International Research or Research Across Borders may make researchers feel excited about the possibility of travel and research across borders, however, research of this nature presents challenges as cultural appropriateness, local adjustments, and rules and norms of the travel must be considered when developing a research study. 

“Research Across Borders” is a blog series that builds from Jonthon Coulson’s Research Writing & Ethics intern work and guides created in collaboration with Office of Global Engagement and Office of Risk Management to prepare new researchers for research across borders including logistics and practical considerations when developing a research study across borders in international settings.

The first post in this blog series, titled, “Considerations When Developing a Research Study” builds from Hira Shahbaz blog series, “Researcher Highlights: Conducting Culturally Responsive Research Across Borders” and explores recommendations from TC IRB on what researchers should be exploring as they create their research design.

Researchers working across borders can consider ways to:

Understand the Research Ethics Guidelines of the Host Country

  • For example, investigators must obtain IRB approval and a local context review by an “Ethics Committee” at the research site. A local context review and approval must be filed with TC IRB before research can begin. Researchers should clearly understand the host country’s requirements for reviewing and approving human subject research.

Demonstrate Cultural Understanding and Sensitivity

  • Researchers should familiarize themselves with local customs, cultures, and religious norms at their study site.
  • When preparing for a study across borders, consider these following questions:
  • Where is the study site located?
  • Is the study site easy to access or will crossing borders from one location to another be unsafe? 
  • Is there adequate knowledge of the resources, terrain, and transportation at the study site? 
  • Will researchers need special site permissions or access passes or will the standard site permission form suffice?
  • Is the site contextually or socially constrained (e.g., war, emergency, or dispersed populations) making it difficult to access the site? 
  • Is the country or area politically stable?
  • How do local officials or leaders influence the population of interest? 
  • Are there “gatekeeper” considerations in order to access the population of interest? 
  • Do researchers have a clear safety plan for engaging at the study site? 
  • Are there special safety considerations for research staff in this area?
  • How do you know that travel to the research site is safe for participants?
  • Have you met with the Risk Management Office to declare travel plans for research purposes and explore insurance parameters? 
  • Is the researcher prepared to stop a research study if they do not believe they can keep themselves or others safe?
  • How does the economic prosperity or poverty of the area influence the prospective study population of interest?
  • How does educational access or lack of access in the area influence the population of interest?
  • How do you know that compensation is provided in a locally appropriate form?
  • How do you know that the amount of compensation does not provide undue influence in the local economic context?
  • How do you know that literacy levels and language complexity of research materials are appropriate for the research population?
  • In what language will the research be conducted, and how do you know this language is most suitable for the research population?
  • Is the researcher prepared to translate all participant materials in the preferred language of the research ​​population (and have a signed Translation Verification Form)?
  • Can consent procedures meet or exceed U.S. norms for autonomous decision‐making?
  • If there is a risk of coercion in gaining consent, how will you mitigate this risk?
  • Will the consent procedures be pre‐tested for cultural and social norms?
  • Are research participants able to give their consent? (considering age, gender, and citizenship, for example)?
  • How appropriate is the use of written consent? (Written permission can be culturally inappropriate, intimidating, and in some contexts is considered riskier than participation in the research itself.) 
  • How will consent be obtained? 
  • Is signing an informed consent document culturally acceptable for the population? 
  • If there are circumstances in which women or community members do not have the autonomy to decide for themselves, what is the plan for obtaining consent? 
  • What are the known cultural barriers?
  • How will the  researcher clearly convey that participation in a research study is completely voluntary and that an individual is free to decline to participate in a study for any reason? Even after they sign the consent form an individual can still stop the study.

 

  • How might locally sensitive issues (e.g., race/ethnicity, gender, politics, religion, sexual orientation, union membership) affect the risk of participation in this research?
  • What should relevant current social or political events be considered in assessing risk to participants?
  • If there is a risk of coercion in gaining consent, how will the ​​researcher aim to  mitigate this risk?
  • Are there privacy considerations or laws that may interfere with informed consent assurances?
  • How might the local setting for data collection impact the ​​researchers ability to maintain or guarantee privacy?
  • Are investigators required by law to report illegal activity that they discover (i.e., mandated reporting)? 
  • Are there privacy laws that may interfere with confidentiality?
  • How will confidentiality be maintained?

 

  • What is the researcher's local language proficiency, or how does the investigator plan to communicate with participants?
  • How familiar is the researcher with the local customs, cultural norms, and study site access? 
  • Has the researcher adequately informed the IRB office of known safety, hygiene, or risk related concerns? 
  • Has the researcher consulted relevant literature concerning this site? 
  • Has the researcher completed the necessary training and pursued other training resources in preparation for accessing this study site? 
  • Has the researcher adapted study materials to appropriately match cultural norms and expectations at the study site? 
  • Did the researcher engage the community, and included cultural considerations throughout the research process?
  • Has the researcher demonstrated an understanding of the cultural nuances at the study site as variability exists between individuals and within the same group?
  • Has the researcher considered how the population of interest may respond to randomized, control, cohort, recruitment, retention, trial, or other study activities? Will these encounters be new or familiar to this study population? 
  • Has the researcher developed a research ramp-down plan in the event of an emergency to safely secure data and support the well-being of student participants?

 

As part of the ethical approval process for research involving human participants, researchers are required to identify potential risks associated with their research and the action they will take to mitigate risk. Depending on the risk level, researchers may be asked to submit their risk assessment to the IRB for review. The risk assessment process is a careful examination of what could cause harm, who/what could be harmed and how.

Consult these resources TC IRB, TC IRB International Research, International Compilation of Human Research Standards, Office of Global Engagement,  TC IT, Environmental Health and Safety, Office of Risk Management, Office of Sponsored Programs, Office of Teacher Education, Office of Access & Services for Individuals with Disabilities, Office of International Students and Scholars, and Human Resources, to find out more about ways to protect yourself and others when conducting research across borders.

— Myra Luna Lucero, Ed.D. and Mae Lu, B.A.

Tags: Submitting to IRB Tips for Success Ethics

Published Tuesday, Jun 6, 2023