Jo Anna Risk, RN, MPH, CIP
Education Coordinator
Wayne State University IRB

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Adherence to DHHS regulations (Common
Rule and FDA)
Adherence to laws, regulations, and local customs in the country where research will take place
Adherence to travel advisories and safety requirements
Adherence to US Export Control policies and procedures

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Appropriate submission form
Appropriate appendices, if needed (children, pregnant women, prisoners, the cognitively impaired)
Consent/assent documents
Surveys, interviews, advertisements
Full research protocol
Letters of support/local IRB review
Export Control review

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Regulations-which country’s regulations do you follow?
Political sensitivity to US regulations
Knowing what regulations, laws, and guidelines for each country
Cultural sensitivity-cultural context
Language
Informed Consent
Rules for social-behavioral research
Difference between official procedures and usual practices

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What are the norms, attitudes, beliefs of the people
Specific attitudes toward certain medical conditions, treatments
Social attitudes
How the community would view the research
Group consensus versus individual decisions
Avoiding “Ugly American” syndrome

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Women’s rights to consent without spousal approval
Language difficulties
Who is in authority
Individual vs community consent
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Community authority makes decision
How seriously do official rules get followed
(eg. Speed limits)

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No set rules or guidance documents for some countries
Some countries would not understand the regulations under the Common Rule-privacy, confidentiality, personal autonomy, respect for individualism, rights of children to assent, rights of parents to consent for their children,
Takes a bit of work to prepare for these
Most of the development in regulations and guidance focuses on bio-medical research

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Local IRB Review
If there is a local university that has an ethical review board, ask if they would be willing to review the research-key is to make sure research considers cultural norms and values
If they do not have an IRB, for some studies, the PI must form one from the community-would need 5 members, with one non-scientist and a non-affiliated member.
Local IRB may not be needed but WSU IRB makes this determination on case by case basis

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From local community leaders, government officials, state officials, organizations where the research takes place-must always check with local authorities
Consider the community-may vary
◦ Chief of a tribe or community
◦ Local mayor
◦ Religious leaders
◦ Head of the family
Should be written on official document or in other format, given the local context

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Must use translated documents-in language of group to be studied
Forward and Backward translations-PI verification
Certified Translations
All consents, surveys, interview questions, etc.
Persons obtaining consent should be fluent or have translator present
Having an appropriate consent and translation can influence whether a study can go forward-gaining trust

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Will people who participate gain something over their fellow non-participants
Must consider local goods and services when planning compensation
Needs to be in line with local currency exchange in order not to be coercive
Voluntariness may be an issue

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To Research Participants
◦ Would they be subject to backlash if community became aware of their participation?
◦ Would they be in danger?
◦ Have a plan to protect them.
To Research Staff
◦ Careful planning prior to making the trip
◦ Utilize local leaders and community members
◦ Get the official or unofficial sanction of them first
◦ Have a plan for unexpected occurrences
To the University
◦ Sound design, follow plan exactly, administrative review prior to conducting

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International research takes a longer period for the review.-allow 4-6 months
◦ Regular ethical and regulatory review by the local
IRB
◦ Establishing relationship with country and required persons where research will take place
◦ Establishing an IRB, if needed
◦ Translations of documents
◦ Administrative review
 Export Control-Office of Research Compliance
 Administrative approval

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Each study may be different-Lorry Sabo, Office of
Research Compliance-577-9064
◦ eg5628@wayne.edu
Send her Title of study, Department, Letters of
Support/IRB approvals in other country, English version of consent, IRB International Appendix A,
Names of persons that will be contacts/ sponsors, organizations, groups to be included in study
She will do a search to see if any person is on a
Watch List
Department of State –Embargos, sanctions,etc.

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OHRP Website on International Research:
◦ http://www.hhs.gov/ohrp/international/index.html
WSU OVPR Website on Export Control-
◦ http://www.research.wayne.edu/exportcontrol/index.php
WSU Policy on International Research: http://irb.wayne.edu/policies-human-research.php
WSU IRB Education Coordinator:
◦ 313-577-9534