Member Reviewer Checklist s1

CHECKLIST: Transnational Research with Human Subjects Research

The purpose of this checklist is to provide support for IRB members or the Designated Reviewer when reviewing transnational research. This checklist must be used.

IRB Number: PI Name: IRB Meeting Date:
Protocol Title:

Reviewer (Print Name) Reviewer’s Signature Date

List the country or countries the research will be done:
Does the University or researcher have permission to conduct research in the country? / Yes
No
Has there been a local ethics committee (EC) review? / Yes
No
If No, is there a certification by the country? / Yes
No
If No, will the country accept the University’s IRB approval and give permission to conduct the research? / Yes
No
Does the researcher speak the local language? / Yes
No
If No, has the researcher indentified how the communication between the researcher and the subjects be accomplished? / Yes
No
Is the researcher familiar with the local culture/customs/laws? / Yes
No
If Yes, explain how:
What unique research related qualifications does this researcher possess for conducting research in the listed country or countries?
If No, will there be a local collaborator who is familiar with local culture/customs? / Yes
No
Will informed consent be obtained? / Yes
No
If Yes, will the informed consent be obtained from the subject or a surrogate? / Yes
No
If the informed consent is not obtained from the subject, describe the local culture/customs for obtaining consent:
Will written documentation of consent be obtained? / Yes
No
N/A
If Yes, describe how the documentation of consent will be translated:
Is a waiver of the requirement for written documentation appropriate? / Yes
No
N/A
Are there privacy/confidentiality concerns unique to the country’s culture/customs? / Yes
No
If Yes, describe the concerns and their resolutions:
Describe how the researcher will communicate with the University IRB for continuing review, amendments, unanticipated problems, complaints, etc, when on site:
Is the study being done by a student researcher? / Yes
No
N/A
If Yes, describe how the Principal Investigator or faculty sponsor will oversee conduct of the research:

The University of Texas at Austin Page 1 of 2

Institutional Review Board –May 2016