IRB Considerations for International Research

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.

Research with human participants in other countries must comply with both U.S. and international ethical standards, and may require additional consideration for international participants' rights and welfare within different cultural contexts and local regulations.

Research conducted by Cornell faculty, students and staff in foreign countries must be reviewed and approved by the Cornell IRB. In addition to Cornell IRB approval, some international research must also be approved by the local equivalent of an IRB. Where there is no equivalent board or committee, researchers should work with local NGOs, researchers or community leaders to ensure that the project is consistent with cultural and legal expectations, and to secure support for the conduct of the research. As part of its review, the Cornell IRB will require a letter demonstrating support from an appropriate local body, organization or individual who will cooperate with and support the researcher. Researchers are urged to plan for the additional time that will be needed to obtain and document local support and review, and for the Cornell IRB to then review these important documents. Please see IRB Policy: International Human Research for more information.

Both the U.S. and host country standards for protecting human participants must be respected through the IRB review and approval process and the conduct of the research. Where the two sets of standards present a conflict, the research must meet the higher standard. In particular, while we do not impose our standards for written documentation on other cultures, we do not relax our standards for ethical conduct of research or for a meaningful consent and/or assent process, including ensuring additional protections for vulnerable participant populations (e.g., children, prisoners).

Due to U.S. export regulations, Cornell researchers cannot send money or provide other transactions of value (e.g., gift cards, presents) to study participants in any of these locations: Cuba, Crimea - Region of Ukraine, Iran, North Korea, Syria, Venezuela