IRB Series: Overseeing international studies
Experts offer strategies for international research
Be sensitive to cultural context
Reviewing studies that involve international sites and participants can pose unique challenges to American IRBs, including the basic obstacle of translation, an expert says.
"Translation is one of the big issues to deal with in the international setting," says Kathleen MacQueen, PhD, MPH, senior social scientist in social and behavioral health sciences at FHI 360 in Durham, NC.
"Sometimes we’re dealing with languages that may not even be written languages, so we’re improvising how to do translation in the field," MacQueen says. "Those that are written may not have many of the technical words we use as part of the informed consent process."
Other issues IRBs and researchers will encounter include working with local stakeholders and encountering cultural misunderstandings, she adds.
"Make sure investigators understand the local cultural niceties," says Richard L. Sneed, PhD, director of the office of research compliance at the University of Central Oklahoma in Edmond.
Poorly planned translation and interpretation services can cause problems for researchers and the IRB, he adds.
MacQueen and Sneed offer these suggestions for how to anticipate and deal with obstacles to successful international research:
• Watch for translation/interpretation barriers when creating an informed consent process. A classic example of how nuanced language can be is the story about how President Jimmy Carter visited Poland to meet with the Polish president, Sneed says.
"President Carter asked, What are your desires for next year?’ The translation was, What is your carnal lust?’" Sneed says. "Many languages are heavily nuanced where a word pitched up means one thing and a word pitched down means something else."
This can be bewildering for investigators, so IRBs should make sure they are well educated in cultural issues before they engage in international research, he adds.
IRBs and researchers should think about how they will describe the study concept to non-English-speaking participants, MacQueen suggests.
"Talk about the procedures you use to make sure the informed consent process is actually informing people what research is about," she says. "It can be things that wouldn’t be obvious."
For instance, an investigator whose research focuses on sexual and reproductive health of women might find that women in another country do not know what a gynecological exam is. While this is a common frame of reference for women in the United States, it could be that a research study in another setting will need to find a way to explain this concept, MacQueen explains.
One way to anticipate these types of translation challenges would be to hold focus groups among potential study participants.
Ask the focus group women how many have had a gynecological exam, and if only one person raises a hand, then researchers know that the translated informed consent information should start with a basic description of the procedure, she says.
"One of the challenges with informed consent is making sure you don’t go into it with too many assumptions of what people’s lives are like," MacQueen notes.
Another challenge involves language diversity within one country or even a region of a country. For instance, there are 11 official languages in South Africa, she says.
In a country that has university systems and local interpretation resources, it would be a good idea to hire interpreters who are sensitive to the various local dialects, MacQueen says.
"You can work with collaborators to identify people who are fluent in English, as well as in the local language and local dialect," she adds.
"Once you’re in the field with participants, you might hear back that they do not understand what researchers are saying, and it seems your translation is not as good as you thought," MacQueen says. "So you would need to train your team to be sensitive to any potential problems, and you might have a problem with the informed consent form and need to go back to the IRB for a change to it."
• Be sensitive to the local context. "You can’t just walk into a place and recruit people for a research study," MacQueen says. "You especially have to be sensitive with issues involving HIV or tuberculosis infection because these have a lot of stigma attached to them."
If researchers are targeting a population of people who experience discrimination and stigma, they need to be conscious of the local context that creates these problems, she says.
"A study potentially could make their lives more difficult because there are some people who will have strong feelings about the population you’re recruiting from," MacQueen says.
"Most of us have learned that by talking with a broad range of stakeholders and through approaching all persons with respect, we build trust in the community and move forward from there," she adds. "It’s an important lesson that those of us who work in areas like HIV really have to learn and carry with us."
In all international settings, it’s important to respect confidentiality and be inclusive and respectful of local stakeholders, MacQueen adds.
• Avoid cultural misunderstandings. One cultural obstacle researchers and IRBs sometimes encounter involves the issue of autonomy in a setting where autonomy is not fully recognized or where a certain population, such as women, may not have autonomy in making their own informed consent decisions, MacQueen says.
"People might say a woman can’t consent to be in a research study without her husband’s permission, and, therefore, you need to consent the husband to get consent for the woman," MacQueen says. "I think that’s an over-interpretation and incorrect."
The better approach in a setting where women have limited autonomy is to engage the husbands, demonstrating respect to them, she suggests.
"First meet with the community’s leaders, and, if it’s appropriate and good context for it, then meet in the community with the men," MacQueen says. "We try to make it a positive conversation about what the study is and why women might want to be a part of it."
Women who are adults may choose to participate without seeking their husband’s approval, but that is their choice, she adds.
"If a woman wants to bring her husband to the study site so he can hear what’s going on, then we try to support that and provide him with information," MacQueen says. "It’s about respecting the relationship between men and women and husband and wife."
While a husband and wife might share the decision over whether the woman will participate in the study, the actual informed consent is for the woman participant, she adds.
"We don’t undermine their relationship, but we don’t undermine the woman’s decision and autonomy," MacQueen says. "If a woman wants to be in a study without discussing it with her partner, then we’ll tell her about the risks of her secrecy."
Another situation where a research participant has limited or no autonomy is in the situation of studies involving brothel workers.
"That’s a very difficult situation where a woman’s life is controlled, and you would need permission to get into the brothel and recruit research participants," MacQueen says.
And sometimes it might be a situation where a brothel owner forces women to participate in a study. In this case, researchers would need to give women the autonomy they lack by creating a private space where a woman could sit and wait for the length of time that the study intervention might take place. This way the brothel owner or whoever controls her life would not know that she has chosen to not participate, MacQueen adds.
IRB Series: Overseeing international studies University creates international research form and checklist
Focus on culture, translation
The University of Central Oklahoma in Edmond has created an IRB form for international research involving human subjects, as well as an international IRB checklist. Investigators can use these to collect all of the information an IRB might require when they are conducting research in an international setting.
Here are some questions from each tool:
IRB international research form
- What languages are spoken at the study location?
- If working with a local collaborator, provide name (including title and position) and contact information (including email) for individual or institution.
- How will you gain access to participants?
- Will the project be reviewed by a local IRB or ethics committee?
- Describe recruitment procedures, including by whom and how potential participants will be contacted.
- Describe how you will demonstrate that the study tasks or interventions are culturally appropriate.
- Describe how you will demonstrate if risks and benefits are culturally appropriate.
- Describe how you will demonstrate/address that any instruments or interview questions are culturally appropriate.
- Will materials be translated into another language?
- Who will check the translation after it is complete?
- What documents and instruments will be translated?
International IRB checklist
• CONTEXT: Are any of these issues for your project?
- ease of travel for subjects;
- local literacy rate;
- economic conditions;
- local social/political structures;
- relevance of research to local needs;
- inclusion of local officials as researchers;
- adequacy of data safety and monitoring;
- legal rights of local population;
- reporting complaints/adverse events.
• CONSENT: Are any of these issues for your project?
- disclosure of research to those who may not fully trust health care professionals;
- role of women and children;
- status of elderly;
- role of family in consent process;
- oral consent;
- awareness of local languages;
- awareness and sensitivity to local customs;
- local contact person(s) regarding legal rights.
• Local issues:
- role of each site is clearly defined;
- communication between sites is possible;
- local sites compliant with safety regulations;
- local researchers familiar with IRB policies/procedures;
- secure storage of data is possible while at the site.
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