1. Introduction to IRB for International Research Presented by Courtney Jarboe, MS MA CIP December 2016

2. Objectives IRB process Key considerations Preparation Submission
Review
Post Approval
Key considerations
Nigerian case study
Indian case study

3. Key Points
Research conducted by University faculty or staff remains under University purview
U.S. ethical standards still apply, but culture/customs are considered (45 CFR 46, 21 CFR 50, 21 CFR 56)
Researchers must obtain local approval before submitting to the University IRB
Student researchers and faculty leading students must get approval through ITRAAC before final IRB approval is granted.

4. Key Takeaways
Costs
Time
Process variations
Requirement variations

5. Key Ethical Guidelines
The Belmont Report
Declaration of Helsinki
Nuremberg Code
International Conference on Harmonization – Good Clinical Practice (E6)
Council for International Organizations of Medical Sciences: International Ethical Guidelines for Biomedical Research Involving Human Subjects

6. The IRB Process IRB Preparation IRB Submission IRB Review IRB Approval
Post Approval

7. IRB Preparation Main IRB Application* Protocol/Research Plan
Relevant Appendices
(K=Int’l Research)
(J=Students)
Recruitment Material (Drafts)
Informed Consent and/or Assent Draft(s)
Brochures or Information Sheets

8. Local Review International Compilation of Human Research Standards
Applicable to most or all types of human subjects research
Drugs and Devices
Research Injury
Privacy/Data Protection
Human Biological Materials
Genetic
Embryos, Stem Cells, and Cloning

9. IRB Submission Submit all documents via e-mail to irb@umn.edu*
Students should copy their advisor on the submission

10. Informed Consent Process & Documentation Privacy & Confidentiality
IRB Approval
Criteria for
Risks & Benefits
Recruitment Strategy
Informed Consent Process & Documentation
Privacy & Confidentiality
Monitoring of Research

11. Additional Considerations
What’s the researcher’s relationship with the community?
Are there unique considerations for informed consent?
Are the risks to participants acceptable given the location?
Has the researcher obtained necessary approval from local leaders or local ethics committees?

12. Additional Considerations
Addresses ethical challenges present
Research purpose aligns with the nation’s needs
Local standards of care
Public health action(s) as a result of study outcomes
Capacity building as an essential element

13. What you Need to Know: After IRB Approval
Changes in protocol, study team, or funding
Report of unanticipated problems
Continuing Review
Study closures
Bring up the website. Highlight each situation and show the form location.

14. Epidemiology Study of Noma in Rural Nigeria
Key Considerations
Epidemiology Study of Noma in Rural Nigeria
Noma, an inflammatory disease, is prevalent in chronically malnourished children. In Nigeria, there are an estimated 10,000 cases of Noma across the country. There are treatments available, but not all patients respond to those treatments and some remote populations do not have access to the treatments. If not treated, Noma has a fatality rate of 70% and has been difficult to manage in areas of Nigeria where there is minimal or no health care infrastructure. In Nigeria, there is a believe that culture, medicine, and religion are closely connected. Western medicine and philosophy is not well known or generally accepted. Nigerian culture believes Noma is caused by evil spirits.

15. Noma Study Relationship between Noma and acute necrotizing gingivitis
Nigerian children with protein energy malnutrition, either diagnosed with Noma and/or ANG
Parents included for gathering information on medical and environmental factors
Collect blood samples and anthropometric measurements from children
A principal investigator proposes to conduct a study of Noma in several Nigerian communities where the disease is prevalent.The goal of the study is to generate knowledge to help elucidate the relationship between Noma and ANG. Blood samples, anthropometric measurements, and information on medical and environmental factors will be collected. The targeted population is Nigerian children, but their parents will be involved in gathering medical history, environmental and family information. Children with protein energy malnutrition (PEM) and either diagnosed with Noma and/or acute necrotizing gingivitis (ANG) will be solely recruited for the study. Those children will be screened for HIV-1 or HIV-2 and those with positive test results will be excluded from the study. Parents will be informed if the child tests positive and will be referred to government HIV clinics. Similarly, if children require treatment for Noma, the child will be referred to government clinics or a Noma specialty hospital regardless if the child is enrolled in the study. Researchers will obtain informed consent from the child's parent or guardian. 
*Adapted from Lavery et al. (2007), Case 16 pp

