IRB Newsletter: Summer 2025

1. Federally Funded Research  

Along with our colleagues in Research & Innovation, we have been monitoring the ongoing precarity of federal research funding.  

• If you are federally funded and receive a stop work order, termination order, or any other directive from the funder, please reach out to us at: irbhp@cornell.edu. We can help you ensure participant safety and determine whether any IRB protocol amendments are needed.  

2. Deadline for Timely Educational Research  

IRB staff can help you meet your timeline for research projects where students must enroll on the first day of classes (i.e., research taking place in a specific class).

To ensure IRB exemption or approval by August 25th:

• Submit your protocol application (new or amendment) at least four (4) weeks prior to the start of the semester. For Fall 2025, submit protocols by July 28th.  
• Include the starting semester in your protocol title – i.e., ‘Fall 2025.’
• Ensure your protocol submission is well-prepared and complete: fully answer all application questions, attach all relevant documents, and ensure the study is clearly and consistently described.

As always, incomplete applications or slow responses to IRB comments will lengthen the review process. This is also true for studies that require ancillary reviews (e.g., Radiation Safety, Institutional Biosafety Committee).   

3. Artificial Intelligence in your IRB Protocol  

Due to researcher interest, IRB staff and members are hard at work figuring out how to integrate Artificial Intelligence tools into human participant research while ensuring participants and their personal data are adequately protected and studies are in line with University guidelines.

• We just updated our RASS-IRB protocol application with questions asking how AI tools will be utilized in your research.
• We are in the process of developing an AI guidance document.

Right now, AI incorporation in IRB protocols is approved on a case-by-case basis. We are working closely with the IT Security Office to decide when AI tools can be used in a project, and when alternatives should be sought out.  

• For instance, there currently are no external AI tools for voice-to-text transcription that are approved for use in Cornell human participant research; instead, we recommend the Live Meeting Transcription option within Cornell-licensed Zoom for most minimal risk research. Save the transcriptions prior to leaving the meeting and store the transcriptions securely.  
• While human participant research & AI guidance is being developed, we recommend that researchers review the Generative AI in Administration Task Force Report from January 2024.  

4. Revised & New IRB Policies and Guidance 

IRB staff and committee members are updating human participant research guidance and policy documents for Cornell researchers:

• The IRB recently approved a revised version of Policy #1, “Determining Whether a Research Activity Needs IRB Review and Approval” with clarified processes and improved readability.
• A new “Life Cycle of an IRB Protocol” guidance provides an overview of how to submit, modify, and close any IRB protocol. While it was written with beginner researchers in mind, it can be useful for any Cornell researchers interested in IRB processes.  

5. SMART IRB  

As of January 2025, Cornell has joined the SMART IRB platform. SMART IRB is an NIH-funded initiative that allows universities and other research organizations to sign onto a singular set of reliance terms for multi-site/multi-institution human participant research. Instead of establishing protocol-specific IRB Reliance (aka Authorization) Agreements, the SMART IRB Reliance Agreement can be used for non-exempt collaborations with other participating institutions.

SMART IRB:

• Makes IRB review of non-exempt multi-institutional research easier
• Expedites the process of establishing IRB reliance with other participating institutions
• Requires no change in procedure for PIs

If you have a new project involving non-Cornell collaborators, please:

• Work with our team at irb-reliance@cornell.edu and
• Submit a request for a reliance agreement through RASS-IRB. 

6. Reminder: Cornell Buying Manual Section on Paying Human Participants  

In 2023, a new section (630) was added to the Cornell Buying Manual, providing guidelines for providing financial incentives to human research participants.

• Regularly check Buying Manual Section 630 to ensure the incentives you intend to provide participants are in compliance with these guidelines.
• For new studies, make sure you are using the most up-to-date informed consent templates, which include key information about payment logistics (e.g., taxable income, business center staff access to personal identifiers, etc.).
• For any questions, contact IRB staff at: irbhp@cornell.edu.

Thank you, and we wish you success with your research this summer!