Research with Human Participants

Institutional Review Board for Human Participant Research (IRB)

UPDATED November 10, 2021:

At this time, invited guests and visitors to the Cornell Ithaca campus--including research participants*--who are 12 years old or older must show proof of vaccination for COVID-19 or the results of a recent negative COVID-19 test. Principal Investigators are responsible for enforcing this requirement if it applies to their participant population. See the Cornell COVID-19 Visitors Webpage for more details. The Cornell Tech campus has its own visitor policy requiring proof of vaccination, which you can review on the Cornell Tech COVID-19 Visitors Webpage.

No IRB protocol amendment submission is needed to implement these participant eligibility and screening requirements, unless you are revising recruitment or informed consent materials. Please contact with any questions or concerns. The IRB COVID-19 FAQs and guidance materials have been updated to reflect this university policy change.

*If you believe your participant enrollment or retention will be severely negatively impacted by this visitor requirement, please contact IRB Manager Myles Gideon at

All individuals on Cornell's campus--regardless of vaccination status--are required to wear a mask outside (when physical distancing cannot be maintained) and inside campus buildings (except in private, non-shared spaces, or when eating/drinking). As COVID-19 pandemic-related requirements on the Cornell Ithaca campuses are reevaluated and updated, the IRB and ORIA will continue to revise our human participant research-specific FAQs and guidance documents to reflect current guidelines. Thank you for your patience and cooperation, and please contact the IRB if you have any questions.

The IRB office published a newsletter on October 28, 2021. Click to read more.

If you are conducting research with human participants (e.g., surveys, interviews, blood draws, secondary data analysis), you will need to obtain approval from the Cornell Institutional Review Board for Human Participants (IRB) before starting your research. The world of human participant research can be complicated and confusing, but there is a wealth of information on this website (and the IRB office staff are always available) to help researchers at all levels of experience navigate ethical and regulatory considerations in designing and carrying out human subjects research.

Do I need IRB approval?

Not all research activities that involve humans, or data collected from humans, actually meet the definition of "human participant research" under federal regulations. Luckily, the Cornell IRB office 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 participant research"; exempt research is still considered human participant research under federal regulations, though it can be reviewed and approved administratively by IRB staff, rather than the IRB committee.

Submit an IRB protocol application

To obtain IRB approval/exemption for a new study, complete a protocol application form. Make sure to use our informed consent form templates, as well as guidance and templates for specific biomedical procedures (e.g., venipuncture, fMRI).

For changes to your protocol, request an amendment. 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.

Track the status of your IRB protocol, or learn more about the protocol submission and management process.

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 using human participants. Visit the IRB Guidance and Resources page (and poke around this website—there are many gems to find!).

Get Training

All research personnel listed on expedited or full board IRB protocols 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 the training, or learn more about IRB training requirements and options.

IRB Office Hours: IRB staff provide assistance with protocol applications and answer IRB-related questions during bi-weekly office hours. Appointments are not necessary, but encouraged. Visit the IRB Office page for current dates, times, and 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. 

  • Upstate campus principally located in Ithaca (FWA 00004513)