1. Cultural Competence Considerations [and other alliterations] in International Research IRB 2 Continuing Education March 10, 2015

2. Outcomes Consider utility of cultural competence frameworks in the assessment of graduate student’s international research Address the IRB’s purview in assessing risk related to socio-cultural and political contexts in international research If there’s time, further distinguish the larger scope and role of the IRB in the evaluation of international research

3. Intercultural Knowledge & Competence AACU Intercultural Knowledge & Competence Value Rubric: Knowledge:Cultural Self-Awareness Knowledge:Knowledge of Cultural Worldview Frameworks Skills: Empathy Skills: Verbal and Nonverbal Communication Attitudes: Curiosity Attitudes: Openness

4. What is International Research Research studies are considered to have an international component when investigators travel abroad to collect data or investigators use or collect data from participants who are outside of the U.S. Examples include: 1.A researcher traveling to Brazil to conduct a survey with a Brazilian population 2.A researcher analyzing identifiable biological specimens that were collected in India 3.Researchers in the United States conducting an online survey in which subjects who live in other countries may respond. http://research.oregonstate.edu/irb/international-research

5. International Research & Federal Regulations Federal regulations for oversight of international research, together with the Association for Accreditation of Human Research Protection Programs (AAHRPP) make the following stipulations: – The researcher must provide the same or equivalent protections to human subjects in research conducted in other countries. The protections need not be identical to those provided in the U.S. but must be equal in function or effect. Subject autonomy and dignity should be respected. Protections should encompass the ethical principles of respect for person, beneficence, and justice. https://www.seattleu.edu/irb/policies/submissions/international/

6. International Research & Federal Regulations Federal regulations for oversight of international research, together with the Association for Accreditation of Human Research Protection Programs (AAHRPP) make the following stipulations: – The researcher must be familiar with and comply with local laws, regulations, political and socio-economic factors, and cultural context in all locations where the research is conducted. – The researcher must have sufficient knowledge of the local context, which may impact all aspects of the research design, and in particular, the protection of the rights and welfare of subjects. https://www.seattleu.edu/irb/policies/submissions/international/

7. Local Context Seattle University IRB: “The level of knowledge about the local context and local law required for approval is based on the degree of risk to potential research participants. Higher risk studies require more thorough considerations of local context and inclusion of strategies to mitigate harm than do minimal risk studies. In such cases, the IRB may request consultation with experts in the particular international setting.” https://www.seattleu.edu/irb/policies/submissions/international/

8. Local Context OSU IRB Asserts that relevant local context information should be included in the IRB protocol. This includes, but it not limited to, the following: – A description of the research team’s knowledge of or experience in the host country as well as any relevant qualifications for conducting the proposed research within the international setting should be included in the Investigator Qualifications and/or Training and Oversight sections of the IRB protocol. – Cities, regions countries where research will be conducted – Scientific/ethical justification for conducting the research in an international setting – Economic status of the country/community – Current events or socio-political environment in the country that may impact research conduct or alter the risks or benefits to subjects – Societal and cultural beliefs in the country that may impact research conduct or alter the risks or benefits to subjects – If women and children are part of the subject population, their role in the society, including their autonomy and legal capacity to make decisions. http://research.oregonstate.edu/irb/international-research

9. Local Context OSU IRB Asserts that relevant local context information should be included in the IRB protocol. This includes, but it not limited to, the following: – If there are circumstances in which women or community members do not have the autonomy to make decisions for themselves, the plan for obtaining informed consent from both the study subject and any additional authority figures should be included in the Consent Process section of the IRB protocol. – Literacy rate of the potential subject population – Languages and dialects of the potential subject population – Involvement of organizations, community leaders, or experts in engaging the subject population or conducting the research – Relevance of the research to the area’s health, economic, educational, or other needs – Distribution of risks and current and future benefits (Tufts University, 2014). – A description of how the plan for recruitment and subject selection will avoid undue influence or favoritism within the subject population. http://research.oregonstate.edu/irb/international-research

10. Considerations: Research Methods What recruitment methods will be used? – Do those methods violate cultural norms of confidentiality? Does the collection data or specimens involve sensitive, identifiable information? How experienced is the PI in doing research in that country? Panageas, H. & Diccianni, K. (2009). IRB refresher 2009: International research. Presented at the NYU School of Medicine Institutional Review Board Meeting, New York City, NY.

11. Considerations: Informed Consent Are there important historical or cultural considerations? Who will be doing the actual consent process? Consent documentation: – Translation – not just words, but culturally-appropriate concepts e.g., explaining randomization in terms of a lottery – Is a written form appropriate? – Signature requirements Panageas, H. & Diccianni, K. (2009). IRB refresher 2009: International research. Presented at the NYU School of Medicine Institutional Review Board Meeting, New York City, NY.

12. Discussion In what ways can the OSU IRB obtain knowledge of local research context? Panageas, H. & Diccianni, K. (2009). IRB refresher 2009: International research. Presented at the NYU School of Medicine Institutional Review Board Meeting, New York City, NY.

13. Discussion In what ways can the OSU IRB obtain knowledge of local research context? – Consultant Interface or Consultant Documentation: United States Faculty International Faculty International IRB member Other Networks – Knowledgeable IRB Member or Administrator – Site Visits Panageas, H. & Diccianni, K. (2009). IRB refresher 2009: International research. Presented at the NYU School of Medicine Institutional Review Board Meeting, New York City, NY.

14. Discussion When investigators are indigenous to the international research site, does that origination sufficiently qualify them or does the IRB need additional consultation?

15. Discussion If the research plan is not culturally sensitive or appropriate but the research poses no risk, does the IRB require changes to ensure that the subjects are not insulted or irritated?

16. Discussion What is the IRB’s purview, if any, regarding the cultural competence of graduate student investigators?