International Research Advisory Committee (IRAC)
What is IRAC?
IRAC is an advisory committee that reviews any international research studies submitted to COMIRB to ensure all international issues and concerns are adequately addressed prior to IRB review. The committee utilizes reviewers with knowledge of the country or region, confirms local approval has been received (when applicable), and makes recommendations to the study team as necessary. IRAC then passes on their recommendations to the Chair or appropriate panel assigned to conduct IRB review because, as an advisory committee, IRAC only makes recommendations for the review and determination that will be completed by COMIRB.
Studies that require IRAC review
A study requires IRAC review when:
- Funding is directed to an international site
- An affiliated investigator travels to an international site and engages in research activities such as recruiting subjects, consenting subjects, and/or collecting research data
- Investigator is receiving research and analyzing data/samples from international sites*
- *Receiving research and analyzing data/samples from international sites does not necessarily engage the affiliated investigator in international research but is dependent on additional factors such as funding.
- *Receiving research and analyzing data/samples from international sites does not necessarily engage the affiliated investigator in international research but is dependent on additional factors such as funding.
Other Institutional Requirements
General Data Protection Regulation (GDPR)
While receiving data/samples from international sites may not require IRAC review, any data/samples from the European Economic Area (EEA) or the United Kingdom (UK) are subject to the General Data Protection Regulation (GDPR) and require additional considerations.
For questions about GDPR, please visit the Regulatory Compliance GDPR page or contact Brie Labriola.
Import/Export Concerns
Many countries have strict regulations on export of biological samples and may need a Material Transfer Agreement, FDA, or USDA approvals, and/or special customs arrangements. Consider how you will maintain security of the data and samples while in country (e.g., consent forms, biological samples, data) and how data will be transmitted to the US (e.g., secure internet connections to US, encryption for sensitive data). Please visit the Research Agreements page or contact the CRAO Contracts Team.
International Travel
All students and trainees (including residents/fellows) traveling internationally for research or any other academic or experiential purposes must register with the Office of Global Education. Please email [email protected] or call (303) 315 - 2001.
University policy requires that faculty purchase international travel tickets through Concur or Christopherson Travel, which will automatically register you with the Office of International Affairs.
There may be other important considerations when conducting international research (e.g., local contracts, Visas, safety, etc.); please contact the Office of International Affairs to discuss your plans while outside the United States.
University policy requires that faculty purchase international travel tickets through Concur or Christopherson Travel, which will automatically register you with the Office of International Affairs.
There may be other important considerations when conducting international research (e.g., local contracts, Visas, safety, etc.); please contact the Office of International Affairs to discuss your plans while outside the United States.
International Research Advisory Committee Members
| Name | Department/Role |
| John Brett, PhD | COMIRB Chair |
| Sharon Devine, PhD, JD | COMIRB Chair |
| Karen Hampanda, PhD, MPH | Associate Professor, OB-GYN-Gyn & OB Health |
| Christine Sargent, PhD | Assistant Professor, Anthropology |
| Jean Scandlyn, PhD | Clinical Professor Emerita, Anthropology |
| Christine Ahearn, JD | Director of Regulatory Compliance |
| Lori Hopper, CHC, CHPC | HIPAA Privacy Official |
| Alana Jones, MS | Associate Vice Chancellor for the Office of International Affairs |
| Joe Ladmirault, MPA | Post-Award Grant Program Manager, Center for Global Health |
| Alison Lakin, RN, LLB, LLM, PhD | Associate Vice Chancellor of Regulatory Compliance |
| Chris Puckett, JD | Managing Associate University Counsel |
| John Heldens, CIP | Assistant Vice Chancellor for Human Research Protections |
| Brie Labriola, MA | COMIRB Manager |
| Elainya Hawkins, BS | COMIRB Review Specialist |
Questions?
For additional information please consult COMIRB's International Research Guidance or contact the COMIRB Help Desk.