Last Revised: 10.2015
Prior Version: 7.2007
International Research
Introduction
The CWRU IRB policy has special provisions for investigators where some or all of the study
subjects are located outside of the United States. The CWRU IRB requires additional review for
human subjects research projects where some or all of the study subjects are located outside of
the United States.
Policy
All human subject research, regardless of funding, performed outside the United States must
obtain appropriate institutional IRB approval according to federal regulations and the
Federalwide Assurance (FWA). The University recognizes that the procedures normally
followed in the foreign countries may differ from those set forth in this standard operating
procedure. The research, however, may be approved if the procedures prescribed by the
(foreign) institution afford protections that are at least equivalent to those provided in the FWA.
It is the policy of the CWRU IRB that for international research, where the CWRU IRB will
serve as the IRB of record, the faculty and/or staff of CWRU must be ultimately responsible for
the conduct of the research.
The appropriate authorities of the host country, including a national or local ethical review
committee or its equivalent, must also review and approve the proposed research within the
context of their own ethical requirements.
Investigators must provide the same or equivalent protections to human participants in research
they may conduct in countries outside the United States. When conducting transnational or
international research, investigators must be aware of local laws and the cultural context in all
locations where the research is conducted and comply with existing laws and adhere to cultural
norms.
The CWRU IRB usually requires documentation of approval from the host country
/countries ethical review committee(s) prior to review and approval of the protocol.
The CWRU IRB may also utilize local experts knowledgeable about the social and cultural
norms in its review of the study. For studies that are not greater than minimal risk, an expedited
review of the study may be granted.
All relevant CWRU SBER IRB policies apply to international research. In addition,
international protocols should include information:
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Explanations of cultural differences that have influenced the study design or consent
process.
Rationale for conducting the study with an international population.
Information regarding the host country’s IRB, Ethical Review Committee, or equivalent
organization.
Letter(s) of agreement or IRB approval from the local host institution(s) to cooperate in
the proposed research.
A copy of the consent form (if used) in English and the appropriate native language(s).
Information regarding the literacy level of the expected subjects and how this may affect
the informed consent process.
A description of the informed consent process including methods for minimizing the
possibility of coercion or undue influence in seeking consent and safeguards to protect
the rights and welfare of vulnerable subjects.
If remuneration is given to subjects, provide a justification for the amount of money or
goods and how this relates to the average annual income of people in the host country.
The CWRU IRB encourages investigators to make provisions for the study population to benefit
from the research study.
Federally Funded Studies
A Federalwide Assurance (FWA) is necessary to document that the international
institution/performance site will conduct the research in accordance with U.S. federal policy.
Special Consent Situations
1.
For studies involving populations that have no written language: Use an English consent
form as a template for translation and include a statement about the process for informed
consent. The consent form should be signed by the interpreter, the study principal
investigator, and the subject, who will make a mark or thumb print as appropriate.
2.
For studies where obtaining a signature is not culturally appropriate: The principal
investigator may request a waiver of signature and provide justification for the waiver.
3.
For studies involving populations that utilize group consent: Describe and justify the use
of group consent. Provide a method to obtain private or individual subject assent.
Provide a method of protecting those who choose not to participate in the study.
4.
Studies involving Children: The requirements for assent for Children in Research are
applicable. The legal age for consent in other countries may differ from Ohio. The local
legal age should be used for choosing consent versus assent documents.
5.
Translated Consent Documents: All consent forms and associated documents to be used
with potential research subjects must be translated into the appropriate local language and
submitted to the CWRU IRB. The investigator must provide the name and brief
description of the qualifications of the individual or the service that was used to translate
the informed consent documents.
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Prior Version: 7.2007
As a general policy the CWRU IRB does not require independent back translation of
consent documents because the local context reviewers are usually able to read the local
language and can review the content of the foreign language consent form. If the
international site’s ethical review committee (ERC) or IRB approves the translated
documents, the CWRU IRB may accept these approved translations. For specific
protocols the CWRU IRB may require back translation of foreign language consent
forms.
The CWRU IRB prefers to have the translated consent form available at the time of IRB
review; however, at the investigator’s request, the CWRU IRB may allow waiting to have
the translation done until after the approval of the English version. If this is done, the
CWRU IRB will not approve the translated consent form until the accuracy of the
translation has been reviewed.
HIPAA Authorization/Privacy Rule
If the investigator or research study staff is responsible for, or involved with, the use and
disclosure of protected health information (PHI) as defined by the HIPAA rule, then the federal
regulations apply. It is the responsibility of the investigator to comply with HIPAA
Authorization/Privacy Rule requirements if any protected health information that is transmitted
back to the United States.
The HIPAA rule does not apply at research sites outside of the United States where individually
identifiable information may be collected. Once the individual identifiable information is
transferred to a HIPAA covered facility renders any individually identifiable health information
(PHI) by virtue of its being held by a facility covered by HIPAA. Once data is transferred to a
HIPAA covered component, all HIPAA regulations apply.
Conflict of Interest
No IRB member may participate in the IRB's initial or continuing review of any project in which
the member has a conflicting interest, except to provide information requested by the IRB. The
IRB may, in its discretion, invite individuals with competence in special areas to assist in the
review of issues that require expertise beyond or in addition to that available on the IRB. These
individuals may not vote with the IRB.
References or Regulatory Citations
45 CFR 46.107(a)
45 CFR 46.111 (a)(3), (a)(4), (a)(7), (b)
45 CFR 46.116
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