You must provide some form
of documentation of research project approval by either 1) an IRB with a
foreign FWA (Federalwide Assurance), 2) a local review body equivalent
to an IRB, or 3) an independent local community expert or leader (e.g.,
NGO director, university professor), in this order. This review should
demonstrate that the research project has been reviewed for conformance
with local human research protections and research conduct standards for
this international research site. You must also describe the
qualifications of the local review body or expert (
e.g., source and scope of authority, location, membership).
What steps will you take during this process?
- Log into iRIS: https://iris.ou.edu/
- Start your new Study Application as described on the How to Submit a Full Study Application page.
- In Section 150 - Research Design of the application, answer ‘Yes’
that your study involves research conducted outside of the US. Answer
all questions that are presented in Section 170 - International
- Complete the online application and upload the appropriate documents as described on the How to Submit a Full Study Application page.
- Upload the Translator Statement,
cultural review documentation, and translated documents [such as a
recruitment script, data collection instruments, and/or consent
documents (as applicable)] with your other study materials.
Do you need to complete CITI Training?
Yes. You, your faculty
sponsor (if applicable), and anyone listed as key study personnel in
section 3.0 of the application must complete CITI training. You may
still submit your study application documents before training is
complete, but you must complete the training before the study can be
approved. Click here for a link to the website:
What else do you need to submit with your application?