Research Compliance Enhancements

• IRB (Faculty, Staff, Students)
  • Duration: 30 Minutes
  • Date: January 28^th & February 25^th
  • Time: 3pm-3:30pm
  • Zoom Link
• 
  
• IACUC: Dates Coming Soon
• IBC: Dates Coming Soon

• Enhanced system generated renewal notifications are now in place to prevent research delays
  • Expiration System Reminders Sent: 60, 30, 7, Day of Expiration
• External (Non-BGSU) trainings will no longer be accepted due to system compatibility issues
• All CITI training will issue a 3-year approval to meet all regulatory standards
  • All active 5-year completion certificates will remain valid. Course will transition to the 3-year approval renewal cycle upon expiration.
• Training courses redesigned to prevent people from accidently taking the refresher course before the main course

Internally designed to:

• Replace IRBNet for IRB (Institutional Review Board), IACUC (Institutional Animal Care and Use Committee), IBC (Institutional Biosafety Committee), Research Based Disclosures (Sponsored Projects) submissions
• Simplify the compliance process for researchers, volunteer committee members, and administrators
• Be accessible and user-friendly for individuals from diverse backgrounds
• Reduce cognitive overload and promote a welcoming experience for all users

Citi Website

IRB (Human Subjects Research)

• Social & Behavioral Research - Basic/Refresher

IACUC (Institutional Animal Care and Use Committee)

• Working With Amphibians in Research Settings
• Working with Mice in Research Settings
• Working with Rats in Research Settings
• Wildlife Research

IBC (Institutional Biosafety Committee)

• New trainings coming soon

Research Based Disclosures (Sponsored Project Proposals/Awards)

• Responsible Conduct of Research (RCR)
  • As of October 1, 2025, all individuals involved with sponsored projects must complete RCR training prior to award acceptance.
  • We strongly recommend that all sponsored project personnel complete Responsible Conduct of Research (RCR) training at the time of proposal submission to avoid potential delays or issues at the award stage. Many Just-in-Time (JIT) notices require immediate confirmation that RCR training has been completed. Failure to complete RCR training prior to JIT notification will delay the funding decision process or result in loss of funding. 
• Research Security (RS)
  • CITI course modules coming soon. Contact Research Integrity to access the current training option.
  • As of October 1, 2025, all NSF, NIH, DOD, DOE awardees must complete Research Security training prior to award
• Conflicts of Interest (COI)
  • Sponsored project personnel must complete the COI course as directed by the Division of Research

• IRB (Human Subjects Research)
• IACUC (Animal Care and Use)
• IBC (Biosafety)
• Research Based Disclosures (Sponsored Project COI) 

• Researchers should start closing ALL COMPLETED/INACTIVE projects out of IRBNet when able. IRB and IACUC projects can be closed if you are no longer actively collecting or analyzing data and have completed all study-related activities.
• You may close your study if all the research milestones below are complete:
  • When all animal-related work described in the protocol is complete and there are no plans to continue or renew the study.
  • Study is permanently closed to enrollment OR was never open for enrollment;
  • All subjects have completed all study-related interventions OR not applicable (e.g. study did not include interventions, no subjects were enrolled);
  • Collection of private identifiable information is complete OR not applicable (no subjects were enrolled); AND
  • Analysis of private identifiable information is complete OR not applicable (no subjects were enrolled);

Project Closure Guide

Cayuse Roll Out

• Launch Date: December 1, 2025
  • Cayuse IRB is now live!
  • New IRB projects will not be accepted in IRBNet after December 1, 2025.
  • Pending IRBNet projects will be reviewed to completion in IRBNet to prevent research delays. However, projects that are not actively engaged with the IRB may not be finalized.
  • Resource Link: Templates & Forms (e.g., Consent Form Template)
• Researchers should start closing ALL COMPLETED/INACTIVE projects out of IRBNet (Closure Guide).
• All protocols must be in Cayuse by May 1, 2026. Protocols transferred as a legacy submission must be converted to a full protocol by December 31, 2026.
  • If your project is going to end or be closed prior to May 1, 2026, you do not have to do anything in IRBNet or Cayuse.
• Students will need to request cayuse access by emailing the IRB Office. Students MUST use the email format below.
  • Subject Line: Student Access to Cayuse IRB
  • Email Body Includes: Full Name, BGSU Username, Email (e.g., John Smith, Jsmith1234, Jsmith1234@bgsu.edu)
  • Please allow 24-48 hours for the account to be created. 

Submission/Transition Options

• Legacy Protocols: A shell protocol that only requires researchers to answer a few high-level questions about an approved IRB project. Researchers will also need to upload all approved IRBNet protocol documents to the new Cayuse Legacy submission. Current IRBNet approval dates will carry over to Cayuse or the expiration date will be set to December 31, 2026 (See Roll Out Notes Above). Researcher submission time requires an estimated 15 minutes.
  • Condensed Submission Steps: New Study Button / Initial Submission Option / Review Type: Legacy Protocol
  • This submission will require you to upload all approved materials (e.g., approved IRBNet application, consent/assent form(s), study instruments, scripts). Paper applications and forms will be continued to use until the protocol is transitioned to a full Cayuse submission (Deadline December 31, 2026).
• (Recommended Option) Transfer Protocol: Researcher transfers all approved IRBNet form details into Cayuse. After submission, IRB administration will verify the content matches what was previously approved and issues approval in Cayuse. Modification cannot be made during this transition. Current IRBNet approval dates will carry over to Cayuse. Researcher submission time requires an estimated 30-60 minutes.
  • Condensed Submission Steps: New Study Button / Initial Submission Option / Review Type: Select Approved Category of Review
  • You will need to transfer your IRBNet submission into the Cayuse template and upload all approved materials (e.g., consent/assent, study instruments, scripts). Once this is complete, you’ll be able to easily modify or renew your protocol with minimal effort, as Cayuse submissions function as a living document. Modifications cannot be made during the transfer submission. Once approved, you can submit modifications using the "Modification" option in Cayuse). 
• New/Renewal Submissions: Researchers will complete a Cayuse submission and submit through the normal review process. Researcher submission time requires an estimated 30-60 minutes.
• Modifications: Researchers can continue to submit in IRBNet within the timelines above. Cayuse submissions will follow the IRB’s normal review process. Researchers submitting Legacy modifications will upload IRBNet forms into Cayuse. Researcher submission time requires an estimated 15-30 minutes.

