Research with Human Participants

Institutional Review Board for Human Participant Research (IRB)

UPDATED August 3, 2022

Effective October 1, 2022, all Cornell study personnel involved in Exempt research protocols will be required to complete CITI training in human participant research ethics. A newsletter was sent to current IRB PIs and Faculty Advisors on 7/29/22 with more details (see contents here). For more information about Cornell IRB training requirements, visit the IRB Training webpage.

Cornell's IRB is using the RASS-IRB system for new protocol submissions, continuing reviews, amendments, and adverse event and protocol deviation reporting. See more details about the transition to RASS-IRB here. Find how-to documentation and recordings of Zoom training sessions on the RASS Guide Site.

For help, questions, or feedback about the RASS-IRB system, contact the RASS team at: rass@research.cornell.edu. For content-related questions about your IRB protocol or other human participant research topics, email irbhp@cornell.edu per usual. You can also schedule a Zoom meeting with members of the RASS or IRB teams via Microsoft Bookings.

Face masks are still required for in-person, on-campus human participant research. For more information, visit the Cornell IRB COVID-19 FAQs and guidance materials for research on campus during the pandemic, the Cornell COVID Dashboard, and the Cornell Research Continuity Guidance webpage.

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 for a new study, create a new protocol in RASS-IRB. 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 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 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)