Jo Anna Risk, RN, MPH, CIPEducation 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-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.

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