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FAQs
Human Subjects Research
International Settings
RICRO: (970) 491-1553
[email protected]
601 S. Howes, Suite #208
University Services Center
 Where do I find International Research in the Code of Federal Regulations? Please see
§46.101.h: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
(h) When research covered by this policy takes place in foreign countries, procedures normally
followed in the foreign countries to protect human subjects may differ from those set forth in this
policy. [An example is a foreign institution which complies with guidelines consistent with the
World Medical Assembly Declaration (Declaration of Helsinki amended 1989) issued either by
sovereign states or by an organization whose function for the protection of human research
subjects is internationally recognized.] In these circumstances, if a department or agency head
determines that the procedures prescribed by the institution afford protections that are at least
equivalent to those provided in this policy, the department or agency head may approve the
substitution of the foreign procedures in lieu of the procedural requirements provided in this
policy. Except when otherwise required by statute, Executive Order, or the department or agency
head, notices of these actions as they occur will be published in the FEDERAL REGISTER or
will be otherwise published as provided in department or agency procedures.
 How far in advance of leaving the country should I plan to submit my protocol?
Whether you are a CSU faculty member, staff or student, your human subjects’ research study
must be approved by the IRB before it can be implemented. We suggest you apply to the IRB at
least two months before you leave the United States to ensure adequate time for review and
approval before you leave the country. Bring your written IRB approval notification with you on
your trip.
 In addition to IRB Ethics Board review and approval, am I required to contact the consulate
or ministry in country to register my research with the government abroad?
You may be. Please refer to the 2015 Edition of the International Compilation of Human
Research Protections from the Office of Human Research Protections. This document provides
links and information regarding regulations for research in many countries:
http://ricro.colostate.edu/IRB/documents/2015internationalcompilation.pdf
 I have a grant that is funded by NIH, and I will be collaborating with a researcher at another
academic institution abroad. Are both institutions required to review the protocol?
For research that is sponsored by a U.S. Federal agency, where CSU is the prime grantee of the
award, the CSU investigator is responsible for ensuring that all engaged international sites hold a
federalwide assurance, and that the research is approved by the IRB or Ethics Committee of the
participating sites listed on the federalwide assurance. In some circumstances, the IRB may
approve an IAA (IRB Authorization Agreement) between the two institutions, but this will depend
on the activities that each Investigator will perform. You can find International FWA information
for specific International institutions here (select Advanced Search to find International
institutions):
http://ohrp.cit.nih.gov/search/fwasearch.aspx?styp=bsc.
Contact the IRB Coordinators for IAA applicability: [email protected]
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 I am working with an international NGO, and they have agreed to assist me with my research
by providing access to the community. What sort of documentation do I need to provide the
IRB to document this NGO’s agreement to assist me with my research?
If the organization’s role is limited to assisting you with recruitment/access to potential participants,
the CSU IRB require that you obtain a letter or email from the organization to document their
agreement to assist you and to outline their role in your research. If you do not have this document
at the submission of your protocol, please inform the IRB that this is in process. Your protocol can
be reviewed and approved with receipt of this documentation as a condition of approval. Please see
“Letters of Cooperation” here: http://ricro.colostate.edu/IRB/MiscellaneousTemplates.html
 A staff member at an international NGO will be considered a Co-Investigator on my research
(e.g., will consent participants, collect data, and co-author manuscripts). How can I establish
this relationship? Can I add this person to my eProtocol? Is this collaborator required to
have human subjects’ protection training?
If foreign staff will be engaged with your research and the organization does not have its own FWA,
the CSU IRB may agree to extend our FWA to cover this individual investigator. The NGO staff
member would need to have documented Human Subjects Protection training, and we would enter
into an IIA (Individual Investigator Agreement) with this investigator. Please inform the IRB at
submission that individuals at the NGO will be engaged in your research so the agreement process
can be discussed by the IRB and initiated as soon as possible. For more information regarding IIAs,
see: http://www.hhs.gov/ohrp/policy/guidanceonalternativetofwa.html. The NGO staff member
can be added to eProtocol under the “Other Researcher or Key Personnel” role. Note that they will
not have viewing or editing access to the protocol.
 Should I submit translated research instruments, recruitment, and consent with my initial
protocol submission or should I wait until the protocol forms have all been approved in
English first?
The translated finalized research instruments, recruitment and consent are required to be submitted
to the IRB to complete your eFile. Since the IRB may request that you make changes to your
consent or recruitment, please wait until these documents have been approved by the IRB before
submitting your translated documents. The translated files can be submitted to the IRB as a postapproval amendment via eProtocol.
