Human Research News v8,n2: Human Subjects Research Considerations for International Research

Human Research News v8, n2: Human Subjects Research Considerations for International Research

June 3, 2008

Welcome to UCLA Human Research News.

UCLA OPRS Policy 46: "Research Conducted in International Settings" outlines the University of California, Los Angeles (UCLA) Institutional Review Board (IRB) considerations required to assure that adequate provisions are in place for research in international settings that is conducted by or in collaboration with UCLA researchers.

Policy 46 is available on the IRB "Policies and Guidance" page of OPRS website at: http://www.oprs.ucla.edu/human/documents/pdf/46.pdf

The current UCLA OPRS/IRB HS-1 Application to Involve Human Subjects in Research, and HS-7 Exemption From IRB Review Application do not include questions that specifically pertain to research conducted in international settings.

In order to facilitate IRB review of human subjects research conducted in international locations, by providing the UCLA IRBs with the information necessary to fulfill the OPRS/IRB's responsibilities and thus reduce the time required for IRB review of international research, investigators are asked to:

(1) review OPRS Policy 46,

(2) ensure that the applicable sections of the HS-1 or HS-7 applications include information that responds to the considerations outlined in the "Investigators' Responsibilities" sections of Policy 46; and

(3) review and include a completed copy of the attached "International Research Checklist" with each application that is submitted to the OPRS.

Please note: The web-based application for the "webIRB" online application system that will be introduced within the next year will include questions designed to elicit the information required by the UCLA IRBs in order to conduct an adequate review of research in international settings.

Sincerely, Judith L. Brookshire Director, UCLA Office for Protection of Research Subjects

International Research Checklist - For Researchers