How do I submit a new protocol to the IBC?

To initiate the review process, Principal Investigators (PIs) & co-investigators are required to submit a new protocol through the institution's electronic research administration system, Cayuse, using their official institutional credentials.

• Cayuse Link
• If you haven't used Cayuse and require assistance you can contact the Office of Research Compliance at ibc@tamuk.edu or researchcompliance@tamuk.edu.

Once logged in, researchers should navigate to the Hazard Safety module & select “Create New Protocol.”

The submission involves systematically completing all required forms, which capture the essential details regarding the project, study design, comprehensive identification of hazardous materials, personnel listings, & associated safety documentation. Crucially, researchers must attach all necessary supplemental documentation, such as vector maps, strain information, training certifications, & other relevant supporting files. Upon successful completion of all required sections, the protocol must be officially submitted, which electronically routes a notification to the research compliance staff assigned to the IBC for immediate tracking & initiation of the formal review process.

*NOTE* To be included on the agenda for review, protocol submissions must be finalized and submitted at least 14 days prior to the next scheduled IBC meeting.

Initial Review Process

Following submission, the research compliance staff assigned to the Institutional Biosafety Committee (IBC) conducts a pre-review to verify the protocol's completeness, confirms adherence to all relevant federal, state, & institutional regulations—including those from the National Institutes of Health (NIH) & the Centers for Disease Control & Prevention (CDC)—& formally assess the project’s risk level. The research compliance staff assigned to the IBC then assigns the submission to the appropriate IBC member(s) for thorough evaluation based on their specific expertise & availability. Each reviewing IBC member assesses the submission for compliance with ethical & regulatory guidelines, focusing on essential elements such as containment, biosafety practices, & potential risks to the community & the environment. Subsequently, the PI will receive formal feedback via Cayuse & may be required to provide revisions or clarifications, typically within five business days following the scheduled IBC meeting. Should the IBC require any modifications to an approved protocol, the PI will receive detailed feedback directly through the Cayuse system. The PI is then responsible for addressing all comments comprehensively & uploading all revised documentation prior to resubmission for the final protocol review.

Final Approval

Upon successful completion of the review process, the IBC will formally issue a final approval notification to the PI via the Cayuse system. This official approval document will clearly state the expiration date of the protocol, after which the study will require a continuing review & renewal submission if the research activities are to continue.

Protocol amendments

Protocol amendments must be submitted using the electronic Cayuse system, they must be reviewed and subsequently approved before any amended work can begin. Initiating work prior to securing final IBC approval or an official IBC exemption determination constitutes a serious violation of institutional policy and results in formal noncompliance. There is no amendment limit for an approved protocol. At the discretion of the Chair, significant amendments may necessitate the submission of a new protocol for review. PIs are encouraged to reach out to the research compliance staff assigned to the IBC for assistance or any required clarification on the submission process.

IBC@tamuk.edu

Continuing Review

To maintain active status & regulatory compliance, researchers must ensure a Continuing Review Protocol is submitted via Cayuse prior to the expiration date of their current approved protocol. Given that IBC protocols are typically granted a term of three years, timely submission is critical. During this review, the IBC evaluates the overall progress of the study & assesses any ongoing risks associated with the research to confirm the protocol remains compliant with the initial terms and established safety guidelines of the IBCs approval.

Reporting, Documentation, & Support

The reporting of all adverse events & unanticipated problems must be conducted through the Cayuse system. Instances involving personnel safety must be handled immediately in accordance with the situation, such as contacting 911 for medical emergencies. Furthermore, all IBC submissions, approval notifications, & related documents must be retained within Cayuse for a minimum of five (5) years following the date of study completion/closure. All official communication regarding submissions, modifications, & final IBC decisions will be channeled exclusively through the Cayuse platform; therefore, researchers must regularly check their account for critical notifications & updates. For any technical issues or user support related to the Cayuse system or the IBC process, researchers should contact the research compliance staff assigned to the IBC at Texas A&M University-Kingsville via email at ibc@tamuk.edu or researchcompliance@tamuk.edu.