1. Purpose
This SOP outlines the requirements for international research involving human participants
when the research falls under the auspices of WVU IRB.
2. Overview
Approval of international research is permitted if “the procedures prescribed by
the foreign institution afford protections that are at least equivalent to those
provided in 45 CFR 46.” All policies and procedures applied to research conducted
domestically should be applied to research conducted in other countries, as appropriate.
The WVU IRB must receive and review the foreign institution or site’s IRB review
and approval of each project before the commencement of the research at the foreign
institution or site. For federally funded research, approval of research for foreign
institutions or sites “engaged” in research is only permitted if the foreign institution
or site holds a Federalwide Assurance with OHRP and local IRB review and approval
is obtained.
3. General Information
3.1. Approval of research for foreign institutions or sites “not engaged” in research
is only permitted if one or more of the following circumstances exist:
- When the foreign institution or site has an established IRB/IEC, the researcher
must obtain approval to conduct the research at the “not engaged” site from
the site’s IRB/IEC or provide documentation that the site’s IRB/IEC has determined
that approval is not necessary for the researcher to conduct the proposed research
at the site.
- When the foreign institution or site does not have an established IRB/IEC, a
letter of cooperation must be obtained demonstrating that the appropriate institutional
or oversight officials permit the research to be conducted at the performance
site.
- IRB approval to conduct research at the foreign institution or site is contingent
upon receiving documentation of the performance site’s IRB/IEC determination,
or letter of cooperation, as applicable.
- It is the responsibility of the WVU researcher and the foreign institution or
site to assure that the resources and facilities are appropriate for the nature
of the research.
- It is the responsibility of the WVU researcher and the foreign institution or
site to confirm the qualifications of the researchers and research staff for
conducting research in that country(ies).
- It is the responsibility of the WVU researcher and the foreign institution or
site to ensure that the following activities will occur:
- Initial review, continuing review, and review of amendments
- Post-approval monitoring
- Handling of complaints, non-compliance, and unanticipated problems involving
risks to participants or others
The IRB will not rely on a local ethics committee that does not have the policies
and procedures in place for the activities listed above.
- It is the responsibility of the WVU researcher and the foreign institution or
site to notify the IRB promptly if a change in research activities alters the
performance site’s engagement in the research (e.g., previously “non-engaged”
performance site begins consenting research participants, etc.).
-
The WVU IRB will consider local research context when reviewing international studies
to assure protections are in place that are appropriate to the setting in which
the research will be conducted, including knowledge of local laws and cultural
context.
-
In the case where there is no local IRB review, the IRB may require an expert consultant,
either from the local country where the research is conducted or from an international
organization, with the expertise or knowledge required to adequately evaluate
the research in light of local context.
- The informed consent documents must be in a language understandable to the proposed
participants. Therefore, the IRB will review the document and a back translation
of the exact content contained in the foreign language informed consent document,
which must be provided by the researcher, with the credentials of the translator,
detailed in the IRB application or amendment form. Verification of the back
translation should be made available in the protocol files for IRB review.
(See SOP 012: Informed Consent Requirements and SOP 016: Documentation of the
Informed Consent Process.)
4. Monitoring of Approved International Research
4.1. The IRB is responsible for the ongoing review of international research conducted
under its jurisdiction through the continuing review process in accordance with
all applicable federal regulations.
4.2. When the IRB and local ethics committee will both be involved in the review
of research, there is a plan for coordination and communication with the local
ECs.
4.3. The IRB will require documentation of regular correspondence between the WVU
researcher and the foreign institution or site and may require verification from
sources other than the WVU researcher that there have been no substantial changes
in the research since its last review.
5. References
WVU Policies:
SOP 012: Informed Consent Requirements
SOP 016: Documentation of the Informed Consent Process
AAHRPP:
Standard I-3
