Rutgers University is strongly committed to protecting the people who participate in Human Subjects Research. With globalization, many more researchers have extended their work to include people who live in foreign countries. People who volunteer to participate in human subjects studies, no matter where they live in the world, are all to be afforded these same protections as those in the US.
 
Rutgers University’s Institutional Review Board for the Protection of Human Subjects (IRB) has formalized new guidelines and improved procedures to reflect the Federal Office of Human Subjects Research Protections’ (OHRP) requirements involving research conducted outside of the U.S.A. Specifically, the IRB must have sufficient knowledge of the local research context to satisfy these requirements. In addition, each country may have specific rules and regulations governing human subjects’ research and Rutgers investigators conducting the work are obligated to be versed in these requirements and to adhere to them.

All existing forms have been modified to include questions about international research sites. In addition, the continuing review form has also been modified to ensure that all researchers who are currently conducting work outside of the US have had their work reviewed by the IRB.

If researchers are planning on expanding their approved work to include international sites, then an amendment must be submitted to the IRB for approval prior to implementing any changes.

Effective April 15 investigators must use the updated protocol applications found on the ORSP Human Subject website at <http://orsp.rutgers.edu/Humans/default.php >.

The new IRB International Research Guidance and Procedures: Evaluation of the Local Research Content for International Studies can be found online at
<http://orsp.rutgers.edu/Humans/irb_guidance.php > .This document provides valuable information to researchers regarding the steps to take for conducting human subjects work internationally for full/expedited/exempt studies.  

For more information, please contact

Karen Janes, Associate Director of Research Integrity and Compliance
janes@orsp.rutgers.edu or 732-932-0150 ext. 2105

Michelle Gibel, IRB Administrator,
gibel@orsp.rutgers.edu or 732-932-0150 ext. 2104

Erica Graser, IRB/IACUC Administrator
graser@orsp.rutgers.edu of 732-932-0150 ext. 2113

Lauren Zizza Compliance Administrator
zizza@orsp.rutgers.edu or 732-932-0150 ext.2109

 Return to ORSP Home