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

 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

 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

 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

 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

 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)

 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

 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

 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

 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

 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

 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

 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

 Each study may be different-Lorry Sabo, Office of Research Compliance ◦  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.

 OHRP Website on International Research: ◦  WSU OVPR Website on Export Control- ◦ control/index.phphttp:// control/index.php  WSU Policy on International Research:  WSU IRB Education Coordinator: ◦