International Research

Introduction
Research conducted at multiple sites may present difficult challenges both
for investigators and Institutional Review Boards (IRBs). These challenges
may be further heightened with the addition of an international
component to the research. A critical element that must be understood by
all parties is the concept of "engagement." This module reviews the
concept of engagement and its application to international research.

Learning Objectives

By the end of this module, you should be able to:

 Define "engagement" with respect to research.

 Identify the options that may exist for international
collaborators in human subjects research.

"Engagement" in Research
The Office for Human Research Protections (OHRP) provides guidance on
determining whether an organization is either engaged or not engaged in
research. Briefly, an "engaged" non-U.S. organization is one whose
employees or agents participate in the recruitment of subjects, conduct
the consent process, obtain consent from subjects, intervene with human
subjects for research purposes, or receive the private, identifiable
information of subjects (OHRP 2008).

Organizations are not considered engaged in the research if their

employees or agents:

Inform prospective subjects about the availability of the research; provide

prospective subjects with information about the research (which may
include a copy of the relevant informed consent document and other IRB
approved materials) but do not obtain subjects' consent for the research
or act as representatives of the investigators; provide prospective subjects
with information about contacting investigators for information or
enrollment; and/or seek or obtain the prospective subjects' permission for
investigators to contact them (OHRP 2008).
For a full description of the concept of engagement see OHRP's Guidance
on Engagement of Institutions in Human Subjects Research.

Non-U.S. Collaborations
If research funded, conducted, or supported by the U.S. Department of
Health and Human Services (HHS) involves collaboration with an
organization that is engaged in research in a foreign country, the
organization will need to have an assurance filed with OHRP. The
assurance is the same Federalwide Assurance (FWA) for U.S. and non-U.S.
institutions (OHRP 2017). The assurance commits the organization to
having procedures in place that ensure subjects will be protected in a
manner commensurate with the 45 CFR 46, Subpart A (the Common Rule).
Other federal agencies sponsoring international research may use the
HHS assurance process, but they may also choose alternate assurance
processes.

Foreign collaborators may have their own IRBs or comparable local ethics
review committees. Some international research is carried out without the
involvement of collaborators. For example, political scientists from the
U.S. may interview people on the street in Germany or U.S. environmental
scientists may interview fishermen in Panama. Federal regulations do not
require on-site, local review in such cases; however, the researcher and
the IRB that reviews the activity should be mindful of foreign regulations
or other requirements that govern research on the local population.

Summary
It is important to understand when an organization is engaged in the
research. If a collaborating organization is not engaged in the research,
assurances of compliance are not required. If a collaborating organization
is engaged, then an FWA is required.