) or the use or withholding of analgesics;
• in the methods of euthanasia; and
• in the duration, frequency, or number of procedures performed on an animal.

Proposed significant changes require IACUC review (and approval) prior to initiation.

Non-significant Changes

The GVSU IACUC interprets non-significant changes to mean those that do not have the potential to impact substantially and directly on the health and well-being of animal subjects. Examples of non-significant changes include, but are not limited to, changes in:

• the funding source;
• personnel (other than the PI); and
• the use of a new vivarium housing location.

Proposed non-significant changes require administrative review (and approval) prior to initiation.

Submission Process

1. Go to OneAegis.

2. Enter your GVSU network ID and password.  This will take you to your OneAegis dashboard.

3. Select the study from the "My Studies" table at the bottom of the screen.

4. You are now at the study-specific screen. Select, "Start xForm" under the "Actions" menu in the left-hand column.

5. A new window will open.  Select, "IACUC Amendment Request Form."

Once the project has been reviewed either by Designated Member Review or Full Committee Review, the PI will receive an email with a list of questions to be addressed in order to secure approval.  This email will also contain a link to the protocol application. 

To respond, click on the link in the email to access the protocol application and make the requested changes.  In addition, it is very helpful to copy the list of questions into a Word document and type your responses beneath each item.  This document can then be attached to section 12 of the protocol application as supporting documentation.  When all items have been addressed, resubmit the form for review.  

A Closure Report is required upon completion of the project. This report must be submitted no later than 30 calendar days after the protocol expiration date. No research, testing, or instructional use of vertebrate animals may occur after the protocol expiration date.

Submission Process

1. Go to OneAegis.

2. Enter your GVSU network ID and password.  This will take you to your OneAegis dashboard.

3. Select the study from the "My Studies" table on the dashboard.

4. You are now at the study-specific screen. Select, "Start xForm" under the "Actions" menu in the left-hand column.

5. A new window will open.  Select, "IACUC Closure Form."

All instances of non-compliance or complaints regarding this study  must  be reported to the ORCI in a timely manner. Conditions that are suspected to jeopardize the health or wellbeing of animals  must be immediately reported to the IACUC at [email protected] or 616-331-3197. There are no specific forms for this report type.