 I would like to provide some compensation to my participants. What does the IRB consider
to be coercive when providing participants incentives internationally?
As with any compensation or incentives, payments should reflect the degree of risk, inconvenience,
or discomfort associated with participation. Compensation should not be so large as to persuade
participants to consent to the research against their better judgment. Compensation is provided to
participants for their time spent and inconvenience. Items such as rice, tea, t-shirts, or mugs are also
considered compensation. Careful consideration should be made to the economic status of the
region. While providing $10 may not seem coercive to you, this amount may be the average
weekly salary for individuals in the region, thus creating undue influence.
 When recruiting and consenting participants internationally, is it always required that I ask
my participants to sign a consent form? What are my consent options?
The key consideration is the cultural context. What matters is that the participant can be fully
informed and understand what your research is about, and what you are asking them to do, NOT a
particular form. The IRB is receptive to proposals for “non-traditional” means to convey consent.
In principle, YOU and your local collaborators should know best HOW to meet the spirit of
informed consent. Obtaining signed consent from human subjects may not be culturally
acceptable in the country where you will be conducting your research. Using an oral script, short
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cover letter, picture boards, videos, or a mobile app may be appropriate for your population. For
templates for oral consent and a study summary that you can customize and provide your
participants, please see our templates here:
http://ricro.colostate.edu/IRB/ConsentAssentTemplates.html
 Should the CSU IRB contact information be given to participants, or should I provide
participants a local contact to serve as the subjects’ rights contact?
It is the IRB’s strong preference that you provide a local subjects’ rights contact as the RICRO
coordinators are not able to assist in multiple languages, and it is best not to ask your participants to
place international phone calls.
 Are there any issues I should be aware of regarding taking my computer with me
internationally?
Please check with the Export Control Administrator regarding taking your computer with you
internationally.
 What are the major considerations that the IRB reviewers are focusing on when reviewing
international research protocols?
CSU Researchers and the CSU IRB share the responsibilities to ensure that human participants
are provided the same or equivalent protections as provided participants in any research
location. In order to review the risk-to-benefits ratio, the reviewers would like to see that you
have knowledge of the local laws and the cultural context, the consent process is appropriate,
required local and/or International approvals are in place, and that you have developed a data
management plan. As you prepare your international research protocol, please refer to the
International Research Checklist available here: http://ricro.colostate.edu/IRB/Researchers.html
Institutional Review Board (IRB) Contacts:
Evelyn Swiss, Senior IRB Coordinator and Tammy Felton-Noyle, Assistant IRB Coordinator
[email protected]
970-491-1553
Matt Hickey, Ph.D., Professor, Health & Exercise Science, IRB Chair
[email protected]
970-491-5727
International Education/Office of International Programs
Laura Thornes, Director, Study Aboard
[email protected]
970-491-2964
Export Control
Scot Allen, Export Control Administrator
[email protected]
970-491-1563
4/13/2015
Additional references:
Office of Human
Research
Protections International
OHRP- Terms of the
Federalwide
Assurance
2015 Edition International
Compilation of
Human Research
Standards
OHRP – Sample
Short Form
NIH Bioethics
Resources on the
Web
World Medical
Association –
Helsinki- Ethical
Principles for
Research Involving
Human Subjects
European Union
General Data
Protection
Regulation
International
Ethical Guidelines
for Biomedical
Research Involving
Human Subjects
(CIOMS)
International
Conference on
Harmonisation
(ICH) Guidance
Documents
Harvard School of
Public Health –
Global Research
Ethics Map
4/13/2015
http://www.hhs.gov/ohrp/international/
http://www.hhs.gov/ohrp/assurances/forms/fwatermsjun14.pdf
http://ricro.colostate.edu/IRB/documents/2015internationalcompilation.pdf
http://www.hhs.gov/ohrp/policy/ic-non-e.html#sample
http://bioethics.od.nih.gov/index.html
http://www.wma.net/en/30publications/10policies/b3/index.html
http://ec.europa.eu/justice/dataprotection/document/review2012/com_2012_11_en.pdf
http://www.cioms.ch/publications/layout_guide2002.pdf
http://www.fda.gov/RegulatoryInformation/Guidances/ucm122049.htm
https://webapps.sph.harvard.edu/live/gremap/index_main.cfm?CFID=1356404
7&CFTOKEN=31710985