The Cornell University Institutional Review Board for Human Participants (IRB) is responsible for oversight of all human subjects research conducted by the faculty, staff, and students affiliated with its Ithaca, Tech, and AgriTech campuses*. The world of human participant research can be complicated and confusing, but there is a wealth of information on this website to help researchers at all levels of experience navigate ethical and regulatory considerations in designing and carrying out human subjects research. You can also always contact our staff at irbhp@cornell.edu.
*Weill Cornell Medicine has its own IRBs and human research compliance staff.
Do I need IRB approval?
Not all research activities that involve humans--or data collected from humans--actually meet the definition of "human subjects research" under federal regulations. The Cornell IRB office has created a decision tree you can use to help figure out if your study will need IRB review and approval. When in doubt, contact the IRB office.
Note: "Exemption" from IRB review is not the same thing as "not human subjects research." Exempt research is human subjects research that is exempted from U.S. federal regulation 45 CRF 46, based on specific research procedures, participant populations, and privacy and confidentiality practices. At Cornell, research eligible for exemption can be reviewed administratively by IRB staff, rather than the IRB committee. A protocol submission is still required for exempt research, as investigators cannot self-exempt.
Submit an IRB protocol application
To obtain IRB approval/exemption for a new study, create a new protocol in RASS-IRB. We recommend you use our informed consent form templates, as well as guidance and templates for specific biomedical procedures (e.g., venipuncture, MRI).
For changes to your protocol, you must request an amendment in RASS-IRB. For full board protocols, you must also submit a request for continuing approval (renewal) each year, regardless of whether or not any of your study procedures or personnel have changed.
You can check on the status of your protocol in RASS-IRB. How-to documentation for RASS-IRB is available on the RASS Guide Site.
Looking for Guidance and Resources?
The IRB office has a variety of resources that can help you to understand the main processes and guidelines used by the Cornell IRB, as well as external policies, regulations, and best practices that might apply to your research with human participants. Start with our Life Cycle of an IRB Protocol resource for general information about Cornell IRB procedures, and the visit the IRB Guidance and Resources page for more detailed guidance and requirements.
Get Training
All research personnel listed on an IRB protocol are required to complete human participant research ethics (IRB) training. For NIH-funded clinical trials, research personnel must also complete Good Clinical Practice (GCP) training. Cornell uses the online CITI program to provide these trainings.
Take training, or learn more about IRB training requirements and options.
IRB Staff Consultations: IRB staff are available to meet via Zoom or phone to provide assistance with protocol applications and answer IRB-related questions. We use Microsoft Bookings to schedule Zoom consultations. You can also reach out directly to IRB staff; visit the IRB Office page for contact information.
Federal Wide Assurances (FWAs). Cornell's Human Research Protection Program operates under a Federal Wide Assurance (FWA) filed with the US Department of Health and Human Services. (Note: the Weill Cornell Medicine IRBs operated under a different FWA.)
- Ithaca, Geneva, and Tech campuses: FWA 00004513