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About the Institutional Review Board (IRB) for Human Participants

All research that involves human participants must be either exempted from review or approved by Cornell's Institutional Review Board (IRB) before it can be initiated. Learn More

Now in Effect - Revisions to the Common Rule

Revisions to the Federal policy for the protection of human participants in research (the "Common Rule") are in effect starting January 21, 2019. Our detailed guidance document is the most complete source of information about how the changes will affect Cornell research with human subjects. Scroll down for a broad overview, and to access tools and resources developed by the Cornell IRB to help you understand and manage the New Common Rule.

Summary of Common Rule Changes Affecting Cornell Research

For a more in-depth look at the changes that might affect your research, read our detailed guidance document.

  • Exemption categories: More research qualifies for exemption under the New Common Rule, including: secondary use of identifiable, sensitive data; research using "benign behavioral interventions" (e.g., playing a game, solving a puzzle).
  • No renewal requirement for most studies: The annual renewal requirement is eliminated for the vast majority of expedited studies (and for full board research, when remaining activities are limited to data analysis).
  • Changes to informed consent: New elements are added to the basic information to be communicated during consent and, for federally-funded clinical trials, consent materials must be posted to ClinicalTrials.gov.
  • Expansion of clinical trials: The New Common Rule expands the concept of a "clinical trial" to include some basic biomedical and behavioral health-related research. A new guidance document details compliance obligations specific to clinical trials, and provides basic information on how to register and provide updates on ClinicalTrials.gov.
  • Single IRB ("sIRB") requirement: Multi-institution studies must use a sIRB for review starting in January 2020. For NIH studies, a version of the sIRB requirement has been in effect since January 2018.

Common Rule Changes to Informed Consent

The Common Rule includes new requirements for the informed consent process. In most cases no changes will be needed for consent documents that have already been approved by the IRB. For new studies, researchers should use the updated consent templates. Learn more

Updated Tools, Forms and Templates

More News from the IRB

  • Policy Changes Affecting NIH Studies (learn more)
  • New Guidance on Parental Consent
  • Video Resource: Informed Consent 101



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Contact Information

Janet Jayne
IRB Administrator
t. 607-255-5138

Vanessa McCaffery
Compliance Administrator
t. 607-254-5162

Guilaine Senecal
Assistant Director, ORIA
t. 607-255-8994

East Hill Office Building
395 Pine Tree Road, Suite 320
Cornell University
Ithaca, NY 14850

f. 607-255-0758
e. irbhp@cornell.edu