Cultural Competence Considerations [and other alliterations] - PowerPoint Presentation

Slide1

Cultural Competence Considerations [and other alliterations] in International Research

IRB 2 Continuing Education

March 10, 2015Slide2

Outcomes

Consider utility of cultural competence frameworks in the assessment of graduate

s

tudent’s

i

nternational 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 researchSlide3

Intercultural Knowledge & Competence

AACU Intercultural Knowledge & Competence Value Rubric:

Knowledge:

Cultural Self-Awareness

Knowledge:

Knowledge of Cultural Worldview Frameworks

Skills:

Empathy

Skills:

Verbal and

N

onverbal Communication

Attitudes:

Curiosity

Attitudes:

OpennessSlide4

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:

A researcher traveling to Brazil to conduct a survey with a Brazilian population

A researcher analyzing identifiable biological specimens that were collected in India

R

esearchers in the United States conducting an online survey in which subjects who live in other countries may respond.

http://research.oregonstate.edu/irb/international-researchSlide5

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/Slide6

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/Slide7

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/Slide8

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-researchSlide9

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-researchSlide10

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. Slide11

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. Slide12

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. Slide13

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

NetworksKnowledgeable 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. Slide14

DiscussionWhen investigators are indigenous to the international

r

esearch

s

ite,

d

oes

that origination sufficiently qualify them or does the IRB need additional consultation?  Slide15

DiscussionI

f

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? Slide16

DiscussionWhat is the IRB’s purview, if any, regarding the cultural competence of graduate student investigators?