International Research

1. International Research Jo Anna Risk, RN, MPH, CIP Education Coordinator Wayne State University IRB

2. Requirements • 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

3. Submission Requirements • 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

4. Issues You May Encounter • 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

5. Cultural Context • 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

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

7. Rules for Social-Behavioral Research • 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

8. Basic Guidance for International Research • 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

9. Letters of Support • 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

10. Translations/Language Issues • 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

11. Coercion • 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

12. Safety • 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

13. Review Issues • 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

14. More on Export Control • 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.

15. Lots to Learn • OHRP Website on International Research: • http://www.hhs.gov/ohrp/international/index.html • WSU OVPR Website on Export Control- • http://www.research.wayne.edu/export-control/index.php • WSU Policy on International Research: http://irb.wayne.edu/policies-human-research.php • WSU IRB Education Coordinator: • 313-577-9534