16. Noma Study Children will be screened for HIV-1 or HIV-2
Children with positive test results will be excluded from the study
Parents will be informed of result
Child will be referred to government HIV clinics
Children requiring treatment for Noma will be referred to government clinics or a Noma specialty hospital 

17. Noma Study
What factors or concerns should the IRB consider when reviewing this study?
Context from previous Noma study:
Gingival fluids were collected by local nurses from children affected by ANG or noma along with gender matched controls. The children were between 6 months and 12 years of age at the time of sample collection. The study was carried out with the prior approval of the Niger Ministry of Health, the WHO noma programme in Niger, and the Swiss non-governmental organization “Sentinelles”, and complied with the Declaration of Helsinki. A brochure with an explanation of informed consent was prepared in French and translated orally by local staff to the children's parents or guardians. The parent or guardian of each child signed the consent form, usually by a cross and/or a fingerprint. The consent forms were all sent to the GESNOMA office in Geneva, Switzerland.
Whiteson, K. L., Lazarevic, V., Tangomo-Bento, M., Girard, M., Maughan, H., Pittet, D., … the GESNOMA study group. (2014). Noma Affected Children from Niger Have Distinct Oral Microbial Communities Based on High-Throughput Sequencing of 16S rRNA Gene Fragments. PLoS Neglected Tropical Diseases,8(12), e3240. 

18. Informed Consent Process & Documentation Privacy & Confidentiality
IRB Approval
Criteria for
Risks & Benefits
Recruitment Strategy
Informed Consent Process & Documentation
Privacy & Confidentiality
Monitoring of Research

19. Barriers to age-appropriate immunization in rural India
Key Considerations
Barriers to age-appropriate immunization in rural India
Despite the availability of safe and effective vaccines, the coverage of immunization against the six main vaccine-preventable diseases is still variable across different regions of India.
Prinja, S., Gupta, M., Singh, A., & Kumar, R. (2010). Effectiveness of planning and management interventions for improving age-appropriate immunization in rural India. Bulletin of the World Health Organization, 88(2), 97–103.

20. India Study
Plan to identify barriers and develop solutions for a rural region of India with low immunization rates
Plan to:
review immunization records of 814 hospitalized children
Observe local clinics and vaccine storage units

21. India Study Plan to interview Mothers of children <18 months old
Pregnant women
Local health workers

22. India Study
What factors or concerns should the IRB consider when reviewing this study?
International Compilation of Human Research Standards (India’s guidelines)

23. Informed Consent Process & Documentation Privacy & Confidentiality
IRB Approval
Criteria for
Risks & Benefits
Recruitment Strategy
Informed Consent Process & Documentation
Privacy & Confidentiality
Monitoring of Research

24. Valuable Resources
International Compilation of Human Research Standards
World Health Organization’s Casebook on Ethical Issues in International Health Research
ClinRegs
Global Alliance for Genomics & Health
Global Health Training Centre

25. Additional Readings
Aellah, G., Chantler, T., Geissler, P. (2016). Global Health Research in an Unequal World: Ethics Case Studies from Africa. Boston, MA: Centre for Agriculture and Biosciences International Lavery, J., Grady, C., Wahl, E., Emanuel, E. (Eds.). (2007) Ethical Issues in International Biomedical Research: A Casebook. Oxford, NY: Oxford University Press Macklin, R. (2012). Ethics and Global Health: Research, Policy, and Practice. Oxford, NY: Oxford University Press