Who can be a pi:

• As of December 1, 2025, only Faculty/Staff can serve as PI on NEW Cayuse submissions (Students are not eligible to serve as PI). Students can be listed in any other role.
  • Cayuse requires the PI to submit the protocol for review. It does not have the ability to route to an advisor for pre-review/approval.
• Students can remain PI on IRBNet and Cayuse Legacy protocols until the end of their current degree. After graduation, protocols must either be closed or transferred to a faculty/staff member.

Important Note:

Students can fully complete an IRB protocol in Cayuse without any initial action from their advisor. Once the student designates their advisor as the Principal Investigator (PI), the advisor automatically gains edit access to the protocol.

Submission Workflow:

• Student Completes Protocol:
  The student fills out all required sections of the IRB protocol.
• Routing to PI for Review:
  After completion, the student routes the protocol to the PI for certification. At this point, the student can no longer make edits.
• PI Review Options:
  Upon receiving the protocol, the PI has two options:
  • Certify the Protocol: Submit it directly to the IRB for review.
  • Reopen for Edits: Return the protocol to the student for revisions.

Example Scenario:
A graduate student completes their IRB submission at 2:00 AM and routes it to their advisor. The system automatically emails the PI a direct link to the protocol. The PI can then either reopen it for edits or certify and submit it to the IRB.

Retrospective aPPROVAL (NO CONSENT) & wAIVERS OF Written cONSENT:

• BGSU and the IRB are committed to ensuring all faculty, staff, and students know how their data is being used for research. The informed consent process is critical to conducting ethical research. People within the university can still use data to internally enhance BGSU learning experiences and laboratories. Any project requesting a waiver of written consent must include a strong justification and must be reviewed by the full committee. If you are granted a waiver of written consent, you must still get verbal consent. Contact the IRB Office prior to submitting a project seeking a waiver of consent to ensure the project is feasible.

New Consent Form Template & Process

• As of December 1, 2025, there will be a new consent form template available. The IRB strongly recommends you use the template for your project to ensure a smooth review.
• .The new template address common questions asked by researchers and meets today’s research standards.
  • The informed consent process should clearly state what data will be shared and how broadly it will be shared. Clarify who will have access to the data (e.g., other researchers, advisors, the public). It should indicate if data will be shared for future research, what identifying information will be retained, and how confidentiality/anonymity will be maintained.

Classroom Project (Not for Research):

• The IRB will no longer review classroom projects not intended for public dissemination (e.g., publications, external presentations, etc.).
• IRB reviewers are faculty volunteers who take on committee tasks in addition to their normal department responsibilities. To increase our efficiency, their efforts will be focused on reviewing research projects only.

Institutional Assessments

• Starting December 1, 2025, all institutional assessments will be required to be processed via a Cayuse IRB submission. This includes campus assessments not intended for research.
• System allows multiple departments to review the assessment to ensure regulatory compliance.
• Assists the university in scheduling assessments/research to enhance response rates.
• Prevent faculty from having to contact multiple departments for approval.

Discontinuing Document Stamping

• Starting December 1, 2025, Cayuse consent/assent documents will not be stamped since Cayuse clearly indicates the approved versions within the system.
  • The change is being made due to most researchers only using online platforms.

Cayuse Roll Out:

• Launch Date: Coming Soon
• First-ever online submission system for IBC protocols
• Students will need to request system access by emailing the IBC Office.

New Policy:

• A new policy governing the use of biohazardous and regulated materials is coming soon

CITI Trainings:

• CITI courses are being implemented
• Renewal notifications will be in place at launch to prevent research delays.

Cayuse Roll Out:

• Launch Date: Coming Soon
• All protocols must be in Cayuse by May 2026. Protocols transferred as a legacy submission must be converted to a full protocol by Dec. 31, 2026.
• Digital tracking of animal numbers.
• Real-time visibility of training status for all personnel.
• Students have never been eligible to serve as PIs.
• Students will need to request system access by emailing the IACUC Office.

Researchers should now submit all IRB projects through Cayuse IRB instead of IRBNet. This new system offers a streamlined, user-friendly experience with improved workflows, real-time status tracking, and intuitive forms to make submissions faster and easier. Visit the Research Compliance Enhancements page to learn more about the rollout and find resources to help you transition from IRBNet to Cayuse IRB.

Resources Links:

• Templates & Forms (e.g., Consent Form Template)
• Cayuse IRB Website
  • Important Notes:
    • CITI Training Integration with Cayuse is still being set up so records will not appear within the system. This feature will be online soon. Still ensure all study team members have complete the CITI Training prior to submission.
    • Students will need to request system access by emailing the IRB Office. Students MUST use the email format below. 
      • Subject Line: Student Access to Cayuse IRB
      • Email Body Includes: Full Name, BGSU Username, Email (e.g., John Smith, Jsmith1234, Jsmith1234@bgsu.edu)
      • Please allow 24-48 hours for the account to be created.
  • Human Ethics - Cayuse Help Center
  • CITI Training (SSO Access)
  • IRBNet Website
  • Research Integrity Enhancements Page