IRB Guidance and Resources

Cornell IRB guidance and policies, and links to external sources to help you plan, obtain, and maintain IRB approval for your project

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 irbhp@cornell.edu 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 mbg223@cornell.edu.

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.

Looking for guidance and resources? The links and documents below will 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.

Cornell IRB Guidance & Procedures

External Regulations & Guidance

Here is a list of selected laws, regulations and guidelines concerning the conduct of research with human participants:

The Federal Policy for the Protection of Human Subjects (the “Common Rule”)

The Belmont Report

HIPAA Privacy Rule

Family Educational Rights and Privacy Act (FERPA)

Food and Drug Administration (FDA) 21 CFR Regulations

General Data Protection Regulation (GDPR)

New York State’s Article 24-A: Protection of Human Subjects

New York Civil Rights Law Section 79-l: Confidentiality of records of genetic tests