International Research Addendum

This is an addendum for international research. You will complete this form after submission of complete research protocol (exempt, expedited, full board review).

Title of Protocol *
PI/Faculty Advisor *
1. Identify the country(s) where the research will be conducted: *
2. Identify the site(s) within the country(s) where the research will be conducted. *
3. Will there be a local IRB(s) which will have review and oversight jurisdiction at the foreign site(s)? *

3. Will there be a local IRB(s) which will have review and oversight jurisdiction at the foreign site(s)? No Yes, please identify Yes, please identify
4. Provide citations for country-specific laws, regulations and guidelines that govern research. Include applicable websites *
5. Describe country specific local customs, practices, language barriers, literacy issues, cultural issues, and standards of care which may impact the conduct of the research. *
6. Identify an independent expert on local customs who can serve as a consultant to the PSC IRB, if the IRB requires additional information. Include A. Name; B. Email; C. Telephone; D. Mailing Address *
7. Will external investigators be involved in conducting this research?

If yes, provide contact information for the external investigators *
8. Is this research funded by the Department of Health and Human Services? *

8. Is this research funded by the Department of Health and Human Services? Yes No
CERTIFICATION I understand and agree that as the Principal Investigator of this research, I am responsible for the safe and proper conduct of the research in full compliance with the Common Rule, equivalent standards, applicable country-specific laws, regulations and guidelines where applicable. *

Draw or Type

I understand this is a legal representation of my signature. Clear

Full Name

I understand this is a legal representation of my signature.